1. Help us Help you: IRB Policy Updates Susan Bankowski, MS, JD IRB Chair

2. New and Updated Policies Targeted Connections Combined VA-OHSU review FWA – 3/22/2012 Engagement in Research – 3/22/2012 Collaborations– 3/22/2012 Future Human Subjects Research & JIT – 2/8/2012 International Research – 2/24/2012 State Laws and Regulations – 10/11/2011 Child Assent – 10/10/2011 FAQs and Chair Letter on eIRB Approval Memos – 2/22/2012

3. New VA-OHSU Combined Review!!!! Old Dual IRB Review System New Combined VA-OHSU Review

4. VA-OHSU Combined Board Process + Include VASQ Submit in eIRB + Combined Board IRB Review + VA Approval OHSU Approval

5. Federal Wide Assurance An Institution must have an FWA to conduct federally funded human subject research. An FWA is a promise to the feds that we’ll follow the human subject research regs. OHSU FWA00000161

6. Federal Wide Assurance – cont. OHSU extends its FWA to cover all research, regardless of funding source. Covers all non-exempt human subject research at OHSU. We can extend our FWA to cover collaborators.

7. Engagement in Research OHSU is considered “engaged in human subject research” when: OHSU employees or agents –intervene or interact with human subjects for purposes of research; –obtain individually identifiable private information about human subjects for purposes of research; –obtain informed consent of human subjects for participation in research; or OHSU receives financial support for the conduct of a particular research project (even if all activities involving human subjects are conducted elsewhere, including the VA). We rely on OHRP guidance for case scenarios http://www.hhs.gov/ohrp/policy/engage08.html http://www.hhs.gov/ohrp/policy/engage08.html

8. Engagement in Research – cont. When OHSU is engaged in research at another site, the IRB will review the OHSU activities, taking into account the whole study for risk determination. When OHSU receives an award and has many sites, each site’s activities will be analyzed to determine engagement and need to IRB review/FWA coverage. Can use a request for determination to figure out engagement.

9. Collaborations When determining applicable requirements, consider: 1.Which institutions are engaged in human subjects research per federal definitions, and to what extent? 2.Which institutions must have a Federal-Wide Assurance (FWA) on file with OHRP? 3.Which institutions must provide IRB review for the project? How will each institution’s IRB review requirements be met? 4.What steps must be taken when OHSU provides IRB oversight for non-OHSU investigators regarding Conflict of Interest in Research regulations and training in the responsible conduct of research? 5.What protections must be in place when data and/or specimens are shared across institutions?

10. Collaborations – cont. Determine Engagement Figure out which FWA(s) will apply Which IRB(s) reviewing? –Each institution conducts its own IRB review; –OHSU agrees to rely on the review of the IRB of a collaborating institution; –A collaborating institution agrees to rely on the review of the OHSU IRB; or –An OHSU-approved third-party IRB provides review.

12. Human Subjects Research in the Future & JIT Future Human Subject (FHS) Review –For research applications lacking definite plans for the involvement of human subjects, the IRB must have in place mechanisms to ensure that any research supported under the award receives IRB review and approval prior to the involvement of human subjects. –IRB conducts review of plan and gives approval to release funds. Just-in-Time Review –May be conducted when get a good score, but must be full IRB review

13. Future Human Subject - examples These include activities such as: institutional grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon development of instruments, prior animal studies, or purification of compounds.

14. International Research When an OHSU investigator conducts human subject research at a non-US site, the OHSU IRB has oversight authority for that research. IRB review will give special consideration of the following: –Whether necessary information has been provided about the local research context, –If the consent process is appropriate to the population and procedures, and –If adequate provisions are outlined for data and safety monitoring.

15. International Research - Cont. The OHSU IRB is required to gain knowledge of local context in order to conduct its review. Does a local IRB or other analogous review body exists to provide local context and guidance. –Evaluation of the protocol by a review board local to the study site, consultation with an expert in the respective country, and/or other means to obtain knowledge of the local context is required. The level of risk, amount of community involvement, logistical complexity, and potential for interaction with local laws will dictate the type of local level review that is required.

16. State Laws and Regulations When there are overlapping State and Federal laws, the law or statute that is most restrictive or best protects participants takes precedence.

17. State Laws and Regulations – cont. Laws Concerning Children or Minors – Age of Majority –Relation of Adopted Child to Adoptive Parents –Medical or Dental Treatment –Diagnosis or Treatment for Mental or Emotional Disorder or Chemical Dependency –Educational/School Records –Wards of the Court Reporting Abuse Public records Disclosure Disease Reporting HIV Testing Inmates Rights Genetic Privacy Rights Protected Health Information

18. Child Assent While children may be legally incapable of giving informed consent, they nevertheless may possess the ability to assent to or dissent from participation. Children should be asked whether or not they wish to participate in the research, particularly if the research –does not involve interventions likely to be of benefit to the subjects; and –the children can comprehend and appreciate what it means to be a volunteer for the benefit of others. Age of assent is generally 7, but may vary depending on cognitive ability and maturity of child.

19. Child Assent – cont. When the research offers the child the possibility of a direct benefit that is important to the health or well-being of the child and is available only in the context of the research, the IRB may determine that the assent of the child is not necessary

20. Information on Approval memos E-signatures - fulfills the 21 CFR part 11 Approval Dates –Approval date is IRB approval date –For expedited, it is chair approval date –Documents get approval when Chair approves Approval of study documents –Docs only listed on industry sponsored trials Availability of approved documents –Post-processing can take a few days http://www.ohsu.edu/xd/about/services/integrity/policies/loader.cfm?csModule= security/getfile&pageid=2067739

21. SUSAN BANKOWSKI, MS, JD BANKOWSK@OHSU.EDU QUESTIONS?