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POLICY ON PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH
Contents
1.    Introduction
2.    The Institutional Review Board (IRB)
3.    Responsibilities of the Research Investigator
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1.     Introduction

1.1.    It is the policy of the Board of Trustees, the President, and the Faculty that all research involving human participants conducted within or under the auspices of the College of Charleston shall be guided by the ethical principles embodied in the Belmont Report and conform to all applicable laws, rules, and regulations of the State of South Carolina and Federal sponsoring agencies in order to protect fully the rights and welfare of all research participants.  Further, all such research shall be performed in compliance with the highest standards of ethics, practice, and conduct of each of the professions involved in the research.

1.2.    To ensure compliance with its policy, the Board of Trustees has established an Institutional Review Board for the Protection of Human Participants in Research (IRB) at the College of Charleston which shall review all research involving human participants conducted at, or under the auspices of, any unit of the College of Charleston, whether or not supported by an external agency.


2.    The Institutional Review Board (IRB)

2.1    Responsibilities

2.1.1.    The IRB shall maintain an active Federalwide Assurance (FWA) on file with the U.S. Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP).

2.1.2.    The IRB shall approve written procedures and review them on a regular basis to ensure compliance with this policy, guided by best practices as embodied in the federal regulations. 

2.1.3    The IRB has the responsibility and authority to approve, require modifications in, or disapprove all research activities involving human participants that fall within its jurisdiction as specified by both the federal regulations and local institutional policy.  Research that has been reviewed and approved by the IRB may be subject to review and disapproval by officials of the institution.  However, those officials may not approve research if it has been disapproved by the IRB.  Research that has been reviewed and approved by the IRB is subject to continuing IRB review and must be reevaluated at least annually, or more frequently if specified by the IRB.

2.1.3.    Continuing or serious non-compliance with the requirements of this policy will be reported by the IRB to the College of Charleston's Assistant Vice President for Research, and, as appropriate, to the funding agency and the Office of Human Research Protection (OHRP), U.S. Department of Health and Human Services.

2.1.4.    When research involving human participants is conducted through a cooperative research project at, or in cooperation with, another entity, all provisions of this policy remain in effect. 

2.2.    IRB Membership

2.2.1.    The President shall appoint at least nine (9) regular voting members including one community representative who is not affiliated with the College of Charleston, and at least one non-scientist.  The Research Protections & Compliance Manager of the Office of Research & Grants Administration (ORGA) shall serve as a non-voting ex-officio member.  Alternate members may also be appointed by the President.

2.2.2.    Regular voting IRB members are appointed for a term of three years with reappointment possible.

2.2.3.    The Chair of the IRB and the Research Protections & Compliance Manager shall submit to the President a slate of individuals recommended to replace outgoing IRB members and alternates.  The President will appoint the new members and alternates.

2.2.4.    An IRB Chair and an IRB Vice-Chair shall be elected from the regular voting membership by the regular voting members for a one-year term at the first IRB meeting of the academic year, with no limit on terms.

2.2.5.    The IRB may solicit ad hoc reviewers with specific expertise to assist in protocol reviews on a case-by-case basis.  Ad hoc reviewers may participate, but not vote, in the designated reviews.

2.3.    IRB Meetings

2.3.1.    The IRB shall meet approximately monthly.  Meeting dates and correspondence deadlines shall be made public to the College at the beginning of each semester.  A scheduled meeting may be cancelled if no applications for full review are received for that meeting.

2.3.2.    A simple majority shall constitute a quorum and must include at least one regular voting member whose primary concerns are in nonscientific areas. When a quorum of regular members is not present, the IRB Chair may delegate full responsibilities of membership to an alternate member for the duration of the meeting.

2.3.3.    ORGA provides staff support to the IRB by recording the minutes of its meetings, distributing announcements and agendas for its meetings, and serving as a repository of all IRB files.

2.3.4.    ORGA serves as the first and primary contact point for inquiries and submissions to the IRB.

3.    Responsibilities of the Research Investigator

3.1.    The Research Investigator has the primary responsibility for protecting the rights and welfare of human research participants and is responsible for complying with all applicable provisions of the College of Charleston’s FWA and institutional policies and procedures.

3.2.    The Research Investigator is expected to be knowledgeable about and adhere to the requirements of federal regulations, applicable state law, and the Code of Ethics of his/her profession.

3.3.    Determination of human research participant involvement shall be made by the Research Investigator in accordance with the definitions in the federal regulations 46 CFR 46 Subpart A, Section 46.102 (d)(e)(f). When it is not clear whether the research involves human participants, assistance in making the determination shall be sought from the Research Protections & Compliance Manager.
       



 
MERGED WITH HUMAN RESEARCH PARTICIPANT POLICY DOCUMENT
Approved:    Institutional Review Board  04-25-96
Revised:    Institutional Review Board  10-23-98, 04-27-01, 09-12-08, 9-17-10
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