1	IRB Process – Clinical Research Irina Fonareva, BA Lori Kelly, RN, BSN December 12, 2006 OHSU APOM RIP seminar
2	Introduction to OHSU IRB process Overview of the IRB process Pre-requisites for doing research at OHSU Preparing initial IRB submission Overview of the eIRB on-line submission system
3	"IRB process" IRB process
4	What is the IRB? The Institutional Review Board (IRB) is an administrative body responsible for reviewing all human subjects research and ensuring compliance with federal regulations. The primary role of the IRB is to protect the safety and welfare of human subjects.
5	What research studies need an IRB approval? All research that is conducted with human subjects, regardless of funding Research involving activities such as collection of tissues, blood, genetic material, private information, and any chart review
6	What is Research Involving Human Subjects? Research involving human subjects is an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed in theories, principles, and statements or relationships). If planning to publish – get an IRB approval (most journals require an explicit statement that the study has been reviewed and approved by the IRB)
7	Quiz: Do any of these studies require IRB review and approval? 1) A randomized controlled trial of the Naturopathic Anti-Inflammatory Diet (multi-center clinical trial) YES 2) Trends in emergence agitation with multiple anesthetics (chart review of Anesthesia & PACU records of DCH patients) YES 3) Parental satisfaction with medical procedures (survey of parents of patients undergoing procedures at DCH) YES 4) Perceived quality of life in patients with fibromyalgia (secondary data analysis from the dataset your colleague collected) YES
8	Levels of IRB review Exempt review (e.g. research on educational tests) http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.101 Expedited review (e.g. low risk survey studies) http://www.hhs.gov/ohrp/humansubjects/guidance/expedited98.htm Full board (e.g. drug studies, interventional studies) * At OHSU IRB determines the level of review for your study *
9	Take home message: While several types of studies may be eligible for exemption from review, no investigator may exempt herself/himself from review. The IRB has sole power to exempt studies from review. * No research involving human subjects conducted under the auspices of OHSU can be done without IRB approval! *
10	JUST DO IT!
11	Where to find information about research at OHSU? Research Development Administration (RDA) http://www.ohsu.edu/research/rda/ General Clinical Research Center (GCRC) http://gcrc.ohsu.edu/ Oregon Clinical and Translational Research Institute (OCTRI) http://www.octri.org/octri/public/default.aspx
12	How to find IRB page? Go to ozone at http://ozone.ohsu.edu/ Go the Research Resources Find IRB home page (bottom right segment) Put it in your Favorites or Go to http://www.ohsu.edu In search type IRB home Open the page Put it in your Favorites or Type in the URL http://www.ohsu.edu/research/rda/irb/
13	Becoming familiar with OHSU IRB IRB Home Page: http://www.ohsu.edu/research/rda/irb/ IRB Process: http://www.ohsu.edu/research/rda/irb/process.shtml IRB Forms Templates: http://www.ohsu.edu/research/rda/forms.shtml#hsf IRB Contact Information: http://www.ohsu.edu/research/rda/irb/staff.shtml
14	OHSU IRB initial submission process: necessary steps Complete required research training Download forms from the IRB website Complete forms required for your protocol Submit the protocol using eIRB system Resubmit the protocol after analyst review incorporating all suggestions
15	Step 1: Completing research pre-requisites
16	Research Training Required for: Principal Investigator Sub-Investigators Study coordinator/staff Everyone listed in the IRB submission
17	Responsible Conduct in Research (RCR) Need to complete once (~30 min) Available at http://www.ohsu.edu/cc/ed/bb/login.shtml You need: RCR for all RCR involving human subjects Any other modules needed for your particular study
18	Conflict of Interest in Research Form (CoIR form) Form submitted annually Guidelines at: http://www.ohsu.edu/research/rda/coir/requirements.shtml Download form at http://www.ohsu.edu/research/rda/forms.shtml#hsf Contact CoIR office with questions Email: coir@ohsu.edu. Phone: 503-494-7887
19	Registering to eIRB system Go to login page from this page http://www.ohsu.edu/research/rda/eirb/ Click on the green registration link at the bottom
20	Checking the progress of your team To check your own compliance: http://www.ohsu.edu/cc/ed/bb/login.shtml To check your and your investigators’ compliance: http://ozone.ohsu.edu/research/rda/apps/eirbinfo/index.php To update or correct information, contact 4-7887 or rdaweb@ohsu.edu
21	Learning more about research: Clinical Research Coordinator Workshop (RDA) Free 2-day workshop open to anyone involved in clinical research at OHSU. Covers basic areas of clinical research including IRB process, sponsored research basics, audits and more. Registration is required. Check RDA calendar at http://ozone.ohsu.edu/research/rda/education/calendar/calendar.php Human Investigations Program (HIP) at OHSU http://www.ohsu.edu/academic/dmice/hip/
22	Steps 2 and 3: Downloading and completing forms
23	Step 2: Downloading IRB forms templates Submission checklist: handout Download forms from IRB web page: http://www.ohsu.edu/research/rda/forms.shtml#hsf TIP: Always go to the web to download forms for a new protocol because the forms might change
24	Forms needed for any protocol
25	Step 3: Completing basic forms PPQ: Complete to the best of your ability. E-mail Cindee Gray (grayc@ohsu.edu) for any corrections and feedback. Print out the edited form, sign, and date. Send the signed form to Cindee for getting all other required signatures. Include your protocol and lay summary protocol with it.
26	Completing basic forms Lay Protocol Summary: Should be easily understood by a lay person Brief description of the study (try to stay within 1-2 pages) 8^th grade level, short sentences, simple explanations TIP: Complete this form first, and you can cut and paste sentences for your complete protocol and for Initial Review Questionnaire (IRQ).
27	Completing basic forms Complete Protocol: No IRB template Can use the protocol for your grant submission If using GCRC, use their template at: http://gcrc.ohsu.edu/ Describe the purpose, participants, procedures, and data analyses with sufficient detail Tell IRB all they need to know to make a decision about your study
28	Other forms that might be needed depending on the study Consent forms: for direct subject contact HIPAA authorization forms Waiver of authorization forms Advertisements Screening and Follow-up Scripts Interview and survey measures Device brochures Data Use Agreements Etc.
29	Different types of studies require different forms: 1) Secondary data analysis/Chart review * 2) Prospective observational study * 3) Interventional studies 4) Sponsored clinical trials * Handouts available
30	Avoiding most common problems Verify that: all the study personnel are registered in the eIRB system and listed on the IRQ all study personnel have completed their training and CoIR form everyone at OHSU participating in the conduct of the protocol are listed under persons authorized to use and disclose information all procedures for the study are listed in the protocol and in the consent form the risks listed in the Human Subjects section of the protocol match those listed in the consent form
31	Getting answers for your questions IRB policies and procedures are available on-line: http://www.ohsu.edu/research/rda/irb/policies.shtml Going through IRQ will help: Answer IRQ questions and the program will take you to the right pages. Help notes are also available in the IRQ. Contact IRB staff with questions: http://www.ohsu.edu/research/rda/irb/staff.shtml TIP: If there is a problem getting help, complete everything to the best of your ability and submit. An analyst will be assigned to your study, and s/he will tell you what is missing and what to do to get your study approved.
32	Department Rules for APOM Investigators
33	APOM Department Rules: If you need funding of any kind to sponsor your study, do not proceed until you have discussed your budget with Cindee Gray. E-mail your PPQ to Cindee Gray (grayc@ohsu.edu) before forwarding her the form for signatures. When forwarding PPQ (and any other hard copy forms) to Cindee Gray, please include a copy of your protocol and lay protocol summary so that people who sign your PPQ know what the study is about.
34	Finally you are ready to submit!
35	Step 4: Using eIRB system for on-line submission What is eIRB and how do I get there? eIRB is an an on-line documentation submission system http://www.ohsu.edu/research/rda/eirb/ eIRB Training: http://www.ohsu.edu/research/rda/eirb/sim.shtml eIRB Manual: http://www.ohsu.edu/research/rda/eirb/manual.shtml FAQ: http://www.ohsu.edu/research/rda/eirb/faq.shtml
36	Setting up your study in eIRB After registration in eIRB you can log in: http://www.ohsu.edu/research/rda/eirb/
37	Submitting your study Only the PI can submit a study Submit electronic forms whenever possible make sure to use available IRB templates Handling hard copies (forms with signatures): - check the box in the eIRB document page stating that you will be submitting hard copies other than PPQ - use special form (eIRB Hard Copy Submission) to accompany your mailed documents
38	After submitting your protocol How long does it take to process your protocol? Review usually takes 6-8 weeks
39	Step 5: If the IRB requests revisions: All issues must be resolved to get an approval! Options: make required changes or provide a justification for your original procedures If making changes, make sure to edit all the documents the change is affecting (protocol, consent,etc.) Resubmit your edited forms in 2 versions: a copy with changes tracked and a clean copy. Use your analyst’s help with wording and ask exactly what will get your study approved. Consider submitting a cover letter with your responses to each of the analyst’s suggestions.
40	After receiving your IRB approval
41	Useful links: IRB: http://www.ohsu.edu/research/rda/irb/ eIRB: http://www.ohsu.edu/research/rda/eirb/ GCRC: http://gcrc.ohsu.edu/ OCTRI: http://www.octri.org/octri/public/ Big Brain: https://www.ohsu.edu/bigbrain/ ORIO compliance records: http://ozone.ohsu.edu/research/rda/apps/eirbinfo/index.php RDA: http://www.ohsu.edu/research/rda/ OHSU CTO: http://www.ohsu.edu/research/crp/cto/ NIH: http://www.nih.gov/ FDA: http://www.fda.gov/
42	To be continued… Next RIP seminar topics will include: (January 9^th, 2007) Research considerations for the APOM department investigators eIRB advanced topics (CRQ, PRAF, AE) Submitting documents for a clinical trial
43	"Questions" Questions?