The Federal Policy for the Protection of Human Subjects, known as the Common Rule, was published in 1991. Despite major changes in the research landscape, including new techniques to analyze biospecimens and increasing numbers of multi-site trials, the Common Rule has not been significantly revised since then.
In 2011, HHS and the FDA published an Advanced Notice of Proposed Rulemaking (ANPRM) with ideas and questions to the public about how the Common Rule could be updated. That public feedback has been incorporated into the Notice of Proposed Rulemaking (NPRM) published by HHS in the Federal Register today: https://www.federalregister.gov/articles/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects
In addition to the publication of the NPRM, HHS has created a website with additional information: http://www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html
What key changes are proposed in the NPRM?
The NPRM’s goal is to “better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.” It includes proposals to modernize research oversight, particularly in relation to biospecimens, as well as to improve the informed consent process, require IRB oversight that is more proportional to the risks of proposed research, and increase data security and privacy standards.
Here are some of the proposed changes that may affect accrual:
- Secondary use of non-identified biospecimens has been added to the definition of “human subject” for research purposes. Broad consent must be obtained for nearly all use of biospecimens or identifiable private information, and privacy and information protection standards must be met for their storage and maintenance. The HHS Secretary will develop and publish a template for the broad consent for biospecimens or identifiable public information.
- Economically or educationally disadvantaged persons have been added to the list of categories of subjects who are potentially vulnerable to coercion or undue influence. Additional safeguards to protect the rights and welfare of vulnerable subjects must be included in research when some subjects may be in a vulnerable category.
- Cooperative research (research being conducted at more than one institution) must rely on a single IRB for review. This is intended to help avoid duplication of effort and reduce the challenge of reconciling the changes from multiple IRBs.
- Studies that are solely conducting data analysis or accessing follow-up clinical data from standard clinical procedures will no longer require annual review. Instead, investigators must confirm that the research is ongoing and there are no changes that would require review.
- The Common Rule will be applied to all clinical trials not subject to FDA regulation that are conducted at a U.S. institution that receives Federal support for human subjects research. Previously, clinical trials not directly receiving Federal support were not covered, although many institutions voluntarily complied.
There are also a number of proposed revisions to the informed consent section:
- Guiding principles for the general informed consent process have been added that are intended to produce informed consent documents better designed to inform potential participants without including extraneous information. Informed consent should include “the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.”
- The basic elements of informed consent are relatively unchanged. However, the NPRM adds some additional elements to be included as appropriate, including a statement regarding potential commercial profit for biospecimens and a statement regarding whether clinically relevant results will be disclosed to subjects.
- The NPRM notes that investigators do not have an obligation to return clinically relevant research results. However, the NPRM also acknowledges that subjects may be less likely to consent if they are told they will not receive clinically relevant results. If investigators do anticipate returning results, they must have a plan approved by the IRB.
- To track compliance with the new informed consent guidance, a copy of the final version of the informed consent form must be posted on a publically available federal website within 60 days after the trial is closed to recruitment.
In addition to directly affecting accrual, the proposed changes could make it easier to do research about accrual. The NPRM seeks to reduce regulatory requirements for social and behavioral research collecting information via surveys or interviews, and other types of low-risk activities, such as benign interventions in adults. Moving forward, IRB review and informed consent documents may not be required for these activities. This could make it easier to assess the clinical trial screening process, evaluate patient knowledge or beliefs, or collect information about barriers to accrual.
How can I comment?
Public comments may be submitted on the NPRM for 90 days. The NPRM includes 88 specific questions for the public, although any element of the NPRM may be commented on. Based on the public comments received, HHS will prepare and publish a final rule that will likely have a significant impact on many elements of the research enterprise. Public comments must be received no later than 5 p.m. on December 7, 2015. Comments may be submitted via the Federal eRulemaking Portal at http://www.regulations.gov/#!docketDetail;D=HHS-OPHS-2015-0008, or by mail. Identify comments with the docket ID number HHS– OPHS–2015–0008. Complete information about submitting comments is available in the Federal Register publication. Comments received, including any personal information, will be posted without change to http:// www.regulations.gov. You can find suggestions for submitting effective public comments here: http://www.hhs.gov/regulations/regulations-toolkit/index.html