Human Subjects Research at Bowdoin College

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
  • Beneficence
  • Justice

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 Research Oversight Committee (ROC), which serves as the Institutional Review Board (IRB) for Bowdoin College. The ROC 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 ROC is composed primarily of faculty members, appointed to the committee by the Committee on Governance. 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 ROC is mandated by the federal government, as per 45 CFR 46.107.

However, it is not just the ROC that has responsibilities for human subjects protection. Any faculty member, staff member, or student 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 researcher. Bowdoin College suggests the use of a training module sponsored by the National Institutes of Health (NIH) for any researcher not otherwise trained in these areas. Training can be completed at through the National Cancer Institute web-based tutorial. All members of the research team must complete training before participating in human subjects research. Documentation of training must be submitted to the ROC before a research project will be reviewed.

All research involving human subjects must be submitted for ROC approval. 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 ROC chair makes the determination of whether a research project is "exempt" from further ROC review. Thus, even if an investigator expects that a project will be exempt from research, he/she must submit it to the ROC 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 ROC, 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 ROC.
  • Full Committee Review – Procedures that are potentially harmful to the subjects (even if the researcher 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 ROC with a quorum present.

    The ROC 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. During Spring Semester 2007, the ROC will meet on the first Friday of February, March, April and May.

    All research requiring committee review must be submitted to the ROC at least two weeks in advance of the scheduled ROC meeting. For ease of distribution, the ROC requests that all materials be submitted electronically. However, one copy of the project application shall be submitted in hard copy, with the investigator's original signature on the cover page. This hard copy will be kept in the ROC permanent files. Projects expected to be exempt from ROC review may be submitted at any time. The ROC 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 ROC shall consist of the following components:

    A determination that research is exempt from ROC review or a decision on a project qualifying for expedited review will be communicated to the investigator in a timely manner. A researcher submitting a proposal that undergoes full committee review should expect to receive feedback from the ROC within 48 hours of the conclusion of the convened ROC meeting.

    There are three possible outcomes to the review of a research proposal:

    • Approval – A protocol that has been approved by the ROC requires no further action by the investigator before the research may commence.
    • Revise/Resubmit – A protocol that has been deferred by the ROC 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 ROC meeting.
    • Deny – A protocol that has been denied by the ROC 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 ROC prior to initiating the research study.

    No research may begin before it is approved.

    If a protocol is approved, the investigator will be provided with a hard 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 ROC. At a minimum, every 12 months a continuing review form must be submitted, updating the ROC on the status of the research and whether any new risks or benefits have been identified. Other reasons for submitting documents to the ROC include

    Federal regulations require that all ROC records be retained for at least three (3) years after completion of the research. These files will be kept in the office of the Dean for Academic Affairs. 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 ROC meetings
    • records of continuing review activities
    • copies of correspondence between investigators and the committee
    • list of ROC members
    • written procedures for the ROC