Board Member Retreat 2017

1. Board Member Retreat 2017 Informed Consent ExemptCategories Continuing Reviews Transition of Expedited Studies Single IRB QA/QI

2. Effective date and compliance date for all but the single IRB provision in the Rule remains January 19, 2018. ***However, on October 7th, 2017, HHS requested a 1 year delay in the “general implementation date” of the Rule, while “allowing the use of three burden-reducing provisions during the delay year.” Revised Common Rule (2018 Rule)45 CFR 46

3. Informed Consent

4. Requirements regarding IC content and organization • Required elements • Broad consent is a new option • Posting requirement for federally-funded clinical trials • Waiver of ICP no longer required for screening/recruitment Revised Common Rule:Changes Related to Informed Consent

5. a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” Informed Consent Requirements

6. The fact that consent is being sought for research and participation is voluntary • The purposes of the research, expected duration of participation, study procedures • Reasonably foreseeable risks • Benefits • Appropriate alternative procedures/treatments, if any See 45 CFR 46.116(a)(5)(i), Federal Register Vol. 82, No. 12, p7213-14 Key Information

7. Overview Study details Purpose of the research Voluntary Participation Benefits and Risks

8. Research involving collection of identifiable private information or identifiable biospecimens. One of two statements is required Identifiers might be removed and info or biospecimens could be used for futureresearchwithout additional IC from the subject or LAR; OR A statement that subject’s info or biospecimens, even if identifiers are removed, will not be used or distributed for future research. Informed Consent Requirements:New Required Element

9. A statement that the subject’s biospecimens, even if de-identified, may be used for commercial profit and whether the subject will share in any such profit. • A statement regarding whether clinically relevant research results, including individual results, will be disclosed to subjects, and if so, under what conditions. • Whether research involving biospecimens will or might include whole genome sequencing. See 45 CFR 46.116(b) and (c) New Additional Elements: If applicable, the consent document must also now include

10. Broad consent is an option for the storage, maintenance and secondary research use of identifiable private information/biospecimens. • Permissible only for secondary research. • If utilized, a waiver cannot be granted to allow study team to subvert a participant’s refusal to provide broad consent. • If obtained, specific IC elements are required 116(d) See 45 CFR 46.116(a), (d) and (f) Informed Consent: Broad Consent

11. De-identify = Not human subjects research • Code specimens • Request waiver of ICP and HIPAA authorization (as under pre-2018 Common Rule) • Obtain broad consent in initial encounter (research or non-research) to allow future/secondary use See 45 CFR 46.116(a), (d) and (f) Secondary Research with Biospecimens:Options available to researchers

12. Rule’s definition of “clinical trial”: • “A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control” to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.” Informed Consent:Posting Requirement for Clinical Trials

13. Each clinical trial “conducted or supported by” a federal agency, one IRB-approved consent form must be posted . . . on a publicly available federal website. • Timing: After the trial is closed to recruitment and no later than 60 days after the last study visit by any subject, as required by the protocol. Posting Requirement Continued…

14. If broad consent is obtained, the IRB cannot grant a waiver to allow the study team to conduct secondary research on identifiable private information or identifiable biospecimens. • Waiver of informed consent process no longer required if identifiable private information or biospecimens will be obtained for screening or recruitment purposes. • This applies to info obtained verbally as well as to identifiable info/biospecimens obtained by accessing records or a biorepository • NOTE, however, that the Privacy Rule has not changed, so a partial waiver of HIPAA authorization is still required if PHI that will be collected or viewed as part of screening/recruitment!!!See 45 CFR 46.116(f) and (g) Informed Consent: Waivers

15. New Exempt Categories45 CRF 46.104 Weldon George, MPH IRB Manager

16. Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. Exempt Category 1

17. Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met: i. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; ii. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or iii. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7). Exempt Category 2

18. Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met: A. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects; B. Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or C. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by .111(a)(7). Exempt Category 3

19. ii. For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else. iii. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

20. Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met: • i. The identifiable private information or identifiable biospecimens are publicly available; • ii. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects; Exempt Category 4

21. iii. The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E [HIPAA], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or iv. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

22. Secondary research only • Data/specimens can be both retrospective and prospective • Four stand-alone qualifications (no interdependency) • Data/specimens are publicly available • Data is recorded such that subject identities cannot be readily ascertained and the investigator does not contact or re-identify subjects; or • Data includes only identifiable health information protected under HIPAA; or • The research is conducted by or on behalf of a Federal dept. or agency using gov’t data obtained for non-research reasons and, if identifiable, adheres to specified privacy standards Exempt 4 Summary

23. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended. Exempt Category 5

24. i. Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

25. Exempt Category 6

26. Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §__.111(a)(8). Exempt Category 7 –Brand New

27. New exemption to enable storage or maintenance of identifiable data/specimens for secondary research o Broad consent must be obtained (no waiver of consent is allowed but waivers of documentation of consent are unlikely but possible) o Limited IRB review is required for all research under this exemption

28. Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met: • i. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §__.116(a)(1) through (4), (a)(6), and (d); • ii. Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §__.117; Exempt Category 8

29. iii. An IRB conducts a limited IRB review and makes the determination required by §__.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and iv.The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.

30. PRIM&R website References

31. BREAK

32. Continuing Reviews Jamie Reddish, MPH

33. New subsection (f)(1) – Eliminates expedited CRs, if… • Research is Expedited • Limited IRB Review • Study is in data analysis • Follow-up is part of clinical care. Continuing Reviews- Federal Regs.

34. Pre-2018 Rule – Continuing Review

36. Please note this protocol remains approved under the pre 2018 Rule and full continuing review will be required. OR • Please note per the 2018 Rule this protocol is now Exempt and continuing reviews will no longer be required and your application will be closed per USF HRPP policy. OR • Please note this protocol now qualifies for an Annual Check-in and traditional full continuing reviews are no longer required. Approval Letters

37. Continuing Review- Lite (2018 Rule)

38. Study Closure

39. No Change! Full Board Continuing Review

40. Single IRB Review:What’s it all about? Julie Moore, J.D., M.S. PA, CIP Associate Director Research Integrity & Compliance

41. Reviewing IRB is responsible for the ethical review of research • Local (relying, ceding) IRB retains responsibility for: • Local context issues • Providing oversight/ensuring compliance • Negotiating reliance agreements The Basics

42. SMART IRB Reliance Initiative • NIH Single IRB Policy • Revised Common Rule • 21st Century Cures Act Single IRB Review: Driving factors

43. USF signed on in April 2017 • SMART IRB reliance agreement can serve as the master reliance agreement for multi-center studies when both the ceding institution and the reviewing IRB’s institution have signed the agreement. • For more information about participating institutions, see the SMART IRB website. SMART IRB National Reliance Initiative

44. Effective date: January 25, 2018 • Applies to all multi-site human subjects research regardless of funding mechanism (grants, contracts, cooperative agreements) submitted to the NIH on or after January 25, 2018. • Specific to US sites only. • Applies to all sites conducting the same protocol. • Awardee responsibility: Lead PI must include plan for using single IRB in the proposal/application NIH Single IRB Policy:The Basics

45. If USF is the prime applicant: • Currently, USF will cede review of NIH-funded multi-site studies to Western IRB. • Proposal must be sent to WIRB at least 2 weeks in advance of submission to USF SR, to allow WIRB to provide estimate for the IRB fees portion of the budget. • USF IRB administration assists with coordinating this process. NIH Single IRB Policy:Operationalizing at USF

46. If USF is a Subrecipient: • At proposal: Study teams will need to contact USF IRB administration to discuss whether USF can agree to rely upon the proposed single IRB and to request a letter of support. • Obtain info about sIRB fees from the lead site (whether commercial or academic IRB will serve as the sIRB). • At award: Study teams will need to contact USF IRB administration to discuss process for entering into a reliance agreement (formal contract via which USF cedes IRB review to an external IRB).

47. This Policy means fewer IRBs but not less work! NIH Single IRB Policy:Other Important Information

48. NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research NIH Single IRB Policy FAQs for Extramural Community USF IRB Newsletter, January 2017 NIH Single IRB Policy:Resources

49. The Revised Common Rule includes a provision requiring all federally funded multi-center studies to utilize a single IRB. ***NOTE, however, that the compliance date for this provision is January 20, 2020. Stay tuned . . .

50. HRPP - Quality Assurance Quality improvement Program Wendy Duncan, RN, BSN, CIP