Bryn Mawr College is committed to safeguarding the welfare, rights, and privacy of all persons who participate as subjects in research projects conducted under its auspices, and to ensuring that the subjects of such research are aware of their rights and the protections available to them. Moreover, the College is required to assure the federal government that such safeguards are being provided and enforced. These safeguards derive from the following ethical principles, which were first articulated in the Belmont Report issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979:
Respect for persons: recognition of the personal dignity and autonomy of individuals and special protection of those persons with diminished autonomy or particular vulnerabilities, including prisoners, children, those who are mentally or cognitively disabled, pregnant women, or economically or educationally disadvantaged persons. Human subjects should enter into research voluntarily and with adequate information.
Beneficence: the obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks. Possible risks to human subjects should be weighed against possible benefits to the subjects, as well as against the possible improvement of knowledge.
Justice: fairness in the distribution of research benefits and burdens. In selecting human subjects for research, investigators should ensure that no group of participants is either consistently selected to participate in research, or consistently deprived of the opportunity to do so.
The Institutional Review Board for the Protection of Human Subjects (the IRB) is the body charged with reviewing, prior to its commencement, all research, whether funded or not, involving human subjects conducted under the auspices of Bryn Mawr College by its faculty, students, or staff, as well as research by outside investigators using Bryn Mawr College students, personnel, or facilities. "Research" is defined as "systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge" (45 CFR 46.102d). Research subject to review thus includes, but is not limited to, pilot studies; class projects aimed for publication; Master’s theses; Ph.D. dissertations; co-supervised work; independent research; and senior theses, whether such research takes place on or off the Bryn Mawr campus, including work done outside of the United States. Class-based or lab projects should be reviewed on a biannual basis with the departmental reviewer to determine whether these projects are exempt or not.
The procedures for review described below adhere to the regulations of the Department of Health and Human Services (45 CFR 46, as amended and published in the Federal Register on June 18, 1991), and to the Single Project Assurances filed with the HHS by the College. In addition, the IRB has consulted Protecting Human Subjects: Institutional Review Guidebook (1993), prepared by the Office for Protection from Research Risks of the National Institutes of Health; and has adopted sections from the policies of Connecticut, Middlebury, Smith, and Wellesley Colleges, and the University of Pennsylvania, all of which are based on the same federal standards.
Faculty members, staff members, or students who are planning research projects involving human subjects are responsible for initiating the review process by submitting their research proposals to the faculty member in their department who has been designated as the "departmental reviewer." (Each department and the Graduate School of Social Work and Social Research should appoint a faculty member as the "departmental reviewer" who will be responsible for overseeing this initial review.) The IRB committee consists of at least five faculty members appointed by the provost; a member of the community unaffiliated with the College, also appointed by the provost; and, serving ex officio, the college counsel and the director of faculty grants. The departmental reviewer, a representative of the IRB, reviews the proposed research and then assigns the proposal to one of the following categories:
It is expected that most research projects will fall into the exempt category. Research in the exempt category requires no further review beyond the departmental level. Proposals determined by the departmental reviewer to require expedited review will be forwarded to the chair of the IRB, who will designate a member of the IRB to conduct the review. Proposals judged by the departmental reviewer to require full review will be forwarded to the chair of the IRB committee, and the IRB committee as a whole will perform the review.
All research proposals are evaluated by the departmental reviewer, the chair of the IRB, or the full IRB committee with regard to the degree of "risk," if any, to human subjects. The IRB will provide the departmental reviewer with a set of forms to aid in the determination of risk. If a research proposal is determined by the departmental reviewer to involve minimal or more than minimal risk, the departmental reviewer will send the proposal to the chair of the IRB committee for expedited or full review. Under an expedited review procedure, the chair and/or one additional member of the IRB, designated by the chair, will review the proposal; the proposed research must involve no more than minimal risk (see p. 5, lines 1-3) and the only involvement of human subjects must fall under one or more categories, specified under Expedited Review, on pages 4-6 of this document. Full committee review is required when the procedures of the research present more than minimal risk (see p. 6, #5 under Full Committee Review) to the subject and/or fall into one or more of the categories specified under Full Committee Review on p. 6 of this document.
There are four possible outcomes to a review:
Research approved by the IRB that is continuing must be re-reviewed on an annual basis by the IRB; the IRB chair will determine whether a full or expedited review is required.
A letter describing the decision of the IRB committee will be sent to the investigator. Faculty members, staff members, or students who have submitted research proposals for review and have been asked to make revisions or have been denied approval may request the IRB to review its decision, and may write to or appear before the committee to discuss that decision.
The IRB committee will meet twice each semester, with dates designated and circulated to all members of the faculty before the beginning of each semester. Research proposals requiring full review should be submitted at least two weeks before the committee meeting. Any proposal in need of full review that does not meet this deadline will be reviewed during the next scheduled meeting. Research proposals that have been conditionally approved will be dealt with by the IRB committee on a case by case basis. Deferred projects (see "Revise and Resubmit, p. 8) will be reviewed at the next scheduled meeting. Research proposals in need of expedited review may be sent to the chair of the IRB at any time. Departmental review timetables are left to the discretion of the departments and their reviewers. The IRB is available as an advisory board if there are any questions regarding the review process and categories of review. The Grants Office provides the relevant forms to investigators to assist them in preparing proposals for review, and to departmental reviewers and investigators to assist them in determining the appropriate category of review. (See Appendix for "Summary Forms" and "Forms A and B-1–4.)
All research, including that which the investigator believes falls into the exempt category, must be submitted to the departmental reviewer for confirmation of the relevant review category. The criteria used to determine the categories of review are described below.
If ANYof these apply:
All necessary forms and instructions for completing them may be accessed in the Appendix.
All records must be retained for three years after the completion of the research. Records may include such items as research proposals, informed consent documents, progress reports, reports of any injuries to subjects, and all related correspondence concerning the use of human subjects.
The IRB will meet twice each semester: in September, November, February, and May. The IRB chair will inform the college community of the exact dates of those meetings by the end of August for the September and November meetings, and by the end of December for the February and May meetings.
For research requiring full IRB Committee review, the investigator should submit to the chair a copy of the proposal and Form "Full Committee Review" for each of the 10 members of the IRB. The chair should receive these forms at least two weeks in advance of the stated IRB meeting.
Departmental and/or IRB approval must precede commencement of any work involving human subjects.
The IRB must be notified if adverse events occur and what actions the investigator has taken to respond.
Data collection involving human subjects that extends beyond one year must be re-reviewed, and re-approval granted, by the departmental reviewer if the status of the research is exempt, or by the IRB if the status of the research is expedited or requires full IRB review.
Changes in the procedures of collecting data from human subjects must be re-reviewed and approved by the departmental reviewer and/or the IRB.
Each proposal should indicate the purpose of the project, a description of the subjects, including how they will be recruited, a full description of all procedures, and copies of all instruments (e.g., questionnaires, surveys, consent forms, recruitment flyers and procedures). Sample recruitment letters or advertisements should also be included. Complete details about proposal components for each level of review are provided in the Appendix.
Subjects must have sufficient information to make an informed decision to participate in the research study. If subjects cannot give informed consent, it must be obtained from their legal representatives. For example, when subjects are minors (under 18) or when they are mentally incapacitated, legal representatives are required.
Consent documents should be clearly written and understandable to subjects. The consent form should include language that is nontechnical. Scientific, technical, or medical terms should be plainly defined. (See "Components of a Consent Form," and "Model Consent Form," in the Appendix.)
Children (those under 18) should be given an explanation – at a level appropriate to the child’s age, maturity, experience, and condition – of the procedures to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. Children should be asked if they wish to participate in the research or not. Mere failure to object on the part of the child should not, in the absence of affirmative agreement, be construed as assent. In the proposal, the investigator should indicate: 1) how assent will be obtained (what the investigator will say to the child and whether or not the child’s parent(s) or guardian(s) will be present); 2) how assent will be documented. The child may either sign a very brief assent form or verbally indicate a willingness to participate.
There are some situations where a written consent form may not be required: (1) if the principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior); (2) if the consent document is the only record linking the subject with the research; or (3) if the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.
If there is no written consent form, an oral presentation of the research should be provided to the subjects by the investigator, with documentation that such a presentation was made to the subjects.
For proposals reviewed by the IRB, a letter will be sent to the investigator by the IRB chair, indicating one of four possible outcomes:
Research conducted outside of the United Sates by Bryn Mawr faculty, students, or staff must be reviewed in accordance with Bryn Mawr College IRB review procedures. Such research must also conform to the standards for research involving human subjects of the host country. Collaboration with colleagues at a local institution in the host country often provides a good method for ensuring compliance with host country law and human subject conventions in research. Please see the Guidelines for International Researchers
The investigator should send a copy of the proposal, including interview schedules, consent forms, and copies of flyers or advertisements to the President’s Office. If the President approves the proposal, she will forward it to the IRB for human subjects review. If she does not approve the project, the investigator will be informed of this by the President and no action will be taken by the IRB.
If some portion of the research is conducted at another institution, that institution must also review and approve the research protocol. The Bryn Mawr College IRB will normally request some evidence of review and agreement from the host institution. If the host institution does not have a Human Subjects Review Committee, a letter on institutional letterhead signed by an official of the host institution agreeing to permit access to the study population will be required.