Investigators Manual on Research with Human Subjects by olliegoblue27


									                       WAKEMED INSTITUTIONAL REVIEW BOARD

OVERVIEW                                                                  POLICY AND PROCEDURE 101

The WakeMed Institutional Review Board (IRB) policies and procedures govern research with human
subjects at WakeMed. Our hope is that these policies and procedures will assist in creating better and
more complete interactions with the IRB. They are meant to serve as a reference guide specifically
for persons involved in research who enroll human participants.

This information is a work in progress. The current documents reflect current requirements for
submission of protocols and information; however, these requirements and regulations are subject to

        The *WakeMed Institutional Review Board (IRB) was established over 20 years ago and
        operates in compliance with federal regulations governing institutional review boards set forth
        in 21 CFR Part 56 and 45 CFR 46 and regulations governing informed consent set forth in 21
        CFR Part 50.
        *NOTE:   The name, Institutional Review Committee (IRC), was officially changed to Institutional Review Board
                 (IRB) as of January 1, 2002

        The WakeMed IRB is composed of highly qualified individuals whose primary responsibility is
        to ensure that the rights and welfare of study participants are protected. We believe that the
        rights of subjects should be protected by local review committees pursuant to federal
        regulations and located in institutions where research involving human subjects is conducted.
        This enables us to work closely with investigators to assure study participants are protected
        and at the same time that the application of policies is fair to the investigators. We also
        contribute to the education of the research community and the public regarding the ethical
        conduct of research. In addition to a simplified submission process, WakeMed IRB provides:
                  IRB meetings, twice a month
                  Board decisions promptly communicated
                  Continuing review reminders

        The WakeMed IRB shall review and have authority to approve, require modifications in or
        disapprove all research activities covered by government regulations.

        If you have any questions, please call the Board’s office at 919-350-8795 or e-mail We look forward to working with you in providing
        quality clinical research in an ethical manner.

        The WakeMed IRB holds a Federal-wide Assurance (FWA). The assurance covers all
        federally funded and non-federally funded human subject research projects. The assurance
        requires that an **Institutional Signatory Official, the Human Protections Administrator and
        the IRB Chair complete the web-based Office for Human Research Protections (OHRP)
        education modules before submitting the assurance to ensure that these individuals are
        aware of the responsibilities that must be fulfilled under the assurance.
        The institution holding the FWA is responsible for the protection of human subjects in all
        research in which the institution engages, including safeguarding the rights and welfare of
        human subjects within its local research context, educating IRB members of the research
        community in order to establish and maintain a culture of compliance with Federal regulations
        and institutional policies relevant to the protection of human subjects, and implementing
        within its local research context appropriate oversight to ensure compliance.
                 **Institutional Signatory Official – West H. Lawson, MD
                 IRB Chair – Miriam P. Rogers, Ed.D, RN
                 Human Protection Administrator – Frances A. Whitten

Confidential                                    Page 1 of 3                                      August 2007

OVERVIEW                                                              POLICY AND PROCEDURE 101

        Federal regulations (21 CFR 56.107, 45 CFR 46.107) require that an IRB be comprised of at
        least 5 individuals to include the following:
                  Men and Women
                  Members with both scientific and non-scientific backgrounds
                  At least one member representing cultural or ethnic diversity
                  At least one member representing the welfare of special interest groups (i.e.,
                   children, prisoner), when applicable
                  At least one member not affiliated with the company or institution

        Except when an expedited review procedure is used, proposed research must be reviewed at
        a convened meeting at which a majority of the members of the IRB are present, including at
        least one member whose primary concerns are in nonscientific areas. In order for research
        to be approved, it must receive the approval of a majority of the members present. If the
        quorum fails during a meeting (e.g., loss of a majority through recusal of members with
        conflicting interests or early departures, or absence of a nonscientific member), the IRB may
        not take further actions or votes until the quorum is restored.

        All IRB members, principal and co-investigators, research coordinators, registered nurses,
        and/or students involved in the use of human subjects in research:

               a. must complete a minimum of one of the training opportunities described below and
                  include a copy of certificates with each study submitted:
                         Approved training module web-sites:
                            o National Cancer Institute
                            o Office for Health and Human Services (OHPR)

               b. must review the WakeMed IRB Policies and Procedures at


                  The IRB will not have a member vote on the initial or continuing review of any project
                   in which the member has a conflict of interest. However, the member may provide
                   information requested by the IRB. It is the member’s responsibility to inform the
                   Board if conflict of interest exists before deliberation of the research.
                  All principal and co-investigators, research coordinators, registered nurses, and/or
                   students shall disclose to the IRB whether or not they stand to gain or have a conflict
                   of interest with the study they are involved in and shall include this information on the
                   informed consent in a Commercialization and Conflict of Interest statement. Also,
                   see WakeMed Administrative Policy, Conflict of Interest.

Confidential                                   Page 2 of 3                                 August 2007

OVERVIEW                                                            POLICY AND PROCEDURE 101

        Federal regulations (21 CFR 56.115 and 45 CFR 46 115) require that an IRB maintain the
        following information during the study and for three years after study closure; i.e.,
                  All relevant research material such as protocol, informed consent, investigator
                   brochures, patient education, patient recruitment, etc.
                  Initial, ongoing, and expedited reviews and approvals
                  Safety data collected during the study (reports on serious and unanticipated events)
                  Written records of all activities

For more information on IRB operations, refer to the Code of Federal Regulations (CFR -- Title
21 Food and Drugs, Part 56 Institutional Review Boards or Title 45 Public Welfare, Part 46
Protection of Human Subjects) or contact the IRB office at 919-350-8795

Confidential                                 Page 3 of 3                                August 2007

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