VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

IRB. Serious violation (e.g., one that affects subject safety) may prompt the chair to suspend the study pending IRB review of the violation(s). Whenever a researcher anticipates the need to deviate from the procedures previously approved by the IRB, the researcher must obtain the approval of the IRB in advance. When a deviation occurs without prior notification, the IRB should be notified promptly. 19. RESPONSIBILITIES OF THE DEPARTMENT OF RESEARCH The Department of Research is responsible for: (i) providing services for the VCOM IRB, and (ii) maintaining VCOM IRB records. These administrative tasks are the responsibility of the IRB Administration, and are defined as follows: • Receive from investigators all research protocols which involve human subjects, keep investigators informed of decisions and administrative processing, and return all disapproved protocols to them. • Assist the VCOM IRB Leadership in the review of applications and make a preliminary determination as to level of review required • Designate procedures for the retention of signed consent documents for at least three years past completion of the research activity. • Will maintain and arrange access for inspection of VCOM IRB records as provided for in 45 CFR 46 Section 115 of the regulations. • Is responsible for ensuring constructive communication among the research administrators, department heads, research investigators, clinical care staff, human subjects, and institutional officials as a means of maintaining a high level of awareness regarding the safeguarding of the rights and welfare of the subjects. • Will document in its records that each individual who conducts or reviews human subject research has ready access to copies of 45 CFR 46, regulations of other federal departments or agencies as may apply, the Belmont Report, and all other pertinent federal policies and guidelines related to the involvement of human subjects in research. • Will report promptly to appropriate institutional officials, the OHRP, and any sponsoring organization: o Any injuries to human subjects or other unanticipated problems involving risks to subjects or others. o Any serious or continuing noncompliance with the regulations or requirements of the IRB. o Any suspension or termination of IRB approval for research. • Will ensure: o Solicitation, receipt, and management of all assurances of compliance (whatever the appropriate format), and certifications of VCOM IRB review (where appropriate) for all affiliates to this institution; and o Subsequent submission of these documents to the proper authorities as a condition for involvement in human subject research activities sponsored by DHHS or any other federal department or agency for which this Policy applies. • When the VCOM IRB accepts responsibility for review of research that is subject to this Policy and conducted by any independent investigator who is not otherwise subject to provisions of this

VCOM Institutional Review Board Policies and Procedures

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