Reduced administrative burdens and greater protection for human subjects are the goals of proposed revisions to the Federal Policy for the Protection of Human Subjects, also known as the Common Rule.
Changes in the Notice of Proposed Rulemaking (NPRM) “focus heavily on promoting the ethical principle of autonomy, in hopes of building public trust in the research enterprise,” says Karen Hale, RPh, MPH, director of the Office of Responsible Research Practices at The Ohio State University in Columbus.
The current regulations were developed in 1991, when research studies generally took place at a single site. Updated requirements were needed, according to the U.S. Department of Health and Human Services, due to the expansion of research into new scientific disciplines, such as genomics; an increase in multisite studies; and technological advances. The following are some of the proposed changes, released in September 2015:
• Redefining “human subject” so that most research involving biospecimens would be subject to the Common Rule.
To date, there is no clear guidance regarding informed consent and storage of biospecimens. “This change is long overdue. There is ample evidence that people care about the future use of their biospecimens,” says Ruth Macklin, PhD, professor in the Department of Epidemiology and Population Health at Albert Einstein College of Medicine in Bronx, NY.
Researchers analyzed 109 comments submitted after the federal government published its Advance Notice of Proposed Rulemaking in 2011.1 This proposed mandated consent for use of all biospecimens regardless of how they were collected.
“Most of the comments were from researchers or IRB [Institutional Review Board] or other oversight members, who argued it would hinder important research in significant ways,” says Jean Cadigan, PhD, the study’s lead author. Cadigan is an assistant professor in the Department of Social Medicine at the University of North Carolina, Chapel Hill.
The researchers found little support for the proposal to mandate consent. “This is quite a departure from the current way researchers can get and use specimens,” notes Cadigan. If specimens are de-identified, their use is not considered human subjects research, and even if they are identifiable, an IRB can waive the requirement for consent for their use if certain criteria are met. “Most commenters felt strongly that there was no need to change the current process of de-identifying specimens and/or letting researchers use them without consent,” says Cadigan.
A small minority of the comments analyzed by the researchers came from the general public, and tended to support mandated consent. “So we have a potential disconnect between how those in the research establishment view use of biospecimens and how the general public views their use,” Cadigan says.
• Specifically excluding certain categories of activities from research within the scope of the Common Rule.
Hale says the implication of allowing such activities to proceed without further administrative or IRB review seems trivial, in that many are already carried out “in parallel” in non-research settings without additional regulatory scrutiny.
“Presumably, there is little additional ‘protection’ added by review of these activities,” says Hale. “It makes sense to focus efforts elsewhere, such as on review of more complex research activities and on researcher and participant education.”
However, Macklin sees this as a “serious flaw” in the proposed changes, which would exclude IRB review of some social science research, such as interviews, surveys, and focus group discussions.
“The assumption is that this type of research is minimal risk and therefore does not require IRB review,” Macklin explains. Numerous circumstances exist that can place human subjects of such research at more than minimal risk, however. “The risks of such research are not only those of revealing confidential results of the studies, as the proposed change assumes,” Macklin says. Some examples are questionnaires or in-depth interviews regarding intimate partner violence, and studies of sexual behavior, rape or sexual abuse.
“Just as many developing countries have begun to include ethical review of social science studies, the U.S. will be moving backwards,” says Macklin.
As a member of her institution’s IRB for the past 35 years, as well as a member of committees at the World Health Organization, Macklin has reviewed many social science studies that could place potential participants at greater than minimal risk.
“If it is left to social science researchers to determine the risk level of their proposed studies, there can be no oversight of this type of research,” says Macklin.
The proposed requirements would also exclude public health surveillance. “Arguably, public health surveillance is not research but is public health practice,” says Macklin. Governmental authorities collect such information as part of their responsibility to protect the health of the public.
“However, surveys and questionnaires conducted by social science researchers directly involve human participants in research that is not designed to benefit them individually,” says Macklin.
• Informed consent requirements would highlight the most important information and make consents shorter, to make it easier for a prospective subject to decide whether to participate in research.
“Success would be judged by having improved participants’ understanding of their choices before enrolling in research,” says Hale.
Currently, the complexity and length of consent forms make it unlikely that potential participants actually review and understand all the information. “If this is successfully accomplished, it might result in research participants actually reading the consent forms,” says Macklin.
This goal is “laudable as written,” says Susan L. Rose, PhD, executive director of the Office for the Protection of Research Subjects at University of Southern California, Los Angeles — but it’s difficult to assess how it would actually be implemented at this point.
“Many clinical trials routinely have consents in the 20-plus page category,” she notes. “This creates a useless consent.” Alternative, novel consents are one possibility, says Rose, “but the NPRM is silent on emerging technologies.”
The complete proposed revisions can be reviewed at https://federalregister.gov/a/2015-21756 and are open for public comment through Dec. 7, 2015.
- Cadigan RJ, Nelson DK, Henderson GE, et al., Public comments on proposed regulatory reforms that would impact biospecimen research: The good, the bad, and the puzzling. IRB: Ethics & Human Research 2015;37(5):1-10.
- Jean Cadigan, PhD, Assistant Professor in the Department of Social Medicine at the University of North Carolina, Chapel Hill. Phone: (919) 962-1140. Fax: (919) 966-7499. Email: [email protected]
- Ruth Macklin, PhD, Professor, Department of Epidemiology & Population Health, Albert Einstein College of Medicine, Bronx, NY. Phone: (718) 430-3574. Fax: (718) 430-3076. Email: [email protected].
- Susan L. Rose, PhD, Executive Director, Office for the Protection of Research Subjects, University of Southern California, Los Angeles. Phone: (213) 821-1154. Fax: (213) 740-9299. Email: [email protected].
- Karen Hale, RPh, MPH, Director, Office of Responsible Research Practices, The Ohio State University, Columbus. Phone: (614) 292-1840. Email: [email protected].
