1. J. Andrew Bertolatus MD Internal Medicine IRB/HSO 13 September 2017
Consenting
J. Andrew Bertolatus MD
Internal Medicine
IRB/HSO
13 September 2017

2. Objectives Discuss ethical justification for consent
Review regulatory requirements for consent
Review some special cases

3. Ethical background: Nuremberg code
Response to medical atrocities in the Nazi camps during WW II

4. Nuremberg Code
1. “The voluntary consent of the human subject is absolutely essential.”
Legal capacity
Lack of coercion
Information

5. Declaration of Helsinki 1964
“Participation by individuals capable of giving informed consent as subjects in medical research must be voluntary”.

6. Belmont Report 1976
Respect for persons
Beneficence
Justice

7. Respect for persons Consent requires Information Comprehension
Voluntariness
Risks and Benefits

8. Consent ≠ Document Consent = process
Recruitment
Initial screening/consenting
Ongoing re-evaluation of consent
New information

9. “Common Rule” consent requirements
“Legally effective consent” of subject or LAR required
Opportunity to consider
No coercion/undue influence
Understandable language

10. General Requirements for informed consent
Statement that study involves research
Purpose
Duration of participation
Procedures - what is experimental vs. standard care

11. Elements cont’d “Reasonably foreseeable” risks or discomforts Benefits
Payment/care ≠ benefit
Outcome under study, not a benefit
“may/will be no benefit”
Benefits to others?

12. Elements con’t Alternative treatments (if a treatment study)
Extent of confidentiality of identifiable records
If > minimal risk:
Medical treatment available?
Compensation available?

13. Contact Info
For ? re: research (PI)
For ? re: rights of subjects (HSO)
For ? of RRI? (PI or HSO)

14. Voluntary participation
No penalties for refusing to participate.
No penalties for discontinuation

15. Additional elements “when appropriate”
Risks to subject/embryo/fetus which are “currently unforeseeable”
Condition for termination without regard to consent
Costs
Consequences of withdrawal, procedures for “orderly termination”

16. New findings will be provided?
# of subjects in study (Iowa, study-wide)

17. Can consent be waived? Minimal risk
No adverse effect on rights/welfare
Research not “practicable” without waiver
Pertinent info provided if appropriate

18. Special cases Children Pregnant women Cognitive impairment
Parent/guardian consents
May need both parents
Pregnant women
Consent of father can be required
Cognitive impairment
LAR

19. Can documentation of consent be waived?
If main risk of study is loss of confidentiality, and consent is only document linking subject to study
If study has minimal risks and involves procedure which don’t require written consent outside research.

20. Case study
An investigator wants to study the influence of race (of person in photo) on fMRI imaging of certain brain regions.
He doesn’t want to tell subjects the main purpose of study.
Can this be done?

21. Deception studies Essentially a waiver of 1st required element
Must justify need (i.e. study not practicable without deception)
Minimal risk
Debriefing

22. Case study
An oncology study is underway, after IRB approval obtained. Study has an approved English language consent. An eligible subject is admitted, but speaks only Spanish. Can he be enrolled?

23. Yes – “short form” Summary of study presented orally in Spanish
General description of elements of consent (available in Spanish)
Need witness who speaks both languages
Generally if >1 such subject – consent should be translated

24. Case study
You find a subject who is eligible for your study. He’s an English speaker, but he’s legally blind. Can you enroll him?

25. Yes
Consent must be read to subject, by, or in presence of, an impartial witness.
Subject can make mark; witness signs consent

26. Case study
You are conducting a study on subjects admitted to ICU. Many subjects too ill to provide consent for themselves.
Can you call LAR and get consent over the phone?

27. No
Consent must be documented by signing, unless there is a waiver of documentation (unlikely)
Fax? – OK
- +/-; not confidential

28. Case study
You are thinking about conducting a large scale clinical trial of 2 different aspirin doses (within SOC) to prevent CV complications.
Can you use an electronic consent procedure?

29. Maybe FDA draft guidance Mar 2015
Electronic signature OK
Issues:
Identity verification
Date stamping/tracking
Must be able to provide written copy for subject (or subject can print off)
Storage/record keeping

30. How will the changes to the “Common Rule” that are proposed in the “NPR” affect the consent process (if/when adopted)?

31. Proposed Changes Consents shorter (≈2 pg?)
Information “a reasonable person would want to know”
Appendix for details
Requirement for posting consent (e.g., like clinical trials.gov)

32. More
Have to tell if de-identified data from study might be shared, used
Broad consent for use of biospecimens and clinical data encouraged
HHS will provide templates for consent