Policy 7-94: Research with Human Subjects

Background

Along with all academic institutions receiving federal funds, Centenary College is subject to compliance with federal regulations regarding the protection of human subjects used in research projects, both those conducted on campus and those executed by college personnel and/or students at other sites. Specific compliance with regulations of the Department of Health and Human Services is required for research funded by this agency as well as a number of additional ones. H.H.S. regulations are widely employed as a model for protection of human subjects in research and other activities.

Purpose

This policy establishes an Institutional Review Board (I.R.B.) to evaluate potential risks to human subjects involved in college-related activities. Its purpose is to conduct initial and continuing review of human research projects according to federal guidelines (See Federal Register, vol. 46, no. 16; 45 CFR Part 46; Jan. 26, 1981) and to make recommendations to investigators and the institution concerning research procedures.

It is the task of the I.R.B. to ensure that risks to research subjects are minimized and that the attendant risks in the research are reasonable in relation to anticipated benefits. "Risk" should be interpreted in a broad sense to include not only physical risk but also legal, psychological, social, and economic risk. Discomfort, pain, and embarrassment should be minimized and justifiable in terms of anticipated benefits.

Methodology

In its review, the I.R.B. shall ensure that selection of subjects is equitable and not coercive, that informed consent will be sought and documented from prospective subjects, adequate provisions are in place to protect their privacy, and data are maintained in confidence. Investigators shall supply the board with data of sufficient specificity to support an informed decision, a description of the informed consent process, and a copy of the consent forms to be used. Should the research involve a survey, interview, or test, a copy of the form shall be submitted to the I.R.B. with the research proposal.

Informed Consent

The informed consent process should ensure that prospective research subjects are provided with all necessary information (in understandable terms) that could influence their decision in giving consent to participate in the research project. 45 CFR 46, cited above, provides detailed information on informed consent and its documentation, including conditions under which informed consent can be waived. The consent form may not include any language that releases or appears to release the investigators or the institution from liability or that waives or appears to waive any subject's legal rights.

The Institutional Review Board

Composition

The I.R.B. shall be comprised of five members with diverse backgrounds, each appointed by the Provost. These shall include:

  1. Three faculty members.
  2. At least one member not affiliated with a scientific discipline.
  3. At least one member unaffiliated with Centenary College.
  4. Representation of persons whose primary concern is the protection of "vulnerable" subjects, such as children or institutionalized persons.

Proceedings

The I.R.B. shall normally meet with a majority of members present, and a majority vote shall be required for decisions. Exclusions from this rule are only permissible under expedited procedures and exemptions for low risk research, as specifically allowed under H.H.S Guidelines. Members with conflicts of interest in a particular research project shall be excluded from all decisions related to that research.

Retention of Records

All records of proposals, committee action, correspondence, membership, and operating procedures shall be retained for a minimum of three years after completion of research reviewed by the board.

Adopted, December 15, 1994.

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