Faculty Handbook

Assurance Of Compliance With HHS Regulations For Protection Of Human Subjects

Abstract

I. Statement of Applicability, Principles and General Policies

  1. Applicability
    1. All research sponsored by the University is covered by the Assurance
      1. Certain categories of research may be declared exempt from the regulations of eligible for expedited review by the Institutional Review Board (IRB).
      2. Declaration of exempt or clearance for expedited review requires
        1. complete research protocol, and
        2. a completed Western Connecticut State University HUM-1 form, and
        3. an Informed Consent form.
    2. Exempt and expedited review will be provided by the Chairperson of the Research and Development Committee or designee and the Director of the Office of Sponsored Research Administrative Services.
  2. Ethical Principles
    1. The University must be in full compliance with Title 45, Part 46 of the Code of Federal Regulations. A copy of the Regulations is on file in the Office of Sponsored Research Administrative Services.
  3. Institutional Policy
    1. Informed consent is required of all human subjects, unless such consent is altered or waived by the IRB.
      1. Conditions of waiver or modification of written consent include (45 CFR 46.116, 46.117)
        1. Declaration of exemption
        2. Minimal risk and research
          1. in which the only record of participation is the consent document
          2. involving “no procedures for which written consent is required outside of the research context,”
          3. directed toward evaluation of the “Social Security Act, or other public benefit or service program” and is “subject to the approval of state or local government officials,”
          4. which could not practicably be carried out without waiver or alteration.

II. Implementation

  1. Responsibilities of Investigators
    1. Preparation of a complete research protocol and submission of HUM-1 and Consent form to the Office of Sponsored Research Administrative Services.
      1. The Chairperson of the Research and Development Committee or designee and the Director of the Office of Sponsored Research Administrative Services will refer to the IRB all protocols which are not exempt or processed by expedited review.
    2. Investigators will comply with decisions of the Institutional Review Board (Human Subjects Research Review Committee), including alterations or supplements which may be required.
      1. An appeal for reconsideration may be filed with the Committee if the investigator deems such action appropriate.
    3. Maintain records concerning human subjects, e.g., consent, when required.
    4. Report alterations in originally approved research protocol.
    5. Provide information necessary for consideration by an extramural agency of a supplementary proposal, continuation of committed support, or renewal of expired support.
  2. Responsibilities of the Institutional Review board (Human Subjects Research Review Committee) concerning the use of human subjects in research.
    1. Examine all research protocols involving human subjects.
    2. Approve research which satisfies requirements of the Office for Protection from Research Risks of the National Institute of Health of the Department of Health and Human Services.
    3. Certify that requirements for informed consent are satisfied when required.
    4. Review ongoing research projects at least annually.
    5. Terminate research which is not conducted in conformity with the terms and conditions under which the protocol was approved.

Rev. 8/01


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