Ivor Pritchard, Ph.D. April12, 2019 Ivor.Pritchard@hhs.gov Informed Consent in the U.S. Revised Common Rule: New General Requirements and Broad Consent Ivor Pritchard, Ph.D. April12, 2019 Ivor.Pritchard@hhs.gov

Informed Consent

Additions to the General Requirements for Informed Consent “…information that a reasonable person would want to have in order to make an informed decision about whether to participate…” (.116(a)(4)) “Informed Consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject … in understanding the reasons why one might or might not want to participate in the research…. (.116(a)(5)(i)) “Informed consent as a whole must present information in sufficient detail… and must be organized in a way that …facilitates the…understanding of the reasons why one might or might not want to participate”. (.116(a)(5)(ii))

“Key Information” “Informed Consent must begin with a concise and focused presentation of the key information…to assist a prospective subject… in understanding the reasons why one might or might not want to participate in the research.” (.116(a)(5)(i))

Finding Key Information in the Informed Consent Form

The New Front and Back of Informed Consent

Key Information is Generally, but Not Always…….. We are asking for consent and your participation is voluntary This research is about…. The risks and discomforts are expected to be… The possible benefits to you or society are expected to be… Instead of participating, you could do ….. But the IRB might require something else…. (Preamble, January 2017)

What’s Informed Consent ? The Recipe Approach Old Rule Revised Rule Basic Elements 1-8 Additional Elements 1-6 Basic Elements 1-8, plus [new] 9 Additional Elements 1-6, plus [new] 7, 8, and 9.

What’s Informed Consent? The Desiderative Approach The Facts Advice

3 Key Examples An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights (Required (§_.116.(b)(7)) The amount of compensation for participating in a Phase 1 trial with healthy volunteers A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained. (Required (§_.116.(b)(5))

What is Key Information? Key Information is decision-oriented Key Information is study-specific There is more than one way to present Key Information

Broad Consent Broad Consent can be used as a means of enabling subjects to agree to a range of possible secondary research studies in the future using the subjects’ identifiable biospecimens Broad Consent may be used for secondary research studies meeting the full range of requirements under the rule, or to qualify certain secondary research activities for an exemption If Broad Consent is used, all of the information described in §_.116(d) must be included

Broad Consent Incorporates Some Elements from Specific Informed Consent Reasonably foreseeable risks Potential benefits to subjects or others Confidentiality safeguards Participation is voluntary and may be discontinued without penalty When appropriate, a statement about commercial profit and whether subjects will or will not share in it When appropriate, whether research might include whole genome sequencing (§_.116(b)(2),(3),(5),(8) & (c)(7),(9))

Broad Consent Includes Some Distinct Elements A general description of the types of research that may be done, with sufficient information that a reasonable person would expect the consent would allow The identifiable materials that might be used, whether there might be sharing, and with what types of institutions or researchers The period of time the materials may be stored, maintained, or used Who to contact about subject rights, storage and use of materials, and research-related harm §_.116(d)(2)-(4),(7) .

Additional Elements of Broad Consent Unless they will be informed of specific studies using their information or specimens, a statement that the subject will not be informed of specific studies, and that the subject might not have chosen to consent to some of those studies Unless they will receive research results, a statement that clinical results might not be returned to the subject §_.116(d)(5)-(6)

Implications of Broad Consent Broad Consent allows subjects a means to exercise their autonomy in deciding whether or not to allow secondary research use The use of Broad Consent will involve some mechanism for tracking the affected biospecimens If an individual was asked to provide broad consent and refused to consent, an IRB cannot waive consent to a secondary research study §_.116(e),(f)

Exemption 7: Storage or Maintenance of Identifiable Information or Identifiable Biospecimens for Secondary Research with Broad Consent Broad Consent is obtained and documented as specified in the section on broad consent and the exemption Limited IRB review of the broad consent process and form Limited IRB review of privacy and confidentiality considerations if there are changes to the storage and maintenance §_.104(d)(7)

Exemption 8: Secondary Research Use of Identifiable Information or Biospecimens with Broad Consent Limited IRB review of whether the research falls under the broad consent Limited IRB review of the privacy and confidentiality safeguards The investigator does not include returning individual research results to subjects as part of the study plan except when required by law Documentation or waiver of documentation of consent provisions has occurred §_.104(d)(8)

Secondary Research Options in the Revised Common Rule Non-identifiable information or biospecimens Identifiable private information or identifiable biospecimens Not human subjects research Exempt Research If: Nonexempt research (IRB REVIEW) Publicly available or Recorded in de-identified form Certain Uses under HIPAA or Certain government- conducted research Storage of Information or biospecimens with broad consent and limited IRB review Exemption 104(d)(7) Secondary Study with broad consent and limited IRB Review Exemption 104(d)(8) Waiver of informed consent Study Specific Informed consent per 46.116(a)-(c) Broad consent per 46.116(a) & (d) Exemption 104(d)(4)(i)-(ii) Pre-existing data or biospecimen requirement eliminated Exemption 104(d)(4)(iii)-(iv)

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