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The Responsibilities of Research

Responsibilities of Parties Involved in Research

arrow Vice President for Research (VPR)
arrow Committee Chairs
arrow Committee
arrow Committee Administrative Office
arrow Research Investigators
arrow IRB-HSR Investigator Agreement
arrow Organizational Chart for Compliance Committees

Vice President for Research (VPR)

  • Responsible for the performance of all research involving human participants, animals, and recombinant or synthetic nucleic acid molecules including compliance with Federal, state, or local laws.
  • Provide both meeting space and sufficient staff to support the committees' review, record-keeping duties and education/training efforts.
  • Overview all research (whether exempt or not) and decide whether the institution will permit the research.
  • Maintain and arrange access for inspection of committee records.
  • 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.
  • Appoint chairs and committee members with input from the schools.
  • Provide funding for committee efforts

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Committee Chairs

  • The chairs will report promptly to VPR, appropriate institutional officials, and any other sponsoring Federal department or agency head any significant or material finding or action.
  • Responsible for granting an exemption of a research study.*
  • 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.
  • Responsible for day-to-day administrative oversight and coordination of the committee office, which includes protocol distribution, review and tracking.
  • Responsible for running the committee meetings, and act as administrative point of contact for researchers, federal regulators and staff.

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Committee

  • 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.
  • 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.
  • 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.
  • The committees will observe the quorum requirements.
  • 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.*
  • Where appropriate, the committees will determine that adequate additional protections are ensured for fetuses, pregnant women, prisoners, and minors, as required.*
  • 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.
  • Each committee will prepare and maintain adequate documentation of its activities.
  • The committees will forward to the Chair any significant or material finding or action including:
    • any injuries or other unanticipated problems involving risks to participants, animals or others,
    • any serious or continuing noncompliance with the regulations or requirements of the committee,and
    • any suspension or termination of committee approval for research.
  • 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.
  • 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

  • Facilitate University compliance with laws and regulations which require institutional review and approval for all research and teaching protocols involving human participants/animals.
  • Promulgate and disseminate relevant policies from Federal and State governments, VPR and the committee to principal investigators and relevant administrators. Prepare and disseminate any relevant and required reports.
  • Develop and conduct a formal training program for principal investigators, committee members, students, and relevant administrators concerning research responsibility, policy and procedures.
  • Schedule facility inspections and prepare reports of inspections for the VPR, the chair of the committee and other agencies. Disseminate relevant information to the principal investigator and their contact person.**
  • Maintain close interaction with and provide computerized database support for the committee and research personnel to facilitate protocol preparation, submission, review and accountability.
  • Coordinate with the chair of the committee and counterpart administrative support offices for efficient and effective operation of the committee.
  • 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.
  • Committee will retain study documents for at least three years past completion of the research activity.
  • 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.**
  • Investigate all anonymous reports of infractions regarding human/animal welfare issues and generate a report of the resolution.

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Research Investigators

  • Acknowledge and accept their responsibility for protecting the rights and welfare of human research participants/animals and for complying with all applicable provisions.
  • Research investigators who intend to involve human research participants or animals will not make the final determination of exemption from applicable Federal regulations.
  • 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.*
  • 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.
  • 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.
  • Promptly report to the committee any injuries or other unanticipated problems involving risks to human participants, animals or others.
  • Acknowledge and accept their responsibility for the training of personnel in safe handling of recombinant or synthetic nucleic acid molecules, infectious materials, and biological agents in their laboratories.

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Notes:
* applies only to Medical Human Subject Research
** applies only to Animal Research

 

 
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  Maintained by: Office of the Vice President for Research
Last Modified: Sunday, 10-Feb-2013 14:07:27 EST
Copyright 2014 by the Rector and Visitors of the University of Virginia

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