The procedures 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 Federalwide Assurance (FWA #00000765) and Institutional Organizations (IORG #0005195).
- Pre-Proposal Training
- Categories of Review
- IRB Proposal Components
- Informed Consent, Assent
- Consent for photo/video recordings
- Site Permission
- When a Written Consent Form may not be Required
- Timetable of Review Process
- Retention of Forms
- Other Policies
Prior to submitting proposals for IRB review, all researchers (i.e., faculty, staff, and students) whose work involves human participants must complete the human subjects research training and receive certification. Departmental reviewers must also complete this training.
There are three categories of review, depending on the level of risk to participants. These levels of review are exempt, expedited or full review. Consult the overview of review categories to determine which policy applies to your research. 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.
Once the category of review has been determined, researchers must fill out the requisite forms. Forms A and either B, C or D (depending on level of review) are required. Each proposal should indicate the purpose of the project, a description of the participants, 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.
Please note that the IRB requires two levels of review, from both the department and the IRB.
Participants must have sufficient information to make an informed decision to participate in the research study. If participants cannot give informed consent, it must be obtained from their legal representatives. For example, when participants are minors (under 18) or when they are mentally incapacitated, legal representatives are required. Remember that informed consent is a process and is not merely obtaining a signature.
Consent/Assent documents should be clearly written, with short sentences that are understandable to participants. These forms should include language that is nontechnical. Scientific, technical, or medical terms should be plainly defined. Use the second person in the consent/assent form.
Circumstances in Which a Signed Consent Form May Not Be Required
- There are some situations where a signed consent form may not be required; you should specify which condition applies in your IRB application: (1) if the research presents no more than minimal risk (exempt or expedited research) and involves procedures that do not require signed consent when they are performed outside of a research setting and a waiver will not adversely affect the rights and welfare of a subject and the research could not be practically carried out without a waiver and if the consent document is the only record linking the participant with the research; Or (2) if the principal risks are those associated with a breach of confidentiality concerning the participant’s participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior) and the only document linking the subject and the research is the consent document; the principal risk would be potential harm from a breach of confidentiality.
- The respondent will receive a brief script that is either given in writing or provided orally, see Oral Consent Script draft.
Departmental and/or IRB approval must precede commencement of any work involving human participants. All proposals require that the Departmental Reviewer sign off and send the complete IRB proposals to the IRB chair. The IRB will meet twice each semester: in October, December, February, and May. The IRB chair will inform the college community of the exact dates of those meetings at the beginning of each semester.
For more, see Review Process
All records must be retained for three years after the completion of the research (this is subject to change). Records may include such items as research proposals, informed consent documents, progress reports, reports of any injuries to participants, and all related correspondence concerning the use of human participants. (Under review)
Research Conducted Outside of the United States
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 participants of the host country. Students must submit either an e-mail or a letter from an academic or an NGO in the host country indicating that they will provide on-the-ground support for the student. 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 participant conventions in research. Please see the Guidelines for International Researchers and Listing of Social-Behavioral Standards.
Outside Investigators Wishing to Use Bryn Mawr College Students, Faculty, and Staff as Subjects
For Students: The investigator should send a copy of the proposal, including interview schedules, consent forms, and copies of flyers or advertisements to the Dean of the Undergraduate College if undergraduate participation is sought, and to the Dean of GSSWSR or SAS if graduate students are being sought. If the Dean approves the proposal, she will forward it to the IRB for human participants review. For studies involving athletes, the Director of Athletics should review the study proposal first before it is sent to the IRB.
For Faculty: In the case of faculty participants, the Provost or her designee should be consulted.
For Staff: In the case of staff participants, Chief Administrative Officer should be consulted.
For Alumni: For research involving Bryn Mawr College alumni, the Executive Director of the Alumnae Office, should review the proposal before it is sent to the IRB. If these individuals do not approve the project, the investigator will be informed of this and no action will be taken by the IRB.
Research Conducted at Off-Campus Sites with Their Own Human Subjects Committees
If some portion of the research is conducted at another institution, that institution must also review and approve the research protocol. Documentation of that approval must be presented to the Bryn Mawr College IRB. 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.