HRPP/IRB

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Institutional Review Board Committees (IRB)

  • Reviews all proposed human subject research to determine that:
    1. Risks to participants are minimized by (a) using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk; and (b) when appropriate, by using procedures already being performed on participants for diagnostic or treatment purposes;
    2. Risks to participants are reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result from participation in a study. In evaluating risks and benefits, the IRB Committee should consider only those risks and benefits that result from the research (as distinguished from risks and benefits of therapies participants would receive if not participating in the research). The IRB Committee should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility;
    3. Selection of participants is equitable considering the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations and potential need for additional protections, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons;
    4. Informed consent will be appropriately documented, in accordance with, and to the extent required by Federal and State regulations and Institutional policies and procedures including the IRB;
    5. When appropriate, the research plan makes adequate provisions for monitoring data collected to assure the safety of participants;
    6. When appropriate, there are adequate provisions to protect privacy of participants and to maintain the confidentiality of data;
    7. There are adequate provisions to protect the rights and welfare of vulnerable populations from coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. The IRB Committee must determine if additional safeguards need to be included in the study to protect the rights and welfare of these participants;
    8. When appropriate, the need for ancillary care, additional monitoring, counseling, and social support are provided; and
    9. When appropriate, the informed consent document includes the additional elements of informed consent.
  • Conducts timely continuing reviews of approved research, as appropriate.
  • Reviews all proposed human subject research in accordance with the basic ethical principles (Respect for Persons, Beneficence, Justice) of The Belmont Report.
  • Reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.
  • Evaluates research applications involving the use of radiological procedures (e.g., x-rays, radionuclides, etc.), which the participant would otherwise not receive as part of his/her medical care.
  • Participates in mandatory annual training, including the required CITI training modules, and keeps abreast of current events.

The Human Research Protection Program

  • Assures compliance with the Federal Wide Assurance (FWA)
  • Assures Vanderbilt University Medical Center policies and procedures are effectively applied in compliance with State and Federal laws and regulations, the FWA, OHRP, FDA, NIH, OCR, and any other applicable Federal agency.
  • Provides interpretation and application of Federal regulations.
  • Develops, implements, and interprets VHRPP policies and procedures.
  • Takes action on non-compliance according to VHRPP policies and procedures, as necessary.
  • Ensures adequate resource allocation and annual review of resources.
  • Actively participates in the IRB Optimization Committee.
  • Supports and facilitates the IRB process.
  • Maintains ongoing educational programs (e.g., News You Can Use, Research Matters, IRB Essentials, etc.) for Investigators, key study personnel, IRB Committee members, and VHRPP staff.
  • Participates in mandatory training, as well as other ongoing educational activities to keep abreast of current events.
  • Provides regular training and education to IRB Committee members and keeps the Committees abreast of current events.
  • Mentors and trains new staff as needed, including VHRPP staff, Investigators, and key study personnel on human subject protections and the IRB process. Provides 3 and 6-month evaluations to the VHRPP staff.
  • Performs and documents quality assurance activities to assure compliance.
  • Provides internal and external monitoring, which is designed to assess compliance and safety in human subjects research.
  • Performs directed audits and random compliance reviews. Formulates and implements, as needed, recommendations for the Investigator and his/her staff.