From the ∗Center for Healthcare Organization and Implementation Research (CHOIR), VA Boston Healthcare System

†Department of Health Policy and Management, Boston University School of Public Health, Boston, Massachusetts

‡VA Ann Arbor Center for Clinical Management Research

§VHA National Center for Patient Safety

∥University of Michigan, Ann Arbor, Michigan.

Correspondence: David C. Mohr, PhD, VA Boston Healthcare System Boston, MA United States (e-mail: [email protected]).

The authors disclose no conflict of interest.

The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs or the U.S. government.

In response to the designation of broad categories of activities as nonresearch in the Federal Policy for the Protection of Human Subjects (Common Rule) in Title 38 Code of Federal Regulations Part 16 (38 CFR 16.102(l)) published January 19, 2017, the VHA enacted new policies and guidelines for determining nonresearch activities within VHA. In accordance with these VHA policies and guidelines, this program has documentation as nonresearch by VA National Center for Patient Safety, which is authorized to deem projects as nonresearch activities for which formal institutional review board oversight is not required, as defined per VHA Handbook 1058.05 in the section “Officials Authorized to Provide Documentation of VHA Program Office Non-Research Operations Activities” and later updated in section 5a of the VHA Program Guide 1200.21.

This material is based on work supported by the Department of Veterans Affairs, Veterans Health Administration, Office of Research and Development, Health Services Research and Development (QIS 19-458).