Understanding the Final Revisions to the Common Rule and the Implications for Informed Consent
Originally promulgated in 1991, the Federal Policy for the Protection of Human Subjects (the Common Rule)1 codified the ethical framework for the conduct of research involving human participants that is conducted or supported by the federal government. Throughout the years technology and clinical research landscapes have modernized, making it essential for the Common Rule to reflect these advances. In the TRIbune Winter 2017 edition, we discussed proposed updates to the Common Rule as outlined in the Notice of Proposed Rulemaking (NPRM)2. On January 19, 2017, the Department of Health and Human Services (HHS) and fifteen other federal departments and agencies issued final revisions (the Final Rule) to the Common Rule. Since the beginning of the rulemaking process in 2011, the overall purpose of the Common Rule updates has been to improve protections for human subjects while reducing administrative burdens for researchers. January 19, 2018, is both the effective date and compliance date of the Final Rule for all provisions, except those relating to cooperative research, for which the compliance date is January 20, 2020.
Major Revisions from the Notice of Proposed Rulemaking (NPRM)
The Final Rule departs from many of the provisions recommended in the NPRM that was published in the Federal Register in September 20152. The public comment period, the period of time during which the public could submit comments expressing their opinions regarding the NPRM, concluded on January 6, 2016. Upon conclusion, HHS received over 2100 comments reacting to the proposed rule changes. Efforts led by the Council on Governmental Relations (COGR)3 to review and analyze the public comments found that stakeholders and members of several major research institutions expressed great opposition and sharp criticism to many of the proposals presented in the NPRM, citing unnecessary complexity, excessive costs to research institutions, and undue burden and challenges to the conduct of research. Subsequently, the Final Rule seems to address several of the objections to the proposed version, and a number of noteworthy changes were made. The following list encompasses the most prominent and controversial provisions to the Common Rule that were eliminated in the Final Rule4,5:
- Expanding the definition of “human subject” to include nonidentified biospecimens, and requiring informed consent for such research,
- Adopting the new concept of excluded activities,
- Expanding the Common Rule to cover clinical trials that are not federally funded,
- Adopting the standardized privacy safeguards for identifiable private information and identifiable biospecimens, and
- Obtaining a waiver of the consent requirements relating to research with identifiable biospecimens.
HHS was responsive to many of the concerns that were raised by stakeholders during the comments period, particularly the intensive criticism regarding revising the definition of “human subject” to include biospecimens that are used, studied, or analyzed, even if they cannot be identified. This provision would have required obtaining consent before using biospecimens, potentially halting the conduct of important research.
The Final Rule
While many of the NPRM provisions were removed, the Final Rule did incorporate several changes that will still have significant effects on the conduct of research involving human participants. The most notable changes adopted in the Final Rule include the following4,5:
- Establishing new categories of exempt research based on their level of risk, allowing Institutional Review Boards (IRBs) more time to review studies that pose a greater risk,
- Removing from the definition of research certain categories of activities (proposed as exclusions in the NPRM) that were determined to be low-risk,
- Removing continued review of ongoing research in certain instances where such review does little to protect subjects, and
- Requiring U.S.-based institutions engaged in cooperative research to use a single IRB for the portion of the research that takes place within the U.S.
The Final Rule is clearer and far more flexible and modest in scope than the NPRM, dramatically decreasing the cost of implementation while offering improved protections against unethical practices. However, some stakeholders still question whether the Final Rule will improve the efficacy of research and reduce regulatory oversight. Opposition still persists over provisions such as the regulatory requirement of a single IRB, which is regarded by some as costly and inefficient. Leaders have indicated that there may be future communication between HHS and stakeholders regarding aspects of the Final Rule that warrant further guidance. Of note is that many of the proposed changes to informed consent practices were incorporated into the Final Rule in an effort to enhance the content and comprehension of informed consent documents (ICDs) and better protect research participants. As a result, significant changes will be made to the way ICDs are written.
The Final Rule’s Impact on the Informed Consent Process
Future or shared access to stored biospecimens and other private information is imperative for conducting future research pertaining to diseases, genetics, and health outcomes. For the protection of human subjects, ensuring that participants have control over the uses of their data is also essential. Thus, the Final Rule allows the use of broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens. Broad consent allows participants to prospectively consent to the re-use of their biospecimens and private information in future unspecified research, removing the need for the investigator to re-obtain informed consent for each study. This optional alternative is intended to ease the administrative burden for investigators. For example, instead of re-obtaining consent for a specific study or securing IRB approval to waive the consent requirement, researchers may choose to obtain broad consent. Furthermore, the Final Rule adds several requirements for researchers who wish to obtain broad informed consent, including but not limited to advising the participants about the nature of the research that may be conducted; the information and/or biospecimens that will be used; the length of time the information and/or biospecimens may be stored, maintained, and utilized; and if research results will be disclosed to the participant4,5.
The Final Rule also seeks to enhance participant protection by improving and clarifying ICDs. As proposed in the NPRM, prospective participants must be provided with key information that is both concise and focused that is presented at the beginning of the consent form. To facilitate the understanding of an ordinary person, the Final Rule requires that ICDs are shorter, clearer, and organized in a way to assist in making a voluntary informed decision regarding participating in research. Additionally, to improve the quality of consent forms and to provide useful examples for others, the Final Rule mandates that a copy of the final ICD must also be posted to a public federal website within 60 days after the close of the trial’s recruitment. However, departing from the NPRM, the Final Rule did not adopt the requirement that certain extraneous information be included only in the appendices instead of the ICD. The overall objective is to foster comprehension rather than imposing limitations on the length of consent forms4,5. Additionally, differing slightly from the NPRM, new elements of informed consent have been added to increase transparency pertaining to the removal of identifiers from identifiable private information or biospecimens, use of biospecimens for commercial profit, the disclosure of research results, and whether the research may comprise whole genome sequencing4,5.
Currently, there is considerable uncertainty in the research community about whether the Final Rule will take effect on January 19, 2018. Laws and legislation such as the Congressional Review Act6, the Midnight Rules Act7, the Regulations from the Executive in Need of Scrutiny Act8, and the White House Memorandum9 could affect implementation of the Final Rule by causing delays or modifications. For example, the White House Memorandum may temporarily postpone, for sixty days, the effective date of regulations that were published in the Federal Register but have not yet taken effect. To date, there have not been any executive orders issued from the administration that would delay the effective date for the Final Rule, however, it is essential for stakeholders to take heed. Assuming that the Final Rule is not rescinded, these changes will have a keen impact on all institutions that accept federal funding from HHS or any of the several other federal departments covered under the Common Rule (Common Rule Agencies). Preparation and implementation of the final provisions will require research organizations to commit a significant amount of time and resources to updating policies, procedures, practices, and documents. Compliance with the Final Rule will not be required for research studies that were ongoing and initially approved by an IRB, waived, or determined to be exempt before January 19, 2018. However, institutions may choose to comply with the Final Rule for individual studies at their own discretion5.
Technical Resources International (TRI) values the importance of staying current on regulations related to human subjects protection as well as associated ethical issues that are essential to the protection of participant safety and the regulatory review of informed consent documents. The new regulations will not go into effect until January 2018; however, the Human Subjects Protection (HSP) team at TRI has taken a proactive approach to analyze the changes and their effect on our Standard Operating Procedures (SOPs) and policies. We are continuously refining our tools and resources to reflect changes to federal regulations, thereby assisting our clients in properly implementing the changes into their processes, particularly in relation to conducting informed consent discussions and in the development of ICDs.
- Federal Policy for the Protection of Human Subjects; Final Rule, 82 Fed. Reg. 7149. (2017, January 19). Retrieved from https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects
- Federal Policy for the Protection of Human Subjects; Proposed Rules, 80 Fed. Reg. 173 (2015, September 8). Retrieved from https://www.federalregister.gov/documents/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
- Analysis of Public Comments on the Common Rule. (2016, May 9). Retrieved from http://www.cogr.edu/Human-Subjects-and-Animal-Research
- Common Rule Overview. (2017, February 1). Retrieved from http://www.cogr.edu/sites/default/files/Summary%20of%20Changes%20to%20the%20Common%20Rule_COGR.pdf
- Disapproval of Regulations by Congress: Procedure under the Congressional Review Act. (2001, October 10). Retrieved from https://www.senate.gov/CRSpubs/316e2dc1-fc69-43cc-979a-dfc24d784c08.pdf
- H.R.21 - Midnight Rules Relief Act of 2017. (2017, January 5). Retrieved from https://www.congress.gov/bill/115th-congress/house-bill/21
- H.R.26 - Regulations from the Executive in Need of Scrutiny Act of 2017. (2017, March 29). Retrieved from https://www.congress.gov/bill/115th-congress/house-bill/26
- Memorandum for the Heads of Executive Departments and Agencies. (2017, January 20). Retrieved from: https://www.whitehouse.gov/the-press-office/2017/01/20/memorandum-heads-executive-departments-and-agencies
About the Author
Jessica Fair is a Human Subjects Protection Specialist with experience in regulatory affairs and clinical research operations. Her areas of expertise include bioethics, regulatory affairs, clinical operations, and public health.