| Vice
President for Research and Graduate Studies (VPRGS) |
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Responsible for the performance of all research involving human participants, animals, and recombinant DNA including compliance with Federal, state, or local laws. |
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Provide
both meeting space and sufficient staff to support the committees'
review, record-keeping duties and education/training efforts. |
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Overview
all research (whether exempt or not) and decide whether the institution
will permit the research. |
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Maintain
and arrange access for inspection of committee records. |
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Ensure
constructive communication among the research administrators,
department heads, research investigators, clinical care staff,
human participants, and institutional officials as a means of
maintaining a high level of awareness regarding the safeguarding
of the rights and welfare of the participants and animals. |
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Appoint
chairs and committee members with input from the schools. |
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Provide
funding for committee efforts. |
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| Committee
Chairs |
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The
chairs will report promptly to VPRGS, appropriate institutional
officials, and any other sponsoring Federal department or agency
head any significant or material finding or action. |
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Responsible
for granting an exemption of a research study.* |
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Make
the preliminary determination of eligibility for expedited review
procedures. Expedited review of research activities will not
be permitted where full board review is required. |
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Responsible
for day-to-day administrative oversight and coordination of the
committee office, which includes protocol distribution, review
and tracking. |
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Responsible
for running the committee meetings, and act as administrative
point of contact for researchers, federal regulators and staff. |
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| Committee |
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Responsible
for procedural and record-keeping audits not less than once every
year for the purpose of protecting the rights and welfare of
humans and animals. |
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Review,
and have the authority to approve, require modification in, or
disapprove all research activities, including proposed changes
in previously approved research. For approved research, the committee
will determine which activities require continuing review more
frequently than every twelve months or need verification that
no changes have occurred if there was a previous committee review
and approval. |
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Committee
decisions and requirements for modifications will be promptly
conveyed to investigators. Written notification of decisions
to disapprove will be accompanied by reasons for the decision
with provision of an opportunity for reply by the investigator,
in person or in writing. |
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The
committees will observe the quorum requirements. |
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Committees
will have effective knowledge of subject populations, institutional
constraints, differing legal requirements, and other factors,
which can foreseeably contribute to a determination of risks
and benefits to participants and participants' informed consent
and can properly judge the adequacy of information to be presented
to participants. The committees will ensure that legally effective
informed consent will be obtained and documented in a manner
that meets the requirements. The committees will have the authority
to observe or have a third party observe the consent process.* |
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Where
appropriate, the committees will determine that adequate additional
protections are ensured for fetuses, pregnant women, prisoners,
and minors, as required.* |
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Scheduled
meetings of the committees for review of each research activity
will occur not less than every 12 months and may be more frequent,
if required by the committee on the basis of degree of risk. |
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Each
committee will prepare and maintain adequate documentation of
its activities. |
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The
committees will forward to the Chair any significant or material
finding or action including: |
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any
injuries or other unanticipated problems involving risks to participants,
animals or others, |
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any
serious or continuing noncompliance with the regulations or requirements
of the committee, and |
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any
suspension or termination of committee approval for research. |
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Committees
will have the authority to suspend or terminate previously approved
research that is not being conducted in accordance with the committee's
requirements or that has been associated with unexpected serious
harm to participants or animals. |
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The
committees will ensure effective input (consultants or voting or
nonvoting members) for all initial and continuing reviews. The
committees’ minutes will document attendance of those other
than regular voting members.* |
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| Committee
Administrative Office |
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Facilitate
University compliance with laws and regulations which require institutional
review and approval for all research and teaching protocols involving
human participants/animals. |
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Promulgate
and disseminate relevant policies from Federal and State governments,
VPRGS and the committee to principal investigators and relevant
administrators. Prepare and disseminate any relevant and required
reports. |
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Develop
and conduct a formal training program for principal investigators,
committee members, students, and relevant administrators concerning
research responsibility, policy and procedures. |
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Schedule
facility inspections and prepare reports of inspections for the VPRGS,
the chair of the committee and other agencies. Disseminate relevant
information to the principal investigator and their contact person.** |
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Maintain
close interaction with and provide computerized database support
for the committee and research personnel to facilitate protocol
preparation, submission, review and accountability. |
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Coordinate
with the chair of the committee and counterpart administrative
support offices for efficient and effective operation of the committee. |
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The
committee office will receive from investigators all research
protocols which involve human participants or animals, keep investigators
informed of decisions and administrative processing, and return
all disapproved protocols to them. |
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Committee
will retain study documents for at least three years past completion
of the research activity. |
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Determine
which animal research personnel are required to complete mandatory
training modules and validate their completion of each relevant
module. Also, ensure the enrollment of all animal research personnel
in the Employee Health or Student Health program for animal exposure.** |
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Investigate
all anonymous reports of infractions regarding human/animal welfare
issues and generate a report of the resolution. |
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| Research
Investigators |
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Acknowledge
and accept their responsibility for protecting the rights and welfare
of human research participants/animals and for complying with all
applicable provisions. |
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Research
investigators who intend to involve human research participants
or animals will not make the final determination of exemption from
applicable Federal regulations. |
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Provide
a copy of the committee-approved and signed informed consent document
to each subject at the time of consent, unless the committee has
specifically waived this requirement. All signed consent documents
are to be retained in a manner consistent with Federal and sponsor
regulations.* |
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Promptly
report proposed changes in previously approved research activities
to the committee. The proposed changes will not be initiated without
committee review and approval, except where necessary to eliminate
apparent immediate hazards to the human participants or animals. |
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Report
progress of approved research to the Chairs of the committees,
as often as and in the manner prescribed by each approving committee
on the basis of risks to human participants/animals, but not less
than once per year. |
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Promptly
report to the committee any injuries or other unanticipated problems
involving risks to human participants, animals or others. |
| Review
the IRB-HSR Investigator agreement form. Form. |
Organizational
chart for Research Compliance Committees. Chart.
(reviewed 7/00). |
Note:
* applies
only to Medical Human Subject Research
** applies
only to Animal Research
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