Troubleshooting Informed Consent. Sandra Meadows, MPH, CIP Office of Responsible Research Practices June 26, 2018

Transcription

1 Troubleshooting Informed Consent Sandra Meadows, MPH, CIP June 26, 2018

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3 Session Objectives Identify common submission screening questions Examine IRB-required modifications related to the consent process Discuss common post-approval monitoring findings Review best practices and available resources 3

4 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 4

5 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 5

6 Informed Consent Overview Regulations Ethical human subjects research Respect for persons Interactive ongoing process Nature and circumstances are important 6

7 Regulations Federal Regulations 21 CFR Part 50, Informed Consent of Human Subjects 45 CFR Part 46, Protection of Human Research Subjects 7

8 Regulations Definition Informed Consent: Agreement to participate in research Individual or legally authorized representative Sufficient information Adequate opportunity to consider voluntary participation 8

9 Informed Consent Attributes Written documentation Sufficient opportunity to consider participation No coercion or undue influence Free of exculpatory language Understandable language Regulations 9

10 Understandable Language 12-16% of U.S. adults cannot read 22% have basic reading skills Regulations Target reading level misses one third of audience Kutner, M, Greenberg, E, Jin, Y, and Paulsen, C, (2006) The Health Literacy of America s Adults: Results From the 2003 National Assessment of Adult Literacy (NCES ). U.S. Department of Education, Washington, DC, National Center for Education Statistics. 10

11 FDA Draft Consent Guidance Regulations more than one-third of U.S. adults, 77 million people, have basic or below basic health literacy. Informed Consent Information Sheet, Draft FDA Guidance (July 2014) 11

12 Regulations FDA Draft Consent Guidance (Cont.).more than one-half of U.S. adults have basic or below basic quantitative literacy Informed Consent Information Sheet, Draft FDA Guidance (July 2014) 12

13 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 13

14 Frequent Requests/Questions Screening 14

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18 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 18

19 IRB Review Data Collection Convened meeting minutes from Biomedical Sciences and Cancer IRBs 19% Continuing reviews 7% Amendments 85% Initial submissions 19

20 IRB Review Data Collection May 2018 expedited reviews from Biomedical Sciences and Cancer IRBs 3% Continuing reviews 7% Amendments 8% Initial submissions 20

21 IRB Review CATEGORIES OF CONSENT MODIFICATIONS Lay Language 23% Research Methods 32% Risks 13% Benefit 2% Payment 7% Costs 9% Editorial 14% 21

22 Expedited vs. Convened Modifications IRB Review Lay Language Risks Research Methods Payment Benefit Editorial Costs Expedited Convened 22

23 Lay Language IRB Review Before: We will use a local anesthetic to obtain a skin biopsy from your leg. After: We will obtain a small sample of skin from your leg after injecting a drug that will numb the area to prevent pain. 23

24 Lay Language IRB Review Before: The objective of this clinical trial is to assess the efficacy of drug X. After: The reason for this study is to learn whether drug X helps you get better. 24

25 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 25

26 Fiscal Year 2018 Plan Active studies from 2016 to present 50% randomly selected 50% targeted for risks Vulnerable populations Funding PHI Post-Approval Monitoring 26

27 Post-Approval Monitoring Scope 22 visits 9 colleges Wexner Medical Center Office of Health Sciences 27

28 EVENT REPORT REQUIRED Yes No 27% 73% 28

29 OBSERVATIONS

30 CONSENTPROCESS No Consent Obtained Procedures Completed completed Before before Consent consent Unapproved Method method Used used Wrong Consent version Version usedused 30

31 CONSENT DOCUMENTATION CONSENT DOCUMENTATION Physically Physically unable unable to to sign sign Backdating Backdating LAR LAR incomplete incomplete signature signature 31

32 RECORDKEEPING 3 1 Missing consent document Retained only signature page 32

33 Session Overview Regulations Screening IRB Review Post-Approval Monitoring Resources 33

34 Resources Lay Language Stanford University Glossary Children s Hospital of Philadelphia Glossary 34

35 Resources Consent Process Clinical Trial Management Organization (CTMO) Standard Operating Procedure (SOP) Consent SOP Example 35

36 Summary Overview Use correct template Insert required text Describe research completely Distinguish standard care from research Use lay language Follow consent SOP Monitor consent process/records 36

37 SCENARIOS 37

38 Contact Us orrp.osu.edu

39 Questions? 39