1.      The Crozer Chester Medical Center Institutional Review Board (IRB) is the entity designated by the Board of Directors to review, approve, monitor and evaluate research projects and clinical investigations involving human subjects on behalf of the Medical Center.

2.      The IRB conducts its activities pursuant to the rules and regulations regarding human subjects research of the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA), where applicable.  The IRB’s conduct is consistent with the International Conference on Harmonization (IHC) guidance relating to Good Clinical Practice (GCPs) in human subjects research as it corresponds to the HHS and FDA regulations and in accordance with the policies and directives of Crozer.

3.      HHS rules are published in 45 CFR Part 46, Subparts A, B, C and D as amended and copies of these documents may be obtained at http://www.ohrp.osophs.dhhs.gov/polaswr.htm

4.      FDA rules are published in 21 CFR, part 50, Subparts A, B and D and Part 56, Subparts A, B, C, D and E, as amended.  Copies of these documents may be obtained at http://www.fda.gov (click on “clinical trials”).  FDA information sheets are additional guidance documents and may also be found on the FDA website.

5.      Information on the Guidelines for Good Clinical Practice established by the ICH may be found at http://www.ifpma.org/ich1.html

General Considerations

1.      The IRB considers moral, ethical and legal principles in determining acceptable research involving human subjects.  The IRB will review all protocols for the protection of human subjects including:

-          Rights and safety of subjects within the protocol procedures;

-          Compliance with federal guidelines;

-          Readability of informed consent document, and

-          Additional safeguards for special populations, i.e. children, pregnant women, prisoners, mentally disabled, and economically or educationally disadvantaged.

2.      The IRB functions primarily to protect the rights, safety and welfare of all research subjects.  A diversity of membership, with individuals having a wide range of perspectives, helps to insure objective scrutiny of the research protocol and informed consent.  Investigators and others involved in a research protocol do not participate in the IRB deliberations or voting for any protocol in which they are involved.

3.      The IRB will investigate complaints and inquiries regarding the conduct of approved research protocols.  Serious or continuing non-compliance with IRB policies and unanticipated injuries or problems involving risks to subjects shall be reported to all appropriate agencies and are subject to suspension or termination of IRB approval of the protocol.  Any such action and the reasons for the action will be reported in writing, to the investigator and to all appropriate agencies and institutional officials.

4.      The IRB will maintain its general records for 5 years.  In addition, the IRB will maintain records regarding research projects for 5 years after completion of the research.