Bryn Mawr College

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 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.

The Review Process

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:

• exempt from IRB review
• expedited IRB review
• full IRB review

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:

1. Approved -- no further action is required from the investigator prior to initiating the study;
2. Revise and Resubmit -- more extensive changes are required before the study may begin;
3. Denied -- the proposed research, because of the level of risk involved, cannot be initiated.

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.)

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.

Exempt

Part A (all items must apply)

1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
3. The research does not involve the collection of information regarding sensitive aspects of subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
4. The research does not involve subjects under the age of 18 (except as they are participating in projects that fall under categories 1, 3, 4, and/or 5 in Part B). Category B 2 studies that include minors should be submitted for expedited review.
5. The research does not involve deception.
6. The procedures of this research are generally free of foreseeable risk to the subject.
7. The research does not require a waiver from informed consent procedures.

Part B (at least one item should apply)

1. Research conducted in established or commonly accepted educational settings and involving normal educational practices (e.g., research on regular and special education instructional strategies, research on instructional techniques, curricula, or classroom management methods).
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, where information is recorded anonymously (i.e., so that the human subject cannot be identified, directly or indirectly through identifiers linked to the subject). [NB: All survey/interview/observational research in which elected or appointed public officials or candidates for public office serve as subjects is exempt, whether or not data collection is anonymous.]
3. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens. These sources must be either publicly available or the information must be recorded anonymously (i.e., in such a manner that subjects cannot be identified, directly or through identifiers linked to the subject).
4. Research (including demonstration projects) conducted by or subject to the approval of federal department or agency heads, and designed to study, evaluate, or otherwise examine (i) public benefit or service programs (e.g., social security, welfare, etc.); (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
5. Research involving taste or food quality evaluations or consumer acceptance studies, where 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 U.S. Department of Agriculture.

Expedited Review

Part A (all items must apply)

1. The research does not involve as subjects prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults.
2. The research does not involve the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, or reputation.
3. The research does not involve the collection of information regarding sensitive aspects ofthe subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
4. The procedures of this research present no more than minimal risk to the subject. ("Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.)

Part B (at least one item should apply)

1. Research involving existing identifiable data, documents, records, or biological specimens (including pathological or diagnostic specimens), where these materials, in their entirety, have been collected prior to the research for a purpose other than the proposed research. [NB: These sources are not publicly available and, although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or-video-tapes, names will be recorded, even if they are not directly associated with the data).]
2. Collection of data through use of the following procedures: a) non-invasive procedures routinely employed in clinical practice and not involving exposure to electromagnetic exposure to electromagnetic radiation outside the visible range (i.e., not involving x-rays, microwaves, etc); b) 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; c) weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, echography, sonography, ultrasound, magnetic resonance imaging (MRI), diagnostic infrared imaging, doppler blood flow, and echocardiography; d) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing involving healthy subjects.
3. Collection of data from voice, video, or image recordings made for research purposes where identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
4. Research on individual or group characteristics or behavior (including but not limited to research involving perception, cognition, surveys, interviews, and focus groups) as follows:
   1. Involving adults, where (i) the research does not involve stress to subjects, and (ii) identification of the subjects and/or their responses would not reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation;
   2. Involving children, where (i) the research involves neither stress to subjects nor sensitive information about themselves, or their family; (ii) no alteration or waiver of regulatory requirements for parental permission has been proposed; and (iii) identification of the subjects and/or their responses would not reasonably place them or their family members at risk of criminal or civil liability or be damaging to the financial standing, employability, or reputation of themselves or their family members.
5. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior. [NB: Although confidentiality will be strictly maintained, information will not be recorded anonymously (e.g., use will be made of audio-or videotapes, names will be recorded, even if they are not directly associated with the data).]
6. Research that involves deception. [NB: Deception must be scientifically justified and de-briefing procedures must be outlined in detail.]
7. Prospective collection for research purposes of biological specimens; research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required; collection of blood samples by finger stick or venipuncture.
8. Research previously approved by the convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or (b) where the research remains active only for the purposes of data analysis; or (c) where the IRB has determined that the research involves no greater than minimal risk and and no additional risks have been identified; (d) where no subjects have been enrolled and no additional risks have been identified.

Full Committee Review

If ANYof these apply:

1. The research involves prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively compromised adults as subjects.
2. The research involves the collection or recording of behavior which, if known outside the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
3. The research involves the collection of information regarding sensitive aspects of the subjects’ behavior (e.g., drug or alcohol use, illegal conduct, sexual behavior).
4. The procedures of the research involve more than minimal risk to the subject (where "more than minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the proposed research is greater than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests).
5. Any research which does not fall into any of the categories explicitly identified as qualifying for exempt or expedited status.

Forms

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. 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.

Timetable

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.

Proposal Components

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.

Components of Informed Consent

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.)

Assent

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.

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 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.

Review Outcomes

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.
• 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.

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 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

Outside Investigators Wishing to Use Bryn Mawr College Students as Subjects

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.

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
Jim Baumohl

David Consiglio
Ignacio Gallup-Diaz
Philip Kilbride

Gary McDonogh
Judith Porter
Bethany Schneider
Morgan Wallhagen

Robert Wozniak

 

Outside Representative

 

Glenn Wilson

Alternate:

Marc Schulz

Ex Officio Members:

Samuel Magdovitz
Nona Smith


June, 2003