Waiver of Documentation of Consent & Waiver of Consent

Transcription

1 Waiver of Documentation of Consent & Waiver of Consent Mark S. Schreiner, MD Executive Vice-Chair Committee of for the Protection of Human Subjects (IRB)

2 What will I talk about? Waiver of documentation of consent (verbal consent) Waiver of informed consent

3 What am I not going to talk about? HIPAA

4 Waiver of consent and documentation of consent: Goals of the NPRM to uphold individuals autonomy interests in determining whether their biospecimens and identifiable private information may be used for secondary research, to facilitate the recruitment of prospective research subjects, and to create more flexible rules for documenting informed consent for certain subject populations. Federal Register 2015:80; 53975

5 Waiver of Documentation of Consent

6 Waiver of Documentation of Consent (also referred to as verbal consent) Verbal consent is permitted under a limited set of circumstances The investigator obtains consent but the subject does not sign a consent document Currently, must meet regulatory criteria at: 45 CFR (c)(1) [no equivalent FDA reg.]; or (c)(2) / 21 CFR (c)(1)

7 45 CFR (c)(1) The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality Examples: Possible jeopardy from civil or criminal liability or impact on employment or reputation such as drug addiction, criminal activity, child abuse or HIV status, sexually transmitted diseases

8 45 CFR (c)(2) / 21 CFR (c)(1) Research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context Examples: blood draws, interviews, questionnaires, non-invasive measures such as height and weight IRB may require investigators to give subjects an Information Sheet

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10 NPRM: Makes changes to regulations for waiver of documentation of consent Rationale: to facilitate the recruitment of prospective research subjects, and to create more flexible rules for documenting informed consent for certain subject populations.

11 How would the NPRM change the regulations for waiver of documentation? NPRM retains the current waiver criteria listed under (c)(1) & (2) but the numbering is different Adds a new waiver for subjects who are members of a distinct cultural group or community Also adds a new reminder that research subject to regulation by the FDA is excluded unless authorized by 21 CFR (c)(1) NPRM: 45 CFR (c)(1)

12 Waiver of documentation of consent for distinct cultural groups or communities Allowed if signing documents is not the norm; and Research presents no more than minimal risk of harm; and Appropriate alternative mechanism for documenting that informed consent was obtained Example: record date/time in subject s study records Study documentation must include description explaining why signing forms is not the norm for the distinct cultural group or community NPRM: 45 CFR (c)(1)(iii)

13 Waiver of Informed Consent

14 Requirements for waiver of consent IRB may waive or alter some or all elements of consent if: 1. The research involves no more than minimal risk to the subjects; 2. The waiver or alteration will not adversely affect the rights and welfare of the subjects; 3. The research could not practicably be carried out without the waiver or alteration; and 4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. 45 CFR (d)

15 OHRP s interpretation of practicably consistent with SACHRP s proposal Scientific validity would be compromised if consent were required; Ethical concerns would be raised if consent were required; There is a scientifically and ethically justifiable rationale why the research could not be conducted with a population from whom consent can be obtained; and Practicability should not be determined solely by considerations of convenience, cost, or speed. Federal Register (2015) 80:

16 How would the NPRM change the regulations for waiver of consent? Prioritizes use of non-identifiable data or specimens Adds new restriction for waiver of consent for use of biospecimens Adds new criteria for waiver or alteration of consent for biospecimens Clarifies/revises waiver requirement for recruitment or screening 45 CFR (f)(1)

17 NPRM: Changes to the basic requirements for waiver of consent The numbering is changed New criteria added that mimics HIPAA s wording Prioritizes use of non-identifiable data/specimens (iii) If the research involves accessing or using identifiable biospecimens or identifiable information, the research could not practicably be carried out without accessing or using identifiers; NPRM: 45 CFR (f)(1) (formerly (d))

18 Additional new criteria for waiver of consent for use of biospecimens i. There must be a compelling scientific reasons for the research use of the biospecimens; and ii. Research could not be conducted with other biospecimens for which informed consent was or could be obtained NPRM: 45 CFR (f)(2)

19 IRB cannot waive informed consent when an individual declines broad consent IRB prohibited from waiving informed consent if individuals were asked and refused to provide broad consent to the storage and maintenance for secondary research use of biospecimens and identifiable private information Means broad consent or refusal to consent must be recorded and tracked Could be a logistical nightmare NPRM: 45 CFR (f)(3)

20 Current requirements for consent for recruitment or screening FDA does not consider someone a subject unless they receive a test article Subjects whose names are recorded or records reviewed to determine eligibility are not subjects Under current Common Rule, recording someone s name for recruitment or asking questions to determine eligibility makes them a human subject IRB must either require informed consent or Waive the requirement for informed consent

21 NPRM: Changes to consent requirements for recruitment or screening An IRB may approve a research proposal in which investigators obtain, through oral or written communication or by accessing records, identifiable private information without individuals informed consent for the purpose of screening, recruiting, or determining the eligibility of prospective human subjects of research, provided that the research proposal includes an assurance that the investigator will implement standards for protecting the information obtained, in accordance with and to the extent required by _.105. NPRM: 45 CFR (g)

22 What s not in the NPRM: Waiver of consent for emergency research Waiver of consent permitted for emergency research that is either Approvable under FDA s regulations at 21 CFR 50.24; or Meets criteria enumerated in the Federal Register, Vol. 61, pp (see also Oct 31, 1996 OPRR Reports) NPRM does not include an equivalent regulation to 21 CFR 50.24