Engagement of Institutions in Human Subjects Research

1. Engagement of Institutions in Human Subjects Research K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE HRPP 101 January 25, 2011 (revised 2/3/11)

2. Guidance on Engagement of Institutions in Human Subjects Research VA follows guidance from the Office for Human Research Protections (OHRP), October 16, 2008, http://www.dhhs.gov/ohrp/policy/engage08.html

3. Employees & Agents* • Individuals who • Act on behalf of the institution • Exercise institutional authority or responsibility • Perform institutionally designated activities • May be • Staff • Students • Contractors • Volunteers *Whether or not they receive compensation

4. Engaged in Human Subjects Research* • In general, a VA facility if “engaged” when someone with a VA appointment obtains for the purposes of the research study • Data about the subjects of the research through intervention or interaction with them • Identifiable private information about the subjects of the research • The informed consent of human subjects for the research *VHA Handbook 1200.05, Paragraph 50 4

5. Engaged in Human Subjects Research • If a VA facility is engaged in human subjects research it must • Hold a Federalwide Assurance (FWA) • Have a local VA PI or LSI for that study • Have the facility’s IRB of record approve the study

6. Not Engaged in Human Subjects Research* If a VA facility is not engaged • In any human research then the VA facility • It does not need to have an FWA • In research for an individual study • Its IRB of record does not need to approve that study • It has no jurisdiction over that study • Except the facility Director may determine that the study cannot be conducted on its premises *VHA Handbook 1200.05, Paragraph 51

7. Engaged in Human Subjects Research • Receives an award through a grant, contract, or cooperative agreement for non-exempt human subjects research (even if all activities involving human subjects are carried out elsewhere) • Employees or agents intervene for research purposes with any human subjects by performing invasive or noninvasive procedures such as • Drawing blood • Collecting cheek cells with a cotton swab • Counseling or psychotherapy • Giving drugs or treatments

8. Engaged in Human Subjects Research • Employees or agents intervene with any human subject by manipulating the environment • Controlling light, sound, temperature • Presenting sensory stimuli • Orchestrating social interactions • Employees or agents interact with any human subject • Protocol-dictated communication or interpersonal contact • Asking someone to provide a specimen by voiding or spitting into a container • Conducting interviews or administering questionnaires

9. Engaged in Human Subjects Research • Employees or agents obtain informed consent • Employees of agents obtain identifiable private information or identifiable biological specimens from any source for the research • Even if the institution’s employees or agents do not directly interact or intervene with the subjects • Examples • Observing or recording private behavior • Using, studying, or analyzing for research purposes identifiable private information or identifiable specimens • Provided by another institution • Already in possession of investigators

10. Not Engaged in Human Subjects Research • Employees or agents perform commercial or other services for investigators if all of following are met • Services do not merit professional recognition or publication privileges • Services are typically performed by that institution for non-research purposes • Do not administer any study intervention being tested or evaluated under the protocol • Examples • Routine clinical labs (collect & analyze blood, urine, etc.) • Transcription company • Clinical radiology services

11. Not Engaged in Human Subjects Research • Institutions not selected as research sites, but whose employees or agents provide clinical trial-related services in the protocol that would typically be performed for routine clinical monitoring &/or follow-up such as • Medical history • Physical examination • Assessment of adverse events • Blood tests • Chest x-ray • CT scan

12. Not Engaged in Human Subjects Research • All of the following must be met • Employees or agents do not administer the study interventions • Clinical trial-related medical services are typically provided by the institution for clinical purposes • Employees or agents do not enroll subjects • Employees or agents do not obtain informed consent • When appropriate, investigators from an engaged institution retain responsibility for • Overseeing protocol-related activities • Ensuring reporting protocol-related data to engaged institution (including AEs, etc)

13. Not Engaged in Human Subjects Research • Employees or agents administer the study interventions limited to a one-time or short-term basis if all the following are met • Employees or agents do not enroll subject • Employees or agents do not obtain informed consent • Investigator at engaged institution determines it would be in subject’s best interest & retains responsibility for • Overseeing protocol-related activities • Ensuring interventions are administered as approved by IRB • Ensuring reporting of data (including AEs) • The IRB of engaged institution is notified of this arrangement

14. Not Engaged in Human Subjects Research • Employees or agents • Notify prospective subjects of availability of research • Provide prospective subjects with information about the research • Provide prospective subjects with information about contacting investigators for enrollment • Seek or obtain the prospective subjects’ permission for investigators to contact them

15. Advertising in VA Facilities* The facility Director is responsible for ensuring that recruiting documents, flyers, and advertisements for non-VA research are not posted within or on the premises of a VA facility… General guidance may be posted within VA indicating that Veterans may speak with their health care providers if they wish to participate in research and that information on clinical trials is available at http://clinicaltrials.gov *VHA Handbook 1200.05, Paragraph 5n

16. Not Engaged in Human Subjects Research • Institutions that permit use of their facilities for intervention or interaction with subjects by investigators from the engaged institution • Examples of institutions • Schools • Nursing homes • Businesses • Examples of research – permits investigator from engaged institution may • Conduct or distribute a survey in a classroom • Recruit subjects or draw blood samples

17. Not Engaged in Human Subjects Research • Employees or agents release to investigators at engaged institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research, but they should • Meet their own institutional requirements for releasing the data or specimens • Ensure the release would not violate informed consent provided by the subjects • If informed consent was waived by the IRB, ensure release would be consistent with the IRB’s determinations that permitted waiver of informed consent

18. Not Engaged in Human Subjects Research • Examples of release of identifiable private information or identifiable biological specimens* • Schools that release identifiable student test scores • An agency that releases information about its beneficiaries • Hospitals that release identifiable human biological specimens *Usually institutions whose employees or agents obtain this information or these specimens would be engaged in human subjects research

19. Not Engaged in Human Subjects Research • Employees or agents • Obtain coded private information or human biological specimens • Are unable to readily ascertain the identity of the subjects • The institution that is not engaged and the holder of the key to the code have an agreement prohibiting release of the key to the not engaged institution’s employees or agents • The engaged site’s SOPs prohibit release of the key • Other legal requirements prohibit release of the key

20. Not Engaged in Human Subjects Research • Employees or agents access or utilize individually identifiable private information only while visiting an engaged institution, if their activities are overseen by the engaged institution’s IRB • Employees or agents access or review identifiable private information for purposes of study auditing

21. Engaged in Research Not Involving Human Subjects • Must follow VHA Handbook 1200.01 • Must obtain R&D Committee approval

22. Important Considerations for Determining Engagement in Human Research • Where are research staff appointments? • Will staff at local sites assist with recruitment? • What are the roles of staff from each VA in terms of • Obtaining informed consent • Interacting or intervening with subjects • Obtaining private identifiable information or identifiable biological specimens • What types of data/specimens will the staff use at each institution for the research?

23. Important Considerations for Determining Engagement in Human Research • Does the use of anonymous or coded data/specimens meet OHRP guidance? • Will aggregate data, HIPAA identifiers, individually identifiable private information, or identifiable specimens be used in a manner which enables the user to readily identify the subject? • Can a subject be associated with aggregate data, HIPAA identifiers, private information, or specimens used in the study? Ask follow-up questions based on information provided

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