EXECUTIVE SUMMARY
The updated Common Rule for ethical conduct of human subjects research is significantly different from what was initially proposed. Some changes include the following:
- Researchers do not need to obtain direct consent from persons involved in certain minimal-risk studies involving biospecimens.
- Public health surveillance activities are not considered research.
- Researchers can obtain broad consent to reuse participant biospecimens or other data in secondary studies.
The long-awaited updated Common Rule for federal regulations for ethical conduct of human subjects research is quite different from what was initially proposed.
The updated rule is a “massive improvement over the 1990s version that had essentially become antiquated the moment it hit the presses,” says James G. Hodge, Jr., JD, LLM, professor of public health law and ethics at the Sandra Day O’Connor College of Law at Arizona State University in Phoenix.1
A number of controversial changes that were originally proposed did not make it into the final version. “After reviewing more than 2,100 comments on changes we proposed in our earlier Notice of Proposed Rulemaking, we made a number of significant changes in our final rule,” says Jerry Menikoff, MD, director of the U.S. Department of Health and Human Services (HHS) Office for Human Research Protections, which led the government’s efforts to overhaul the regulations.
The final rule does not require that research involving non-identified biospecimens be subject to the Common Rule, and it does not require that consent be obtained in order to conduct such research. In general, researchers can continue to use such biospecimens in the way they are currently using them.
In Hodge’s estimation, “The research enterprise in the U.S. just got more streamlined without sacrificing privacy or protection.”2 The following are some changes:
• Informed consent forms will be changed to facilitate research participants’ understanding of the study’s scope, including its risks, benefits, and alternatives to participating in the study.
“Over the years, many have argued that consent forms have become these incredibly lengthy and complex documents that are designed to protect institutions from lawsuits, rather than providing potential research subjects with the information they need in order to make an informed choice about whether to participate in a research study,” said Menikoff.
The final rule will now generally expect consent forms to include a concise explanation at the beginning of the document of the key information that would be most important to individuals contemplating participation in a particular study. This should include purpose of the research, the risks and benefits, and appropriate alternative treatments that might be beneficial to the prospective subject.
“We are very hopeful that a new emphasis on concise and focused information will do a much better job explaining research studies to potential participants than 25 pages of charts and boilerplate,” says Menikoff.
• The updated rule clarifies what constitutes research for the purposes of IRB oversight.
While the definition of research is unchanged, “what’s clearly classified now as non-research is important,” says Hodge. “It represents seminal changes.”
Public health surveillance activities are not classified as research. This has been much debated, especially in hospital settings. “Hospital CEOs and others question whether they can share data for surveillance purposes, because they view surveillance mistakenly as research,” says Hodge. “The Common Rule clarifies that it’s not research.”
• The updated rule lessens the burden for studies with very minimal risks, such as studies involving access to private data, or access to biospecimens that are not linked to specific persons.
“We are expecting a lot less IRB oversight of ongoing, longitudinal studies,” says Hodge.
Certain types of educational studies, such as health oversight activities and minimal risk psychological examinations, that might have somehow garnered a research classification in the past are generally not to be considered research going forward.
Some advocated for the Common Rule to apply to all research activities across the board in all settings — whether funded by local, state, or federal governments, or even the private sector. “That was not adopted, but could have changed the game for some private-sector hospitals,” notes Hodge. “Any attempt to apply Common Rule protections beyond federally conducted or funded research is the choice of the hospital.”
A commonly debated question is: How concerned should Americans be about unwarranted, undocumented use of their data for tissue samples? In Hodge’s view, “The truth is, not very. This is the type of activity that will advance medical causes or public health-related findings with little to no risk to the subjects themselves.”
Detecting longitudinal patterns with potential public health implications is the type of work that “opens the door to better outcomes, and it can be revisited if privacy breaches or other abuses arise,” says Hodge.
• If a participant is involved in a federally funded minimal-risk study involving biospecimens or private data, clinical researchers will not have to seek direct consent.
“This is a substantial change that was contentious,” says Hodge.
Some wanted consent for any type of study whatsoever involving secondary research. Others wanted no consent for any studies that involved only biospecimens.
“That debate was solved in this new revised rule with an appropriate balance,” says Hodge.
After obtaining consent for advance use of biospecimens and other data from a research subject, researchers will not have to revisit consent for every future secondary use of that particular data.
“That is a huge plus for the research community,” says Hodge. “It allows all kinds of research that previously would not have been conducted or may have been shut down.” This is because of the expense of having to either revisit informed consent or obtain a waiver from an institutional review board.
None of this means that research can be performed on individuals in clinical settings without informed consent. “That is not what the rule is about. It’s about tissue samples and private identifiable information,” says Hodge. “How clinical research is conducted in the U.S. largely remains the same.”
Revisited as Needed
Hodge points out that the updated Common Rule is not written in stone. “One of the great things is that some key provisions of the rule can be revisited and revised, allowing for a more flexible rule in the years ahead,” he says.
What constitutes a biospecimen in the current version could be adapted to keep pace with technology and societal conceptions, for instance. The ability to deduce an individual’s identify from databases or biospecimens might also need to be revisited.
“Four years from now, we can make changes to the Common Rule to reflect the latest technology,” says Hodge.
REFERENCES
- Federal policy for the protection of human subjects: Final Rule. Federal Register 2017; 82(12):7149-7274.
- Hodge JG, Gostin LO. Revamping the US federal common rule modernizing human participant research regulations. JAMA. Published online February 22, 2017. doi:10.1001/jama.2017.1633.
SOURCE
- James G. Hodge, Jr., JD, LLM, Professor of Public Health Law and Ethics, Sandra Day O’Connor College of Law, Arizona State University, Phoenix. Phone: (480) 727-8576. Email: [email protected].
The long-awaited updated Common Rule for federal regulations for ethical conduct of human subjects research is quite different from what was initially proposed.
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