Ensuring Proper Research Consent: Regulations and Procedures

1. Informed Consent ProcessPatrick Herbison, MEd, CIPResearch Compliance ManagerOffice of Human Research (OHR)patrick.herbison@jefferson.edu These slides contain summaries of regulations (mainly 45 CRF 46) and OHR Policies. Please follow the full regulations and policies.

2. Topics • ‘Normal Consent’ • Variations • Waivers/Alterations • Assent • Surrogate Consent • Physically Unable to Sign • Witnesses • Short Forms • Translations • Consent Amendments/Re-Consent

3. Regulations – Common Rule45 CFR 46.116 • Must obtain consent • Sufficient time • No coercion • In an understandable language • Can’t make subject waive rights • Can’t release PI, sponsor, institution from liability • Elements of consent

4. Regulations – Common Rule45 CFR 46.117 • Usual Process • Written, IRB approved consent • Signed by the subject • Copy given to the subject • Opportunity for the subject to read consent

5. Regulations – Common RuleNotice of Proposed Rulemaking (NPRM) • Simplify the consent form • Specimens are identifiable – Broad consent for future use • Define exclusion categories • Re-define exempt categories • Fewer waivers of consent for research with specimens • Single IRB Review • Eliminate continuing review for expedited and closed studies • Common rule to cover all studies at institutions that receive federal funding

6. Regulations – Common Rule45 CFR 46.116 • Elements of Consent (8 Basic Elements) • Study involves research • Purpose • Duration • Procedures • Experimental procedures • Risks • Possible benefits

7. Regulations – Common Rule45 CFR 46.116 • Elements of Consent (8 Basic Elements) • Alternatives • Confidentiality • Compensation/Treatment in case of injury • Contact info (study, injury, rights as a research subject) • Voluntary participation • Not participate or withdraw without penalty

8. Regulations – Common Rule45 CFR 46.116 • Elements of Consent (6 Additional Elements) • Unforeseeable risks to subject, unborn child • Termination without consent • Cost • Early termination consequences and procedures • Significant new findings • Number of subjects

9. Role of the IRB • To Ensure: • Appropriate consent will be obtained • Approve the consent based on Common Rule (New, Continuing Review, Amendments) • Approve all patient materials • Require amendments and re-consent

10. Waivers - 45 CFR 46 • Waiver of requirement to obtain informed consent or alteration of consent • No more than minimal risk • Will not adversely affect the rights and welfare of the subjects • Couldn’t do study without waiver or alteration • When possible, the subjects will be given information after participation

11. Waivers - 45 CFR 46 • Waiver of requirement to obtain a signed consent form • If either apply: • The consent would be the only record linking subject to a sensitive study • No more than minimal risks and consent is not usually required for any of the procedures

12. Waivers and Alterations – IRB Forms • OHR-2: Describe consent requirements – IRB will decide if appropriate • OHR-3: If you think subject authorization to collect PHI should be waived • OHR-5: If de-identified health information is being collected

13. Assent – OHR-8C • Used for studies involving children/impaired adults • Used for long term situations • Assent cannot be done without consent! Consent Form Assent Form

14. Assent – OHR-8C • Parent/Guardian is consented the usual way • Parent/Guardian signs the consent • For the patient, the process is the same as consent but simplified • Patient signs the assent • Children 7 – 17 should be given the opportunity to assent or if they can understand, use the consent form(TJU Policy 506)

15. Surrogate Consent – OHR-8B • Used for studies involving incapacitated/impaired adults • Used for short term situations • Use approved consent form • OHR-8B replaces consent form signature page OHR-8B Consent Form

16. Surrogate Consent – OHR-8B • OHR-8B gives priority of surrogates • If able, the patient consents as well • Obtain assent or consent if patient later becomes able

17. Physically Unable to Sign ConsentOHR Policy IC 705 • Subject is physically unable (e.g. paralyzed), not mentally unable • The subject’s name and date of signature may be written in • The subject may make their mark or thumbprint if able • There must be a witness • Include the following note on the signature page of consent: • The subject is physically unable to sign the consent form. All pages of the consent form were reviewed with the subject, who voluntarily consented to participate in this study.

18. Witnesses • Generally required if: • The only language the subject speaks and understands is English, but the subject cannot read English • The subject is blind • The subject cannot physically sign the consent form • The short form process will be used

19. Witnesses • Impartial, cannot be study personnel • Must be present for the entire consent discussion • Should be available throughout the study

20. Short Form Consent – OHR-8S - English • A form stating that consent has been explained verbally • Use the short form and a summary (usually the full consent) Short Form OHR-8S Consent Form

21. Short Form Consent – OHR-8S - English • Need an impartial witness (it cannot be study personnel but can be the translator) • Short form is signed by the patient and the witness • The summary (consent) is signed by the witness, person obtaining consent and investigator • Patient is given copies of both

22. Short Form Consent – OHR-8S - English • Short form = 2 forms + 5 signatures + Witness vs. • Regular Consent = 1 form + 3 Signatures • Easier to make a short consent form (use OHR-8A – Consent Form for Blood Draw) • Contact the IRB Before Using!

23. Translations The standard requirements from 45 CRF 46.116 and 46.117 • Informed consent should be documented by the use of a written consent form • Consent forms must be written in a language understandable to the subject

24. Translations Non-English Speaking Subject Not Expected Expected Translated Consent Form Translated Short Form OHR-8S English Consent Form

25. Translations – Not Expected • Use the short form in subject’s language and English consent • The short form explains that consent has been explained verbally • Both must be approved by the IRB before use • Several languages on the OHR forms page (OHR-8S)

26. Translations – Not Expected • Need an impartial witness and translator fluent in both languages • The translator can be the witness but neither can be study personnel • Both must be present for the entire consent discussion • Both should be available throughout the study • Same short form requirements discussed previously • Short form is signed by the patient and the witness • The summary (consent) is signed by the witness, person obtaining consent and investigator • Patient is given copies of both

27. Translations – Not Expected • After consent with the short form, the full consent should be translated and the subject re-consented Translated Short Form OHR-8S English Consent Form Translated Consent Form

28. Translations – Expected • The consent form should be translated and approved by the IRB • Translated documents need documentation of accuracy • For individuals, submit translator’s name and qualifications to the IRB • Translation agencies will provide documentation of accuracy

29. Consent Amendments • From 45 CFR 46.116: The subject will be informed of any change that may affect the subject’s willingness to continue participation (changes to any of the elements of consent). • Who can ask for changes to the consent and re-consent: • Sponsor • PI • Study Personnel • IRB • Other

30. Re-Consent • The study team makes the recommendation on the OHR-12 • The IRB agrees or modifies and includes the requirement on the approval page.

31. Recommendations • A method to ensure most current, IRB approved consent is used • Use a checklist to document the consent process

32. Questions?