9.17 / Research Involving Human Subjects

Effective: July 01, 1997Last Revised: August 03, 2016

  1. Purpose

    To comply with federal regulations regarding the review and approval of research involving human subjects conducted by faculty, staff and students of 黑洞社区.

  2. Preamble

    The purpose of advance review of research involving human subjects by an Institutional Review Board ("IRB") and the requirements of informed consent is to assure that the rights and welfare of subjects who participate in research at 黑洞社区 ("University") are protected and that the University is in compliance with the requirements of Title 45 Code of Federal Regulations, Part 46 ("45CFR46").

  3. Policy

    1. Establishment of University Institutional Review Board

      1. The IRB shall be composed of at least seven and not more than eleven members. At least one member shall be from an area outside the sciences such as law, ethics or religion and at least one member shall not be otherwise affiliated with the University; other members should possess backgrounds related to the research activities of the University. All members of the IRB, except those representing nonscientific areas, shall be selected for their competence in research.

      2. Members of the IRB are appointed by the Vice President for Research and Technology Transfer as the Institutional Official (IO) in consultation with the Deans of the Colleges and the Directors of RTT.

      3. Candidates for membership representing the scientific areas will be nominated by the Deans of the Colleges. Candidates for membership representing the community and nonscientific areas will be nominated by the Vice President for Research and Technology Transfer, the Directors of RTT and other IRB members.

      4. Members shall be appointed for one-year terms and may be reappointed.

      5. The IRB shall consist of members of both genders. Membership selection criteria shall include considerations of racial and cultural backgrounds, areas of professional research competence and community attitudes.

      6. The Vice President for Research and Technology Transfer, the Directors of RTT and a member of the Research Compliance Office shall be ex-officio, non-voting members of the IRB.

    2. Chair and Vice-chair of the University Institutional Review Board

      1. A Chair and Vice-chair of the IRB shall be elected annually by IRB members at the first meeting of the IRB in the fall semester of each academic year.

      2. The Chair shall convene and preside over meetings of the IRB, work closely with the Office of Research and Technology Transfer (RTT), and conduct expedited reviews when assigned by Administrator.

      3. The Vice-chair shall provide assistance to the Chair as needed and preside over the meetings of the IRB in the absence of the Chair.

      4. If the Chair is unable to complete a one-year term, the Vice-chair will be elevated automatically to the position of Chair for the remainder of the term and a new Vice-chair will be elected by members of the IRB.

    3. Responsibilities of the University Institutional Review Board

      1. All research involving human subjects conducted by University faculty, staff and students must be submitted to the IRB for review or certification of exemption from 45CFR46 prior to the initiation of such research. For research conducted by a student, the application must be approved and signed by a faculty sponsor or director, with said faculty sponsor or director listed as principal investigator with the student as co-investigator. The IRB has the authority to approve, require modifications or disapprove the proposed research.

      2. In its review, the IRB will seek to assure that risks to subjects are minimized; that the selection of subjects is equitable; that informed consent is obtained from each prospective subject and documented in appropriate form; that adequate provisions exist to protect, to the full extent permitted by law, the privacy of subjects and to maintain the confidentiality of research data; and that appropriate safeguards have been included in the research plan to protect the rights and welfare of subjects who are members of a particularly vulnerable group.

  4. Implementation

    1. This policy statement will be included in the 黑洞社区 Policies and Procedures Manual and shared with appropriate constituencies of the University.

    2. RTT shall provide administrative support to the IRB by processing applications for IRB review, maintaining records of all applications and actions of the Committee and attending all IRB meetings.

    3. A copy of this policy will be given to each member appointed to the IRB.