Bryn Mawr College is committed to safeguarding the welfare, rights, and privacy of all persons who are participants in research projects conducted under its auspices, and to ensuring that the participants 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, or pregnant women. Human participants 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 participants should be weighed against possible benefits to the participants, as well as against the possible improvement of knowledge.
Justice: fairness in the distribution of research benefits and burdens. In selecting human participants 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 participants 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.
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 Federalwide Assurance (FWA #00000765) and Institutional Organizations (IORG #0005195).
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, the Director of Sponsored Research, and the Grants Associate.
Faculty members, staff members, or students who are planning research projects involving human participants 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 departmental reviewer, a representative of the IRB, reviews the proposed research, determines whether the proposal is exempt from further review or requires an expedited or full review, and confirms that the application is complete (See Departmental Reviewer Guidelines link).
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 participants. The IRB will provide the departmental reviewer with a set of forms to aid in the determination of risk.
Research in the exempt category requires a confirmation of exemption by the IRB chair. Exemption means that there is no risk to participants. The departmental reviewer should send research that is deemed exempt to the IRB chair via email. The IRB chair will confirm the level of review and then send a letter to the researcher confirming the exemption. At that point, unless procedures change, there is no further review by the IRB. (See Form B, which defines the categories of research that are exempt.)
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 (who remains anonymous to the researcher) to conduct the review. Expedited review means that the study poses no more than minimal risk. Proposals judged by the departmental reviewer to require full review will be forwarded to the chair of the IRB, who will forward the proposal to the IRB committee as a whole, who will perform the review. The proposed research must involve no more than minimal risk and the only involvement of human participants must fall under one or more categories, specified under Expedited Review (See Form C, which defines the categories of research requiring an expedited review).
Full committee review is required when the procedures of the research present more than minimal risk to the subject and/or fall into one or more of the categories specified under Full Committee Review (See Form D, which defines the categories of research reuiring a full review).
Research requiring full reviews are reviewed at 4 full IRB meetings during the academic year, in October, December, February, and May. The specific meeting dates are posted at the beginning of each semester.
It is expected that most research projects will fall into the exempt or expedited categories.
There are three possible outcomes to a review:
Research approved by the IRB that is continuing must be re-reviewed on an annual basis in one of the four stated meetings of the IRB which is closest to the anniversary of the proposal’s original approval.
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 (October, December, February, and May), 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 one week before the committee meeting. Remember that the Departmental Reviewer has to sign off on the full review application before it is sent to the IRB chair, one week in advance of the meeting. Any proposal in need of full review that does not meet this deadline will be reviewed during the next scheduled meeting. If the changes requested for a full review are minor, the IRB chair can review the changes and it does not need to go to the IRB committee. If changes are substantial, they will be reviewed at the next stated meeting of the IRB. Research proposals in need of exempt or 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. See IRB Forms link for Forms A, B, C, and D.
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. The departmental reviewer confirms it and if he/she agrees then he/she will forward the application to the IRB chair. The IRB chair then writes a letter confirming the exempt status and the category of exemption. Research should not begin until this letter is received.
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 (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)
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 research requiring full IRB Committee review, the investigator should coordinate with their departmental reviewer to ensure that the departmental reviewer can send the proposal to the IRB chair at least one week in advance of the stated IRB meeting. Proposals that require exempt and expedited levels of review may be submitted at any time. The review process will take approximately ten days for exempt research, and approximately two weeks for expedited research.
The IRB must be notified if adverse events occur and what actions the investigator has taken to respond. See Adverse Events Policy (Under development).
Data collection involving human participants that extends beyond one year must be re-reviewed by the IRB if the status of the research is expedited or requires full IRB review. Research that was given an exemption, does not need to be reviewed on an annual basis unless the procedures and instrumentation will change.
Any changes in the instrumentation and/or the procedures of collecting data from human participants require an amendment to be sent to the IRB chair before any new procedures and instrumentation are implemented.
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. Complete details about proposal components for each level of review are provided in the Appendix.
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 documents should be clearly written, with short sentences that are understandable to participants. The consent form should include language that is nontechnical. Scientific, technical, or medical terms should be plainly defined. Use the second person in the consent form. (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 assured that what they tell the researcher will remain confidential. 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 participant’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 participant 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 participants by the investigator, with documentation that such a presentation was made to the participants. The IRB will need to review the oral presentation and documentation.
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 participants 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 participant conventions in research. Please see the Guidelines for International Researchers (which are currently in development).
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.
(This section under review.)
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.
Leslie Alexander – Chair – Social Work
Jim Baumohl – Social Work
David Consiglio – Head of Research Support and Educational Technology
Glenn Wilson – Outside Representative
Gary McDonogh – Growth and Structure of Cities
Judy Porter – Sociology (Emerita)
Bethany Schneider – English
Jennifer Spohrer – Coordinator of Academic Technology Initiatives
Anjali Thapar (Semester I, 2015-2017), Rob Wozniak (Semester II, 2016-2018) – Psychology
Casey Barrier – Anthropology (Joining Spring 2016)
Nona Smith – Director of Sponsored Research, Ex Officio
Billie Jo Ember – Grants Associate, Ex Officio
Sam Magdovitz – College Counsel, Ex Officio
November 2015 (Under Review)