1. The IRB Process Tony Medure, M.A., CIP, RAC Vanderbilt Human Research Protection Program

2. Outline ► Overview of the IRB ► Type of Research and Reviews  Behavioral vs. Biomedical  Non-human subject and Non-research  Exempt vs. Expedited vs. Standard ► Where to Begin ► The Journey of a Research Proposal

3. Institutional Review Boards ► In response to many research and ethical controversies, Congress passed the National Research Act in 1974.  Established the “National Commission for Protection of Human Subjects of Biomedical and Behavioral Research.”  The Belmont Report was released in 1979 as a result of the Commission’s meeting.  The Code of Federal Regulations (45 CFR 46) was developed from the three basic principles of the Belmont Report.

4. Institutional Review Boards ► The mission of an IRB is to ensure the protection, safety, and welfare of human subjects. ► Overseen by the Office of Human Research Protections (OHRP), which is under the Department of Health and Human Services (DHHS). ► OHRP is separate from the Food and Drug Administration (FDA), which has its own set of regulations. ► Each IRB Committee is composed of scientists, non-scientists, and community members.

5. IRB Oversight ► Non-human Subject and Non-research ► Human Subjects Research  Clinical Investigations  Diagnostic or Therapeutic Procedures  New Interventions or Treatments ► Data and Specimen Repositories ► Humanitarian Use Devices ► Emergency Use of Investigational Drugs ► Case Studies ► Internet Research ► Pilot Studies

6. IRB Reviews ► Behavioral vs. Biomedical ► Exempt vs. Expedited vs. Standard ► Non-human Subject and Non-research

7. IRB Reviews by the Numbers ► In 2008, the IRB received a total of 8409 submissions.  Of those submissions, 1413 were new studies.  Amendments – 3349, Continuing Reviews - 2262, Adverse Events - 753, and Protocol Deviations – 415. ► In 2009, the IRB received a total of 8974 submissions.  Of those, 1578 were new studies.  Amendments – 3814, Continuing Reviews – 2353, Adverse Events – 838, and Protocol Deviations – 391.

8. So where do I start?

9. Investigator Training ► Be sure to complete the required human subjects training before submitting to the IRB. Any key study personnel (KSP) must also complete training.  CITI Program – http://www.citiprogram.org http://www.citiprogram.org ► Continuing IRB Education/Training.  Must complete at least one hour annually.  One additional CITI module, VHRPP workshops (e.g., News You Can Use, IRB Essentials, etc.), or another session focused on human subjects protections.

10. Timing is Everything ► Start your project NOW. It’s never too early to start planning. ► Allow yourself more time than you think you need. ► IRB review may take longer than anticipated depending on the complexity of your study. ► Respond promptly to correspondence from the IRB Committee. ► If you plan to travel abroad, make sure you have all the pieces in place before you leave. Please do not submit your project on Monday and say you’re leaving on Friday.

11. Use the Resources Available to You ► Work with mentors or other experts in your area of study. ► Talk to colleagues that have submitted to the IRB. ► Call the VHRPP to set up an appointment to speak with someone about your project. ► Call or email me with any questions you have. ► Talk to someone in the Biostatistics department and attend one of the weekly clinics. ► Get help with literature searches from the libraries on campus.

12. Putting Your Proposal Together ► A typical proposal/submission includes: an application, a consent form, a protocol, and additional supporting documents (e.g., questionnaires, advertisements, brochures, interview guides, etc.). ► All of the forms you may need are available on the VHRPP website. ► Slide shows and step-by-step video tutorials are available on the VHRPP website. ► Submit your study electronically through DISCOVR-E.

13. The Review Process ► Once your study is sent to the IRB, it will go through the “pre-review” process. ► When your study is ready, it will be sent out for review (Exempt or Expedited) or put on the next available agenda (Standard). ► When the review is complete, you will receive a letter through DISCOVR-E from the IRB Committee with an update on the status of your study (Approved, Approved Pending, or Deferred). ► If your study is approved, no other action is needed on your part. If your study is approved pending or deferred, you need to make the requested changes and submit the changes to the IRB for review. ► After your study is approved, any changes you want to make must be submitted as an amendment to the study prior to implementation. Any changes to Exempt studies must be done within the first year. ► Expedited and Standard studies must be reviewed at least once annually (i.e., Continuing Review).

14. Points to Consider ► Simple research is good research. ► Be aware of working with vulnerable populations (e.g., children, prisoners, etc.). ► Consider working with your advisor/mentor on one of his/her studies. ► Allow ample time for International studies. ► Be sure to partner with a contact abroad to make yourself familiar with the local research context. You will also need approval from a local IRB, Ethics Board, Hospital Administration, or other governing body associated with the site where you plan to conduct your study. This can take a LONG time, so be proactive.

15. Contact Information ► 322-2918 – VHRPP Front Office ► http://www.mc.vanderbilt.edu/irb/ http://www.mc.vanderbilt.edu/irb/ ► 322-2260 – direct line ► anthony.medure@vanderbilt.edu anthony.medure@vanderbilt.edu

16. Questions?