IRB 101

1. IRB 101 An introduction to the federal regulations and how they relate to institutional policy and procedures.

2. Springfield Committee for Research Involving Human Subjects (SCRIHS) SCRIHS is an Institutional Review Board (IRB)

3. Commonly Used Acronyms • Code of Federal Regulations (CFR) • Investigational New Drug number (IND) • Investigational Device Exemption number (IDE) • Primary Investigator (PI) • Informed Consent Form (ICF) • Authorized Study Personnel (ASP) • Adverse Event (AE) • Amendment Summary (AS) • Continuing Review (CR) • Investigator’s Brochure (IB)

4. REGULATION OF HUMAN SUBJECTS RESEARCH • DHHS- Department of Health and Human Services OHRP- Office of Human Research Protections FDA- Food and Drug Administration NIH- National Institute of Health ORI- Office of Research Integrity

5. Who is the IRB? 1 • SCRIHS is currently made up of 19 appointed members: physicians & surgeons – including 1 resident member, pharmacists, medical students, nurses, attorneys, and community members • Areas of specialization include: oncology, surgery, psychology, neurology, cardiology, and medicine-as well as other areas • Dr . Elvin Zook, Chief of the Division of Plastic Surgery , is the current SCRIHS chair

6. Who ? 2 • 45CFR46.107 regulates IRB membership • Each IRB must be comprised of at least 5 members with varying backgrounds, “to promote complete and adequate review of research commonly conducted by the institution” • 1 member -scientific, 1 member –nonscientific, and 1 member-not affiliated with the institution

7. What is the IRB? • The IRB is a group of “appropriately constituted” people which has been formally designated to review and monitor biomedical research involving human subjects and ensure that the appropriate steps are taken to protect the rights and welfare of human participants

8. When ? • SCRIHS currently meets once / month, on the 2nd Wednesday of each month • Erin, Alisha, Gary and Susan are in the office daily

9. Where is the IRB? • The SCRIHS office is located in room 2049, 2053 and 2061 on the 2nd floor of 801 N. Rutledge (the building with the medical library) • Erin 545-7602 or ecampbell@siumed.edu • Alisha 545-7256 or amirabile@siumed.edu • Gary 545-2184 or gfifer@siumed.edu • Monthly meetings are held in the Dirksen Conference Room (in the library) starting at 5:30p.m.

10. WHY ? • Because the government says so: 45CFR part 46 21CFR parts 50, 56, 312, and 812 Belmont Report: Justice, Beneficence, Respect Declaration of Helsinki Nuremberg Code

11. THE “COMMON RULE” • 45CFRpart46 • Subpart A- Basic Policy for Protection of Human Subjects VULNERABLE POPULATIONS • Subpart B- Pregnant Women, Fetuses, In Vitro • Subpart C- Children • Subpart D- Prisoners IRB review of protocols involving prisoners

12. FDA • 21CFR: part 50 – human subjects protections part 54 – financial disclosure part 56 – IRB’s part 312 – IND (drugs) part 600 – Biological Products part 812 - IDE (devices) • Special Publications: FDA Information Sheets HHS Publication FDA 96-4159 “IDE Manual”

13. What is Research? • 45CFR46.102(d) defines research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

14. What is a Human Subject? • 45 CFR46.102(f) defines a human subject as “a living individual about whom an investigator (whether professional or student) conducting research obtains…data” • Chart Reviews • Medical Students & Residents

15. Who made you boss? • 45CFR.109 “An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy”

16. Ok, so now what do I have to do? • Exempt - the IRB must “certify” that the research is indeed exempt, the PI does NOT get to make this determination • Expedited Review - see pages 2-3 on application for approval • Full Board Review - any study involving greater than minimal risk

17. Full Board Review (45CRF46.111) CRITERIA FOR IRB APPROVAL OF RESEARCH: • Risks to subjects are minimized • Risk / Benefit ratio is balanced • Selection of subjects is equitable • Informed Consent and HIPAA Authorization will be sought and documented • Adequate provisions for monitoring data to ensure safety • Privacy and confidentiality will be protected • Additional safeguards are in place to protect vulnerable populations

18. Full Board Review • Application for approval (SIU vs. Non-SIU) • ASP form • HIPAA Application • HIPAA Authorization- 23 copies • Informed Consent- 23 copies w/ protocol # • Protocol- 23 copies w/ protocol # • Investigator’s Brochure / Tech. Manual- 3 copies • Billing Papers: unless you are given a waiver

19. Common Issues/ Problems • OBTAIN PROTOCOL NUMBER (and use it) • ENOUGH COPIES • COLLATE • MEETING THE DEADLINE (always last Wednesday of the month) • NIH GRANT REVIEW • PROTECTED CLASSES • WAIVER OF CONSENT- 4 points

20. NIH Grant Application Review • 45CFR46.103(f) Requires that each application or proposal for HHS supported human subject research be reviewed & approved by the IRB. • 45CFR46.122 “Federal funds…may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.”

21. Vulnerable Populations“vulnerable to coercion or undue influence” • Fetuses and Human In Vitro Fertilization • Women • Children & Minors • Cognitively Impaired Persons – new SCRIHS policy • Prisoners • Traumatized and Comatose Patients • Terminally Ill Patients • Elderly/Aged Persons • Minorities • Students, Employees, Normal Volunteers • International Research

22. You mean I don’t have to get Informed Consent? The 4 points • A PI may seek a waiver or alteration of informed consent if the IRB can find that the PI has justified (in writing) the 4 points of justification. 45CFR46.116 • No more than minimal risk • Waiver or alteration will not adversely affect rights / welfare • Research could not practicably be carried out without the waiver / alteration • Subjects will be given additional pertinent information after participation, whenever appropriate

23. Expedited Review (45CFR46.110) • Application for approval • ASP • HIPAA Application • ICF- 3 copies (unless waived) • Protocol - 3 copies • HIPAA Authorization- 3 copies (unless exempted or waived) • ALSO, you must submit any questionnaires, interview questions, etc. that you may be using in your study

24. Common Issues / Problems • No monthly deadline for submission • Waiver of Consent and/or Authorization - must meet all points of justification • 2 committee members assigned to review and allowed 2 weeks to return comments • See 45CFR46.110 and DHHS “Notice to Federal Register” for expedited categories

25. Exempt from Review (45CFR46.101) • A letter, addressed to Dr. Elvin Zook containing the following: • title of your research project • a brief proposal of what you wish to do • purpose, why are you doing the research? • state whether any identifiers will be used, or not • Waiver of HIPAA Authorization or HIPAA De-Identification Form • any other pertinent information such as surveys or questionnaires • INCLUDE YOUR NAME AND PHONE NUMBER

26. Common Issues / Problems • Submit your letter and information to the SCRIHS office, NOT Dr. Zook’s office • No monthly deadlines for submission • A letter will be issued to you/PI stating that your proposal has been reviewed and is indeed exempt from IRB review, DO NOT proceed until you hear from us

27. And so, it continues… • Amendment Summaries - if you need to make a change to your research, informed consent- including the process, protocol, IB, Tech. Manual, or wish to advertise for participants • minor changes can be reviewed administratively • other changes may by required to go to the full board for review • All changes must be approved by the IRB prior to implementation

28. Yes, we Do have written guidelines for AE submission • Adverse Event Reports: The reporting guidelines are in the SCRIHS procedures manual, pages 41-44, which outline the “what”(event) is required to be turned in “when”(time deadlines) • These requirements have changed and will be updated in the new Procedures Manual

29. No, the fun is NOT over YET • Continuing Review Statements: (45CFR46.109) • This happens at least once/year regardless of whether your research needed full board or expedited review. The IRB can require that a project be reviewed on a more frequent basis, usually based on the risk involved. These ALWAYS go to the full board for review • Letters / monthly deadlines • It is the responsibility of the PI to know the continuing review deadline for his/her studies and ensure that all necessary paperwork is sumbitted on time to the IRB office

30. Finally, a light at the end of the research tunnel • Termination forms - if your study is complete, fill one of these out and submit to our office

31. Miscellaneous Topics • Call ahead for a protocol number and USE it • IND / IDE # is required PRIOR to IRB review • Submission of correct number of copies • Submit verification if the company/sponsor is requesting changes with an an amendment summary • Submit a list of changes to protocol/IB • Try to use the computer or type your forms

32. Remind me AGAIN why I am doing research! • Please call and ask if you don’t know or need help. Contrary to what you may think we are here to help.

33. COMING SOON • BRAAN- paperless IRB • Conflict of Interest • IRB Accreditation