OHRP effort rubs some the wrong way
Social/behavioral researchers feel left out
The new public outreach campaign by the OHRP is a much-needed step in the right direction, say many clinical researchers. But the campaign’s centerpiece — an educational pamphlet designed to answer basic questions about research participation — is leaving nonclinical researchers feeling left out in the cold.
"There are statements in the brochure that would not apply to the research that we do here," says David Kreiner, PhD, professor of psychology and associate dean of the graduate school at Central Missouri State University in Warrensburg. "I wouldn’t want to distribute this here because I think it would be confusing to people who would volunteer for our studies."
The pamphlet is titled "Becoming a Research Volunteer: It’s Your Decision." Under the first heading, "What Is Research?" a bullet point states that "Scientists do research because they don’t know for sure what works best to help you." Other items refer to possible side effects and all of the benefits of research studies listed are medical treatments.
CMSU faculty often conducts social and behavioral studies, with students frequently serving as subjects, but there is no biomedical research on campus. Concerns about experimental treatments and side effects are not relevant.
"I think the OHRP intends this to be used in the context of clinical and biomedical research, that’s the way I am reading it," Kreiner says.
It’s unfortunate that the pamphlet is not applicable to his setting because basic education about research study design, ethics, informed consent and other tenets of human subjects research would be very welcome, he notes.
Students and others considering participation often have no prior knowledge of what research participation entails, he says. Individual researchers and study coordinators make efforts to educate subjects about the risks vs. benefits of their projects, but it would be helpful if people had some basic knowledge.
"There are issues to consider, even though the chance of someone experiencing any side effects or harm from participation in our research is very small or nonexistent," he says.
Federal officials have concentrated compliance and education efforts where they feel they are most urgently needed — in biomedical research — because of the increased risk of many clinical trials, he says.
As a result, most of the information they put out is targeted at centers conducting medical studies. The IRB at Central Missouri has to carefully read and tailor the compliance guidance to fit their setting, which is sometimes difficult.
The educational pamphlet seems to focus almost exclusively on issues faced by subjects participating in clinical trials, which themselves are just a subset of biomedical research, says Greg Koski, MD, senior scientist at the Institute for Health Policy at Harvard Medical School and the former director of the OHRP.
"There’s a wide variety of medical research studies that aren’t clinical trials that this pamphlet would not be useful for, either," he notes.
This unfortunately contributes to the perception that the agency is focused only on clinical trials oversight. In reality, the agency’s mission is to enforce the precepts contained in the Belmont Report on Ethical Principles and Guidelines for the Protection of Human Subjects of Research, which was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
If the commission saw fit to include biomedical and behavioral research together, then it is possible for OHRP to develop guidance that is applicable to a wide variety of research involving people, Koski says. "The overall guiding ethical principles are the same," he notes.
The new outreach effort is a long time coming, and is very much needed, but the agency needs to make more of an effort to broaden the scope to include research arenas other than clinical drug and device trials.
When he was head of the agency, Koski worked to form relationships with institutions focused on social and behavioral research as well as medical research in an attempt to include their perspective in the guidance and directives offered, he says.
Within the federal government, change often is slow. It took quite a while before OHRP was able to launch an outreach effort to potential research participants, something Koski wanted to do when he was there. Now that the initial effort has been made, the office needs to work on broadening its perspective.
"I don’t think it’s a case of needing separate materials for clinical research and social and behavioral research," he adds. "They were able to write the Belmont Report so that it covered all areas."
The pamphlet and other materials in the OHRP’s new public outreach campaign can be found on the Department of Health and Human Services web site at: www.hhs.gov/ohrp/outreach/.
The new public outreach campaign by the OHRP is a much-needed step in the right direction, say many clinical researchers. But the campaigns centerpiece an educational pamphlet designed to answer basic questions about research participation is leaving nonclinical researchers feeling left out in the cold.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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