"Difficult trade-off" with research regs

More low-risk research may occur

The goal of proposed reforms in regulations governing human research subjects is to enhance protections for research subjects while reducing burden, delay, and ambiguity for investigators, according to the National Institutes of Health (NIH) Office of Science Policy, which received more than 1,000 public comments on the proposed changes.

The NIH is dealing with a "difficult trade-off" between giving research participants the right kind of information and control over their participation and not bogging down research with excessive oversight and consent procedures, according to Megan Allyse, PhD, a postdoctoral fellow at the Center for the Integration of Research on Genetics and Ethics/Center for Biomedical Ethics at Stanford (CA) University.

In a 2012 paper, researchers argue that relying on the Health Information Portability and Accountability Act to protect participants from participation-related risks in noninvasive research is insufficient to protect the autonomy and psychological health of potential research participants.1

"The current proposed changes were an attempt to see if there were any areas in which oversight requirements could be lowered without sacrificing the autonomy of participants," says Allyse, the paper's lead author.

One suggestion in the proposed regulations was that social science research methodologies — in particular, surveys and interviews — should be exempted from prospective review as long as the informational risks associated with protected health information (PHI) were contained, she notes.

"We found this proposal problematic because it suggests that PHI is the only thing at stake in behavioral research," she says. "On the contrary, there are a variety of potential psychosocial consequences to participating in behavioral research that involves the use of deception or discussion of psychologically disruptive topics."

These include the realization of adverse health risk or status, the experience of significant trauma, severe social stigmatization, persecution, or discrimination.

"We suggest, rather than forcing researchers to relearn the requirements for minimal risk research, some baseline institutional review should be conducted to ensure the actual level of risk at stake in such studies," she says.

Overprotection is concern

Edward Goldman, JD, associate professor in the OB/GYN Program in Sexual Rights and Reproductive Justice at University of Michigan Health System in Ann Arbor, says, however, that as long as privacy is protected, the proposed change would allow more low-risk research to occur without any real risk to the subject population.

"The existing and proposed regulations are designed to protect human subjects from improper research. They are not designed to advance research," says Goldman.

While it is, of course, ethical to protect subjects from harm, overprotection has the potential of causing injury because it could deny some access to research that could improve medical knowledge and treatment, he argues.

"Expanding the regulations to all research should increase safety. But we need to be sure we are not unnecessarily stopping useful research," he says. (See related story on patient consent and data sets, below.)


  1. Allyse M, Karkazis K, Soo-Jin Lee S, et al. Informational risk, institutional review, and autonomy in the proposed changes to the common rule. IRB: Ethics & Human Research 2012;34:17-19.


Megan Allyse, PhD, Postdoctoral Fellow, Center for the Integration of Research on Genetics and Ethics/Center for Biomedical Ethics, Stanford (CA) University. Phone: (650) 725-4027. E-mail: megand@stanford.edu.

Edward Goldman, JD, Associate Professor, OB/GYN Program in Sexual Rights and Reproductive Justice, University of Michigan Health System, Ann Arbor. Phone: (734) 764-2179. E-mail: egoldman@umich.edu.

Access to data sets is ethical concern

There are potential ethical concerns in asking donors of blood, DNA, or tissue samples to give consent before those samples could be used in subsequent research, argues Edward Goldman, JD, associate professor in the ObGyn Program in Sexual Rights and Reproductive Justice at University of Michigan Health System in Ann Arbor.

"We generally believe that consent is critical to make sure a potential subject wants to participate and to show the public that we are not using their data without their knowledge or permission," he says.

The problem is that as large data sets are accumulated from newborn screening, cancer databanks, and trauma databanks, and the necessary steps are taken to protect privacy, the databanks are less useful if individual permission is always required, says Goldman.

"This is a delicate balancing act. We never want the public to believe we are using clinical data for research without permission. But as these databanks grow, permission is less and less possible," he says. "The revised regulations seek to expand protection, but do not consider the value of community."

Every academic medical center has large repositories of clinical data that could be used for epidemiological research with proper privacy protection, he explains.

One possible solution is the government's recognizing the value of this data and allowing its use with a general consent from all patients with the opportunity for an opt-out, says Goldman.

"Individual consent may not be possible, due to the large size of the repositories," he acknowledges. "But it is exactly the large size that makes the repository useful for certain types of research."

Genetic samples

There are ethical concerns with the proposed suggestion that participants should be asked to give blanket consent to all future uses of their genetic samples once they are contributed to a biobank, unless the study intends to return results to participants, says Megan Allyse, PhD, a postdoctoral fellow at the Center for the Integration of Research on Genetics and Ethics/Center for Biomedical Ethics at Stanford (CA) University.

"As past litigation has demonstrated, participants are often uncomfortable with certain uses of genetic samples — especially if they were not explicitly aware of those uses when they consented," says Allyse.

Allyse argues that since consent is a major stumbling block in many genetic studies, this provision would create a positive incentive to design studies that do not return results.

"Given that most of the ethical analysis that has been done on the subject supports the return of genetic results where feasible, and almost always if the results have direct health implications, this incentive is problematic," she says.