Engagement in Research

1. Human Research Protection Program Office of the Institutional Review Board Engagement in Research Elaine V. Neal, CIP, EMT-B, Assistant Director Office of the Institutional Review Board December 2007

2. Federal Regulation • Department of Health and Human Services (DHHS) Regulations at 45 CFR 46.1039(a) require that: • Each institution engaged in human subjects research must provide the Office for Human Research Protections (OHRP) with a satisfactory Federalwide Assurance (FWA) to comply with regulations, unless the research is exempt under 45 CFR 46.101(b).

3. FWA • Formal agreement between NS-LIJ and OHRP • Documentation of commitment to operate in compliance with the federal regulations governing research with human subjects • Statement of commitment to conduct research within the ethical standards outlined in the Belmont Report • Applies to all research involving human subjects regardless of source of funding or support conducted at NS-LIJ, as well as to research conducted elsewhere by physicians, students, staff, or other representatives of the NS-LIJ in connection with their institutional responsibilities

4. Human Subject • “A living individual about whom an investigator…conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” -- 45CFR46.102 • “An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient.” -- 21CFR50.3

5. New York State Law • Makes no distinction between living and deceased individuals in the definition of “human subject”.

6. When does an institution become engaged in research? • Employees or agents: • Intervene or interact with living individuals for research purposes; • Obtain individually identifiable private information for research purposes [45 CFR 46.102(d), (f)]. • Automatically engaged whenever direct HHS award is made to support research. • Awardee institution bears ultimate responsibility for protection of human subjects under the award.

7. “Agent” • Agents include: • All individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility.

8. Institution Engaged in Human Subjects Research • Employees or agents intervene with living individuals by performing invasive or non-invasive procedures for research purposes • Examples: blood draws; collection of biological specimens; dispensing drugs; administering other treatments; etc. • Employees or agents intervene with living individuals by manipulating the environment for research purposes • Examples: controlling environmental light, sound, or temperature; presenting sensory stimuli; etc.

9. Institution Engaged in Human Subjects Research • Employees or agents interact with living individuals for research purposes • Examples: engaging in protocol-dictated communication or interpersonal contact; conducting research interviews; obtaining informed consent

10. Institution Engaged in Human Subjects Research • Employees or agents release individually identifiable private information, or permit investigators to obtain individually identifiable information, without subjects’ explicit written permission • Examples: releasing patient names to investigators for solicitation as research subjects; recording private information from medical records in identifiable form

11. Institution Engaged in Human Subjects Research • Employees or agents obtain, receive, or possess private information that is individually identifiable (either directly or indirectly through coding systems) for research purposes • Example: obtaining individually identifiable private information from medical records

12. Institution Engaged in Human Subjects Research • Employees or agents obtain, receive, or possess individually identifiable private information (either directly or through coding systems) for the purpose of maintaining “statistical centers” for multi-site collaborative research

13. Institution Engaged in Human Subjects Research • Employees or agents maintain “operations centers” or “coordinating centers” for multi-site collaborative research • Institution receives a direct HHS award to conduct human subjects research, even if activities will be carried out by a subcontractor or collaborator

14. Institution Not Engaged in Human Subjects Research • Employees or agents act as consultants but at no time obtain, receive, or possess identifiable private information • Should consultant access/utilize individually identifiable private information while visiting research team’s institution, consultant’s activities become subject to oversight of research team’s IRB. Consultant institution would not be considered engaged and would not require an Assurance. • Should consultant obtain “coded” data for analysis at consultant’s institution, consultant’s institution is engaged and requires an Assurance, unless a written agreement unequivocally prohibits release of identifying codes to consultant.

15. Institution Not Engaged in Human Subjects Research • Employees or agents • Perform commercial services for investigators; AND • Adhere to commonly recognized professional standards for maintaining privacy and confidentiality (e.g., a qualified laboratory performs analyses of blood specimens solely on a commercial basis)

16. Institution Not Engaged in Human Subjects Research • Employees or agents • Inform prospective subjects about the availability of research • Provide prospective subjects with written information about research • Provide prospective subjects with information about contacting investigators for information or enrollment • Obtain and appropriately document prospective subjects’ permission for investigators to contact them

17. Institution Not Engaged in Human Subjects Research • Institutions (e.g., schools, nursing homes, etc.) permit use of their facilities for intervention or interaction with subjects by researchers (e.g., school permits investigators to test students whose parents have provided written permission for their participation)

18. Institution Not Engaged in Human Subjects Research • Employees or agents release identifiable private information to investigators with prior written permission of subject (e.g., with written permission of subject, clinician releases subject’s medical record to investigators)

19. Institution Not Engaged in Human Subjects Research • Employees or agents release identifiable private information or specimens to state or local health department or its agent for legitimate public health purposes within the recognized authority of that department • HOWEVER, utilization of such information or specimens by department investigators for research purposes would constitute engagement

20. Institution Not Engaged in Human Subjects Research • Employees or agents release information and/or specimens to investigators in non-identifiable (no link) form, where such information/specimens have been obtained by the institution for purposes other than the investigator’s research • Employees or agents receive information or specimens for research from established repositories operating in accordance with • An applicable OHRP approved FWA; • OHRP guidance on repositories; AND • Written agreements unequivocally prohibiting release of identifying information to recipient investigators

21. Institution Not Engaged in Human Subjects Research • Institutions (or private practitioners) whose clinical staff provide protocol-related care and/or follow-up to subjects enrolled at distance sites by clinical trial investigators in OHRP recognized Cooperative Protocol Research Programs (CPRPs) (e.g., NCI CCOP program) • CPRP registered clinical trial investigator retains responsibility for oversight of protocol related activities; • Clinical staff may not accrue subjects or obtain informed consent for research participation; • Clinical staff may only provide data to investigator in accord with terms of informed consent; AND • Informed consent document states that such data are to be provided by clinical staff as directed by investigator

22. For assistance… Contact the Office of the IRB: 5 Dakota Drive, Suite 307 Lake Success, New York 11042 Phone: 516-719-3100 E-mail: irb@nshs.edu