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.
The extent of the review of the project will be based on the following criteria:
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 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 106 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:
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:
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:
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
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. 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 subitted 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: