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About the Institutional Review Board (IRB)

 

IRB Administration
The administrative office of the Insitutional Review Board is located in the Division of Research and Sponsored Programs. The Institutional Official overseeing the activities of the IRB is Nancy Lewis, Assistant Vice President for Research Compliance. 
 
IRB Members
  • Peter Gerhardstein, PhD, IRB Chair
  • Marissa Barbieri, IRB Associate Director
  • Eric P. Hoffman, PhD, School of Pharmacy and Pharmaceutical Sciences
  • Suk Young Kang, PhD, Department of Social Work, College of Community and Public Affairs
  • Kenneth Kurtz, PhD, Psychology
  • Pong-Yu (Peter) Huang, PhD, Watson College of Engineering and Applied Science
  • Nicole Fenty, PhD, Department of Teaching Learning Education Leadership
  • Rodney Gabel, PhD, CCC-SLP Founding Director SLP Decker College of Nursing and Health Sciences
  • Timothy Cortesi, Assistant Director of Technology Support Services, ITS
  • Allen D. Alt, MD, Retired Community Physician
  • Titilayo Okoror, PhD, Department of Africana Studies, Harpur College (alternate member) 
IRB Coordinator Michele Lukovich is the support staff for the IRB and can be reached at hsrrc@binghamton.edu or (607) 777-3818.
 
IRB RESPONSIBILITIES
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). 
 
All research studies involving human subjects conducted by University faculty, staff, and students in connection with their institutional responsibilities, or done under the sponsorship or auspices of the institution, must be reviewed and approved by the IRB prior to commencement of the research. The IRB serves to confirm that all University researchers comply with OHRP regulations, as well as state and local laws, and University policies.
  
The primary purpose of the IRB is to protect the rights and welfare of human subjects involved in research activities being conducted under its authority. In so doing, the IRB shall ensure adherence to the criteria for IRB approval as listed in 45 CFR 46.111 and 21 CFR 56.111 i.e., that:
  • The risks to human research subjects are minimized by using procedures that are consistent with sound research design and that do not unnecessarily expose the research participants to risk.
  • The risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result.
  • The selection of human subjects for research participation is equitable.
  • Human research subjects are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research; and that informed consent is obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required by federal regulations and IRB policies.
  • Informed consent of human research subjects is obtained in advance of research participation and appropriately documented in accordance with, and to the extent required by federal regulations and IRB policies.
  • The research plan, when appropriate, makes adequate provisions for monitoring the data collected to ensure the safety of human research subjects.
  • There are adequate provisions to protect the privacy of human research subjects and to maintain the confidentiality of research data.
  • Appropriate additional safeguards have been included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, pregnant women, decisionally impaired persons, or economically or educationally disadvantaged persons).
The IRB and IRB Office staff serve to assist investigators in the design of ethical and regulatory compliant human subject research studies.
 
IRB members are appointed with one-year, renewable appointments by the Assistant Vice President for Research Compliance with the approval of the president. In compliance with HHS regulations, the IRB is comprised of people from diverse backgrounds and with the professional competence necessary to review specific research activities conducted by the members of the campus community. A variety of professions are represented, including at least one member whose primary expertise is in a nonscientific area and at least one community member who is not otherwise affiliated with the institution personally or through an immediate family member. 
 
FederalWide Assurance (FWA)
Binghamton University holds a Federalwide Assurance with the Office for Human Research Protections (OHRP) in the U. S. Department of Health and Human Services (DHHS). FWAs are required for every institution that is “engaged” in federally-supported human subject research. An FWA is an agreement with HHS to review and approve research involving human subjects in accordance with the ethical principles outlined in the Belmont Report and the DHHS regulations at 45 CFR Part 46.
  • Binghamton University FWA# 00000174
An institution that receives a direct HHS award to support research is automatically considered to be “engaged”, even if all of the activities involving human subjects are carried out by a subcontractor or collaborator. In this case, the awardee institution is ultimately responsible for protecting human subjects under the award. 
 
CONtact information
Peter Gerhardstein, Chair
Marissa Barbieri, IRB Associate Director
Michele Lukovich, IRB Coordinator
 
ITC Building, Room 2204
PO Box 6000
Binghamton NY 13902-6000
Telephone (607) 777-3818
hsrrc@binghamton.edu
 
Anyone who would like to obtain information about a research study, or who has questions, concerns, complaints or wishes to discuss problems should contact the IRB Office.
 
RESEARCH PARTICIPAtion

Binghamton University supports the advancement of both biomedical and social and behavioral research. Volunteers like you from our community are always welcomed to be study participants and your safety and welfare, and our commitment of ethical practices, are our highest priority. Binghamton University is accredited through the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) and holds an approved assurance of compliance (FWA) with the federal Office for Human Research Protections (OHRP). OHRP aslo provides information about becoming a participant. You can access the brochure "Becoming a Research Volunteer: It's Your Decision" at https://www.hhs.gov/ohrp/education-and-outreach/learn-about-research/brochures/index.html to learn more.  You can also be integral in discovering new treatments to improve the physical and mental health of many by participating in a Clinical Trial.  For more information, go to ClinicalTrials.gov.

For information on what to expect a research participant at Binghamton University (i.e. what is an Informed Consent, who do I contact to ask about a study, are there studies I can join at Binghamton as a member of the community, what are my rights as a participant), please reach out to the IRB Associate Director at (607) 777-3918 or at hsrrc@binghamton.edu .

The researcher team conducting the study you are participating in should provide you with answers to specific questions about the study. You may contact the researcher with questions at any time before, during or after the study. If you would like to obtain information about a research study, please contact the IRB Office at (607) 777-3818.

If you have questions, concerns, complaints or wish to discuss problems or your rights as a research subject please reach out to the Office of Research Compliance at (607) 777-3532. Anonymity, if desired, will be protected to the extent possible. As an alternative method of contact, an email may be sent to hsrrc@binghamton.edu  or a letter sent to the attention of the IRB Associate Director at the address noted above.

Becoming an IRB Member

The IRB Office accepts nominations and applications for faculty, staff, and community member service on the the IRB. Members are appointed for one-year, renewable terms. The IRB Office provides initial and ongoing education to all IRB members. Members agree to attend one IRB meeting per month and parking passes are provided for non-Binghamton employees. The time commitment is approximately 4-8 hours per month. Meetings last 1-2 hours and the members attending each meeting must review study materials in advance to prepare for the discussion. At times, IRB members will be asked to serve as secondary reviewers on expedited research reviews.
 
The Binghamton University IRB is, by law and mission, diverse with respect to scientific and non-scientific interests, sex, race, ethnicity, and affiliation with Binghamton University. Members bring varying opinions from their respective backgrounds to decide how best to safeguard the rights and welfare of human subjects in research. Decisions are made through majority rule votes by a quorum of members. If you have an interest in medical, social, or behavioral science research and would like to be involved with protecting the rights, safety and welfare of individuals who volunteer to participate in research, this volunteer opportunity may be for you.  
Send nominations or requests along with a curriculum vitae or resume, and a completed application to the IRB Office at: hsrrc@binghamton.edu. If you have any questions about becoming an IRB member, please contact the IRB Associate Director at 607-777-3918.
 
Community Members
Unaffiliated community members play an important role on the IRB. They bring fresh insight and perspective to board decisions about how best to protect research participants. The Community Member has the particular responsibility of bringing the perspective of the volunteer research participant to the review of protocols. Community members do not have a current affiliation with Binghamton University. They also must not have an immediate family member (spouse or child) affiliated with the institution.
 
Non-Scientist Members
IRB members with a non-scientific background may be employed at Binghamton University or they may be community members.  There must be a non-scientist member at every IRB meeting. 

Last Updated: 12/10/21