Human Subjects Research Policy
All research involving human subjects must be submitted for IRB approval. Click here and refer to Chart 1 to determine if your project is considered Human Subjects Research. The IRB requests that Principal Investigators (PIs) submit their protocols at least two weeks in advance of scheduled IRB meetings to give the committee enough time for proper review. Protocols submitted in less time may not be reviewed until the next scheduled meeting. Even for projects not requiring full committee review (including modifications or continuing reviews of existing protocols), investigators should allow two weeks for appropriate review.
*Some class assignments are considered research and need to be reviewed by the IRB. Click here to determine if your project is considered human subjects research. Please note: all honors projects involving research on human subjects must be reviewed by the IRB.
*Documentaries and ethnographies frequently meet the definition of human subjects research. If your documentary or similar project is intended to produce generalizable knowledge, rather than making an artistic statement or a scholarly contribution that does not generalize beyond the content of the work itself, it is considered research and needs IRB approval. All scholars who are obtaining information about living humans, regardless of whether they believe their projects meet the definition of research, are encouraged to contact the IRB regarding steps to ensure the protection of their participants.
*Researchers that are not affiliated with the College (off campus) require permission from the College prior to initiating their research. Please contact Cara Martin-Tetreault, director of sponsored research for more information.
The extent of the review of the project will be based on the following criteria:
- Exempt Research – Most research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior in which the identity of the subject cannot be established. This includes collecting or studying existing data, records or specimens, if these sources are publicly available or if the information is recorded in a way that the subjects cannot be identified. The IRB chair makes the determination of whether a research project is "exempt" from further IRB review. Thus, even if an investigator expects that a project will be exempt from research, he/she must submit it to the IRB for review.
- Expedited Review – This includes research in which the probability and magnitude of harm or discomfort anticipated are not greater than those encountered in daily life or during the performance of routine physical or psychological tests. The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing. Projects eligible for expedited review will be reviewed by a member of the IRB, and the investigator will be notified of a decision in a timely manner. Expedited review does not need to take place at a convened meeting of the IRB.
- Full Committee Review – Procedures that are potentially harmful to the subjects (even if the rinvestigator views the harm as not unreasonable) are subject to full committee review. Research involving prisoners, pregnant women, fetuses, the seriously ill or mentally or cognitively compromised adults as subjects must be reviewed by the full committee. Research published with the identity of the subject, invasive collection of body fluid or tissue samples, manipulative observations including deception, or stressful physiological recordings fall into this category. Full Committee Review must take place at a convened meeting of the IRB with a quorum present.
The IRB will convene for meetings a minimum of six times a year. There shall be at least three convened meetings in the fall semester and three convened meetings in the spring semester. If a situation requiring a convened meeting arises, there is the possibility of the committee meeting during the summer.
For ease of distribution, the IRB requests that all materials be submitted electronically to IRB@bowdoin.edu and that one, single-sided hard copy of the project application with the investigator's and faculty sponsor's original signatures on the application shall be submitted to Jean Harrison, IRB Administrator, in Room 103 of the Edward Pols House. Projects expected to be exempt from IRB review may be submitted at any time. The IRB chair will review these in a timely manner and respond directly to the investigator with a determination of whether or not the project is exempt.
Each research proposal submitted to the IRB shall consist of the following components:
- Human Subject Protocol Application Form
- Proposal, including detailed study plan
- Informed Consent Template (sample text)
- Copies of all instruments (e.g. questionnaires, surveys, interview scripts) to be used
- Recruiting tools (e.g. letters, fliers, advertisements)
- Evidence of completion of human subjects training for all investigators and faculty sponsor(s) listed. (Choose "Social & Behavioral Research Investigators" module)
**Please note that faculty and students must show evidence that training has been completed in the past 3 years. Applications will not be reviewed until updated training certificates are presented for all PIs and faculty sponsors listed, even if they have been previously submitted with another protocol**
Protocols cannot be reviewed until all application components listed above have been received.
A determination that research is exempt from IRB review or a decision on a project qualifying for expedited review will be communicated to the investigator. An investigator submitting a proposal that undergoes full committee review should expect to receive feedback from the IRB within 48 hours of the conclusion of the convened IRB meeting.
There are three possible outcomes to the review of a research proposal:
- Approval – A protocol that has been approved by the IRB requires no further action by the investigator before the research may commence.
- Revise/Resubmit – A protocol that has been deferred by the IRB usually requires that additional information be submitted. The investigator will receive written details describing what additional information is required. For projects requiring full committee review, the revised protocol will be reviewed at the next convened IRB meeting.
- Deny – A protocol that has been denied by the IRB cannot be initiated. The investigator will receive written details describing the reasons for denial of approval.
The investigator is required to wait for approval from the IRB prior to initiating the research study.
No research may begin before it is approved.
If a protocol is approved, the PD/PI will be provided with a copy of an approval letter.
After the initial approval, there are certain circumstances under which the investigator is required to submit further documentation to the IRB. At a minimum, every 12 months a Continuing Review form must be submitted, updating the IRB on the status of the research and whether any new risks or benefits have been identified. Other reasons for submitting documents to the IRB include:
- an adverse event that is related to study procedures AND unexpected or serious, [Adverse Event Form]
- a change to the described research procedures,[Modification Form]
- a change in the research staff, [Modification Form] and
- termination of the study [Termination Form].
The IRB reviews and approves any proposed modifications to approved research activities before they are initiated. The letter from the IRB to the Principal Investigator at the time of approval states that any proposed changes must be submitted to the IRB prior to implementation. Principal Investigators should use the Modification Form (above) to describe any modifications to either the described research procedures or staff.
In the unlikely event that a change to approved research must be initiated without IRB approval in order to eliminate apparent immediate hazards to a research participant, these changes are submitted to the IRB within 3 business days after the event. The IRB reviews these changes to certify that they were consistent with ensuring the participants continued welfare.
Bowdoin College is required to assure the federal government that the welfare, rights, and privacy (where applicable) of research subjects are being safeguarded. This follows from a set of principles outlined by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in the Belmont Report.
The three ethical principles expressed in the Belmont Report as being relevant to research involving human subjects are
- Respect for Persons
Bowdoin College has submitted a Federal Wide Assurance (FWA) to the Office for Human Research Protections (OHRP) at the United States Department of Health and Human Services (DHHS). This assurance is mandatory for the College as federally-funded human subject research is being conducted on campus. Having submitted this assurance means that the College must be in compliance with the HHS regulations (45 CFR 46) for the protection of human subjects.
To monitor the College's compliance with these federal guidelines, there is a standing faculty committee, the Institutional Review Board (IRB) for Bowdoin College. The IRB has been established to approve all research projects under the auspices of Bowdoin College which involve the use of human subjects – regardless of the funding source for the research.
The IRB is composed primarily of faculty members, appointed to the committee by the Committee on Governance and Faculty Affairs. Each member serves a three-year term on the committee, on a rotating basis. In addition to the requirements of committee composition designated by the College, the composition of the IRB is mandated by the federal government, as per 45 CFR 46.107.
However, it is not just the IRB that has responsibilities for human subjects protection. Any investigator, faculty member, staff member, student, or guest of the college who is planning to participate in a research project involving human subjects must receive training in Human Participant Protection, even if their research is found to be exempt. The required training reviews concepts such as the use of ethical principles and federal regulations, definitions of research terms (such as Informed Consent), and a description of the roles of both the IRB and the investigator. Online training is available at no cost through the Collaborative Institutional Training Initiative for any researcher not otherwise trained in these areas. *All members of the research team must complete training before participating in human subjects research. Documentation of training must be submitted to the IRB before a research project will be reviewed, and evidence of training must be submitted with all applications even if they have been previously submitted with another project.
Federal regulations require that all IRB records be retained for at least three (3) years after completion of the research. These files will be kept with the IRB administrator at IRB@bowdoin.edu. Files to be retained include:
- copies of all proposals reviewed, approved consent documents, progress reports, and reports of injuries to subjects
- detailed minutes of all IRB meetings
- records of continuing review activities
- copies of correspondence between the investigator and the IRB
- list of IRB members
- written procedures for the IRB