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Definitions and Principles

Research Involving Human Subjects

The Subcommittee on Protection of Human Subjects constitutes the Institutional Review Board for research involving human subjects at Swarthmore College.

Human Subjects Research at the College is guided by the ethical principles of respect for persons, beneficence, and justice as outlined in The Belmont Report, and procedures described in the Code of Federal Regulations 45 CFR, Subtitle A, Part 46, Protection of Human Subjects as most recently amended.

Research is defined in the the Code of Federal Regulations 45 CFR, Subtitle A,Section 46.102(d) as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The regulations add that "activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities."

A human subject is defined in the Code of Federal Regulations 45 CFR, Subtitle A, Section 46.102(f) as "a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information."

Basic Principles

Research should minimize the risks to participants' physical, emotional, and social well-being. Participation must be voluntary, and this must involve subjects having adequate information about the aims of the research, the risks and benefits involved, and their right to refuse initial participation and/or to withdraw at any time. To this end it is crucial that researchers use appropriate verbal or written procedures to obtain subjects' informed consent.

Subjects' participation and performance in research should not be linked to coercive rewards or penalties either directly or by implication, for example when a researcher is affiliated with an institution on which a research subject depends, but does not take care to address this affiliation adequately.

Subjects should not normally be placed in situations involving more than everyday levels of physical danger or emotional stress. If exposure to such situations is deemed essential to a research project, special care must be taken to ensure that subjects can withdraw whenever they want. Subjects must give written consent to participate, on a form that explicitly describes the risks involved and clearly indicates that the subject may withdraw from the research at any time and for any reason without penalty. In all such projects a mechanism must be provided by which subjects may anonymously comment on their experience in the research if they so desire.

Since breach of confidentiality can be a major source of risk to participants' well-being, researchers must maintain the privacy of their subjects' records. In most cases data should be coded and the subjects' names or Social Security numbers removed from 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 research. If it is necessary to retain the name of the respondent then there must be some other assurance of protection of privacy. A proposal must identify a specific date by which all relevant identifying information will be destroyed and the College informed of this action in writing.