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Informed Consent Requirements Under the Revised Common Rule
Health Law Perspectives
September 15, 2018

As January 21, 2019, the general compliance date for the revisions to the Federal Policy for the Protection of Human Subjects (also known as the Common Rule) approaches, and as entities subject to the Common Rule ramp up efforts to ensure compliance with the revised regulations (referred to as the 2018 Requirements),  it is important to review and understand the new requirements related to informed consent, as well as the underlying policy rationale.

This article provides a summary of the new required information to be provided to prospective research participants as part of the informed consent process, a summary of the new posting requirement for informed consent forms, and recent related guidance from the HHS Office of Human Research Protections (OHRP).[1]  For more information on the 2018 Requirements generally, see  this firm’s February 22, 2017 article, Federal Agencies Issue Revised Common Rule.  For more information on the long and winding path leading up to the general compliance date of January 21, 2019, see this firm’s June 1, 2018 article, Ready for Compliance with Revised Common Rule?.  

 Informed Consent Process - Additional Information Required

The commentary to the Final Rule addressing the 2018 Requirements highlights the concerns that federal departments and agencies have with the current approach to informed consent, noting that information may not be presented in a way that effectively aids prospective subjects in their decision whether to participate in a study:

In considering changes to the general requirements set forth in [the regulation], we considered arguments put forth by some that consent forms have evolved to protect institutions rather than to provide potential research subjects with the most important pieces of information that a person would need in order to make an informed decision about whether to enroll in a research study.  Instead of presenting the information in a way that is most helpful to prospective subjects – such as explaining why someone might want to choose not to enroll – these individuals argued the forms may function more as sales documents or as a means to protect against institutional liability.  We also considered a growing body of literature that suggests informed consent forms have grown too lengthy and complex, adversely affecting their ability to effectively convey the information needed for prospective participants to make an informed decision about participating in research.[2]

The 2018 Requirements attempt to address these concerns in a few ways.  First, the initial text of the regulation addresses the general requirements for informed consent[3]was revised to identify and expand on such requirements in separate sections, to “emphasize the fact that this paragraph includes multiple independent and important regulatory requirements.”[4]  In addition, three additional general requirements were added:

  • Reasonable Person Standard: The prospective research participant must be provided with information “that a reasonable person would want to have in order to make an informed decision,” as well as an opportunity to discuss such information. OHRP has stated that this requirement aligns with the standard approach for clinical informed consent.[5]
  • Start with Key Information: The informed consent “must begin with a concise and focused presentation of the key information” most likely to assist in comprehension of why one may or may not want to participate in the study.  In the commentary to the Final Rule, the federal departments and agencies provide an example in the context of a complicated clinical trial with a 20-25 page consent document, stating the expectation that the key information would be presented at the beginning in no more than a few pages.[6]  The commentary also compares the new requirement to the type of information that a physician would deliver in the clinical context, which is echoed in other materials.[7]  
  • Sufficient Detail: The informed consent must provide sufficient detail, and not “merely provide lists of isolated facts.” Rather, the consent process must facilitate understanding of why one may or may not want to participate in the study.  As an example, OHRP’s director has provided a comparison between a general statement that an individual may benefit from participation and a more specific statement that there is a less than 10% chance that the individual will benefit from participation.[8]

Second, the basic elements of informed consent were revised to include a new element addressing the collection of identifiable private information or identifiable biospecimens.[9]  In particular, the informed consent must state whether such information or biospecimens could be used or distributed for future studies (even if identifiers are removed).  The purpose of this additional requirement is to increase transparency for potential study participants.  

Third, the additional elements of informed consent were  revised to include three new statements that must be included, when appropriate.[10]  These are: (1) a statement that the subject’s biospecimens may be used for commercial profit; (2) a statement whether clinically relevant research results will be disclosed to the subjects; and (3) with respect to research involving biospecimens, a statement whether the research may include genome sequencing.

OHRP has provided further context and insight into these revisions through various means, including educational sessions, a Q&A section on OHRP’s website,[11] and a July 12, 2018 video of OHRP’s director addressing the new requirements (posted on YouTube and available via OHRP’s website).[12]  In particular, the July 12, 2018 video provides some specific examples that entities subject to the 2018 Requirements may find helpful. The most detailed example relates to a prior study involving breast cancer patients.  The informed consent document for the study apparently included just one sentence addressing why the study was being conducted (to determine whether radiation treatment provided after chemotherapy and surgery would reduce risk of breast cancer recurrence and help patients live longer).  In comparison, a New York Times article addressing the same topic, but with a focus on decision-making in the clinical context, apparently included significantly more detail as to the risk involved.  The article said that there was “no question” radiation would reduce the rate of recurrence by two-thirds, but that it was also unclear whether it would lead to longer survival. In the video, OHRP’s director emphasized that breast cancer patients may make different decisions regarding participation in a study when provided with this level of detail, given their personal set of values (also implying that although the news article was not particularly long, it still managed to convey more meaningful information than the informed consent to aid in the decision-making process).

It is likely that OHRP will release more formal guidance as the general compliance date approaches.  In the commentary to the June 19, 2018 final rule (which delayed the general compliance date), the federal departments and agencies noted that commenters have requested guidance documents on the new “reasonable person” standard as well as the new requirement for a presentation of the key information at the beginning of an informed consent document.[13]  Although the federal departments and agencies did not specifically reference the request for guidance on informed consent in response to the commenters, they generally agreed that further guidance on the 2018 Requirements would be useful and they would work to issue guidance promptly.[14]

 New Posting Requirement for Informed Consent Forms

The 2018 Requirements obligate researchers conducting federal or federally-funded clinical trials to post a copy of the IRB-approved version of the consent form used to enroll subjects to a publicly available federal website that will be established as a repository for consent forms.[15] The informed consent form is to be posted no later than 60 days after the trial is closed for recruitment.  For research being carried out between collaborating personnel at more than one institution, only one posting will be required.  If the federal department or agency supporting or conducting the clinical trial determines that certain information is confidential, the department or agency may permit particular redactions to the information posted.

Currently, the Common Rule does not have a requirement to post consent forms from clinical trials. According to the commentary to the Final Rule for the 2018 Requirements, the primary purpose of this addition is to improve the quality of consent forms in federally funded research, by subjecting these documents to public scrutiny.[16]  In adopting this proposal, the federal departments and agencies stressed that increased transparency will foster public discussion, enabling individuals to work together to improve the quality of informed consent.[17]  OHRP’s director has also stated that individuals responsible for writing consent forms “will hopefully write better, more informative consent forms” as a result of the new requirement.[18]

Concerns have been raised by regulated entities about this requirement, including that making the forms publicly available may increase litigation, increase administrative burden without a corresponding increase in protection for subjects or the research community, and lead to longer consent forms to protect against perceived noncompliance or legal challenge, and the resulting resource will not be helpful given the sheer volume of informed consents (as opposed to provision of a few exemplar samples).[19]  However federal departments and agencies have dismissed these concerns, noting among other things, that existing evidence fails to suggest that inappropriate litigation over clinical trials is a current problem.[20]  The federal departments and agencies also indicated that they believe the new changes regarding the acceptable content, including the requirement to include a concise presentation of key information at the beginning of the document, will assist in limiting attempts to pad consent forms with additional information as a response to the posting requirement.[21]

On August 28, 2018, OHRP announced via its listserv the two publicly available federal websites that will satisfy the consent form posting requirement at this time: ClinicalTrials.gov and a docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021).  Further instructions and guidance from HHS and other federal agencies will follow, and additional federal websites that satisfy the posting requirement may be identified in the future.         

Hooper, Lundy & Bookman’s Academic Medical Center/Teaching Hospital Group provides assistance to health care providers and IRBs in all aspects of research and privacy compliance.  For assistance, please contact Amy Joseph in Boston at 617.532.2702; Paul Smith, Katrina Pagonis, or Andrea Frey in San Francisco at 415.875.8500; Kelly Carroll in Washington, D.C. at 202.580.7700; or Sandi Krul or Jennifer Siegel in Los Angeles at 310.551.8111.

 1 This article does not address the 2018 Requirements with respect to waiver or alteration of informed consent or the new “broad consent” category.  For more information on those provisions, see Federal Agencies Issue Revised Common Rule.

2 82 Fed. Reg. 7149, 7211 (Jan. 19, 2017).

3 § ___.116 (there is a blank before the section number because each agency has adopted the regulation in a different part of the Code of Federal Regulations). 

4 § ___.116(a); 82 Fed. Reg. 7212.

5 See What’s New in Informed Consent: Revisions to the Common Rule, available at https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-videos/index.html.

6 82 Fed. Reg. 7213. 

7 Id.; see also The Common Rule, Updated, J. Mnikoff, J. Kaneshior, I. Pritchard, New England Journal of Medicine, Vol. 376 No. 3 (Jan. 19, 2017), available at https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html (“So, for example, in a complicated randomized cancer clinical trial, this section of the consent form would probably include information about the most important risks, similar to what a doctor would commonly say to a patient in the clinical setting.”). 

8 See n. 2, supra.

9 § ___.116(b).

10 § ___.116(c).

11 See https://www.hhs.gov/ohrp/education-and-outreach/revised-common-rule/revised-common-rule-q-and-a/index.html#informed-consent.

12 See n. 4, supra.  

13 83 Fed. Reg. 28497, 28500-01 (June 19, 2018).

14 83 Fed. Reg. 28501.

15 82 Fed. Reg. 7227-29.

16 82 Fed. Reg. 7229.

17 82 Fed. Reg. 7228-29.

18 See “Informed Consent Under the NPRM,” available at:

https://www.youtube.com/watch?v=ycERM2UkxVs&index=3&list=PLrl7E8KABz1FtLMpK2zPa8nqV-F-xhW2C.

19 82 Fed. Reg. 7228.

20 82 Fed. Reg. 7228-29.

[21] 82 Fed. Reg. 7228.

 

 

For media assistance, please contact Maura Fisher at 202-580-7714.