1. Office of Research Oversight Office of Research Oversight 1 Human Subject Protection Issues for HSR&D Researchers Tom Puglisi, PhD, CIP Chief Research Oversight Officer HSR&D National Meeting February 21-23, 2007 Office of Research Oversight

2. Office of Research Oversight Office of Research Oversight 2 Frequent Problem Areas in HSR&D Research Research vs Quality Improvement Research vs Program Evaluation Compartmentalizing Project Activities Patients and Providers as Subjects Information Security Engagement

3. Office of Research Oversight Office of Research Oversight 3 Definition of Research Definition of Research 38 CFR 16.102(d) A systemic investigation, designed to develop or contribute to generalizable knowledge. Includes research development, testing, evaluation May include demonstration and service programs Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purpose

4. Office of Research Oversight Office of Research Oversight 4 Research vs Quality Improvement Research is “designed” to develop or contribute to generalizable knowledge “Design” => plan / methodology “Design” => intention ─ Prospective intention to conduct research ─ Post Hoc intention to conduct research

5. Office of Research Oversight Office of Research Oversight 5 Research vs Program Evaluation Independence of the Program Under Evaluation Research Team did not design the program Research Team did not implement the program Program existed prior to the evaluation Program will continue after the evaluation

6. Office of Research Oversight Office of Research Oversight 6 Compartmentalizing Project Activities “The whole is greater than the sum of the parts” Intent of the activity as a whole is critical to research vs non-research determination Unless activities and information access are strictly limited in writing, all members of the research team are generally accountable for the project as a whole, including their intellectual contributions

7. Office of Research Oversight Office of Research Oversight 7 Patients and Providers as Research Subjects Subjects may feel “undue influence” to participate Confidentiality risks are real Harm may be substantial

8. Office of Research Oversight Office of Research Oversight 8 Information Security Anonymous vs ─ Not Identifiable ─ De-identified ─ Coded VA Security Requirements ─ Storage ─ Transmission ─ Encryption

9. Office of Research Oversight Office of Research Oversight 9 “Engagement” in Research Federal Policy (Common Rule) 38 CFR 16.103(a) Each institution engaged in research … conducted or supported by a Federal Department … shall provide written assurance satisfactory to the Department … that it will comply with the requirements set forth in this policy.

10. Office of Research Oversight Office of Research Oversight 10 General Consequences of Engagement Federalwide Assurance (FWA) is REQUIRED Institutional Review Board (IRB) review and approval are USUALLY (but not always) REQUIRED

11. Office of Research Oversight Office of Research Oversight 11 Engagement in Human Research Engagement in Human Research VHA Handbook 1200.5 § 3.b. A VA facility is engaged in human subject research (and needs an Assurance) whenever its employees or agents: Intervene or interact with living individuals for research purposes, or Obtain, release, or access individually-identifiable private information (or individually-identifiable specimens) for research purposes – See 38 CFR 16.102(f)

12. Office of Research Oversight Office of Research Oversight 12 VA Facilities Housing Research Repositories Are engaged in a human research activity (ie, maintaining a research repository) Facility IRB must review and approve protocol with ◦ Requirements for operating the repository ◦ Requirements for accepting, storing, and sharing data ◦ Requirements for maintaining privacy and confidentiality Are typically NOT considered involved in the conduct of individual projects using repository data ◦ Review of individual projects by Repository Facility’s IRB typically not required unless PI is also at the facility

13. Office of Research Oversight Office of Research Oversight 13 Critical Question: IRB Review by Non-Engaged VA Facilities When is the VA facility “responsible” for activities of “non-facility” researchers? Involving the facility’s “patients” but conducted outside the facility? Involving the facility’s employees but conducted outside the facility?

14. Office of Research Oversight Office of Research Oversight 14 Definition of Research Definition of Research 38 CFR 16.102(d) Examples of HSR&D Research

15. Office of Research Oversight Office of Research Oversight 15 Office of Research Oversight http://www1.va.gov/oro/ 811 Vermont Avenue, N.W., Suite 574 (10R) Washington, D.C. 20420 PHONE: (202) 565-5184 FAX: (202) 565-9194