Tarius SAC Tracker®
Background Analysis: US HHS Advisory Committee to Discuss Common Rule Topics – JUL 10-11, 2018 (SACHRP)
The US Department of Health and Human Services (HHS) has scheduled a meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP) on Tuesday to Wednesday, July 10-11, 2018 to discuss topics related to the Common Rule.
The Common Rule
The Federal Policy for the Protection of Human Subjects was first published in 1991 and later codified in separate regulations by 15 federal departments and agencies. The HHS regulations are codified in section 45 of the Code of Federal Regulations (CFR), in part 46, and they are broken into four subparts: subpart A, also known as the “Common Rule”; subpart B, providing additional protections for pregnant women, human fetuses, and neonates; subpart C, providing additional protections for prisoners; and subpart D, providing additional protections for children.
The 2018 Revised Common Rule
On January 19, 2017, a Final Rule was issued in the Federal Register to revise the existing Common Rule. The intent of the revised Common Rule is to strengthen patient protections while reducing the administrative burden for low-risk research. The HHS has highlighted the following elements as important revisions:
· The requirement for consent forms to provide potential research subjects with a better understanding of a project’s scope, including its risks and benefits, so they can make a more fully informed decision about whether to participate.
· Requirements, in many cases, to use a single institutional review board (IRB) for multi-institutional research studies. The proposal from the original (2015) Notice of Proposed Rulemaking (NPRM) has been modified, however, to add substantial increased flexibility in now allowing broad groups of studies (instead of just specific studies) to be removed from this requirement.
· For studies on stored identifiable data or identifiable biospecimens, researchers will have the option of relying on broad consent obtained for future research as an alternative to seeking IRB approval to waive the consent requirement. As under the pre-2018 rule, researchers will still not have to obtain consent for studies on non-identified stored data or biospecimens.
· The establishment of new exempt categories of research based on the level of risk they pose to participants. For example, to reduce unnecessary regulatory burden and allow IRBs to focus their attention on higher-risk studies, there is a new exemption for secondary research involving identifiable private information if the research is regulated by and participants protected under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) rules.
· Removal of the requirement to conduct continuing review of ongoing research studies in certain instances where such review does little to protect subjects.
· Requirement that consent forms for certain federally funded clinical trials be posted on a public website.
The 2018 Revised Common Rule - Effective and General Compliance Dates
On January 22, 2018, an Interim Final Rule was posted in the Federal Register that extended the effective and general compliance dates of the initial Final Rule from January 19, 2017 to July 19, 2018. On April 20, 2018, a Notice of Proposed Rulemaking (NPRM) was posted in the Federal Register, proposing an additional six-month delay of the general compliance date, to January 21, 2019. This NPRM is intended to provide regulated entities additional time for the preparations necessary to implement the 2018 Requirements. The Notice also proposed three options for institutions with research studies initiated before January 21, 2019. The first option, and default, is to continue to follow pre-2018 Requirements for the duration of the study. The second option is to choose to follow pre-2018 Requirements, except for three burden-reducing 2018 Requirements (described further below), until January 21, 2019, when all of 2018 Requirements would become applicable. The three provisions, intended to reduce burdens on regulated entities, are:
(1) a revised definition of “research,” which deems four categories of activities not to be research;
(2) an allowance for no annual continuing review of certain categories of research; and
(3) an elimination of the requirement that =IRBs review grant applications or other funding proposals related to the research.
The third option would be to follow pre-2018 requirements until January 21, 2019, and at some point thereafter choose to follow all of the 2018 Requirements for the duration of the study.
Also note that the revised Common Rule has provisions that further extend the compliance and effective dates for Cooperative Research.
The SACHRP was established to provide expert advice and recommendations to the HHS Secretary on general issues and topics associated with the protection of human research subjects. The Committee typically meets 2-3 times annually. Recent SACHRP meetings have focused on interpreting aspects of the revised Common Rule and on drafting related recommendations to the HHS Secretary. The SACHRP recommendations are made available to the public at this website.
The Agenda for the meeting includes three key areas for discussion, as follows: “key information” for informed consent; exemptions for FDA-regulated and HHS-funded research; and topics pertaining to permission by parents or guardians and assent by children.
The Subpart A Subcommittee (SAS) and Subcommittee on Harmonization (SOH) will present their recommendations regarding the description of “key information,” as required by the revised Common Rule at CFR 46.116(a)(5)(i), a section pertaining to informed consent.
At the last SACHRP meeting on March 13-14, 2018, the Committee heard presentations on this topic. The Committee also considered a draft SACHRP commentary on questions posed by the HHS Office of Human Research Protections (OHRP) regarding possible OHRP/FDA joint guidance on the new consent requirements at Section 46.116(a)(5)(i) and (ii), which state:
(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
(ii) Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate.”
The Committee members had a wide variety of perspectives on the topic. They acknowledged that consent forms can be up to 30 pages long and difficult to read, and there is a need for a more succinct summary of the information. However, the members were divided on whether the key information section should be able to stand alone, or whether it is merely meant to introduce the reader to the full informed consent. Another concern from Committee members was that the addition of a key information section could inadvertently expand the consent form, making it even longer, and they pointed to past cases where this has occurred. The Committee also mentioned the variability of the amount of information, for example, between informed consent for cancer treatments, with a high level of risk, compared to less serious treatments with smaller risks. They pointed to the difficulty of crafting a guideline that will address such a wide range of risks and complexity.
The speakers and the Committee members at the March 2018 meeting noted that the discussion and draft document were very preliminary, and that Subcommittee work would continue, for presentation and further discussion at the next SACHRP meeting.
Exemptions for FDA-Regulated and HHS-Funded Research
The Committee will discuss the application of the revised Common Rule’s exemptions at 46.104(d) for FDA-regulated research, and recommendations on the interpretation of CFR 46.104(d)(1) and (2) for HHS-funded research.
Permission and Assent
The SAS will present and discuss recommendations on the interpretation of “reasonably available” at CFR 46.408(b), a section pertaining to permission by parents or guardians and assent by children. The Committee will also discuss issues surrounding payment to subjects for participation in research.
Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.
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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.