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IRB Guidelines
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The following guidelines govern the activities of the SDHPC IRB.
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A. Purpose
An Institutional Review Board (IRB) is established and empowered under the auspices of that institutions executive authority. The IRB is established to review biomedical and behavioral research involving human subjects. The IRB has the authority to ensure that research is designed and conducted in such a manner that protects the rights and welfare of participating subjects.

B. Membership
The IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution.

The IRB shall be sufficiently qualified through the experience and expertise of its members and the diversity of the members, including consideration of race, gender, and cultural backgrounds. The IRB shall make every nondiscriminatory effort to ensure that no IRB consists entirely of men or entirely of women.

The IRB shall include at least one member whose primary concerns are in the scientific area and at least one member whose primary concerns are in nonscientific areas.

The IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

The IRB shall not have members participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest.

The IRB may invite, at its discretion, individuals with competence in special areas to assist in the review of complex issues, which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

C. Leadership
The IRB Chair will oversee the committee and its members. The Coordinator, Research Programs will distribute materials for meetings and take minutes for said meetings.

D. Meetings
The IRB shall meet on a monthly basis. Materials to be reviewed at each meeting shall be distributed no less than two weeks prior to the assigned meeting.

E. Responsibilities
The IRB shall review all research involving human subjects and all other activities, which even in part involve such research, regardless of sponsorship. All such activities must be reviewed and approved by the IRB.

No intervention or interaction with human subjects in research, including recruitment, may begin until the IRB has reviewed and approved the research protocol.

Specific determination as to the definition of "research" or "human subject," and their implication for the jurisdiction of the IRB under Institutional policy are determined by the IRB.

It is the IRB's purpose and responsibility to protect the rights and welfare of human subjects.
The IRB reviews and oversees such research to ensure that it meets well-established ethical principles and that it complies with federal regulations including but not limited to Title 45 CFR Part 46 and Title 21 CFR Parts 50 and 56, (CFR - Code of Federal Regulations) that pertain to human subject protection, as well as any other pertinent regulations and guidelines, such as the Good Clinical Practice (GCP) Guidelines (E6) of the International Conference on Harmonization (ICH).

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Last Updated: February 02, 2005