1. THE IRB Ingrid Binswanger RWJ Clinical Scholars Program

2. Why is it important to have an IRB? Tuskegee Syphilis experiment 1932-1972 by the Public Health Service Tuskegee Syphilis experiment 1932-1972 by the Public Health Service Actively prevented 399 African American men from getting treatment for syphilis to study natural history Actively prevented 399 African American men from getting treatment for syphilis to study natural history Concealed important details of experiment from the participants, e.g. role of autopsy Concealed important details of experiment from the participants, e.g. role of autopsy Penicillin available in 1940s but denied to all participants Penicillin available in 1940s but denied to all participants 28 died directly of syphilis, 100 died of related complications, 40 of their wives got infected, 19 of their children born with congenital syphilis 28 died directly of syphilis, 100 died of related complications, 40 of their wives got infected, 19 of their children born with congenital syphilis

3. The IRB: Things to Know Committee of your peers Committee of your peers –9 people per committee at UW –At least one scientist, one non-scientist, one person not a part of UW Protecting the interests of participants is foremost Protecting the interests of participants is foremost Also seek to protect you (investigator) in the event that something goes wrong with your study Also seek to protect you (investigator) in the event that something goes wrong with your study IRB is bound by Federal regulations IRB is bound by Federal regulations –Office of Health Research Protection (OHRP) –FDA You are welcome to join a committee You are welcome to join a committee

4. Plan for the time it takes At least… 2-3 months if full committee review required 2-3 months if full committee review required 1-2 weeks for Exempt 1-2 weeks for Exempt 1-2 months for minimal risk 1-2 months for minimal risk May be longer due to recent Federal Investigation May be longer due to recent Federal Investigation

5. IRB: The Process 1. You contact IRB (type of application?) 2. Read the instructions, write application, and send everything you are supposed to at least half of applications missing informationat least half of applications missing information 3. Submit your proposal 4. Pre-screen by IRB staff -- will let you know of any errors before full committee review 5. Committee reviews application 6. You respond to committee requests for changes (Answer all questions!) 7. Committee reviews answers to the initial review and approves

6. Application types Exempt – educational research, use of existing data, etc. Exempt – educational research, use of existing data, etc. Minimal Risk – purely a medical record review Minimal Risk – purely a medical record review Full Committee Review – everything else Full Committee Review – everything else Waiver of Consent available Waiver of Consent available

7. My experience Many conversations: Was the study “minimal risk?” Many conversations: Was the study “minimal risk?” Did I need WA state IRB approval instead of UW? Did I need WA state IRB approval instead of UW? Did I need VA approval since supported by VA? Did I need VA approval since supported by VA? Needed Dept. of Corrections review and National Death Index review as well (not IRBs) and now needs VA scientific committee review Needed Dept. of Corrections review and National Death Index review as well (not IRBs) and now needs VA scientific committee review 1 month to get minimal risk approval 1 month to get minimal risk approval

8. UW halts research involving prisoners By Warren King Seattle Times medical reporter University of Washington officials have halted three research projects involving prisoners until federal authorities approve the work, university officials said yesterday….

9. Federal Certificate of Confidentiality Good tool for extra protection when asking about AIDS, genetics, sexual behavior etc. Good tool for extra protection when asking about AIDS, genetics, sexual behavior etc. Can be used as a recruitment tool Can be used as a recruitment tool NIH Certificate of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/co c/index.htm NIH Certificate of Confidentiality Kiosk http://grants1.nih.gov/grants/policy/co c/index.htm http://grants1.nih.gov/grants/policy/co c/index.htm http://grants1.nih.gov/grants/policy/co c/index.htm

10. IRB: Helpful hints It’s a conversation It’s a conversation –You can explain why a requested change will not meet your needs and explain why At UW, IRB rarely declines any research proposals outright At UW, IRB rarely declines any research proposals outright –but almost always request modifications Smart to integrate pilot testing into your proposal Smart to integrate pilot testing into your proposal

11. Believe it or not, the process can HELP your research Forces you to put study questions, hypotheses, co-investigators, planned analysis on paper and to think about how you will manage your data Forces you to put study questions, hypotheses, co-investigators, planned analysis on paper and to think about how you will manage your data You may receive feedback that can help you protect the safety and privacy of your participants and protect you in the event of an adverse event You may receive feedback that can help you protect the safety and privacy of your participants and protect you in the event of an adverse event

12. Other IRBs & Cooperative Agreements Only one IRB review may be necessary for collaborative work with certain institutions; rules may dictate which IRB reviews protocol Only one IRB review may be necessary for collaborative work with certain institutions; rules may dictate which IRB reviews protocol Check the UW IRB website for list of institutions with a cooperative agreement (Fred Hutch, Children’s, OHSU, etc.) Check the UW IRB website for list of institutions with a cooperative agreement (Fred Hutch, Children’s, OHSU, etc.) If collaborators are at institutions without a cooperative agreement, they will also need to submit to their IRBs If collaborators are at institutions without a cooperative agreement, they will also need to submit to their IRBs –Do these simultaneously to save time If you are using state data, you may need to submit to the WA state IRB If you are using state data, you may need to submit to the WA state IRB Designated UW VA Committee at the VA Designated UW VA Committee at the VA

13. Modifications New people who can access identifiable data, e.g. research assistants and statistical helpers should be added on Modification forms New people who can access identifiable data, e.g. research assistants and statistical helpers should be added on Modification forms Must ask for approval for ALL changes e.g. in approach, consent, questions, piloting, etc. Must ask for approval for ALL changes e.g. in approach, consent, questions, piloting, etc.

14. Electronic submissions UWise – electronic system phase 1 of deployment UWise – electronic system phase 1 of deployment Certain departments sending in all applications via UWise – check IRB website or call IRB Certain departments sending in all applications via UWise – check IRB website or call IRB

15. Web links UW IRB http://www.washington.edu/research/hsd/index.ph p UW IRB http://www.washington.edu/research/hsd/index.ph p http://www.washington.edu/research/hsd/index.ph p http://www.washington.edu/research/hsd/index.ph p OHRP website: http://www.hhs.gov/ohrp/ OHRP website: http://www.hhs.gov/ohrp/http://www.hhs.gov/ohrp/ Training on human subjects: http://www.washington.edu/research/hsd/training. html Training on human subjects: http://www.washington.edu/research/hsd/training. html http://www.washington.edu/research/hsd/training. html http://www.washington.edu/research/hsd/training. html Cooperative agreements: http://www.washington.edu/research/hsd/coopag.h tml Cooperative agreements: http://www.washington.edu/research/hsd/coopag.h tml http://www.washington.edu/research/hsd/coopag.h tml http://www.washington.edu/research/hsd/coopag.h tml UW IRB Questions? 543-0098 UW IRB Questions? 543-0098

16. Questions? Comments?