POLICY ON PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH
2. The Institutional Review Board (IRB)
3. Responsibilities of the Research Investigator
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
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)
2.1.1. 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
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
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
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
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
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 &
MERGED WITH HUMAN RESEARCH PARTICIPANT POLICY DOCUMENT
Approved: Institutional Review
Revised: Institutional Review
Board 10-23-98, 04-27-01, 09-12-08, 9-17-10