VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

Confidentiality is intended to allow the investigator and others who have access to the research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative or other proceeding whether at the federal, state or local level. This protection is not limited to federally supported research. The IRB should be aware that the Certificate of Confidentiality has not been adequately tested in the courts and thus cannot be relied upon as an absolute guarantee of protection. The IRB should also be aware that the agency granting the Certificate of Confidentiality may require specific related language in the informed consent document. 7.7. Vulnerable Subjects Safeguards When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons, additional safeguards must be included in the study (see Section 17. Vulnerable Subjects ). 7.8. Continuing Review The IRB should determine which studies require annual or more frequent review in evaluating an application based on the degree of risk. These criteria can be found in Section 9. Types of Review . For studies not reviewed by the full board, justification for annual continuing review must be documented by IRB administration. Studies that do not require annual continuing review must submit a progress report to IRB administration annually (Expedited approvals) or every two years (Exempt approvals). 7.9. Recruitment & Payment The IRB must consider the appropriateness of the methods for identifying, recruiting and compensating subjects and potential research subjects (see Section 16. Recruitment & Incentives ). 7.10. Required Certification Anyone who will come in contact with human subjects or human subject data (faculty, staff or students) must receive this training, regardless of source of research funding. Current VCOM training requirements are based on NIH Policy. An investigator can demonstrate that he or she has obtained the required training through completion of an approved web-based training module on the ethical use of human subjects. VCOM requires completion of the CITI training module for the Protection of Human Research Subjects (or a comparable program, previously approved by IRB Administration). Prior to IRB approval, key personnel should upload verification of the required CITI training to their IRBNet user profile. RECORD KEEPING The IRB Coordinator will maintain adequate documentation of IRB activities, which include the meeting agenda and minutes. Documentation regarding proposed research will include copies of research proposals reviewed in each meeting and any scientific evaluations if applicable, and all approved sample consent forms for the proposed research. Progress reports and any reports of injury to subjects will also be filed. 8.

VCOM Institutional Review Board Policies and Procedures

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