In recent years, the world of human subjects research has expanded not only with regard to the number of clinical research trials being conducted and the array of drugs and devices being tested, but also with respect to the technology employed to conduct the research and the nature of the research itself. As one example, increasing reliance on repositories of human biospecimens or individually identifiable health information has changed the research landscape and the associated risks and benefits. Until recently, applicable federal regulations have failed to keep pace.
The Common Rule
Despite the expansion and modernization of clinical research, the principle federal regulations governing protection of human subjects and ethical conduct in federally supported clinical research (the Federal Policy for the Protection of Human Subjects, generally known as the “Common Rule”), have remained largely unchanged since they went into effect in 1991. However, on September 8, 2015, sixteen federal agencies issued a Notice of Proposed Rulemaking (the “NPRM”) with the intent of clarifying the regulations and making them less burdensome on the research community while maintaining protections for clinical trial participants. The NPRM was in follow-up to an Advance Notice of Proposed Rulemaking issued in 2011 which solicited public comment on the notion of updating the Common Rule. On January 19, 2017, after fielding over 2100 comments on the NPRM, the agencies issued a final rule approving long-awaited updates to the Common Rule (referred to herein as the “Final Rule”) to be effective, with limited exception, on January 19, 2018.
Below is a summary of some of the key changes contained in the Final Rule.
Definitions. The Final Rule updates certain definitions that existed under the Common Rule and adds others. Although various changes that were proposed under the NPRM were included in the Final Rule, there were several proposed changes the agencies declined to adopt. One notable example was the agencies’ refusal to change the definition of “human subject” to include “non-identifiable biospecimens.” Such a change would’ve been a significant departure from the Common Rule and would’ve had the effect of requiring informed consent for research on non-identifiable biospecimens. As it stands, and will remain under the Final Rule, informed consent is not required for secondary research involving non-identifiable biospecimens.
Consent. The Final Rule updates various provisions relating to informed consent in the clinical research setting including the following:
- To ensure that potential research subjects are informed of the information they need to make an educated decision about whether or not to participate in a research trial, the informed consent form must now contain a concise summary of key information relating to the research (including the purpose(s), risks, benefits, alternatives, and other information required to be addressed in more detail throughout the form) at the beginning of the form.
- The Final Rule adds the following four elements to the existing informed consent requirements: (i) whether biospecimens collected as part of the research will be used or distributed for future research; (ii) whether specific technology determined to be capable of generating identifiable information or identifiable biospecimens will be used; (iii) a statement that biospecimens may be used for commercial profit and whether the subject will share in such profit; and (iv) whether clinically relevant research results will be disclosed to subjects.
- Under the Final Rule, researchers may obtain a broad consent to store, maintain and use identifiable data or biospecimens. There are various requirements and caveats associated with these provisions, but they afford researchers greater flexibility with respect to informed consent for certain future research. As outlined above, consent is not required to conduct secondary research using non-identifiable biospecimens.
- Consent forms for certain federally-funded trials must be posted on a public website (to be created) at any time after the study is closed to recruitment, but no later than 60 days after the last study visit of any study subject.
Oversight. The Final Rule makes various changes relating to IRB oversight of human subjects research including the following:
- Multi-site research studies (“cooperative studies”) must be reviewed by a single IRB unless review by multiple IRBs is required by law. This is a significant change to the Common Rule as it previously existed and, given the practical complexities involved in implementing this change, the effective date for compliance is delayed until January 19, 2020.
- The Final Rule relaxes the requirements for IRB oversight in relation to “low-risk” studies in several ways. First, the Final Rule revises and expands the Common Rule’s previously existing concept of “exempt” research. Additionally, during the standard of care follow-up and data analysis phases of clinical studies when research subjects are no longer at risk, continued IRB oversight and review is no longer required. Finally, unless otherwise required by the IRB or requested by the researcher, studies under expedited review do not require continued IRB review and oversight.
Compliance Researchers, institutions and IRBs should ready themselves to comply with the Final Rule as of January 19, 2018. Compliance efforts should include revising policies, procedures and forms, and educating research staff on the new requirements. Clinical studies that have been approved or determined to be exempt prior to January 19, 2018 may continue to operate under the Common Rule as it currently exists, but research institutions may choose to apply the Final Rule to such research through a formal determination with the responsible IRB.