1. 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

2. Informed Consent

3. 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))

4. “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))

5. Finding Key Information in the Informed Consent Form

6. The New Front and Back of Informed Consent

7. 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)

9. 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.

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

11. 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))

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

13. 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

14. 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))

15. 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) .

16. 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)

17. 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)

18. 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)

19. 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)

20. 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 (a)-(c)
Broad consent per (a) & (d)
Exemption 104(d)(4)(i)-(ii) Pre-existing data or biospecimen requirement eliminated
Exemption 104(d)(4)(iii)-(iv)

21. Questions, Comments, and Thank You