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Submission of Human Subjects Research for Approval by the Institutional Review Board at Swarthmore College
October 2006
This document is split into two parts:
Anyone who plans to do research that involves human subjects should first review the procedures and guidelines as laid out in this document.
Procedures followed by the IRB are outlined in the Swarthmore College IRB Procedures for Approval of Human Subjects Research.
For the context of this document "Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." 45 CFR, Subtitle A, Part 46.102d.
Types of research that require review include:
Both funded and un-funded research;
- Pilot studies;
- Class projects that will be submitted for publication;
- Some Senior Theses involving Human Subjects Research;
- Independent research performed by faculty, students or staff;
All research involving human subjects must be reviewed annually at the minimum. Some research may require more than annual review.
If research requires IRB approval, two copies of IRB Form 2 should be submitted to the IRB Chair.
Types of research that do not require review include: (see 45 CFR, Subtitle A, Part 46.101b for a more complete listing):
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
- research on regular and special education instructional strategies, or
- research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; or
- 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.
- 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.
If your research does not require IRB approval, submit IRB Form 1 to the IRB Chair.
If it is not clear if review is necessary, the proposed research should be discussed with the IRB Chair.
1. Research on Human subjects shall follow the Code of Federal Regulations 45 CFR, Subtitle A, Part 46, Protection of Human Subjects as most recently amended, and should be guided by the principles laid out in The Belmont Report. For non-invasive experiments special attention should be placed on the sections in 45 CFR, Subtitle A, Part 46 on minimization of risk to the subjects and informed consent procedures. These regulations do not pertain to activities relating to students within the context of an academic course. Activities by students enrolled in a course which involve subjects outside the course may, however, be subject to review if funded by the U.S. Government or if requested by the Dean of Swarthmore College.
2. Subjects should not normally be placed in emotionally stressful situations. If such stress is deemed essential to the experiment, adequate provision must be made for rapid termination of the experiment at the subject's request. The informed consent form to be signed by all subjects shall explicitly describe how the subject may withdraw from the experiment at any time and for any reason without penalty. A copy of the form must be given to the subject. In all experiments a mechanism shall be provided by which the subject may anonymously comment on their experience in the experiment if they so desire. (At least two contacts must be given, the Dean's Office or the IRB would be appropriate avenues.)
3. Subjects' participation must be voluntary; their participation and performance should not be linked to participation in a college course either directly or by implication. (For example, the faculty member performing the research might be a reader on a thesis committee or in some other way cause the student to believe it would be to their advantage to participate in the experiment.)
4. The experimenter should maintain privacy of the subjects' records. In most cases data should be coded and the subjects' names or SS numbers removed from the records and destroyed. Subjects' names or other identifiers should not be published in any report of work performed for either internal or external publication without the express, written permission of the subject. There should be no file of identifying names or numbers that would permit the association of responses or results with subjects which is maintained beyond the duration of the experiment.
If it is necessary to retain the name of the respondent then there must be some other assurance of protection of privacy. The proposal should identify a specific date by which all relevant identifying information will be destroyed and the College informed of this action in writing. Privacy considerations include work in which the subject is only measured or photographed and work in which subjects only respond to a questionnaire (but see questionnaires sent by mail, below.)
The College IRB does not grant approval for experiments performed at other institutions although the IRB will make suggestions after reading a proposal. Responsibility for protection of subjects at other institutions must be borne by the other institution.
As a general matter the IRB does not deal with questionnaires sent through the mail as the College is not responsible for the content of the mails. (Anyone has the right to send a student a questionnaire in the mail.) The IRB does, however, deal with cases in which human subjects are interviewed at the College and cases in which funding for the project is provided by U.S. Government or its agencies, (i.e., approval is required as part of the application process).
If individuals outside the College propose to perform experiments or administer questionnaires other than by mail, they must request permission from the Dean's office. The Dean then forwards the proposal including all protocols, informed consent forms, questionnaires, and other documentation to the IRB, for review. The IRB sends the results of its review to the Dean for use in his or her decision to grant permission for the study.
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