IRB Policies and Procedures
Policies and Procedures for Reviewing Research Involving Human Subjects
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).
Categories of Review
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.
Part I (all items must apply)
- The research does not involve prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
- The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place participants at risk of criminal or civil liability or be damaging to the participant’s financial standing, employability, or reputation.
- The research does not involve the collection of information regarding sensitive aspects of participants’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The research does not involve participants under the age of 18 OR only involves observation of participants under the age of 18 in which there is no interaction between the researcher and participants [45CFR 46.401(b) or educational research [45CRF 46.101(b)(1)].
- The research does not involve deception.
- The procedures of this research are generally free of foreseeable risk to participants.
- The research does not involve collecting image, voice recordings or video recordings of participants.
Part II (at least one item should apply)
- The research will be conducted in established or commonly accepted educational settings (e.g., school or university classrooms, educational centers, etc.), such that participants are aware that learning takes place there. The research focuses on educational questions (e.g., the effectiveness of instructional strategies, techniques, curricula, or classroom management methods) and involves normal educational practices, such as lectures, seminars, didactic sessions, workshops or standardized testing, that are not outside the nature or scope of methods commonly used in education. The research goals are pedagogical, focused on improving student understanding, educational performance, ability to function productively in the classroom, and so forth.
- [45CRF 46.101(b)(2)] The research will involve the use of cognitive, diagnostic, aptitude or achievement tests; survey procedures; interview procedures; or observation of public behavior and information will be recorded anonymously (i.e., so that participants cannot be identified, directly or through identifiers linked to individuals) and the information collected poses no risk of civil or criminal liability nor would be damaging to participants’ employability or reputation if disclosed.
- [45CRF 46.101(b)(3)] The research will involve the use of cognitive, diagnostic, aptitude or achievement tests; survey procedures; interview procedures; or observation of public behavior AND all participants are elected or appointed public officials or candidates for public office.
- [45CRF 46.101(b)(4)] The research will involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources are either publicly available or anonymous (i.e. participants cannot be identified). All data, documents, or records must already exist prior to IRB review; the proposed research must be strictly retrospective.
- [45 CRF 46.101(b)(5)] The research (including demonstration projects) will be conducted by or subject to the approval of federal department or agency heads, and is designed to study, evaluate, or otherwise examine:
- Public benefit or service programs (e.g., social security, welfare, etc.);
- Procedures for obtaining benefits or services under those programs or procedures;
- Possible changes in or alternatives to those programs or procedures;
- Possible changes in methods or levels of payment for benefits or services under those programs
- [45 CRF 46.101(b)(6)] The research involves taste or food quality evaluations or consumer acceptance studies and the tested products are wholesome foods without additives or foods which contain additives at or below levels found to be safe by the FDA or approved by the EPA of the Food Safety and Inspection Service of the US Department of Agriculture.
Part I (all items must apply)
- The research does not involve prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
- The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the participants at risk of criminal or civil liability, be stigmatizing, or be damaging to the participant's financial standing, employability, insurability, or reputation.
- The research does not involve the collection of information regarding sensitive aspects of the participants' behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The research procedures present no more than minimal risk to participants, meaning that the probability and magnitude of harm or discomfort are no greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological tests.
Part II (at least one item should apply)
- The research involves materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) but contain personally identifying information. (Note: If the materials are publicly available or de-identified (i.e., contain no personally identifying information or links to personally identifying information), and no other boxes in Part II are checked, then your research qualifies as exempt from IRB review. Fill out Form B instead.)
- The research involves collecting data in the form of voice, video, digital, or image recordings.
- The research studies individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or employs survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (Note: Research on public officials or that is anonymous and presents no foreseeable risk may qualify as exempt from expedited or full review. See Form B.)
- The research involves deception, but the topic is not sensitive, participants are not vulnerable, and they will be debriefed at the end of their participation.
- The research involves collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Examples:
- physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
- weighing or testing sensory acuity;
- magnetic resonance imaging;
- electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
- moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- The research was previously approved through a full IRB proposal, and one or more of the following apply:
- (i) no new participants will be enrolled and (ii) all participants have completed all research-related interventions or (iii) only long-term follow-up on participants remains,
- remaining research activities are limited to data analysis.
- no participants have been enrolled and no additional risks have been identified.
- above categories do not apply, but the IRB has determined at a convened meeting that the research involves no more than minimal risk and no additional risks have been identified.
Full Committee Review
Part I: Full Review Category Checklist
- The research involves participants who are prisoners, fetuses, pregnant women, seriously ill, or mentally or cognitively compromised adults.
- The research involves the collection of information regarding sensitive aspects of participants’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
- The research procedures involve more than minimal risk to the participants. The probability and/or magnitude of harm or discomfort anticipated is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological tests.
- The research does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.
All necessary forms and instructions for completing them may be accessed in the Appendix.
Retention of Forms
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.
IRB Proposal Components
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.
Components of Informed Consent
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.
Circumstances in Which a Written Consent Form May Not Be Required
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:
- Approved: A protocol which has been approved by the IRB requires no further action from the investigator prior to initiating the study. If the study should extend beyond 12 months, the investigator should send a letter to the IRB chair, informing her/him of the current status of the project, any changes in the protocol, and whether any adverse events have occurred.
- Revise and Resubmit: A protocol that has been deferred by the IRB usually requires that additional information be submitted to the IRB prior to approval. A revised application should be submitted to the IRB clarifying the issues involved or providing the requested documentation. The IRB will review the revised application at its next meeting. If the proposal received a full review and substantive changes are required, the review will take place in the next IRB meeting. If the changes are minor, those changes can be handled via email. If the IRB requests changes for exempt or expedited reviews, those changes are handled via email.
- Denial: A protocol that has been denied approval by the IRB cannot be initiated by the investigator. The reasons for the denial are provided in writing. The investigator will be given the opportunity to respond either in writing or in person at the next meeting of the IRB. This is a very rare occurrence.
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. 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).
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.
(This section under review.)
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. 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.
Institutional Review Board for the Protection of Human Subjects
Leslie Alexander – Chair – Social Work
Casey Barrier – Anthropology
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
Anjali Thapar (Semester I, 2015-2017), Rob Wozniak (Semester II, 2016-2018) – Psychology
Billie Jo Ember – Grants Associate, Ex Officio
Nona Smith – Director of Sponsored Research, Ex Officio
Sam Magdovitz – College Counsel, Ex Officio