INSPIRing Changes to the IRB Process: New templates and more
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1 INSPIRing Changes to the IRB Process: New templates and more John F. Ennever, MD, PhD, CIP Director, Human Research Protection Program Office of Human Research Affairs Boston Medical Center and Boston University Medical Campus
2 Learning objectives List 3 major changes in policy effective November 1, Describe the process within INSPIR for including a separate protocol. Describe the new policy regarding limited and non-readers, including requirements in the informed consent form and when existing studies have to come into compliance. 2
3 New Policies as of November 1 affecting only NEW submissions (1) Initial submissions of clinical trials that involve a drug, device, or surgical intervention must have a detailed protocol Sponsor or cooperative group protocol, or Local PI-written based upon template posted on our website 3
4 New Policies as of November 1 affecting only NEW submissions (2) Initial submissions must use new consent form template Sponsor-provided consent forms must use new header and have required information on the first page 4
5 New Policies as of November 1 affecting only NEW submissions (3) Study staff on all initial submissions of biomedical clinical trials must complete GCP (good clinical practice) training CITI, CRRO training, or sponsor training 5
6 New Policies as of November 1 affecting ALL submissions Plans for findings with potential health or reproductive importance (pertinent and/or incidental findings) must be described Inclusion or exclusion of limited- and non-readers must be specified Default position is to include and this requires a witness line on consent form 6
7 What in INSPIR has changed? Part 1: New Pathways (1) An abbreviated pathway when a separate detailed protocol is attached (a requirement for new biomedical clinical trials) Acceptable protocols: sponsor, cooperative group, ones based upon our template or one of the NIH templates NOT Acceptable: Grant application 7
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9 What in INSPIR has changed? Part 1: New Pathways (2) Abbreviated pathway for chart reviews If no external funding, exempt under equivalent protections With funding and retrospective only, exempt category 4 With funding and includes prospective, expedited with waiver of consent. 9
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11 What in INSPIR has changed? Part 2: New Process (3) Short Forms Investigator requests specific languages (no change) IRB approves use of specific languages (no change) IRB staff upload approved (stamped) short forms (with PI name, telephone number filled in) into consent form section (new) IRB staff upload additional page for signatures of witness and person obtaining consent; page is signed and appended to existing English-language consent form when short form is used (new) 11
12 12
13 What in INSPIR has changed? Part 3: Modified Questions (1) Plan for the return of subject level findings Before: Asked if study results would be returned: if no, no other questions; if yes, asked to explain how Now: Asks if the study could yield findings of potential health or reproductive importance (pertinent and/or incidental findings): if no, no other questions; if yes, asked to explain plan to return or reasons not to do so. 13
14 What in INSPIR has changed? Part 3: Modified Questions (2) Inclusion of limited- and non-readers Before: Limited- and non-readers were one of a dozen special populations, no directions for witness signatures in consent form Now: Specific question about limited- and non-readers; if no, justify exclusion; if yes, consent form must include (or has been read to me) and place for witness signature. 14
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16 What in INSPIR has changed? Part 3: Modified Questions (3) Screening processes Before: Screening questions only had to be answered if sensitive identifiable information was being kept or clinical procedures just for screening. Now: Screening questions (including provisions for abbreviated consent ) must be answered if screening involves any interaction with potential subjects. 16
17 What in INSPIR has changed? Part 4: Previously Optional Questions, Now Required Four questions were optional when first introduced, now are required PI confirming human subjects training and filing Conflict of Interest forms Privacy protections PI confirming no recruitment incentives Whether a repository stores genetic information 17
18 What in INSPIR has changed? Part 5: Lower-Impact Changes Exempt submissions must provide a lay summary Cede requests have new questions about local policies Drug and device studies have new and reworded questions Not Human Subjects Research submissions answer whether the study meets the definition of research Studies recruiting from Community Health Centers have specific guidance 18
19 More Information 19
20 How you will recognize the new INSPIR 20
21 Thank you! 21
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