As genomics and personalized medicine advance, there is increased awareness that “race” is an inappropriate proxy for groups that may share a genetic background. However, proposals that assume that self-reported race correlates with biological/genetic difference are still being submitted and approved at institutions across the country—even as genetic evidence reveals that the difference between races is smaller than differences among individuals of any particular race. Such studies risk perpetuating racist stereotypes, inappropriately influencing clinical medicine, and reinforcing inaccurate ideas about biology and race. It’s important that research oversight professionals understand how to approach the continued wave of race-based research.

On February 21, PRIM&R hosted a webinar to provide guidance for IRBs in this area. The speaker panel consisted of Michael Henderson, JD, LLM, MS; Kathleen Reeves, MD; and Nicolle Strand, JD, MBioethics, all of Temple University.

After the webinar, presenters responded to some of the attendee questions that time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand.

Should IRBs focus only on participant safety or are there other considerations built into the process?

As we mentioned during the webinar, IRBs should have a fair amount of latitude to consider ethical issues, especially ones that were not conceived of at the time the regulations were written. As we know, participant safety is not the only thing IRB professionals can and should consider. Risks can be much broader than simply biomedical—for example, we are perfectly justified concerning ourselves with psychological and social risks as well. Although in the case of race-based medicine, the “risks” may not flow directly to the participants, the greater potential harm is clinical and societal, in the long term. Race-based research risks infecting clinical medicine and further entrenching the myth that race is biological. That is enough of a harm to be relevant to IRBs and ethicists.

Isn’t it true that people of certain races do suffer from some diseases disproportionately? Such as sickle cell?

Individuals most commonly afflicted by sickle cell disease are those with ancestry from regions of the world where malaria was endemic. There is a very loose correlation with skin color, but it is far from exact. People who descend from India, certain areas in the Middle East, and certain areas in southern Europe, as well as people who descend from parts of Africa, meet this criteria and thus are potential carriers of the sickle cell gene. Talking about populations who are at risk for certain genetic diseases with more precision is incredibly important. Instead of saying “black people” or “African Americans” suffer from a disease disproportionately, we should describe the relevant ancestry that leads to a predisposition. This, again, is both more precise and less potentially harmful because it reminds us that ancestry may have genetic components, but social categories of race do not. We also want to guard against the inference that phenotypic appearance and believed ethnic ancestry should never be the basis for making scientific and clinical decisions that should be based on the confirmation of genetic characteristics.

As we stated in the presentation, there will be those that ask: “what is the harm in making such assumptions and inferences?” We contend, and studies bear out, that the harms of race-based medicine are legion and can range from mischaracterization of disease, misinformation regarding human physiology, and bad science; to clinical biases in treatment, over/under-prescribing of appropriate drugs, and persistent health disparities.

If a study was going to do ancestry testing, would you recommend that the study return those results to subjects and if yes, would you recommend genetic counseling?

This is a complicated question slightly outside the scope of our webinar, but I want to give a short answer. First, it is incredibly important that the informed consent process make very clear when ancestry testing is a part of the research and make clear whether results will be returned. And second, in some cases, not just individual but community consent may also be required. The classic example of a study that would have greatly benefited from community consent is the Arizona genetic research on the Native American Havasupai tribe. The failure to obtain community consent in that case resulted in real community harm when the Havasupai learned that their ancestry did not match their own cultural and historical understanding. I don’t think that returning ancestry results is necessary in every study, ethically, but instead that each researcher must consider the context and benefits of returning those results thoughtfully before the research begins and then be sure the participants are informed of the plan beforehand. Genetic counseling is not generally necessary for ancestry results.

Would it be appropriate to target an African-American community, or Chinese-American community—social, racial, or ethnic communities—to recruit for studies that are interested in studying the genetic variation of, say, populations with recent African or East Asian ancestry?

Sure. There is nothing inherently inappropriate about this. But I would urge the researcher to consider his or her goals in this research and the long term objectives. Is the objective to use proxies for genetics in the future, by better correlating genetics with social racial categories? If so, that may not be a worthwhile endeavor and may be ultimately harmful in furthering a biological basis for race. Clinical medicine already suffers from the overuse of poor proxies when one variable is easier to collect than another. Doing this kind of research to show that, for example, people from the Asian subcontinent are more likely to have a certain genetic mutation, so that, in the future, clinicians can use a shortcut and simply assume that mutation is present in patients who appear Asian, is not necessarily adding social or clinical value to the world, which is something we should always strive for in our research.

I am a compliance monitor and I look at “sound design.” I have also been a researcher and believe design must be considered. In my training, I was told that we are not supposed to comment on design. The assumption is that it is like academic freedom. How do you respond to that?

In general, IRBs are tasked with some specific charges when they examine protocols, such as determining whether risk outweighs potential benefit. But, as we all know, IRBs also serve as an ethical check on research, including for ethical considerations that are not directly addressed in the Common Rule. Many highly cited articles about research ethics assert that part of the criteria for ethical research is that it must have the potential to add value to our society, and that it must be properly designed such that it could yield statistically significant and sound results. If these elements are absent from a protocol, it is absolutely within the IRB’s purview to determine that the research does not meet relevant ethical standards. It is not quite the same as academic freedom. Academic freedom says that researchers can study whatever topic they like, and must not be constrained by university administrators or IRBs in this arena. For example, an IRB cannot refuse to approve a study because its members do not agree with the political implications of the study. But, study design is inherently apolitical. If a study cannot possibly add value to our society, in part because it employs inappropriate design that will lead one to draw conclusions that are unfounded, then it is simply not good science, and bad science is itself unethical. There is also the ethical consideration for the IRB for making sure that a study is methodologically sound so as to not waste the subject’s time and resources on studies that ultimately need to be repeated.

PRIM&R thanks Mr. Henderson, Dr. Reeves, and Ms. Strand for sharing their expertise.

The recording of this webinar is available for individuals to purchase in PRIM&R’s online store. If you would like to purchase the webinar for group viewing, please download the order form (PDF) and send it to registration@primr.org.