VCOM Institutional Policy and Procedure Manual

VCOM Policy and Procedure

Policy #R004

16.1. Advertisements ..............................................................................................................................31 16.2. Direct Solicitation .......................................................................................................................... 32 16.3. Payments to Research Subjects .....................................................................................................32 16.4. Lotteries & Door Prizes.................................................................................................................33 17. VULNERABLE SUBJECTS..........................................................................................................33 18. RESEARCHER NONCOMPLIANCE & PROTOCOL VIOLATION.....................................34 18.1. Noncompliance of Investigators....................................................................................................34 18.2. Protocol Violation & Deviations ...................................................................................................36 19. RESPONSIBILITIES OF THE DEPARTMENT OF RESEARCH..........................................37 20. RESPONSIBILITIES OF THE PRINCIPAL INVESTIGATOR..............................................38 20.1. Application Process .......................................................................................................................38 20.2. Following Approval ......................................................................................................................39 20.3. Student Research ...........................................................................................................................40 21. DURATION OF POLICY ..............................................................................................................40 SIGNIFICANCE This document sets forth the policy and procedures for the protection of human subjects involved in research activities conducted at or sponsored by the Edward Via College of Osteopathic Medicine (VCOM), including research activities (a) by faculty, staff, and students, (b) performed in VCOM facilities, or (c) otherwise supported by resources or facilities under the control of VCOM or institutions accepting the VCOM IRB as their IRB of record. The policy and procedures are designed to conform to Title 45 Code of Federal Regulations Part 46 as implemented by the United States Department of Health and Human Services (DHHS) “Basic HHS Policy for the Protection of Human Subjects.” The procedures and safeguards herein will apply to all VCOM-sponsored research activities. However, where a sponsoring agency has more restrictive or elaborate requirements for the protection of human subjects, those requirements will take precedence over this policy and will be followed in the review of those research projects. Additional Office for Human Research Protections (OHRP) requirements exist for the protection of vulnerable populations such as fetuses, pregnant women, children, and prisoners. Those requirements must be followed when subjects are to be drawn from any of those populations (see Section 17. Vulnerable Subjects ). These procedures will also apply to all unsponsored research activities of VCOM; however, the VCOM Institutional Review Board (IRB) has the authority to modify these procedures and safeguards when it deems necessary, provided that such modifications preserve adequate protection for the rights and welfare of the subjects of unsponsored research. Such modifications include expansion of the coverage or modifications of the criteria or documentation for obtaining informed consent. The VCOM IRB will comply with OHRP requirements regarding cooperative research projects. When sponsored research is conducted at or in cooperation with another institution, this policy will remain in effect. VCOM may accept the review of an IRB established under another assurance of compliance with OHRP; however, such acceptance must be in writing and signed by VCOM's IRB Chair. VCOM will implement administrative overview, carried out at least annually, to ensure that its procedures for protecting the rights and welfare of human subjects are being effectively applied and are in compliance with the requirements of 45 CFR 46 and this policy. This administrative overview will be the responsibility of IRB Chair. 1.

VCOM Institutional Review Board Policies and Procedures

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