New Coordinator Training

1. New Coordinator Training Developed and Presented by the Study Coordinators' Advisory Committee

2. Study Coordinators' Advisory Committee Mission Statement: The Wayne State University (WSU) Study Coordinators’ Advisory Committee (SCAC): Provides guidance, networking, and mentoring to study coordinators, and Acts as liaison to the IRB for the WSU research community to discuss areas of concern regarding human research. The committee is open to all who are interested

3. Resources From the WSU IRB The Investigator Handbook - comprehensive document containing everything you need to know to gain Institutional Review Board (IRB) approval. Join the IRB Research Listserv - form changes, training opportunities, policy changes and other occasional announcements. Tools, links, and resource documents All are at IRB website www.irb.wayne.edu

5. Key Points • Acronym • IRB: Institutional Review Board • View IRB as a helpful collaborator • No human research activity without IRB approval • You cannot exempt yourself, all studies must be reviewed by IRB. • Call if you are unsure if the project requires IRB review

6. Contact Information Institutional Review Board (IRB) 87 E. Canfield, Second Floor Detroit , MI 48201 (313) 577-1628 www.irb.wayne • Education Coordinator (313) 577-9534 • Associate Director (313) 993-7155 • Link to SCAC information, membership list , SCAC Handbook and listserv sign-up at the IRB website: • http://irb.wayne.edu/study_coord_adv_comm.php

7. Review Process • Review Boards: • Medical (M1, MP2, MP4, & PH1) MP2 & MP4 - Pediatrics and adults M1 – adults and VA PH1- Phase 1clinical trials • Social, Behavioral , Education (B3) • Types of Reviews: Exempt, Expedited, Full Board • No submission deadlines for exempt and expedited review • See IRB website for deadlines for full board review

8. Review Process IRB is the “Final” step for most protocols. Some units of WSU and its affiliates require pre-review (VAMC, DMC, KCI’s PRMC, Oakwood & Psychiatry, etc.) before the protocol is submitted to the WSU IRB Always check with your institution about other reviews prior to sendin

9. IRB Forms http://irb.wayne.edu/forms-requirements-categories.php Essential to have the correct version, always download a new copy: • Medical/Behavioral Protocol Summary Form • For all expedited and full board Studies • Appendices-Children, Prisoners, Biological Specimens, etc • Medical Exempt Protocol Summary Form • Social, Behavioral , Education Exempt Protocol Summary Form • HIPAA Summary Form • Amendment Submission Form • Continuation Form-submit 7 weeks before expiration. • Closure Form-Submit when all data collection is done and before expiration. • Repeatedly submitting after expiration is considered non-compliance.

10. Consent Templates • Behavioral Template • Behavioral Assent Template • Medical Template • Parental Permission Template • Parental School Permission Template • Parental School Information Sheet • Humanitarian Use Device Template • Assent Template • Information Sheet • Short Form Consents are available in Arabic, Bengali, Chinese, Hindi, French, German, Italian, Polish, Russian, Spanish, and Swahili • Available on IRB website • Do not remove any of the sections unless prompted to do so

11. Other IRB Forms • Unexpected Problem Form • Unexpected Problem Follow-up Form • Single Time Emergency Use of a Test Article • Coordinating Center Application • Humanitarian Use Device (HUD) Form • Administrative Application • Authorization to Use Another IRB for Protocol Approval Agreement • Authorization to be the IRB of Record for Collaborating Entity • Data Use Agreement • Additional Key Personnel List • Amendment Forms-4 • Continuation Form

12. Mandatory CITI Training https://www.citiprogram.org/ Required training must be completed prior to submitting a new protocol or adding new personnel. Renewal at WSU required every 3 years. Transferable to other institutions that use CITI program for mandatory education

17. Additional Training • Offered by the Education Coordinator weekly (313) 577-9534 (see website for posting: http://irb.wayne.edu/education.php) • IRB 101, Initial Submissions, Submitting Continuations and Amendments, Informed Consent: Highly Recommended • Other Presentations: • Unexpected Problem Reporting • Research Non-Compliance • Others tailored to your needs

19. The Informed Consent Process and Options

20. Informed Consent Process • Must occur before any study procedures are done • Do not rush • Present a summary first to give the potential participant a basic idea of the study • Present the full consent, reading to the participant if needed • Allow time for questions • Go over key points in consent again • If requested provide an unsigned copy to take home for further consideration

21. Informed Consent Process • Must make sure the participant fully understands his/her rights and responsibilities • Each page must be initialed by the participant, parent, and/or legally authorized representative (LAR) • Signatures and printed name with dates are obtained from the participant or their LAR • Person obtaining consent signs and dates • Witness signs if applicable

22. Informed Consent Process If sponsor requires, the PI also signs and dates consent Assent required for children 7-17 Refer to IRB Policy on Consent Process Provide copies of the signed and dated Informed Consent to the participant Encourage review of the consent at each visit Signature page should always be on last page, with IRB approval stamp box

23. Informed Consent Process • Informed consent is an ongoing, interactive process, rather than a one-time information session • Any changes related to risk & approved by the IRB must be re-consented. • Both parents must sign if pediatric study is high risk. (level III)

24. Documentation • Must include key points of Informed Consent process • Was obtained before any study procedures occurred • Presented consent • Time was allowed for questions • Verbalized understanding • Other pertinent details (witnesses, LAR, etc.) • Signed copies given

25. Informed Consent Options Written Consent Parental Permission Form Assent Oral Consent Information Sheet Waiver of Consent

26. Assent • Simplified • Used for children under 18 and cognitively impaired adults • Adult (Parent/LAR)still has to sign full informed consent or parental permission form • Exception: Mother under 18 can consent for her child, but not for herself-requires parental permission • 7-12 years oral assent; 13-17 years signed assent

27. Languages • If planning to enroll non-English speaking participants: get informed consent document translated in to language and IRB approved prior to use • Certified translationor • Forward and backward translation by two independent people • If unplanned enrollment-use short form on website and have translator available for it and translating English version of consent

28. HIPAA Health Insurance Portability and Accountability Act of 1996 -Purpose • To improve portability of and continuity of health insurance coverage , combat waste, fraud, and abuse in health insurance and health care delivery and simplify administration of health insurance • The Office of Civil Rights (DHHS) has oversight • PHI: Protected Health Information: private health information that is identifiable because it contains:(name, address, phone, e-mail, MRN, SS#, Health Insurance #, DL#, unique ID code, etc.)

29. The Privacy Rule and HIPAA • When medical records, databases, archives, tissues, path reports, images etc. are accessed for research data collection purposes, HIPAA rules apply. • A HIPAA Summary Form must be completed when this is the case. • If consent is being obtained, an HIPAA authorization must also be signed. • If a waiver of consent is being requested (for retrospective chart reviews, for example) a waiver of authorization should be requested.

30. HIPAA and Research • PHI that is USED and DISCLOSED must be clearly identified on HIPAA Summary Form and HIPAA Authorization Form and must match. • The recipients (entities) to which PHI is disclosed must be clearly identified on both forms. • A Disclosure occurs when PHI is sent outside of WSU and its affiliate institutions. (to sponsors, etc.) • HIPAA Language from sponsor templates must not be included in informed consent form. • Authorized members of the institution’s workforce have access to participant’s records.

31. HIPAA and Recruitment into Research • Someone with a clinical relationship must first introduce the study to potential participant, prior to research team members approaching subject. • This person does not need to be named as key personnel on research. • Mining research records to identify participants to contact (if PHI is documented) must be covered by a waiver of authorization(and consent waiver). • Review of medical records to determine feasibility of studying certain population does not require waivers prior to accessing record.

32. Questions? • Don’t hesitate to call the IRB if you need help (313) 577-1628 • Consult the Investigator Handbook on the IRB website (www.irb.wayne.edu) • Contact a member of the SCAC • Link to SCAC information, membership list , SCAC Handbook and listserv • http://irb.wayne.edu/study_coord_adv_comm.php • Research Subject Advocate- Office of Research Compliance-(313)577-9064