1. Is IRB Review or an OHSRP Determination Required?

2. When do NIH Investigators need IRB Review and Approval…? 2

3. Definition of Terms Research: a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)). Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. Research Collaboration: the activity of investigators and other staff working together on research projects, whether the individuals are all internal to NIH or a combination of both internal and external 3

4. Definition of Terms cont. Coded: Identifying information, that would enable the investigator to identify the individual, who is the source of the specimens/data has been replaced with a code (e.g., a series of numbers and letters) – Coded & Linked: A key to decipher the code exists – Coded & Unlinked: No key to the code exists Anonymous: There are no identifiers nor a code; the specimens/data have been completely de-identified. 4

5. Engagement in Human Subjects Research Engagement in human subjects research: one is considered engaged in human subjects research when for the purposes of the research he/she interacts or intervenes with humans subjects to collect human specimens/data or uses identifiable or coded human specimens/data for research and can link the specimens/data to the individuals. When NIH investigators are engaged in human subjects research (not meeting the criteria for an exemption), IRB review and approval is required. 5

6. Other Examples of Engagement Other examples of engagement in research: obtaining informed consent, or when NIH investigators have identifiers, conducting analyses, running assays or co-authoring a manuscript 6

7. Research Collaborations When NIH investigators are retaining identifiers and sharing de-identified human specimens/data with another investigator as part of a research collaboration, they are considered engaged in human subjects research and prospective NIH IRB review and approval of the research is required (or a reliance agreement must be in place). – This is true whether the research collaboration is part of the primary protocol or is secondary research. – One common example: an NIH investigator shares his/her coded specimens/data for analysis or testing at another site, receives coded results back, and then uses the results to write a paper with the collaborator. 7

8. Protocol Content Requirements When de-identified specimens/data will be shared as part of a research collaboration and the NIH investigators have identifiers….. – The IRB-approved protocol should contain a statement that research collaborators will be provided coded (without the access to the key) or de-identified specimens/data. – It should also describe the research that will be conducted (whether by the collaborator or the NIH investigators). 8

9. Consent Form Content Requirements When de-identified specimens/data will be shared as part of a research collaboration and the NIH investigators have identifiers….. – The consent document should explain that specimens/data may be shared with other investigators. For primary research described in the IRB-approved protocol: The consent should include language that the purpose of the sharing, e.g. a research that is consistent with the protocol, and that the subjects’ identities will not be shared. For new secondary collaborative research: The consent should include language that specimens/data will be stored for future research; there will be prospective IRB approval of the research plan before sharing; and the subjects’ identities will not be shared. 9

10. When the Protocol and Consent Requirements Have Not Been Met…. The NIH investigators must amend their protocol accordingly and receive prospective IRB approval prior to sharing. If the secondary research is substantially different from the research aims of the original protocol, the IRB may determine that a new protocol is required. The IRB will determine whether the planned research is consistent with or not inconsistent with the language in the consent. 10

11. Research Activities Involving Human Specimens/Data under an IRB-Approved Protocol When NIH investigators are conducting research with specimens/data that have been collected under an IRB- approved protocol, the new activities should be reviewed and approved by an IRB rather than submitted to OHSRP as a request for an determination. The rationale behind this policy is that all research related to a protocol should be described in the protocol and approved by the IRB. 11

12. Merging De-Identified Specimens/Data with Data on an IRB-Approved Protocol If NIH investigators are obtaining de-identified specimens/data from another source and plan to conduct new analyses or testing and merge the results with data from an IRB-approved protocol, the protocol should be amended to include the research. Again, the rationale behind this policy is that all research that is part of the science of a protocol should be described in the protocol and approved by the IRB. 12

13. When Can NIH Investigators Get an OHSRP Determination that IRB Review is Not Required…? 13

14. Categories of Activities that Do Not Require IRB Review There are two main categories of research for which NIH investigators typically receive an OHSRP determination of excluded from IRB review: – “Not human subjects research”, i.e. the NIH investigator is not engaged – “Exempt research”, e.g. research using survey or focus group procedures with no risk to human subjects or medical chart reviews where no identifiers are retained There are some activities, including research activities, that do not require either a determination or IRB approval (For more information, please see SOP 5, Appendix 1.) 14

15. “Not Human Subjects Research” The research activity is considered “not human subjects research”, e.g. because the NIH investigators will have no interaction with human subjects or have no access to identifiers. This is the most common scenario that is submitted to OHSRP for a determination. 15

16. Questions???