Title of Regulation: 8VAC35-70. Research Involving Human Subjects (adding 8VAC35-70-10, 8VAC35-70-20).

Statutory Authority: § 23-91.29 of the Code of Virginia.

Effective Date: January 2, 2012.

Agency Contact: Kenneth W. Hubble, Agency Regulatory Coordinator, George Mason University, 4400 University Drive, Fairfax, VA 22030, telephone (703) 993-3091, or email khubble@gmu.edu.

Summary:

This regulation adopts standards for human subject research at George Mason University.

CHAPTER 70
RESEARCH INVOLVING HUMAN SUBJECTS

8VAC35-70-10. Scope.

This policy applies to all research involving human subjects conducted by George Mason University. Research is conducted by George Mason University when its employees or agents are engaged in research as defined by the U.S. Department of Health and Human Services in the Office of Human Research Protections' Guidance on Engagement of Institutions in Human Subjects Research dated October 16, 2008.

8VAC35-70-20. Federal regulations adopted.

George Mason University will conduct research involving human subjects only if the research has been approved by and will be subject to continuing review by an Institutional Review Board (IRB) designated by George Mason University and operating in accordance with 45 CFR Part 46 with the following exceptions:

1. 45 CFR 46.103(a): Department or agency head means the President of George Mason University or any other official to whom the president has delegated authority.

2. 45 CFR 46.103(b): Institution means George Mason University.

3. 45 CFR 46.103 and 45 CFR 46.120-124: These sections are not followed as they are requirements of federal departments and agencies funding research and not applicable to George Mason University.

DOCUMENTS INCORPORATED BY REFERENCE (8VAC35-70)

Guidance on Engagement of Institutions in Human Subjects Research, October 16, 2008, U.S. Department of Health and Human Services, Office of Human Research Protections.