IRB REVIEW OF RESEARCH
IRB (PACS) APPLICATION
LETTERS OF AGREEMENT/SITE PERMISSION
INFORMED CONSENT AND RECRUITMENT
TYPES OF REVIEW
IRB REVIEW OF RESEARCH
Any activity that meets the definition of "human subjects" and "research" by federal regulations needs IRB review.
According to the Department of Health and Human Services "Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge (e.g., dissemination of findings through publications and/or presentations at regional/national/international conferences). Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected, is NOT considered research.
"Human subject" is defined as a living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
If you are unsure if your project meets the definition of Human Subjects Research please contact the IRB at firstname.lastname@example.org or 607-777-3818.
If you are working with existing data that contains private information with direct identifiers (e.g., name, social security number) or indirect identifiers (e.g., study code), it meets the definition of "human subjects" and therefore IRB review is needed. When submitting your IRB application please use the Existing Data Protocol form on the IRB website.
If the primary goal is to evaluate the program for internal, institutional purposes only, and not to contribute to generalizable knowledge or to disseminate beyond the institution, it does not meet the definition of "research" and therefore does not need IRB review.
For collaborative research involving multiple institutions that are considered "engaged" in research (see the IRB Policies and Procedures for an explanation of engaged), an Institutional Authorization Agreement (also known as the Reliance Agreement) can be established for there to be a single IRB of record. The IRB of Record will be responsible for reviewing and approving the collaborative research and other institutions will rely on the IRB of Record so as to eliminate the need for a separateIRB application process. Please contact the IRB office directly at email@example.com if you believe a reliance agreement needs to be established. The IRB office will requie the study title as well as the names of the investigators from Binghamton University and the collaborating institutions.
Yes, Binghamton University PIs must receive Binghamton IRB approval to conduct research with human participants, regardless of where the research takes place. Please contact the IRB office at firstname.lastname@example.org or 607-777-3818 before submitting any documentation to the IRB for transnational research.
You should also be aware that your project may need local IRB approval (or the equivalent ethical review), in addition to approval from Binghamton's IRB. Please see the IRB Policies and Procedures for more information about requirements for transnational human participant research.
If the primary goal is to fulfill a course/major requirement (not for generalizable knowledge or to be distributed beyond Binghamton), it does not meet the definition of "research" and therefore does not need IRB review.
Faculty advisors must review all the IRB documents prior to submission and complete a Faculty Statement. Please visit the IRB website to download the Faculty Supervisor Statement.
All investigators, faculty supervisors (when applicable), and research study personnel are required to complete human subjects research training available through CITI. Depending on the nature of your research, you may need to take Group 1: Biomedical Research or Group 2: Social and Behavioral Researchers. Additional information on required training and how to register for CITI can be found at the IRB website.
All investigators, faculty supervisors (when applicable), and research personnel (e.g., research assistants) listed on the IRB protocol in PACS must complete the required human subjects research CITI training. Anyone who will be directly involved in participant recruitment, informed consent procedures, the collection of data, or have access to identifiable data should be listed as a study team member in PACS. Faculty advisors should also be listed as study team members and must complete CITI training.
CITI certification is valid for 4 years.
If you have a valid CITI certification for conducting human subjects research from another institution, you do not need to complete the training again. Please be sure to upload your CITI certification from the outside institution to the Local Site Documents page in PACS.
Regardless of what institution or organization study team members belong to, any research personnel listed on the IRB protocol in PACS must complete human subjects research CITI training or the equivalent. This includes anyone who will be directly involved in participant recruitment, informed consent procedures, the collection of data, or have access to identifiable data. Research personnel who are not affiliated with Binghamton Univerity but are listed on a Binghamton IRB protocol may register for CITI courses under the Binghamton University account. Additional information on required training and how to register for CITI can be found at the IRB website. Please be sure to upload any External Study Team member training certification documents to the Study Team Members page in PACS.
IRB (PACS) APPLICATION
All submissions are given an initial review by IRB office staff within 2 days to determine if they should be reviewed as exempt, expedited, or full board review. Exempt and expedited studies are considered minimal risk. In general, time from submission to approval for exempt and expedited research can take anywhere from a few days up to a few weeks depending on the completeness of the IRB submission, extent of revisions required by the PI, responsiveness of the PI, and complexity of the research design. We highly recommend that you submit your IRB application as soon as possible to provide sufficient time for review and approval.
Studies that require full board review are reviewed at the monthly convened IRB meetings during the fall and spring semesters. Although initial feedback can be provided any time during the year for research requiring full board review, a decision to approve, approve with conditions, require modifications, defer, or dissaprove cannot be made outside of a convened meeting. The deadlines for research requiring full board review are available on our IRB website. Investigators who think their studies may require full board review are highly encouraged to contact the IRB office to discuss proposal details prior to submission in PACS.
All IRB applications must be submitted via PACS. Please visit the IRB website for instructions on how to register for a PACS account and submit an application.
You can access the IRB application forms/templates, as well as detailed instructions on how to submit a research study application at the IRB website. Below is a basic list of materials that should be included in each IRB application:
- Study Protocol Narrative or Secondary Analysis of Existing Data Protocol
- Informed Consent/Assent Document(s)
- Recruitment Advertisements (i.e., email scripts, flyers, social media posts, etc.)
- Letter(s) of Agreement/Site Permission Letter(s) (if recruiting off-campus)
- Faculty Supervisor Statement (if a student is the study PI)
- Any Data Collection Instruments (if conducting procedures online, both a hard copy of the instrument as well as the electronic link must be provided)
For purposes of the application, study team members are individuals (affiliated with Binghamton or external to the University) who:
- Interact with human subjects (e.g., informed consent process, manipulating subject’s environment for research purposes, conducting data collection procedures);
- Are involved with collecting, reporting or analyzing identifiable subject data; or
- Are faculty advisors providing direct oversight of research involving human subjects.
All local study team members must have a PACS account to be added to the Study Team Members page in PACS. External study team members do not need a PACS account, however you will need to provide contact information and upload certification of CITI trianing.
The IRB evaluates every research protocol according to the ethical principles described in the (Belmont Report) and according to federal, state, and University regulations. In general, the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.
There are many possible considerations, but they should not be difficult to understand if one assumes the subject's perspective. The IRB's role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.
- Who are the subjects and how are they recruited?
- Could they be lured or coerced to participate?
- Is recruitment occuring through an outside organization/institution (e.g., a school or hospital) and is a letter of agreement appropriate?
- Do subjects understand, in advance, what they are agreeing to participate in and give their consent willingly?
- Is it possible that the research procedures may be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences?
- Could the subject be endangered, compromised or embarrassed if information collected leaked out?
Some of the most common risks to participants are:
- Physical Harms
- Physical risks include physical discomfort, pain, injury, illness or disease brought about by the methods and procedures of the research.
- Psychological Risks
- Psychological risks include the production of negative affective states such as anxiety, depression, guilt, shock and loss of self-esteem and altered behavior. Sensory deprivation, sleep deprivation, use of hypnosis, deception or mental stresses are examples of psychological risks.
- Social/Economic Risks
- Social/Economic risks include alterations in relationships with others that are to the disadvantage of the subject, including embarrassment, loss of respect of others, labeling a subject in a way that will have negative consequences, or in some way diminishing those opportunities and powers a person has by virtue of relationships with others. Economic risks include payment by subjects for procedures not otherwise required, loss of wages or other income and any other financial costs, such as damage to a subject's employability, as a consequence of participation in the research.
- Loss of Confidentiality
- In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. The more sensitive the research material, the greater the care that must be exercised in obtaining, handling, and storing data.
- Legal Risks
- Legal risks exist when the research methods are such that the subject or others will be liable for a violation of the law, either by revealing that the subject or others have or will engage in conduct for which the subject or others may be criminally or civilly liable, or by requiring activities for which the subject or others may be criminally or civilly liable.
- Invasion of privacy
- The potential for coercion during recruitment
It is possible that there may be no foreseeable risks associated with participation in the research. However, please carefully assess any potential risk (even if it is low in probability or magnitude). The potential for breach of privacy or confidentiality is frequently overlooked by PIs submitting IRB applications.
- Provide complete information in the protocol regarding the experimental design and the scientific rationale underlying the proposed research, including the results of previous human studies.
- Assemble a research team with sufficient expertise and experience to conduct the research.
Only collect personal information that is absolutely essential to the research activity.
- If personal data must be collected, it should be coded as early in the activity as possible and securely stored so that only the investigator and authorized study staff may access it.
- Identities of individual subjects must never be released without the express consent of the subject.
- Remind participants of their right to withdraw from research
- Setup surveys such that questions can be skipped if participants do not wish to answer
- Study procedures should be conducted in a private space.
You may begin collecting study data only after the IRB has provided a final approval letter for the study via PACS. Additionally, the IRB will stamp and date the informed consent documents in PDF format.
LETTERS OF AGREEMENT/SITE PERMISSION
Yes. If you are recruiting students from a classroom, you need a letter of agreement from the instructor. Please use the letter of agreement template available on the IRB website and adjust the letter accordingly.
If you are simply posting flyers, a letter of agreement may not be needed. If you or the organization staff will be distributing flyers individually, however, or any type of in-person recruitment procedures will be taking place in addition then a letter of agreement likely will be needed. Please contact the IRB office if you are unsure if the project requires a letter of agreement (email@example.com/ 607-777-3818).
If you are recruiting patients or employees from local clinics, you need a letter of agreement from the clinic stating that they give you permission to recruit their patients or employees. Please use the letter of agreement template available on the IRB website and adjust the letter accordingly.
If the online site, social media platform, etc. has not placed any restrictions on who has access to post information a letter of agreement is not needed. If, however, there are some restrictions regarding who has access, a letter of agreement may be needed. Please contact the IRB office if you are unsure of if the project requires a letter of agreement (firstname.lastname@example.org/ 607-777-3818).
INFORMED CONSENT AND RECRUITMENT
Fully informing participants of the risks, benefits, and procedures involved in a study is a standard requirement in research with human participants. Ethically and legally, consent is not considered to be "informed" unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual's decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies. Visit the IRB website to access the Binghamton University Informed Consent Template.
The Binghamton University Informed consent template is available at the IRB website. Please check the website each time you submit a new study protocol to ensure you are using the most up-to-date template.
Both consent and assent involve informing potential participants about the research and its risks and benefits, and documenting their understanding and agreement to participate. The reason the different terms are used has to do with the age of the participants. In research involving adults, "consent" is obtained from individuals to participate in the study. In research involving minors (under 18), a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to "assent" or agree to participate as well.
Both assent and consent templates can be found at the IRB website. Plese check the website each time you submit a new study protocol to ensure you are using the most up-to-date template.
No. There are two sets of circumstances where the IRB may waive the requirement for parental permission. The first involves research or demonstration projects that meet all of the following criteria:
- Are conducted by or subject to the approval of state or local government officials and are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
- Could not practicably be carried out without the waiver or alteration.
The second involves research that meets all of the following criteria:
- Poses no more than minimal risk to the children;
- Would not adversely affect the rights and welfare of children if the IRB approved a waiver or alteration of the requirement for parental permission;
- Could not be carried out without the waiver or alteration; and
- Whenever appropriate, would provide the children with additional pertinent information after participation.
The Common Rule (federal regulation for protecting human subjects in research) allows IRBs to waive the requirement for obtaining informed consent or to approve an informed consent that omits some or all of the required elements of informed consent. In order for the IRB to waive or alter consent, the following requirements have to be met:
- The research involves no more than minimal risk to the subjects;
- The research could not practicably be carried out without the requested waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
The Common Rule (federal regulation for protecting human subjects in research) allows IRBs to waive documentation of informed consent (i.e., obtaining signature) in the following circumstances:
- The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern;
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
Yes. Complete the 'Waiver of Documentation of Consent' section of the protocol narrative form and adjust your informed consent accordingly. Participants must still be provided with a copy of the consent form for their records.
No if you are having participants actually type in their name or collecting an electronic signature. Yes, if you are not actually collecting participant names and they are simply checking a box saying that states they agree to participate.
Electronic informed consent is acceptable as long as it contains all the required elements of informed consent. Please use the informed consent template available on our IRB Submission and PACS page and adjust your informed consent accordingly.
Stamped informed consents are available in PACS under your study history.
For internet-based surveys the informed consent language should be provided at the beginning of the survey and participants should either check a box that states "I agree to participate" or there should be a statement that indicates "by proceeding to complete and submit the survey you are implying consent to participate in the research."
If, for study design purposes, the researcher needs to keep track of who participated or if the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the participant may type in his/her name and the date in the spaces provided on the consent form.
We prefer that you do not use students from your own courses because it is difficult to avoid giving your students the perception that they have an obligation to participate. In other words, there is a potential for implied or actual coercion. Nonetheless, recruitment can be done if it is executed by an individual who has no oversight of the class and is not responsible for assigning course grades. Additionally, if the collection of identifiable information is necessary, the course instructor conducting the research must not have access to the data until final course grades have beeen assigned through official University processes. Lastly, in the event that extra credit is being provided by the instructor for the course, an alternative extra credit assignment must be provided to those who do not wish to participate in the research.
TYPES OF REVIEW
Research involving human subjects may be deemed Exempt if it meets the criteria for one of the eight categories noted in the federal regulations. Research may qualify for Exempt status if it involves very minimal or no risk. Projects will not be given Exempt status if they include any degree of deception, involve more than very minimal risk to participants, involve sensitive information, or include protected classes or vulnerable populations. Exempt research still requires IRB review despite being exempt from some of the federal regulations. These studies are reviewed by the IRB Coordinator. The exempt review process is less rigorous than expedited and full board research, but is held to the same ethical standards to protect the human subjects involved in research.
To qualify for an expedited review, research must fall into nine (9) federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. A proposal that does not fulfill the criteria for Exempt status may undergo an Expedited review.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research. At Binghamton, the IRB Associate Director, at minimum, reviews all expedited research. Reviewers conducting an expedited review may exercise all of the authority of the IRB except that they may not disapprove a study.
Any proposed research not qualifying for Exempt status or Expedited review requires a Full Review, in which a majority of IRB members review and vote on the proposal. These typically involve projects that place human subjects at more than minimal risk, or that involve sensitive topics or vulnerable populations such as prisoners, terminally ill patients, children, veterans, or cognitively impaired persons.
- Exempt research: You will receive a response within 2-3 business days after the submission of your initial IRB application and 1-2 business days from receipt of any subsequent requests for revisions and/or documents. Time from initial receipt to final approval is dependent on the response time of the investigator to submit the requested revisions and documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.
- Expedited research: You will receive a response within 2-5 business days after the submission of your initial IRB application and 2-3 business days from receipt of any subsequent requests for revisions and/or documents. Time from receipt to final approval is dependent on the response time of the investigator to submit the requested revisions and documents. Once all the requested revisions and documents are received and accepted, the approval letter will be sent within 2 business days.
- Full Board research: Although initial feedback can be provided within 2-5 business days after the submission of your initial IRB application, research requiring full board review are reviewed at a convened meeting which occurs monthly September-December and February-May. A determination letter (to approve/approve with contingencies/reject) will be sent 1-2 business days after the convened meeting.
*International research may take longer to review as consultation from an expert will be sought to gain sufficient knowledge of the local research context.
You must submit a modification via PACS for any changes you make to your research procedures, research personnel, consent documents, recruitment, study population, compensation, data collection tools, etc. This applies to approved exempt, expedited, and full board reviewed research. If you are unsure if you need to submit a modification please contact the IRB at email@example.com or 607-777-3818.
Exempt studies do not require a continuing review submission in PACS, however any study modifications must still be submitted.
If your study received expedited approval prior to the implementation of the Revised Common Rule (Jan 21, 2019), you need to submit a continuing review via PACS at least once a year. PIs will recieve notification of upcoming continuing review deadlines via an email from PACS 90 days, 60 days, and 30 days from the date of expiration. Continuing review is not generally required for expedited studies approved on or after the implementation of the Revised Common Rule except for situations in which it it deemed necessary by the IRB.
All full board approved research requires that a continuing review be submitted in PACS at least once a year or as deemed necessary by the IRB. PIs will recieve notification of upcoming continuing review deadlines via an email from PACS 90 days, 60 days, and 30 days from the date of expiration.
You may close your study if all the research milestones below are complete:
- Study is permanently closed to enrollment OR was never open for enrollment;
- All subjects have completed all study-related interventions OR not applicable (e.g. study did not include interventions, no subjects were enrolled);
- Collection of private identifiable information is complete OR not applicable (no subjects were enrolled); AND
- Analysis of private identifiable information is complete OR not applicable (no subjects were enrolled);
You can submit your modification/continuing review/closure through PACS by clicking 'Create Modification/CR' once you are in your approved study.