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Swarthmore College IRB Procedures for Approval of Human Subjects Research

This document has several parts:

• Ethical and Procedural Guidelines
• Procedures for Review of Proposals for Human Subjects Research
• Outcomes of the Review Process
• Procedures for Continuing Oversight of Ongoing Research
• Education of Investigators, IRB Members, and other Relevant Personnel with Regards to Human Subjects Research

Ethical and Procedural Guidelines

Human Subjects Research at the College is guided by the ethical principals laid out in The Belmont Report. and procedures described in 45 CFR, Subtitle A, Part 46.

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Procedures for Review of Proposals for Human Subjects Research

The types of research requiring review are outlined in the directions for Submission of Human Subjects Research for Approval by the Institutional Review Board at Swarthmore College.  

Exempt Research

It is expected that most research performed at the college will be exempt from review.  This determination will be made by the IRB Chair after reviewing IRB Form 1 as submitted by the researcher.  This determination will generally be made within 2 weeks of submission of the research for approval.

Types of research that do not require review include (see 45 CFR, Subtitle A, Part 46.101b for a more complete listing):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
   1. research on regular and special education instructional strategies, or 
   2. research on the effectiveness of or the comparison among 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, unless:
   1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; or
   2. any disclosure of the human subjects' responses 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. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Expedited Review 

It is expected that almost all research at Swarthmore College that is not exempt from review will qualify for expedited review.  Expedited review is used for research that presents no more than a minimal risk (Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests) to human subjects and involve only procedures that fall into the following categories (a more detailed list is given in 45 CFR, Subtitle A, Part 46.110):

1. Collection of data from voice, video, digital, or image recordings made for research purposes;
2. Research on 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 research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.);
3. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Expedited reviews will be performed by the chair of the IRB and at least one other member of the IRB, at the discretion of the chair.  An expedited review is usually accomplished within two weeks of application.

Full IRB Review 

Full IRB Review is necessary when the research involves any of the following:

1. Prisoners, fetuses, pregnant women, the seriously ill, or mentally or cognitively impaired adults as subjects;
2. The collection or recording of behavior which, if known outside of the research, could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing to the subject;
3. The collection of information regarding sensitive aspects of the subject's behavior such as drug or alcohol use, illegal conduct, or sexual behavior;
4. Research that does not fall into any of the categories defined as exempt in 45 CFR, Subtitle A, Part 46.110.

Full IRB reviews will be performed by all members of the IRB.  An full review is usually accomplished within three weeks of application.

If the research is approved, written verification of the approval will be sent to the researcher and to the Human Protections Administrator.  The Human Protections Administrator will keep this approval on file for at least three years.  Any other outcome of the review process will also be given in writing to the researcher.

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Outcomes of the Review Process

For proposals reviewed by the IRB,  three outcomes are possible:  

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. 

If the research is approved, written verification of the approval will also be sent to the Human Protections Administrator and to the researcher.  The Human Protections Administrator will keep this approval on file for at least three years.  Any other outcome of the review process will also be given in writing to the researcher.

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