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Policy and Procedures  

(updated Oct 2018)
 
MISSION STATEMENT

I. INSTITUTIONAL AUTHORITY UNDER WHICH THE HSRRC IS ESTABLISHED AND EMPOWERED

II. PURPOSE OF THE HSRRC

III. THE AUTHORITY OF THE HSRRC

A. Types of studies that must be reviewed
B. Authority to disapprove, modify, or approve studies based on consideration of human subject protection aspects
C. Authority to require progressive reports from the investigators and oversee the conduct of the study
D. Authority to suspend or terminate approval of a study

IV. THE HSRRC ORGANIZATIONAL STRUCTURE

A. Administration of the institution
B. Other committees
C. Research records
D. Closing a protocol
E. Other institutions
F. Regulatory agencies

V. THE MEMBERSHIP OF THE HSRRC

A. Composition of the HSRRC
B. Appointment of members to the HSRRC
C. Alternate members
D. HSRRC member conflict of interest

VI. MANAGEMENT OF THE HSRRC

A. The chairperson
B. HSRRC members selection and appointment
C. Training of HSRRC chair and members
D. HSRRC office
E. HSRRC chair, member and staff evaluations
F. HSRRC monitoring

VII. CONFLICT OF INTEREST POLICY

A. Conflicts of interest for HSRRC members and consultants
B. Institutional conflict of interests
C. Undue influence of the HSRRC

VIII. FUNCTIONS OF THE HSRRC

A. Exempt and expedited review
B. Full committee review
C. Report, in writing, findings and actions of the HSRRC to the investigator and the institution
D. Determining which studies require review more often than annually
E. Ensuring prompt reporting to the HSRRC of changes in research activities
F. Ensuring prompt reporting to the HSRRC and appropriate institutional officials
G. Suspension and Termination of HSRRC Approvals
H. Monitoring of the Consent process

IX. OPERATIONS OF THE HSRRC

A. Scheduling of meetings
B. Information provided prior to the meeting
C. The review process
D. Full board meeting requirements
E. Further review/approval of HSRRC actions by others within the institution 
G. Communication from the HSRRC
H. Appeal of HSRRC decision

X. HSRRC RECORD REQUIREMENTS

A. HSRRC membership roster showing qualifications
B. Written procedures and guidelines
C. Minutes of meetings
D. Retention of protocols reviewed and approved consent documents
E. Communication to and from the HSRRC
F. Statements of significant new findings provided to subjects
G. Requirements for HSRRC records

XI. INFORMATION THE INVESTIGATOR PROVIDES TO THE HSRRC

A. Professional qualifications to do the research
B. Principal investigators conflicts of interest
C. Investigation advertisements and recruitment incentives
D. Informed consent

E. Control of investigational devices
F. Multi-site study requirements
G. Data Safety Monitoring Boards (DSMB)

XII. STUDENT CLASSROOM PROJECTS/INTERNSHIPS
XIII. QUALITY IMPROVEMENT OR PROGRAM EVALUATION
XIV. DNA/GENETIC RESEARCH

XV. HIPAA AND HITECH
XVI. POTENTIALLY VULNERABLE SUBJECT GROUPS

A. Research involving pregnant women, human fetuses and neonates 
B. Research Involving prisoners 
C. Research involving children 
D. Research involving cognitively impaired subjects
E. Research Involving students, employees, economically/educationally disadvantaged individuals, racial/ethnic minorities, terminally ill, and individuals with AIDS/HIV+

XVII. INTERNATIONAL RESEARCH

XVIII. RESEARCH INVOLVING DRUGS AND DEVICES 

 

 

 

Mission Statement


Binghamton University, State University of New York, investigators and their research staff, and the Human Subjects Research Review Office, share a collaborative responsibility and commitment to maintain the highest ethical standards in our research endeavors. Human Subjects research is constantly evolving and the research community will be notified of regulatory or procedural changes through the listserv, Dateline, and our website. This will ensure that Binghamton University Human Subjects researchers will receive the most up-to-date regulatory and procedural standards.

 

Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the review of research involving human subjects under the terms and conditions set forth by the Office of Human Research Protections (OHRP) of the Federal Government Department of Health and Human Service (HHS) and the Food and Drug Administration (FDA). OHRP defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge and human subjects is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.


All employees, students, faculty and staff must comply with these regulations, as well as state and local laws, and institutional policies. Failure to comply with the required rules and regulations can result in loss of funding for human subjects research for the entire institution.

 

All human subjects research conducted by Binghamton University faculty, staff, and students must be reviewed and approved by our HSRRC prior to the commencement of human subjects research, if Binghamton University is considered "engaged" in the research as defined by the HHS. Comprehensive list of criteria and scenarios in which an institution is considered "engaged" can be found here: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/guidance-on-engagement-of-institutions/index.html

 

I. Institutional authority under which the HSRRC is established and empowered


Binghamton University's HSRRC is guided by ethical principles, Federal, State, and local laws regarding all research involving humans as subjects. These guiding ethical principles have been set forth by the Nuremburg Code of 1947, the Declaration of Helsinki of 1964, and the Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research of 1979.

 

The Federal Regulations include:

  • The Office of Human Rights and Protection, the Department of Health and Human Services United States Code of Federal Regulations (CFR) Title 45 CFR. 46
  • Food and Drug Administration (FDA) Title 21 CFR 50 and 56 this also includes:
    • Investigational New Drug Applications – IND 312;
    • Radioactive Diagnostic Drugs 361;
    • Investigational Device Exemptions IDE 812
  • Department of Education 34 CFR Part 97, 98 99, 350 and 356
  • Department of Defense (DOD)-Department of Navy (DON) Title 32 CFR 219
    • DoDD 3216.02 Protection of Human Subject and Adherence to Ethical Standards in DoD-supported research
    • Title 10 USC 980 Limitation on Use of Humans as Experimental Subjects
    • DoDD 3210.7 Research Integrity and Misconduct
    • DoDD 6200-2 Use of Investigational New Drugs in Force Health Protection

Binghamton University has secured from the U.S. Department of Health and Human Services, Office for Human Research Protections a Federal Wide Assurance (FWA00000174). The FWA is an assurance of compliance with the federal regulations for the protection of human subjects in research. The Assurance defines the responsibilities of the Institution, the HSRRC, the HSRRC administrative office and staff, and the investigator to protect human research subjects.

 

II. Purpose of the HSRRC


The primary responsibility for protecting the rights and welfare of human subjects rests with each individual who initiates, directs, or engages in research. It is the responsibility of Binghamton University HSRRC to insure that the rights and welfare of the human research subjects recruited to participate in research activities conducted under Binghamton University auspices are protected.

 

III. The Authority of the HSRRC

 

A. Types of studies that must be reviewed


All research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the Human Subjects Research Review Committee (HSRRC) prior to commencement of the research.


This includes non-funded research as well as research involving subjects from outside the university. Binghamton University allows researchers to conduct research involving vulnerable population requiring additional protection outlined in the federal regulations.


B. Authority to disapprove, modify, or approve studies based on consideration of human subject protection aspects


By regulation, action on protocols that require full HSRRC review may be taken only at convened meetings at which a majority of the members of the HSRRC are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present Principal investigator(s) may be invited to the meeting to provide justification or clarification.

 

Given the authorities that IRBs have under HHS regulations at 45 CFR 46.109(a), when conducting an initial or continuing review of a research study, or a review of proposed changes to a previously approved research study, an IRB can take any of the following actions: :

  1. Approve the research study or proposed changes as submitted without any conditions;
  2. Approve the research study or proposed changes as submitted with conditions. Revised study may be reviewed by the HSRRC Chair or a HSRRC member designated by the HSRRC Chair;
  3. Require modifications to secure approval and defer or table the research study or proposed changes for further review at a future date after the required modifications are submitted by the investigator; or
  4. Disapprove the research study or proposed change.

 

In cases where a study is disapproved or modifications are requested, the HSRRC will provide its rationale for the action taken. The investigator may request an appearance before the Committee to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the Committee.

 

C. Authority to require progressive reports from the investigators and oversee the conduct of the study


The HSRRC may require progress reports or summary of findings from the investigator at any time and may determine a need to oversee the conduct of the study. The HSRRC has the authority to observe, monitor or request that an audit be performed to ensure that proper scientific, ethical and regulatory requirements are followed.

 

Monitoring for Compliance: Monitoring of ongoing studies may include the following:

  • Determining whether the investigator has current, complete copies of all informed consents in his/her files for subjects enrolled in the study.
  • Determining whether the investigator has a copy of the current protocol and a blank copy of the most recent informed consent document.
  • Determining whether the investigator has complete and current copies of correspondence from the HSRRC and, if applicable, the study sponsor.
  • Determining whether the investigator has adhered to inclusion/exclusion criteria.

D. Authority to suspend or terminate approval of a study


The HSRRC has the authority to determine if a research project should be suspended or terminated for cause. If appropriate, the action will be reported to appropriate institutional officials, the head of any supporting Federal Department or Agency (if applicable), the Office of Human Research Protections under DHHS, and the corporate study sponsor (if applicable). If the project that is suspended or terminated involves a drug, device, or biologic regulated by the Food and Drug Administration, the FDA shall also be notified of the suspension/termination.

 

IV. The HSRRC Organizational Structure


A. Administration of the institution


For matters relating to the execution of their duties and responsibilities, the HSRRC staff reports directly to the Assistant Vice President for Research Compliance,
who serves as the Authorized Institutional Official.


The following are reported to the Assistant Vice President for Research Compliance who in turn communicates with the Office of Human Research Protections (OHRP) with the Federal Department of Health and Human Services (DHHS):

  • Changes in HSRRC membership.
  • Serious or continuing noncompliance with federal regulations.
  • Any unanticipated problems involving risks to subjects or others.
  • Any suspension or termination of HSRRC approval for a project.
  • Reports of serious or continuing non-compliance, unanticipated problems involving risks to subjects or others, and suspensions and terminations of the HSRRC are also made to:
  • The HSRRC as an information item in the agenda in the next scheduled meeting.
  • Other federal agencies when the research is overseen by those agencies, and they require reporting separate from that to the Office of Human Rights Protection (OHRP), within 14 business days of suspension or termination of research protocol.
  • The Food and Drug Administration (FDA), when the research is FDA regulated, within 14 days of suspension or termination of research protocol.
    • All reports include information and documentation from the convened HSRRC and any documentation reviewed by the Chair and the HSRRC Staff during the initial investigation including all correspondence from the Principal Investigator and any other individuals involved in the review and investigation process.
    • A report is drafted by the HSRRC Chair and the HSRRC staff which is then forwarded to the Institutional Official for finalization, approval and mailing.
B. Other committees


If needed, the HSRRC works in collaboration with other committees and with the campus community as a whole to ensure the protection of human subjects. The following is a list of other offices and committees that may be involved in collaboration.

 

When research involves one of these committees, the Human Subjects Research Review process requires review and approval from these other committees. Letters of review and approval must be received and reviewed by the HSRRC prior to final approval and commencement of research.

 

Institutional Biosafety Committee
The National Institutes of Health require that universities maintain the highest level of scientific integrity and community safety in the review of research involving genetic engineering, the splicing together of DNA from different organisms, and the use of certain biologicals and hazardous materials Strict rules have been established regarding types of experimentation allowable and under what circumstances different classes of experiments can be conducted. The Institutional Biosafety Committee reviews all such research.


Radiation Safety Committee
The use of radioactive materials on campus is governed by the New York State Department of Health. The Radiation Safety Committee advises members of the university in matters involving radiological procedures and safety; establishing procedures pertaining to the ordering, receipt, use and disposal of radioactive materials; and advises faculty on specific problems related to the use of radioactive materials in research and instruction.


Institutional Animal Care and Use Committee (IACUC)
To provide for the care and well-being of animals used for research, training and education at Binghamton University; To support the animal-related needs of University researchers, educators and students; To ensure compliance with all standards mandated by federal and state law, accrediting bodies and the IACUC.


Stem Cell Research Oversight Committee
Prior to commencing research using human embryonic stem cells/cell lines or other
pluripotent stem cells/cell lines regardless of source (not limited to embryos, adult
tissues, amniotic fluid or fetal tissue) Binghamton University investigators must have
their research protocol approved by the campus Stem Cell Research Oversight Committee. Only NIH-Approved human embryonic stem cell/lines listed on the NIH Human Pluripotent Stem Cell Registry may be used at Binghamton University.
http://stemcells.nih.gov/research/registry/


Institutional Conflict of Interest Committee (ICIC)
Binghamton University is an Association for the Accreditation of Human Research Protection Programs (AAHRPP) accredited University, and as such must follow written policies and procedures to identify, manage, and minimize or eliminate financial conflicts of interest of the University and individuals that could influence the conduct of research. Any Investigators has disclosed Significant Financial Interests that may, or may perceive, to influence proposed human subjects research will be subject to review by the ICIC to put forth a Conflict of Interest Management Plan.

 

C. Research records


Regulations require that all human subjects' research records be retained for three years following the completion of the research [45.115(b)] unless otherwise specified by the HSRRC or funding agency.For research covered by the HIPAA Privacy Rule, the requirement is six years after the completion of the research. The investigator must maintain all research records (including a copy of the entire protocol, consent form, amendments, and copies of signed consent forms for each research participant (if applicable) in the lab or office of the investigator.


If the investigator leaves Binghamton University, the records must be kept at the University in the Human Subjects Research Review office or with a designated investigator. The HSRRC office must be informed of this transfer of records prior to the investigators departure. The records will be accessible for inspection and copying by authorized representatives of the DHHS/FDA and the university.


When a student graduates, or otherwise leaves the University, the faculty advisor is then responsible for retaining the human subject documentation. Students may retain the original, while a copy of all research documentation must be maintained in the areas listed above.


The HSRR Office will retain all records required by the regulations (e.g. minutes, correspondence between the HSRR office and investigators, HSRRC rosters, and written procedures required by regulations) for at least three years, and retains all records relating to research that has been conducted or cancelled for at least three years after completion or cancellation of research.
The HSRR Office makes records accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.

 

D. Closing a protocol


Closure of a protocol should occur when the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, collection of private identifiable information is complete, and analysis of identifiable information is complete. Instructions on how to submit a Study Closure can be found here.

 

E. Other institutions


Research that is being conducted in collaboration with another institution must provide our office one of the following if the involved institutions are considered engaged by the federal regulation:

  1. An approval letter from the other institutions IRB, and/or
  2. Institutional Authorization Agreement with the collaborating institution. If the collaborating institution does not have an IRB, Individual Investigator Agreement can be established. Please contact our office for more information and assistance when multiple institutions are involved and are "engaged" in the research as defined by the federal regulation.

If you are collaborating with an institution that are not considered "engaged" in the research as defined by the federal regulation, a letter of agreement (permission) from an individual who has authority at the collaborating institution to sign the document may be needed (e.g., if recruiting potential participants from an elementary school, a letter of agreement from the principal or superintendent will be required).

 

F. Regulatory agencies


Binghamton University's Human Subjects Research Review office is required to communicate with Federal, State and local authorities all information that is outlined in the Federal Guidelines. We also strive to maintain positive and productive relationships with regulatory agencies, local, and state legislators.

 

For Department of Defense (DOD) funded research, special requirements may be applied. For more information on DOD sponsored projects, please visit https://www.ncbi.nlm.nih.gov/books/NBK236819/
https://www.gpo.gov/fdsys/granule/CFR-2013-title32-vol2/CFR-2013-title32-vol2-part219

 

For Food & Drug Administration (FDA) research, please visit https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50

 

V. The Membership of the HSRRC


A. Composition of the HSRRC


The HSRRC members are selected based on appropriate diversity, including consideration of race, gender, cultural backgrounds, specific community concerns in addition to representation by multiple, diverse professions, knowledge and experience with vulnerable subjects, and inclusion of both scientific and non-scientific members.

 

The structure and composition of the IRB must be appropriate to the amount and nature of the research that is reviewed and in compliance with federal regulations. Every effort is made to have member representation that has an understanding of the areas of specialty that encompasses most of the research performed at the University. In addition, the HSRRC will include members who are knowledgeable about and experienced working with vulnerable populations that typically participate in University research.

 

The HSRRC must promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects; and possess the professional competence necessary to review specific research activities.

 

The HSRRC will invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the HSRRC. These individuals may not vote with the HSRRC.

 
B. Appointment of members to the HSRRC


The HSRRC Chairperson in collaboration with the Administrator will identify those areas of research which member's expertise is required. Recommendations for appointment to the HSRRC are requested from individuals in the University and surrounding community. The Institutional Official appoints members to the committee.

 

C. Alternate members


The appointment and function of alternate members is the same as that for primary the IRB members, and the alternate's expertise and perspective are comparable to those of the primary member. The role of the alternate member is to serve as a voting member of IRB when the regular member is unavailable to attend a convened meeting. When an alternate member substitutes for a primary member, the alternate member will receive and review the same materials prior to the convened meeting that the primary member received or would have received. The alternate member will not be counted as a voting member unless the primary member is absent. The HSRRC meeting minutes will document when an alternate member replaces a primary member.

 

D. HSRRC member conflict of interest


No HSRRC members (regular or alternate) or consultant may participate in thereview of any research project in which the member or consultant has a conflict of interest (COI), except to provide information requested by the HSRRC. Committee members and consultants may find themselves in any of the following COIs when reviewing research:

  • Where the member or consultant is involved in the design, conduct, and reporting of the research.
  • Where an immediate family member of the member or consultant is involved in the design, conduct, and reporting of the research.
  • Where the member holds significant financial interests related to the research being reviewed.
  • Any other situation where an IRB member believes that another interest conflicts with his or her ability to deliberate objectively on a protocol.

 

VI. Management of the HSRRC


A. The chairperson


The Chair has direct responsibility for assuring that the HSRRC operates in full accordance with regulatory requirements and the highest ethical standards. The Chair works with HSRRC staff, committee members, institutional officials, and investigators to ensure that the rights and welfare of research participants are adequately protected, and that the benefits of the research justify the risks to the research participant.
The Chairperson is appointed by the Institutional Official (Assistant Vice President for Research Compliance) and is appointed usually for a three-year term.

 

Responsibilities
The Chair should play a leadership role in establishing and implementing HSRRC policy. As a primary representative of HSRRC decisions, the HSRRC Chair hasshared authority over all HSRRC policy and procedures in collaboration with the Institutional Official and HSRRC Administrator.

  • The Chair should represent the HSRRC in discussions with other segments of the organization.
  • The Chair should represent the organization in discussion with federal authorities.
  • The Chair should review all protocols presented to the full committee. The HSRRC Chair is expected to have read each full committee protocol and to communicate with other reviewers so that important HSRRC issues are identified or resolved before the full committee meeting.
  • The Chair should direct the proceedings and discussion of the full committee meeting. This includes keeping the discussion focused on important HSRRC issues and seeing that the full-committee meeting process is both efficient and effective.
  • The Chair should vote at full committee meetings.
  • The Chair should have an in-depth understanding of the ethical issues, state law, institutional policy, and federal research regulations that are applicable to studies that are reviewed by the HSRRC.
  • The Chair is not expected to be the only, or ultimate, authority on compliance issues. The HSRRC administrator or other members of the HSRRC organization also take responsibility for compliance verification.
  • The Chair should assist HSRRC administration in the drafting of letters from the HSRRC to researchers regarding HSRRC decisions.
  • The Chair should review and sign HSRRC response letters in a timely fashion.
  • The Chair should review and make decisions about responses to condition for HSRRC approval of research in a timely fashion. This task is shared with the HSRRC Administrator.
  • The Chair should often serves as the reviewer for research that is reviewed by exempt or expedited process. This task is shared with the HSRRC Administrator and the committee members.
  • The Chair should represent the HSRRC in defending or discussing HSRRC decisions with researchers.
  • The Chair should investigate instances of non-compliance in collaboration with the Institutional Official and HSRRC Administrator and develop a plan of action to address the non-compliance and oversee monitoring any remedial action.
  • The Chair should review all of the unanticipated problems/adverse events/complaint forms, and take appropriate action as needed regarding revision or status of the protocol and informed consent.
  • Report as needed to the Institutional Official.
  • The Institutional Official has the authority to remove the Chair, at any time, for cause in consultation with the President and Vice President of Research.

 

B. HSRRC members selection and appointment


The Chair and Administrator review and identify areas in which expertise is required. The Administrator obtains the willingness of the individual to serve on the HSRRC prior to recommending the prospective member to the Institutional Official.

 

1. Length of term/service
Members serve a one-year term and can be re-appointed at the end of their term. Members may resign at any time by submitting a letter of resignation to the Chair of the HSRRC.

 

2. Duties

  • The HSRRC members are responsible for:
  • Completing initial and ongoing educational requirements regarding protection of human subjects.
  • Identifying any conflicts of interest during protocol review and removing themselves from the discussion and voting except to provide information requested by the HSRRC.
  • Reading all material provided to them and being informed and prepared for the meeting.
  • Conducting reviews of full board and expedited protocols as requested.
  • Being an active member of the HSRRC and attending the meetings on time, participating in the discussion, and casting a vote at the convened meeting.

 

3. Attendance requirements

The HSRRC Members in accepting their appointments are informed of the scheduled meetings and it is their responsibility to make every effort to attend each meeting. In the event that a member is not available for a period of three consecutive meetings in one semester or five meetings in a one year period they will relinquish their membership of the committee.

 

4. Removal

The Institutional Official may remove members from the HSRRC prior to the end of their appointment. The HSRRC member removal may occur in the event that the member does not fulfill their duties or responsibilities in reviewing protocols or has displayed inappropriate behavior and has affected the conduct of the meeting. Members cannot be removed based on their voting record, or in an attempt to alter the HSRRC membership to obtain approval for protocols.

 

C. Training of HSRRC chair and members


1. Orientation
The HSRRC members are required to complete the IRB Members Basic Course through the Collaborative Institutional Training Initiative (CITI Program). The training must be completed prior to the first convened meeting that the new appointee is scheduled to attend. Those members requiring a continuing education will be notified by CITI as well as the HSRRC office staff. This continuing education must be completed by the expiration date of 4 years from the last certification date in order to maintain active in the committee.

 

2. Liability coverage for HSRRC members
Section 17 of the NYS Public Officers Law provides that the NYS Attorney General will defend employees should they become involved in litigation if such litigation pertains to an incident involving their duties as long as the employee(s) did not intentionally engage in wrong doing. This protection is also extended to SUNY Associates and volunteers expressly authorized to participate in a state-sponsored volunteer program. Evidence of this authorization includes a volunteer appointment record in accordance with campus procedures and an oath of office executed by the SUNY Associate or other volunteers.

 

3. Use of consultants
The HSRRC will call on consultants to provide to the HSRRC the additional expertise or cultural diversity that may arise. Consultants are chosen by the HSRRC Chair and/or the Administrator and sometimes input from other individuals knowledgeable in the area of study, based on their expertise. 

 

The consultant is required to sign a written confidentiality statement.Those individuals who have a conflict of interest in the research they are asked to review cannot serve as a consultant.

 

The consultant will provide an opinion to the HSRRC in layman terms. This may be accomplished through a written report that will be distributed to the HSRRC or they may attend a meeting to provide their input. If the consultant attends the HSRRC meeting, they will not be involved in the discussion and decision making except to provide information requested by the HSRRC. The Consultant must leave the meeting before final discussion and voting.


All consultant reports will be kept on file in the HSRR Office and the information provided to the HSRRC by the consultant will be reflected in the minutes of the meetings.

 
D. HSRRC office


The HSSRC Office staff will provide the necessary support to facilitate the acceptance, review, approval, continuing approval, and modifications of protocols. The HSRRC staff will facilitate the full board meetings, as well as maintain all records in accordance with university, state, and federal regulations. Full job descriptions and responsibilities of the Associate Director of the IRB and/or the IRB Coordinator will be made available upon request.

 

1. Space and office
The HSRRC's administrative offices with the necessary office equipment and supplies are located in the ITC Biotechnology building rooms 2204, 2205, and 2207. Boardrooms within the ITC complex are reserved to hold the Full Board meetings.

 

2. Personnel
The HSRRC is adequate for conducting HSRRC business. Personnel hires are bound by the Research Foundation of State University of New York (SUNY) and SUNY which encompass all Affirmative Action and Equal Employment Opportunity Requirements. The recruitment and hiring process follow the policy and procedures of the Research Foundation of SUNY and SUNY.

 

3. Human subjects education program
All HSRRC staff and committee members are required to fulfill human subjects research training through the Collaborative Institutional Training Initiative (CITI). The Office staff maintain records to ensure that the members are currently up-to-date on all training. The CITI program also sends out reminders to all CITI registered users of any refresher courses that are required.

 

All HSRRC staff and members also are provided with various opportunities for additional training through online and on-site seminars/workshops. All new federal regulations, policy and procedures revisions and other news that require immediate notification to the research community are accomplished through the HSRRC listserv.

 

4. Legal counsel
If needed, the HSRRC consults the Binghamton University Counsel for the interpretations and applications of law and the laws of any other jurisdiction where research is conducted as they apply to human subjects research.

 

5. Outreach
The HSRRC provides training and educational materials and resources to investigators online through the HSRRC website as well as through individual/group meetings, workshops, class presentations. For investigators who have questions or concerns about their studies and participants who have any questions, complaints, or concerns regarding participation in human subjects research, our office contact information is made widely available through the HSRRC website and the informed consent documents. If necessary, questions, comments or concerns are documented and discussed during the convened meetings.

 

E. HSRRC chair, member and staff evaluations


The Institutional Official will perform evaluations of the HSRR operations, HSRRC, and HSRR staff periodically to ensure effective performance.

 

F. HSRRC monitoring


Internal audits will be performed regularly to ensure the HSRR program is in compliance with federal, state, agency, and system regulations. Areas of review include:

  • Review of the HSRRC minutes to verify that meeting discussion address issues relating the regulatory requirements in 45 CFR 46.111 and for subsections B,C and D for HSRRC approval of research.
  • Review minutes to assure that quorum was met and maintained.
  • Review Complaints/ Adverse Events and Unanticipated Problem reports.
  • Review database, files and minutes to evaluate the continuing review discussions, and to ensure that the Continuing Reviews are reviewed on an annual basis pursuant to federal regulations 45 CFR 46.109(e).
  • Review files to assure presence of all appropriate documentation.
  • Verification of HSRRC Federal Wide Assurances and Institutional Review Board applications with the Department of Health and Human Services

 

VII. Conflict of Interest policy


For the purposes of this policy, a "conflict of interest" shall be defined as any factor, event or interest, whether of a financial or non-financial nature (a "conflict") that could reasonably influence, or reasonably be perceived to influence, review of any research study by a HSRRC Member or Consultant.

 

Binghamton University's policy states that HSRRC members will not review, participate in the discussion of, or vote upon any research protocol for which they have a conflict of interest. No HSRRC member can take part in the initial or continuing review of a protocol in which they have a conflict of interest. HSRRC Members and Consultants with a conflict of interest may provide requested information.

 

A. Conflicts of interest for HSRRC members and consultants

 

Binghamton University policy prohibits HSRRC members from participating in the final discussion of, or voting upon any research protocol for which they, their spouse, dependent children, or partner are involved in the design, conduct, or reporting of the research or holds a financial interest, meaning anything of monetary value, including although not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interest); and intellectual property rights ( e.g. patents, copyrights, and royalties from such rights)
The HSRRC member or consultant may be asked to provide the committee members with information concerning the research. However HSRRC members and consultants with these types of conflicts of interest shall recuse themselves and leave the room for the final discussion and vote of all such studies, and are not counted towards quorum. Absences of Committee members, who have a conflict, from the deliberation and the vote are noted in HSRRC minutes.

 

The HSRRC Chair and committee members are required to complete a Conflict of Interest Form annually. Additionally, the Conflict of Interest Form needs to be updated when new a conflict of interest is acquired that affects or has the potential to affect his/her obligations to review research protocols.

 

Consultants are considered to have a conflict of interest when they, their spouse, dependent children, or partner are involved in the design, conduct, or reporting of the research. Moreover, Consultants are considered to have a conflict of interest when the consultant, their spouse, dependent children, or partner holds a financial interest, meaning anything of monetary value, including although not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interest); and intellectual property rights (e.g. patents, copyrights, and royalties from such rights).

 

B. Institutional conflict of interests


University administrators are required to comply with the New York State Commission on Public Integrity disclosure policies that stipulate that they file at least annually a disclosure of all of their financial activities through JCOPE Additionally, an "Institutional Conflict of Interest Financial Disclosure" is required of all Senior Officers of the University annually in order to be in compliance with the procedures of the Association for Accreditation of Human Research Protection Programs. The Institutional Conflict of Interest Financial Disclosure is facilitated by the Office of Research Compliance.

 

C. Undue influence of the HSRRC


Undue influence can be defined as any pressure or influence which causes an individual to act in a manner that is favorable to an individual investigator or the institution over the welfare and safety of the research participants.

 

Reporting of Undue Influence by HSRRC members, staff, researchers, or research participants is required to ensure the highest ethical standards of research conducted at Binghamton University.


Reports of Undue influence can be submitted to the following individuals:

  • HSRRC Chair
  • HSRRC Administrator
  • Institutional Official
  • Vice President for Research

 

Reporting Procedures:
The Institutional Official (IO) will receive all reports. Upon review of the reports the IO will conduct an investigation or assign an investigation to an individual or a committee. In the event that the IO is involved in the report, the Vice President for Research will be informed and will decide on the investigation action.

 

Actions of Report Findings:
All Undue Influence Investigation will require that a report be documented, and provided to the complainant and to the HSRRC for a full committee review.
The HSRRC may decide to vote and report the Undue Influence issue and correspondence to the OHRP if it is determined, during a convened meeting, that the Undue Influence has not been resolved by the University.

 

VIII. Functions of the HSRRC


The HSRRC Associate Director and Coordinator will review each application submitted through the online portal, Pre-award and Compliance System (PACS) for compliance with federal and state regulations and institutional policies. The Associate Director and Coordinator will determine if the protocol is "Human Subjects research", as defined below, and is eligible for exempt/expedited review pursuant to 45 CFR 46.101(b), 45 CFR 46.110, or21 CFR 56.110.Research involving human subjects means any activity that either:

  • Meets the Department of Health and Human Services (DHHS) definition of "research" and involves "human subjects" as defined by DHHS; or
  • Meets the Food and Drug Administration (FDA) definition of "research" and involves "human subjects" as defined by FDA.

 

DHHS Definitions:
Research: a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge [45 CFR 46.102(d)]

Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]

  • "Intervention" as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(f)]
  • "Interaction" as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
  • "Private information" as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
  • "Identifiable information" as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

 

A. Exempt and expedited review

 

Initial Review
Applications that qualify for exempt review are reviewed for approval by the HSRRC Associate Director and Coordinator. Applications that require expedited review are reviewed by the Associate Director with the Chair or a designated member of the HSRRC who has relevant educational/professional training and experience. The reviewers will review Federal Regulations 45 CFR 46.110, 21 CFR 56.110 (for expedited research) and 45 CFR 46.101(b) (for exempt research) to ensure that the study 1) meets all applicability criteria and 2) represents one or more approvable categories of research.


All comments, questions and additional information must be addressed by the Principal Investigator before the protocol can be approved.


The following should be submitted to the HSRRC office for review through PACS :

  • Protocol Narrative or Existing Data Application (for secondary research)
  • Informed consent/assent documents
  • Recruitment materials (e.g., flyers, email, letter, advertising blurb)
  • Study materials (e.g., survey, visual/auditory stimuli)
  • Letter of agreement/permission from collaborating individual/institution/organization (if applicable)
  • Faculty statement if the principal investigator is a student
  • Grant proposal (if applicable)
  • Any other supplementary documents relevant to the study

 

Continuing Review

Continuing review application must be submitted through PACS prior to the expiration date to avoid any lapse in approval. PACS sends an initial reminder 90 days prior to the expiration date. Investigators need to complete the electronic form through PACS. No additional forms are required for continuing review submission. Continuing review applications are reviewed and approved by the HSRRC Association Director.

 

Modification

All proposed modifications must be approved before investigators can implement the changes in their protocol. Investigators need to complete the electronic form through PACS and upload any relevant documents that are being modified. Modifications will be reviewed by the HSRRC Coordinator and/or Associate Director. The Chair and Committee member with relevant expertise may be consulted depending on the modification.

 

All expedited research, initial, continuing review and modifications are posted on the agenda and presented to the HSRRC at the next convened meeting.

 

Approved Consent Form
All approved consent/assent forms are stamped with an approval/expiration date and are available in PACS under Documents tab. Investigators must used the stamped consent/assent forms to the participants. If any changes need to be made to the informed consent/assent forms, investigator must submit a modification through PACS and upload the modified documents. The modified consent/assent forms will be stamped with a new approval date. Please note that the expiration date does not change. Investigators will receive a new expiration date only when the study is due for a continuing review and the continuing review application has been reviewed and approved by the HSRRC.

 

B. Full committee review

 

Initial Review
By regulation, action on protocols that require full HSRRC review may be taken only at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas. Convened meetings are scheduled every month during spring and fall semesters. There are no convened meetings during summer/winter breaks. However, in urgent cases, meetings may be scheduled during the summer/winter breaks and as necessary to ensure the protection of human subjects.

 

In order for the research to be approved, it must receive the approval of a majority of those members present. In the event a quorum is lost during a meeting, the HSRRC cannot take votes until it is restored. Investigators must submit the following application materials through PACS before the deadline (2 weeks prior to the convened meeting):

  • Protocol Narrative
  • Informed consent/assent documents
  • Recruitment materials (e.g., flyers, email, letter, advertising blurb)
  • Study materials (e.g., survey, visual/auditory stimuli)
  • Letter of agreement/permission from collaborating individual/institution/organization (if applicable)
  • Faculty statement if the investigator is a student
  • Grant proposal (if applicable)
  • Any other supplemental documents relevant to the study


It is highly recommended that investigators submit their protocol well before the deadline in case requests are made to provide more information or revise documents. All application materials are initially reviewed by the HSRRC Associate Director and Chair to determine whether a full committee review is required and if so, to ensure that all documents are complete and sufficiently prepared to be reviewed at the convened meeting.

 

All Committee members will be notified through PACS once a study is added to the meeting agenda and have access to the application materials at least 7 days prior to the convened meeting. HSRRC members will reviewed the materials and post their comments in PACS in preparation for the convened meeting.

 

Investigators will be invited to attend the convened meeting to answer any questions and/or to provide more information. If the investigator is a student,their faculty advisor will be invited to attend the meeting as well.

 

Full Committee Actions
The Full Committee may act on a protocol in one of five ways:

  1. It may be approved
  2. It may be approved with contingencies (e.g., approved once more information is provided or revisions are made). In such cases, the committee will vote whether the revised documents can be reviewed and approved by the Chair with any designated member or by the full committee.
  3. It may approve some components of the proposed research study and defer taking action on other components. The committee may approve components of the proposed research and allow the investigator to initiate research activities only related to those approved components. In such circumstances, the committee must ensure that the approved components of the research study are scientifically valid and satisfy all criteria required for IRB approval, even if the other components are never approved and conducted.
  4. It may be disapproved (in this case, the study may be re-written to address all concerns and re-submitted for full committee review).

The investigator will be notified of the committee decision through PACS within the week of the convened meeting.

 

Modification

All proposed modifications must be approved before investigators can implement the changes in their protocol. Investigators need to complete the electronic form through PACS and upload any relevant documents that are being modified. Modifications will be reviewed by the HSRRC Associate Director. The Chair and Committee member with relevant expertise may be consulted depending on the modification. If the modifications are substantial or pose any risk to participants, the full committee review may be required.

 

Continuing Review

If the Committee voted to approve the expedited review of the annual continuing review, the continuing review can be reviewed and approved by the HSRRC Associate Director (with the Chair if needed). If no such vote was made, the continuing review must be reviewed by the full Committee. Continuing review application must be submitted through PACS prior to the expiration date to avoid any lapse in approval. PACS sends an initial reminder 90 days prior to the expiration date. Investigators need to complete the electronic form through PACS. No additional forms are required for continuing review submission.

 

Approved Consent Form
All approved consent/assent forms are stamped with an approval/expiration date and are available in PACS under Documents tab. Investigators must used the stamped consent/assent forms to the participants. If any changes need to be made to the informed consent/assent forms, investigator must submit a modification through PACS and upload the modified documents. The modified consent/assent forms will be stamped with a new approval date. Please note that the expiration date does not change. Investigators will receive a new expiration date only when the study is due for a continuing review and the continuing review application has been reviewed and approved by the HSRRC.

 

C. Report, in writing, findings and actions of the HSRRC to the investigator and the institution

 

All approval notice and modification requests will be made through PACS. PACS will send an email notification to the investigators alerting that a decision has been made. Approval and modification request letters can be accessed once they are logged into PACS.

 

D. Determining which studies require review more often than annually


In certain circumstances, determined at the time of initial or continuing review, the Committee may stipulate that continuing reviews should take place more frequently than once a year if the risks to participants warrant more frequent assessment. 

 

E. Ensuring prompt reporting to the HSRRC of changes in research activities


Once the HSRRC has approved a project, it must be carried out exactly as planned. Any and all changes (i.e. subject population, recruitment plans, research procedures, study design, study instruments, study sites, or research personnel), must be approved by the HSRRC prior to implementation through the modification process.

 

Investigators need to complete the electronic modification form through PACS and upload any relevant documents that are being modified. Modifications will be reviewed by the HSRRC Associate Director. The Chair and Committee member with relevant expertise may be consulted depending on the modification. If the modifications are substantial or pose any risk to participants, the full committee review may be required.

 

F. Ensuring prompt reporting to the HSRRC and appropriate institutional officials

 

Reportable Events
Principal Investigators or any individual involved in the research must report the following problems to the HSRRC through PACS (using Reportable New Information) within five (5) business days.

  • Adverse events that are (1) unexpected and (2) related or likely related to the research as determined by the principal investigator;
  • Information that indicates a change to the risks or potential benefits of the research. For example: a) An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB b) A paper is published from another study that shows that the risks or potential benefits of the research may be different than initially presented to the IRB;
  • Breach of confidentiality;
  • Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol;
  • Incarceration of a participant in a protocol not approved to enroll prisoners;
  • Specific protocol-defined events that requires prompt reporting to the sponsor;
  • Sponsor imposed suspension for risk;
  • Accidental or unintentional deviations to the IRB-approved protocol that involved risks;
  • Emergency protocol deviations taken without prior IRB review to eliminate apparent immediate hazard to research participants;
  • Complaints of participants that indicate unanticipated risk or which cannot be resolved by the research staff.

 

Review of Reports
The HSRR Office staff reviews the Reportable New Information completed by the investigator through PACS and determines the appropriate course of action using the OHRP guidance on unanticipated problems involving risks and adverse events:

 

Allegations and Findings of Non-Compliance: HSRR Associate Director and the Chair evaluate allegations of non-compliance.

    • If non-compliance is not found, no further action is taken.
    • If the non-compliance is either serious or continuing, it is handled by the convened HSRRC under the section on "Convened HSRRC Review of Problems.
    • If the non-compliance is neither serious nor continuing, the HSRR Associate Director and the Chair work with the non-compliant parties to develop an appropriate corrective action plan. If the non-compliance parties do not work with the HSRRC in a collaborative effort to develop a corrective action plan, the non-compliance is handled as serious or continuing non-compliance.
    • All serious or continuing non-compliance is handled by the convened HSRRC under the section on "Convened HSRRC Review of Problems.

Allegations and Findings of Unanticipated Problems Involving Risks to Participants or Others: All unanticipated problems involving risks to participants or others are handled by the convened HSRRC under the section on "Convened HSRRC Review of Problems"

 

Convened HSRRC Review of Problems: When a research-related incident/problem requires review by the full board, the convened HSRRC considers the following actions:

    1. Suspension of the research.
    2. Termination of the research.
    3. Notification of participants when information about the non-compliance may affect their willingness to continue participation.
    4. Modification of the protocol.
    5. Modification of the information disclosed during the consent process.
    6. Providing additional information to past subjects.
    7. Requiring current subjects to re-consent to participate.
    8. Modification of the continuing review schedule.
    9. Monitoring of the research.
    10. Monitoring of the consent.
    11. Referral to other organizational entities.

FAILURE TO REPORT: Failure to report is a breach of the conditions under which HSRRC approval is given, and could result in suspension or revocation of approval. Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish.

 

G. Suspension and termination of HSRRC approvals


Definitions:

Suspension: Temporarily or permanently withdrawing approval for some or all research procedures. Investigators must cease all research activities. Suspended research must undergo continuing review.
Termination: Permanently withdrawing approval for all research procedures. Terminated research is closed and does not require continuing review.

 

Suspension/Termination Conditions
The HSRRC can suspend or terminate approval of research that:

  • Is not being conducted in accordance with the HSRRC's requirements
  • Has been associated with unexpected serious harm to subjects

 

Suspension/Termination Authority
The following individuals are authorized to suspend or terminate research and who can suspend HSRRC approval on an urgent basis:

  • President of the University
  • Vice President of Research
  • Institutional Official
  • Chair, Human Subjects Research Review

 

Reporting Procedure
Individuals or bodies other than the convened HSRRC suspending or terminating must report that action to the convened HSRRC for review. When the research is suspended or terminated, the convened HSRRC or the individual ordering the suspension or termination must:

  • Consider actions to protect the rights and welfare of currently enrolled subjects, such as:
    • Making arrangements for medical care of a research study (if necessary)
    • Transfer to another investigator
  • Consider procedures for withdrawal of enrolled subjects considering their rights and welfare
  • Consider whether subjects should be informed of the termination or suspension
  • Require any adverse events or outcomes to be reported to the HSRRC

 

The following incidents require reporting to the OHRP 45 CFR 46.103(a) and (b)(5):

  • any unanticipated problems involving risk to subjects or;
  • any serious or continuing non-compliance with this policy or the requirements or determinations of the HSRRC; and
  • Any suspension or termination of the HSRRC approval

 

Suspension and terminations of the HSRRC approval are reported to regulatory agencies and appropriate institutional officials.

 

These reporting requirements apply to all nonexempt human subjects research that is conducted at Binghamton University, State University of New York. Our Federal Wide Assurance (FWA) has adopted the Common Rule for all research.

 

H. Monitoring of the consent process


Situations may arise in which the HSRRC may consider observing the consent process as a method to protect subjects.


The HSRRC Chair will appoint an individual from the HSRR staff or from the HSRRC members. This individual will attend and observe the informed consent process between the Principal Investigator and the subject.

 

IX. Operations of the HSRRC


A. Scheduling of meetings


Monthly full board meetings are scheduled during fall and spring semesters at a time that all board members can attend. There are no full board meetings during summer unless in urgent situations.


B. Information provided prior to the meeting


HSRRC members can access meeting materials (e.g., meeting agenda, protocol(s) to be reviewed, past meeting minutes) through PACS.. All protocols and relevant documents are uploaded to PACS at least seven (7) days prior to the scheduled meeting. The members are informed via email that the materials are available online and asked to review the documents and post their comments in PACS. The meeting materials include:

  • Meeting agenda
    • New Research
    • Modification Requests
    • Continuing Review Request
    • Listing of all approved exempt/expedited protocols
  • Minutes from previous meeting
  • Adverse Event/Complaint Reports
  • All relevant document for protocol review
  • New Business and or topics to be discussed

 

C. The review process

 

All documentations for review is submitted via PACS to the HSRR office for review. Documentations may include Protocol Narrative, Informed Consent and all other documents noted in the Protocol Narrative, Faculty Statement (if student is the Principal Investigator), Letter of Agreement (if applicable), grant proposal (if applicable). Detailed information about the review process is explained in the Functions of the HSRRC section above.

 

D. Full board meeting requirements


A majority of IRB members and at least one member whose primary concerns is in non-scientific areas is required to review and vote. It is strongly recommended that HSRRC members be physically present at the meeting. If physical presence is not possible, a member may be considered present if participating through teleconferencing or videoconferencing. In this case the member must have received all pertinent material prior to the meeting and must be able to participate actively and equally in all discussions. For research to be approved, it has to receive approval of a majority of members present at the meeting.


If this requirement is not achieved or lost at a meeting due to members with conflict being excused, early departures, or a loss of a non-scientist, the meeting is terminated from further votes unless the quorum can be restored. Any absence or loss of quorum should be noted in the meeting minutes.

 

The HSRRC members are selected based on appropriate diversity, including consideration of race, gender, cultural backgrounds, specific community concerns in addition to representation by multiple, diverse professions, knowledge and experience with vulnerable subjects, and inclusion of both scientific and non-scientific members.

 

The HSRRC may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the HSRRC. These individuals may not vote with the HSRRC.

 

E. Further review/approval of HSRRC actions by others within the institution (override of disapproval is prohibited).


By Federal regulation, institutional officials may not approve research that has not been approved by an HSRRC. Consequently, NIH does not have an appeal procedure if a protocol is not approved by an IRB. PIs may request an IRB to reconsider a decision regarding a human subject research activity. Investigators do not have the option to seek the reversal of an IRB decision by submitting the same protocol to another IRB.

 

G. Communication from the HSRRC

 

To the investigator for additional information
Request for additional information or clarification occur via PACS. Investigators are to respond to the request via PACS.

 

To the investigator for conveying the HSRRC decision 
Investigators will receive a determination letter via PACS that informs whether their research is approved, requires a modification, or is disapproved.

 

To Institutional Official for conveying the HSRRC decision 
The Institutional Official can access the minutes of the meeting that includes the boards voting decision of all protocols in PACS and in the shared drive. 

 

To sponsor of research for conveying HSRRC decision

Upon request from the Sponsored Programs and Sponsored Funds, IRB approval/determination letter is emailed.

 

To current or potential research participants
When the HSRR Office receives contact from research participants the following procedures will be followed:

  • Recruitment Information – the office takes the participant's name and informs the potential participant that the Principal Investigator will be contacted and provided with the individual's name and contract information. The Principal investigator is contacted via email and provided with this information.
  • Participants questions regarding research they are involved in – questions involving enumeration, scheduled appointments, or any additional information that is not a complaint - the office takes the participant's name and informs the potential participant that the Principal Investigator will be contacted and provided with the individual's name and contract information. The Principal investigator is contacted via email and provided with this information. The email and all correspondence is printed and filed in the protocol.
  • Complaints – the office takes the information and takes appropriate course of action in consultation with the HSRRC Chair.

 

H. Appeal of HSRRC decision


If an HSRRC Application is disapproved, the reasons for disapproval will be conveyed to the investigator in writing. This letter will include the committee's decision and concerns regarding the study listing the Federal Guidelines that the committee considered in their decision. The investigator may request the HSRRC to reconsider by responding in writing, and may request an opportunity to appear before the HSRRC.

 

The HSRRC allows investigators various levels of appeal from the time a study receives initial review through approval or disapproval. HSRRC decisions are contingent upon the response of the investigator. If the Committee finds that the negotiation is at an impasse, intramural or extramural independent consultant review may be requested.

 

X. HSRRC record requirements


A. HSRRC membership roster showing qualifications


In the fall of each year, the HSRR office will submit to the Institutional Official a copy of the membership roster and curriculum vitae demonstrating the qualifications of each committee member.

 

B. Written procedures and guidelines


Written procedures and guidelines are contained on the Binghamton University Human Subjects Research website. Hardcopies can be downloaded or obtained by contacting the Office of Human Subjects Research.

 

C. Minutes of meetings


The HSRRC Coordinator will take notes during the HSRRC full board meetings. The minutes will contain:

  • Members present
  • Consultants/guests/others shown separately
  • Summary of discussions on debated issues
  • Record of HSRRC decisions
  • Record of voting (showing votes for, against, and abstentions)
  • Separate deliberations for each action
  • When an alternate member replaces a primary member
  • The basis for requiring changes in research
  • The basis for disapproving research
  • A written summary of the discussion of controverted issues and their resolution
  • Justification for any deletion or substantive modification of information concerning risks or alternative procedures contained in the DHHS-approved sample consent document
  • For initial and continuing review, the approval period
  • The names of the HSRRC members who left the meeting because of a conflicting interest along with the fact that a conflicting interest was the reason for the absence
  • Unless documented in the HSRRC records, determinations required by the regulations and protocol-specific findings justifying those determinations for:
  • Waiver or alteration of the consent process
  • Research involving pregnant women, fetuses, and neonates.
  • Research involving prisoners
  • Research involving children
  • Research involving participants with diminished capacity
  • The rationale for significant risk/non-significant risk device determinations


Proceedings are written and available for review within one (1) week of the meeting date. Once approved by the members at a subsequent HSRRC meeting, the minutes must not be altered by anyone including a higher authority. All minutes will be stored in the HSRRC office for 3 years after research completed or otherwise terminated.

 

D. Retention of protocols reviewed and approved consent documents


The HSRR Office will retain all records required by the regulations (e.g. minutes, correspondence between the HSRR office and investigators, HSRRC rosters, and written procedures required by regulations) for at least three (3) years, and retains all records relating to research that has been conducted or cancelled for at least three (3) years after completion or cancellation of research. If a protocol is cancelled without participant enrollment, the HSRRC records are maintained for at least three (3) years after cancellation. In the case of new drug investigations, 2 years after the marketing application is approved or, if no application is filed or if the application is not approved, until 2 years after the investigation is discontinued and FDA is notified.

 

The HSRR Office makes records accessible for inspection and copying by authorized representatives of federal agencies or departments at reasonable times and in a reasonable manner.


HSRRC record requirements include the some or all of following in order to allow a reconstruction of a complete history of HSRRC actions related to the review and approval of the protocol:

  • Protocols (including, when applicable)
  • Investigator brochure
  • Data and Safety monitoring reports
  • Unanticipated problems involving risks to participants or others
  • Documentation of non-compliance
  • Recruitment materials
  • Modifications to previously approved research
  • Scientific evaluations
  • DHHS-approved sample consent document and protocol, when they exist
  • Progress reports submitted by the investigators.
  • Reports of injuries to subjects
  • Records of continuing review activities.
  • Correspondence between the HSRRC and the investigator.
  • Statement of significant new findings provided to participants.
  • For initial and continuing review of research expedited procedure:
  • The specific permissible category
  • Description of action taken by reviewer
  • Any findings required under the regulations
  • For exemption determinations, the specific category of exemption
  • Unless documented the HSRRC minutes, determinations required by the regulations and protocol-specific findings justifying those determinations for:
  • Waiver or alteration of the consent process.
  • Research involving pregnant women, fetuses, and neonates.
  • Research involving prisoners.
  • Research involving children.
  • For each protocol's initial and continuing review, the frequency for the next continuing review

E. Communication to and from the HSRRC


The IRB application is submitted through PACS which can be accessed by going to the HSRRC webpage: https://www.binghamton.edu/research/compliance/humansubjects/irbpacs.html. All questions and /or concerns can be directed to the HSSRC office by telephone (607-777-3818), in person, via PACS, or email at hsrrc@binghamton.edu.

 

The HSRR office communicates with researchers regarding HSRRC decisions and requests for additional information via PACS. The HSRR Office may also contact the researchers via phone or email to further discuss the study. Major revisions or changes concerning applications, policy and procedures are communicated to the researchers throughlistserv, Binghamton University's "Dateline",and the HSRRC webpage.

 

F. Statements of significant new findings provided to subjects


Any and all information that is provided to the human subjects must also be provided to the HSRRC office. This documentation is to be uploaded in PACS.

 

G. Requirements for HSRRC records
  • Protocols.
  • Scientific evaluations.
  • DHHS-approved sample consent document and protocol, when they exist.
  • Reports of injuries to subjects.
  • For initial and continuing review of research by the expedited procedure:
  • The specific permissible category.
  • Description of action taken by the reviewer.
  • Any findings required under the regulations.
  • For exemption determinations, the specific category of exemption.
  • Unless documented in the HSRRC minutes, determinations required by the regulations and protocol-specific findings supporting those determinations for:
  • Waiver or alteration of the consent process.
  • Research involving pregnant women, fetuses, and neonates.
  • Research involving prisoners.
  • Research involving children.
  • For each protocol's initial and continuing review, the frequency for the next continuing review.


XI. Information the investigator provides to the HSRRC


A. Professional qualifications to do the research (including a description of necessary support services and facilities)


Procedures requiring special skills on the part of the investigators, licensure, accreditation, or experience in qualifying the investigator for the performance of the proposed procedures are reviewed by the HSRRC. In addition, the HSRRC will consider the facilities and equipment used to conduct the research and maintain the rights and welfare of the subjects. The Investigators and study team members must fulfill Human Subjects Research educational requirement through the CITI. More information on the required training can be found on the website: https://www.binghamton.edu/research/compliance/humansubjects/educational_requirements.html.

 

B. Principal investigators conflicts of interest


The HHS regulations at 45 CFR part 46 use the term "investigator" to refer to an individual performing various tasks related to the conduct of human subjects research activities, such as obtaining informed consent from subjects, interacting with subjects, and communicating with the IRB. For the purposes of the HHS regulations, OHRP interprets an "investigator" to be any individual who is involved in conducting human subjects research studies. Such involvement would include:

  • obtaining information about living individuals by intervening or interacting with them for research purposes;
  • obtaining identifiable private information about living individuals for research purposes;
  • obtaining the voluntary informed consent of individuals to be subjects in research; and
  • studying, interpreting, or analyzing identifiable private information or data for research purposes.

 

Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated the "principal investigator" with overall responsibilities for the study. In every human subjects research study, investigators have certain responsibilities regarding the ethical treatment of human subjects.

 

HSRRC will review the following questions included in the Protocol Narrative and evaluate whether there is conflict of interest:

  1. Does any investigator who is involved in the design, conduct, or reporting of the study, their spouse, or dependent children have a proprietary or financial interest related to the research? ("Financial interest" refers to any financial interest in the sponsor, product, or service being tested, or any financial interest in a competitor of the sponsor, product, or service being tested.)
  2. Does any investigator who is involved in the design, conduct, or reporting of the study, their spouse, or dependent children have any ownership interest, stock options, or other financial interest related to the research that
    • exceeds $5,000 when aggregated? 
    • is not publicly traded on stock exchange? 
    • involves arrangements in which the value of the ownership interests will be affected by the outcome of the research? 
    • exceeds 5% interest in any one single entity when aggregated for the spouse or dependent children? 
  3. Does any investigator who is involved in the design, conduct, or reporting of the study, their spouse, or dependent children have any compensation related to the research that
    • exceeds $5,000 in the past year, when aggregated? 
    • involves arrangements in which the amount of compensation will be affected by the outcome of the research? 

If there is a definite or probably Conflict of Interest, the IO will review the documents and meet with the Principal Investigator/Researcher to educate and prepare a Management Plan for the research. The Management Plan will be signed by the IO and the Principal Investigator/Researcher. In the event that the Management Plan is not adhered to the protocol, the researcher will then be found non-compliant. The non-compliant will automatically be deemed "serious" and the HSRRC procedures for "Serious Non-Compliance" will be followed. All records related to disclosure and management of financial conflicts of interests and any other related correspondence and documents will be stored for a period of three years following completion of the resear

 

C. Investigation advertisements and recruitment incentives


The HSRRC reviews all brochures, advertisements, and recruitment incentives associated with the research. The HSRRC considers all forms of brochures, advertisement, and recruitment incentives as being directly related to the consent process and must not contain any coercion or undue influence. Payment to research subjects for participation is part of the recruitment incentive. If a subject withdraws early, payment must be prorated to reflect the time and inconvenience of the subjects participating up to that point.

 

Below are some acceptable alternative approaches for encouraging students to show up for scheduled appointments with investigators without imposing penalties on students who fail to show up. Imposing penalties is a violation of 45 CFR 46.116(a)(8). http://www.hhs.gov/ohrp/policy/protocol/ohrp20100108.html


1. Students who show up for an appointment as scheduled could be awarded a credit point, or some fraction thereof.


2. Students who fail to show up for a scheduled appointment could have a decrease in the number of credits that can be earned through participation in research for a particular course, provided such students can still earn the same maximum number of credits by substituting an alternative non-research activity that involves a comparable amount of time and effort. For example, consider circumstances where students enrolled in a course can earn up to 3 extra credit points toward their final grade by participating in 3 separate studies (1 extra credit point per study). Under this option, if a student in the course fails to show up for an appointment for one study without cancelling by the specified deadline, the student is allowed to earn a maximum of 2 extra credit points by participating in two other research studies. However, the student must be able to earn a third extra credit point by completing an alternative non-research activity.

 

D. Informed consent


Informed consent will be sought from each prospective participant or the participant's legally authorized representative in keeping with the criteria outlined in the OHRP regulations: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/index.html


1. Waiver/Alteration of Consent Process


Most common set of conditions for a waiver or alteration

  • The research involves no more than minimal risk to the participants.
  • The waiver or alteration will not adversely affect the rights and welfare of the participants.
  • The research cannot practicably be carried out without the waiver or alteration.
  • Whenever appropriate, the participants will be provided with additional pertinent information after participation.
  • The research is not FDA-regulated.
  • Less common set of conditions for a waiver or alteration -
  • The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.


2. Documentation of Consent Process 


HSRRC follows the federal and state regulation for documentation of consent. Please visit the OHRP website for more information about the federal regulations concerning documentation of consent and Article 24-A for New York State regulations concerning documentation of consent. Please contact our HSRR office for any question or concern regarding the consent documentation process.

 

3. Emergency Waiver of Consent


The waiver of consent may be carried out in human subjects who are in need of emergency therapy and for whom, because of the subjects' medical condition and the unavailability of legally authorized representatives of the subjects, no legally effective informed consent can be obtained. Due to special regulatory limitations relating to research involving prisoners (subpart C of 45 CFR part 46) and research involving fetuses, pregnant women, and human in vitro fertilization (subpart B of 45 CFR part 46), this waiver is inapplicable to these categories of research.


Binghamton University does not have the faculty, staff or facilities to conduct research that would require a Waiver of Emergency Consent. Binghamton University does not oversee the use of emergency uses of test articles in a life-threatening situation.
Information on informed consent requirements in emergency research can be found on the OHRP website https://www.hhs.gov/ohrp/regulations-and-policy/guidance/emergency-research-informed-consent-requirements/index.html.

 

4. Proxy Consent

Research conducted in New York State
New York State Law states that surrogate consent, other than that of a parent or legal guardian, (a legal guardian is defined as an individual who has obtained legal guardianship through the Surrogate Courts Proceedings Act §1700 ff., Domestic Relations Law §81 and Article Six of the Family Court Act) is not allowable, unless there is a legal document that specifically authorizes another to act on behalf of someone for research purposes (Public Health Law Section 2442). For example, the consent of a friend would not be allowed. Those individuals allowed to give consent to a third party include:

  • Persons appointed as health care agents
  • Court appointed guardians
  • Next of kin in the following order: spouse, adult child, parent, and adult sibling when there is a legal document that specifically authorizes another to act on behalf of someone for research purposes as per Public Health Law Section 2442.

Research conducted outside New York State

  • It is the Principal Investigators responsibility to ensure that Federal Guidelines 45.102(c) is followed: (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.Therefore the Principal Investigator must provide to the HSRRC documentation of State Law, where the research is being conducted, concerning proxy care and these laws must be incorporated in the consent process.


5. Research Involving Audio, Video, and/or Photographic Recordings 

Recording the voice or image of an individual creates a type of record that requires unique handling and storage, particularly if the content may be considered sensitive. Research subjects must be informed that such recordings will occur, and be provided with information about the storage, confidentiality, and future use of the recordings.The subjects must be informed of the following:

    • Type of recording that will be utilized
    • Specific identifiers that will be recorded
    • Who will have access to the recordings
    • Confidentiality procedures of the recordings
    • Indicate when the recordings will be destroyed – or – if they will be kept indefinitely
    • Use of the recordings: educational; commercial; analysis by research; unspecified use

The informed consent should include an additional signature line for recording permission or a separate document must be created. If recording is required in order to participate in the research, informed consent must clearly state signing the informed consent indicates agreeing to participate in research and giving permission to be recorded.

 

6. Research Involving Deception 
Sometimes information must be withheld from subjects or false information needs to be provided to them. This may be for substantive reasons (e.g., to distinguish perceptual causes from other causes) or methodological reasons (e.g. to ensure natural reactions or to avoid placebo effects). These circumstances inherently involve a breach of the concept of informed consent. Consequently, several serious concerns must be addressed before such research can take place.

  • Deception cannot be used in any study where there is risk to subjects
  • Subjects must be provided with sufficient information for them to decide whether to participate and, as in all other human subjects research, be allowed to withdraw at any point without penalty
  • No information can be withheld from subjects that could significantly affect their decision to participate (i.e. the subjects would likely participate anyway if they knew all the information)
  • When the deception involves a falsehood told, no information can be provided to subjects that would have a harmful effect on them if the statement were believed
  • Subjects need to be informed about the nature of the research in a way that does not invalidate the data
  • All subjects must be debriefed regarding the true nature of the research after their participation


The debriefing should:

  • Explain all truths not revealed and all falsehoods told to subjects
  • Address the reasons the deceptions were necessary
  • Reassure subjects that their reactions to the deceptions were normal

 

If having incomplete or erroneous information is not likely to be harmful to subjects, the HSRR Office will consider delaying the debriefing until all subjects have completed their participation. Care should be taken in debriefing to protect the well being of the subjects.

 

All debriefings must be submitted as a written text document to the HSRR Office. The debriefing should always be a dialogue. Those conducting the debriefing should be trained to elicit and respond to subject concerns.

 

E. Control of investigational devices


Investigators conducting studies in which an investigational device will be used must ensure adequate control of the device. Adequate control and handling of investigational devices include all of the following:

  • The investigator must ensure that the investigational device is used in accordance with the HSRRC approved protocol and, the investigational plan and applicable FDA regulations.
  • On the qualified, authorized investigators listed on the protocol can administer the investigational device to participants
  • The investigator must not supply the investigational device to any person not authorized to receive it.
  • The investigator must maintain the following accurate, complete, and current records relating to their participation in the clinical investigation. Specifically, records of receipt, use or disposition of a device that relate to:
  • The type and quantity of the device, the dates of its receipt, and the batch number or code mark.
  • The names of all persons who received, used, or disposed of each device.
  • Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of.
  • If the investigation is terminated, suspended, discontinued, or completed, the investigator must return any unused stock of the investigational device to the study sponsor, or otherwise provide for disposition of the unused stock as directed by the sponsor.

 

F. Multi-site study requirements


Research that is conducted by Binghamton University's researcher in collaboration with researchers from another institution can establish an Institutional Authorization Agreement (IAA)to rely on one IRB (Binghamton University's HSRR office or the collaborating institution's IRB) if the collaborating institution has a federalwide assurance (FWA). This is to streamline the review process without compromising research participants' rights and protections. Please contact the HSRR office to determine whether an IAA be established.

 

Please note that for NIH funded research with applications with due dates on or after January 25, 2018, and contract solicitations published on or after January 25, 2018 will be required use a single IRB to conduct the ethical review required for the protection of human subjects. For more information, please visit: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm.

 

Initial IRB documents submitted to collaborating institution's IRB along with the approval letter need to be submitted in order to determine whether IAA can be established to rely on the collaborating institution's IRB. All modifications, revisions, continuing reviews, adverse events, unanticipated problems, complaints and any other correspondence that is received from the collaborating institution must be forwarded to the HSRRC.

 

G. Data Safety Monitoring Boards (DSMB)


Multi site research that involves a large population may require additional oversight, allowing one group to view all data and monitor any adverse events, unanticipated problem or complaints. A Data Safety Monitoring Board (DSMB) is a group of individuals who are expert in their field that are applicable to the study, individuals with statistical experience, lay representatives, and administrators. This group usually meets one to two times a year and reviews all adverse events reports from all of the study sites.

 

The DSMB has the power to recommend termination of the study based on the evaluation of these results. There are typically three reasons a DSMB might recommend termination of the study: safety concerns, outstanding benefit, and futility.

 

While it is important to remember that all studies require careful monitoring, it is also important to know that not all studies require a DSMB. The following questions are designed to help make a determination as to whether or not a DSMB may be needed.

  • Are there multiple study sites that involve a large subject population?
  • Protocols presenting more than minimal risk to subjects. Risk assessment should include the characteristics of the subject population.
  • Is the clinical trial intended to provide definitive information about effectiveness and/or safety of an intervention?
  • Would it be ethically important for the trial to stop early if the primary question addressed has been definitively answered, even if secondary questions or complete safety information were not yet fully addressed?


For more information and regarding the requirement of DSMB, please review the NIH website (https://humansubjects.nih.gov/data_safety) or contact the HSRRC office at hsrrc@binghamton.edu.


DoD sponsored research with greater than minimal risk requires a research monitor, approved by the IRB. The research monitor is the subject/patient advocate and is independent of the investigative team. The research monitor has the authority to stop the research in progress, remove a subject from the study, take the necessary steps to protect the safety and well-being of human subjects until the IRB can assess the monitor's report, and report observations and findings to the IRB or other designated official. The PI must identify the monitor by name and provide the IRB with a written summary of the monitors' duties, authorities and responsibilities.


DoD Instructions on the Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research at http://www.esd.whs.mil/Directives/issuances/dodi/ at DoDI 3216.02.

 

XII. Student Classroom Projects/Internships


Generally speaking, classroom projects do not require IRB review. Please contact the HSRR Office if you have questions about classroom assignments involving gathering information about people through interventions or interactions, or using collected data with identifiable private information. It is the responsibility of faculty members to ensure that any classroom activity that is "research" involving "human subjects" as defined by OHRP is reviewed and approved by the HSRRC before the project starts.

 

Students conducting research that falls under the purview of the IRB at an internship site outside of Binghamton University may obtain an IRB approval from the collaborating institution through a Reliance Agreement. Please contact the HSRR Office to discuss this process.


XIII. Quality Improvement or Program Evaluation


Quality Improvement (QI) and Program Evaluation (PE) generally do not require IRB oversight. However, some QI or PE activities may be considered research if they fit the definition of "research" as defined by OHRP. Please contact the HSRR Office to determine whether your QI or PE activity is considered research and requires IRB approval.

 

XIV. DNA/Genetic Research


The following Binghamton University procedures and NYS laws must be taken into consideration when designing a research protocol that involves the use and storage of human DNA:

  • NY Civil Rights Law Section 79-1(4)(d) Each disclosure or re-disclosure of the (human subjects identified) test results requires the express informed consent of the test subject, and no general waivers are deemed informed consent.
  • NY Civil Rights Law Section 79-1 While informed consent is required to allow research access to specimens; explicit re-consent is not required once linked identifiers are removed.

In the informed consent, researchers need to explain whether the collected DNA samples (de-identified or with identifiers) will be used for future research.

 

A. Archived specimen repository and bank requirements

When proposing to establish an archive of biological materials, the researchers must contact University Environmental Health and Safety at donovan@binghamton.edu and the Institutional Biosafety Committee at rescomp@binghatmon.edu for consultation. An Archived Specimen Repository will require regular inspection by University Environmental Health and Safety and Institutional Biosafety Committee approval.


The Archived Specimen Repository must be sufficiently secure to prevent theft, loss or destruction of valuable information. The laboratory director should be aware of all individuals with access. The facility should be locked and accessible to laboratory personnel with key access. The Archived Specimen Repository should be equipped with key-card access which will provide electronic time-stamped recording of personnel entering the facility.


The protocol must include a detailed description of what type of data has been collected and how all data records are stored and kept secure. All data should be protected and backed-up (on other computers or in file cabinets, etc.). All data must be kept in a secure and defined location. For guidance in protocol completion, please contact the IRB Associate Director within the HSRR Office at hsrrc@binghamton.edu.


In order to function as human biological repository and specimen bank, the Archive will be required to establish an official material transfer agreement (MTA) and data use agreement (DUA) for those researchers interested in obtaining samples. The Office of Entrepreneurship and Innovation Partnerships-Technology Transfer unit (https://www.binghamton.edu/research/innovation/technologytransfer.html) in the Division of Research will oversee this process. Laboratory directors/PIs will be required to forward all MTAs to the HSRR Office at hsrrc@binghamton.edu.


If the specimens in the Archived Specimen Repository are identifiable and belong to living subjects, obtaining a Certificate of Confidentiality before sharing information may be required. This certificate can be obtained through the National Institutes of Health or other non-HHS agencies including but not limited to the CDC and FDA. The appropriate agency will be dependent on the research/repository. Additional information can be found at https://humansubjects.nih.gov/coc/index)

 

XV. HIPAA AND HITECH


Health Insurance Portability and Accountability Act of 1996 (HIPAA) and The Health Information Technology for Economic and Clinical Health (HITECH) Act are separate and unrelated laws, but they do reinforce each other in certain ways. For example, HITECH stipulates that technologies and technology standards created under HITECH do not compromise HIPAA privacy and security laws.


The State University of New York has designated itself as a hybrid entity. A hybrid entity performs both covered and non covered functions as part of its business operations. A covered function is any function the performance of which makes the performer a health plan, a health care provider, or a health care clearinghouse. Note that only one Binghamton University campus Institute is classified as a covered entity.


To gain access for research purposes to Protected health information (PHI) created or maintained by covered entities, the researcher may have to provide supporting documentation on which the covered entity may rely in meeting the requirements, conditions, and limitations of the Privacy Rule.


Health Information Protected by the Privacy Rule
With certain exceptions, the Privacy Rule protects a subset of individually identifiable health information, known as protected health information or PHI. There are eighteen (18) elements that could be used to identify the individual or the individuals' relatives, employers, or household members.


How Can a Covered Entity Use and Disclose Protected Health Information (PHI) for Research and Comply with the Privacy Rule?

  • De-identifying PHI under the Privacy Rule
  • Authorization for Research Use and Disclosures
  • Waiver or Alteration of the Authorization Requirement
  • Limited Data Set and Data Use Agreement


For more information on HIPAA and personal health information (PHI) researchers are encouraged to contact the Human Subjects Research Review Office at hsrrc@binghamton.edu or (607) 777-3818.

 

XVI. Potentially Vulnerable Subject Groups


For research including vulnerable populations as research subjects, the HSRRC must consider the following: recruitment inclusion and exclusion criteria; informed consent and desire and capacity to volunteer; coercion and undue influence; and confidentiality of data.

 

A. Research involving pregnant women, human fetuses and neonates (45 CFR 46 Subpart B)

 

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

  1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;
  2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;
  3. Any risk is the least possible for achieving the objectives of the research;
  4. If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part;
  5. If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisionsexcept that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.
  6. Each individual providing consent under paragraph (d) or (e) of 46.204is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;
  7. For children as defined in 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of 46.408.
  8. No inducements, monetary or otherwise, will be offered to terminate a pregnancy;
  9. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and
  10. Individuals engaged in the research will have no part in determining the viability of a neonate.


Research involving pregnant women, prisoners, and children are subject to the DHHS Subparts B, C. and D.


For purpose of applying Subpart B, the phrase "biomedical knowledge" shall be replaced with "generalizable knowledge". The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the women or the fetus or involving fetuses or neonates as participants.


Fetal Research must comply with the US Code Title 42, Chapter 6A, Subchapter III, part H, 289g.


B. Research Involving Prisoners (45 CFR 46 Subpart C)

For prisoners, "minimal risk" means the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

 

46.303(c) "Prisoner" means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

 

The current HSRRC includes a prison advocate who will be consulted when reviewing research projects involving prisoners. Additional consultation may be sought from researchers with expertise/experience conducting research on prison population.

 

Research involving interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied. The prisoner representative must concur with the determination that the research involves no greater than minimal risk.
Review of modifications and continuing review must use the same procedures for initial review using this expedited procedure including the responsibility of the prisoner representative.


For research that does not involve interaction with prisoners (e.g. existing data, record review) reviewed by the expedited procedure:

  • Research that does not involve interaction with prisoners may be reviewed by the expedited procedure, if a determination is made that the research involves no greater than minimal risk for the prison population being studied.
  • Review by a prisoner representative is not required.
  • The prisoner representative may review the research as a reviewer or consultant if designated by the HSRRC chair.
  • Review of modifications and continuing review must use the same procedures as initial review.

 

For more information on research involving prisoners, please visit the OHRP webpage: https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/prisoner-research/index.html.

 

HSRRC Expedited Review of Research Involving Prisoners

1) ISSUES RELATED TO CONSENT


In a closed institution such as a prison there may be extraordinary organizational and interpersonal pressures which intrude into the decision whether or not to participate as a subject in research. This may be particularly evident in group situations and classroom environments. Wherever possible, prisoners should be given the opportunity to reflect on the decision to participate in private.

 

On occasion, research will be situated in a prison classroom setting assuring the structured program segment for the day. A prisoner who elects not to participate in such research should be offered an alternative program for the time in question to minimize coercion.

 

Some prisoners may feel they will lose privileges or be punished if they choose not to
participate in research; others may hope for favorable treatment or early release if they do participate. Prisoners must be assured they will be neither punished nor rewarded for their participation, and that they can discontinue their participation at any time without an institutional penalty.

 

Many adult prisoners are deficient readers, many have an incomplete formal education, and many speak English poorly or not at all. Investigators must use necessary measures to assure that these populations clearly understand the nature of the research and its potential risks.

 

2) ISSUES RELATED TO CONFIDENTIALITY


Special care should be taken to avoid requesting information in a group setting that could jeopardize the safety of individual prisoners.

 

In the collection of research data, special care should be taken to assure that confidential materials do not come into possession of prison administrators, guards and correctional officers, or other prisoners.

 

Prisoners are much more likely than other populations to be associated with sensitive data. This could include, for example, involvement in illegal activity and HIV/AIDS. Appropriate safeguards are necessary regarding the collection, storage, and destruction of such information.

 

Research conducted with the Bureau of Prisons:

  • A non-employee of the Bureau may receive records in a form not individually identifiable when advance adequate written assurance that the record will be used solely as a statistical research or reporting record is provided to the agency.
  • Except as noted in the consent statement to the participant, the researcher must not provide research information that identifies a participant to any person without that participant's prior written consent to release the information. For example, research information identifiable to a particular individual cannot be admitted as evidence or used for any purpose in any action, suit, or other judicial, administrative, or legislative proceeding without the written consent of the individual to whom the data pertain.
  • Except for computerized data records maintained at an official Department of Justice site, records that contain non-disclosable information directly traceable to a specific person may not be stored in, or introduced into, an electronic retrieval system.
  • If the researcher is conducting a study of special interest to the Office of Research and Evaluation (ORE) but the study is not a joint project involving ORE, the researcher may be asked to provide ORE with the computerized research data, not identifiable to individual participants, accompanied by detailed documentation. These arrangements must be negotiated prior to the beginning of the data collection phase of the project.

 

3) ISSUES RELATED TO CONTENT


Investigators must be aware that research into certain topical areas within the institution setting can be potentially dangerous for participants. For example, the mere act of interviewing a prisoner about sensitive topics such as gang activity, contraband, and prison prostitution may inadvertently label the respondent as an informant. Great care must be taken to balance the research against protection of the prisoner as subject.

 

The risk of suicide is an ever present concern in the penal environment. The investigator must assure that debriefing is readily available to the prisoner whenever the subject is questioned about sensitive topics that could evoke self-injury once the prisoner has returned to the privacy of his or her cell.


C. Research involving children (45 CFR 46. Subpart D)

 

When a proposed research study involves children and is supported or conducted by HHS, the research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that provide additional protection for the children who would be involved in the research. If the proposed research involves FDA-regulated products, then FDA's parallel regulations apply. Please visit OHRP FAQs on Research with Children for more information.


By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.


When reviewing research with children as subjects, in addition to ensuring adherence to the general regulatory requirements of 45 CFR part 46, Subpart A, the IRB also must consider the potential benefits, risks, and discomforts of the research to children and assess the justification for their inclusion in the research. In assessing the risks and potential benefits, the IRB should consider the circumstances of the children to be enrolled in the study-for example their health status, age, and ability to understand what is involved in the research-as well as potential benefits to subjects, other children with the same disease or condition, or society as a whole.


For any protocol involving children, the IRB must determine which of the categories of research apply to that study, if any. OHRP recommends that the IRB document the rationale for this choice.


The HHS regulations at 45 CFR part 46, subpart D permit IRBs to approve three categories of research involving children as subjects:


45 CFR 46.404- Research not involving greater than minimal risk to the children.
To approve this category of research, the IRB must make the following determinations:

  • the research presents no greater than minimal risk to the children; and
  • adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.


45 CFR 46.405- Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research.
To approve research in this category, the IRB must make the following determinations:

  • the risk is justified by the anticipated benefits to the subjects;
  • the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches; and
  • adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.


45 CFR 46.406- Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject's disorder or condition.
In order to approve research in this category, the IRB must make the following determinations:

  • the risk of the research represents a minor increase over minimal risk;
  • the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations;
  • the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition; and
  • adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

A fourth category of research requires a special level of HHS review beyond that provided by the IRB.


45 CFR 46.407- Research that the IRB believes does not meet the conditions of 45 CFR 46.404, 46.405, or 46.406, but finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.


If the IRB believes that the research does not meet the requirements of 45 CFR 46.404, 46.405, or 46.406, but finds that it presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children, it may refer the protocol to HHS for review. The research may proceed only if the Secretary, HHS, or his or her designee, after consulting with a panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and following an opportunity for public review and comment, determines either: (1) that the research in fact satisfies the conditions of 45 CFR 46.404, 46.405, or 46.406, or (2) the following:

  • the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;
  • the research will be conducted in accordance with sound ethical principles; and
  • adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

 

46.408 Requirements for permission by parents or guardians and for assent by children


1. In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with 46.116 of Subpart A.


2. In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by 46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §§46.406 and 46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.


3. In addition to the provisions for waiver contained in 46.116 of subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with federal, state, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

 

All research that is requesting waiver of parental permission, must be reviewed by the full board. The full board must find and document the following:

45 CFR 46.116(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

    1. The research involves no more than minimal risk to the subjects;
    2. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
    3. The research could not practicably be carried out without the waiver or alteration; and
    4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
    5. Permission by parents or guardians shall be documented in accordance with and to the extent required by 46.117 of subpart A.
    6. When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

46.409 Wards


(a) Children who are wards of the state or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:

    • Related to their status as wards; or
    • Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

(b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian (DHHS definition of "Guardian" are found on page 63) or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

 

SCHOOL PERMISSIONS


Schools do not have the authority to give consent for children to participate in research; only parents or guardians have that authority. However, permission from the school must be obtained before conducting research in schools. The letter of permission need to be on the official school letterhead and signed by the school official (e.g., principals or superintendents). Investigators should check with the district office to determine the appropriate procedure for obtaining permission. The research cannot begin until written permission is received by the HSRRC.

 

MINIMIZING COERCION


In conducting research on children, every attempt must be made to minimize coercion to participate. Researchers must remember that children are in a dependent relationship with adults and special care must be taken to ensure that the decision to participate as research subjects made by children is truly voluntary.

When the investigator is unfamiliar with the population to be studied, he/she should consult experts to determine the degree of coercion in the procedures to be used. Such judgments are inevitably subjective and often result in negotiation between the HSRRC and investigators, who should be prepared to justify questionable procedures.

 

D. Research involving cognitively impaired subjects


Cognitively impaired persons have a diminished capacity for judgment and reasoning due to psychiatric, organic, developmental, or other disorder that affects cognitive or emotional functions.


Other individuals, who may be considered cognitively impaired, with limited decision-making ability, are individuals who are also chemically dependent, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical disabilities. Decision making capacity may fluctuate.

 

The HSRRC shall consider the ethical concern of how the individuals with psychiatric, cognitive, or developmental disorders, or those who are substance abusers have the capacity to understand the information presented and their ability to make a reasoned decision about participation.

 

Research should involve cognitively impaired subjects where:

  • They compromise the only appropriate subject population
  • The research question focuses on an issue unique to subjects in this population
  • The research involves no more than minimal risk
  • Research that involves greater than minimal risk may be acceptable where the purpose of the research is therapeutic with respect to individual subjects and where the risk is commensurate with the degree of expected benefit.

 

Surrogate Permission with Subjects Judged Incompetent to Consent


A research subject must be competent to give informed consent; otherwise, the consent of the legally authorized representative of the patient must be obtained. In New York State incompetent subjects include children (those individuals under 18 years of age) and the mentally disabled. If competency issues are anticipated for a study, they must be acknowledged in the research proposal and the procedures used to evaluate competency must be described in detail.

 

DHHS Definition

  • 45 CFR 46.102(e) guardian: means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
  • 102(c) is followed: (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.


New York State Definition


Legal Guardian: an individual who has obtained legal guardianship through the Surrogate Courts Proceedings Act §1700 ff., Domestic Relations Law §81 and Article Six of the Family Court Act.


New York State Law states that surrogate consent, other than that of a parent or legal guardian is not allowable, unless there is a legal document that specifically authorizes another to act on behalf of someone for research purposes (Public Health Law Section 2442). For example, the consent of a friend would not be allowed. Those individuals allowed to give consent to a third party include:

  • Persons appointed as health care agents
  • Court appointed guardians
  • Next of kin in the following order: spouse, adult child, parent, and adult sibling when there is a legal document that specifically authorizes another to act on behalf of someone for research purposes as per Public Health Law Section 2442.

Research conducted outside New York State


It is the Principle Investigators responsibility to determine which individuals are considered ,"children" or "guardians" outside of New York State to ensure that Federal Guidelines 45.102(c) is followed: (c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research. The FDA Regulations 21CFR50.55(e)(1) Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient, if consistent with State law, for clinical investigations to be conducted under 50.51 or 50.52.(2) Where clinical investigations are covered by 50.53 or 50.54 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child if consistent with State law.
Therefore, the Principal Investigator must provide to the HSRRC documentation of State Law, where the research is being conducted, concerning proxy care and these laws must be incorporated in the consent process.

 

E. Research involving students, employees, economically/educationally disadvantaged individuals, racial/ethnic minorities, terminally ill, and individuals with AIDS/HIV+


Students, employees, economically/educationally disadvantaged individuals, racial/ethnic minorities, terminally ill, and individuals with AIDS/HIV+ are also considered vulnerable subjects although the federal regulations do not provide explicit protections for subjects in these categories. When conducting research involving these populations, investigators need to take the following into consideration:

  • The compensation to human subjects should not be so great to constitute an undue inducement
  • Students, employees, or any individual who belongs in a(n) class/organization/institution should be recruited through general announcement or advertisement by an unaffiliated researcher, rather than through an individual affiliated with the class/organization/institution to avoid any form of undue influence.
  • Confidentiality of data- sensitive subjects such as health, sexual activity, or the use of illicit drugs or alcohol, and personal health information present risk to subjects of which they should be made aware and from which they should be protected.

 

XVII. International research

 

Research in foreign countries also presents special concerns regarding the rights and welfare of human subjects. All policies and procedures that are applied to research conducted domestically are applied to research conducted in other countries. In general, the HSRRC accepts the standards of the location in which the research is taking place, unless those standards grossly violate the basic principles of ethical human subjects' research. In addition, the following issues apply to international human subjects' research:

  • The review of international research may fall under "exempt" and "expedited" review.
  • All materials, including consent forms, must have English language translations included with the protocol.
  • OHRP requires that IRB must have knowledge of the local research context – this can be accomplished through an outside consultant who is familiar with the region and provides the committee a summary of the risks to the human subjects in this culture.

 

Involvement of External Consultant

External consultant who is familiar with the local context/laws of the international research will be asked to sign a confidentiality statement. Once the confidentiality statement is received, they will be given access to the study materials through PACS. Consultants will be asked to write a summary assessing any risk involved in the study given its cultural context and the appropriateness of the study.

 

National Ethics Board

Some countries require a separate national ethics board review. Please visit https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html for a list of countries that require additional review from their ethics board.

 

Collaborative Projects


If a project will be conducted in collaboration with a foreign institution and the foreign institution has a FWA, HSRRC can sign an Institutional Authorization Agreement to rely on them for review of the study. Please contact HSRRC to determine whether such agreement can be made.

 

XVIII. Review of research involving drugs and devices

 

Drugs

The HSRR office staff will review all documentation submitted by the Principal Investigator to determine that when an investigator proposes to conduct research that involves a drug that one of the following is true:

  • The drug has an IND number and the IND number is supported by one of the following: (The Investigator Brochure may not be used for this purpose.)
  • Sponsor protocol imprinted with the IND number.
  • Written communication from the sponsor documenting the IND number.
  • Written communication from the FDA documenting the IND number. (Required if the investigator holds the IND.)
  • The drug falls into one of the categories of exemption from an IND. [See 21 CFR 312.2(b)]

 

Control of Investigational Drugs
The HSRRC will review the plan for storage, control, and dispensing of the drug to evaluate whether the plan is adequate to ensure that only authorized investigators will use the drug and they will use the drug only in subjects who have provided consent.

 

Devices
The HSRR office staff will review all documentation submitted by the Principal Investigator to determine that when an investigator proposes to conduct research that involves evaluating the safety of effectiveness of a device that one of the following is true:

  • The device has an IDE and the IDE number is supported by one of the following: (The Investigator Brochure may not be used for this purpose.)
  • Sponsor protocol imprinted with the IDE number.
  • Written communication from the sponsor documenting the IDE number.
  • Written communication from the FDA documenting the IDE number (Required if the investigator holds the IDE.)
  • The device meets the requirements for an abbreviated IDE. [See 21 CFR 812.2(b)]
  • The device falls into one of the categories of exemption from an IDE. [See 21 CFR 812.2(c)]

 

Control of Investigational Devices
The HSRRC will review the plan for storage, control, and dispensing of the device to evaluate whether the plan is adequate to ensure that only authorized investigators will use the device and they will use the device only in subjects who have provided consent.

Last Updated: 10/17/18