Clinical

What do you perceive to be an important ethical issue in clinical research today? Why is it an ethical issue?

The Most Important Ethical Issue?

Many issues in clinical research are debated as ethical issues. The National Institutes of Health (NIH) Clinical Center describes seven main principles as guiding the conduct of ethical research (Links to an external site.):

  1. Social and clinical value
  2. Scientific validity
  3. Fair subject selection
  4. Favorable risk-benefit ratio
  5. Independent review
  6. Informed consent
  7. Respect for potential and enrolled subjects

What do you perceive to be an important ethical issue in clinical research today? Why is it an ethical issue?

We can all agree that these criteria are all intricately interwoven, making it difficult to select the “most important” ethical issue. However, I would argue that fair subject selection is an issue that our healthcare system struggles due to the broader social issues rooted deep into our society.

Fair subject selection entails that the “primary basis for recruiting and enrolling groups and individuals should be the scientific goals of the study – not vulnerability, privilege, or other factors unrelated to the purposes of the study,” (NIH). I interpret this definition from the Ethical Guideline to say that subjects in a clinical trial must be viewed as equal human beings working towards scientific discovery and nothing else, regardless of their socioeconomic position and/or race. While on the surface level, this seems like a valid enough statement, the fact is that our society has failed to view all individuals as equals for a long period of time. Division lines every aspect of our communities and the products that result from clinical trials impact these groups in different ways. Failure to recruit an appropriate, diverse study group results in extrapolation of the trial results, threatening its validity and applicability in the fields. Thus, while in theory, disregarding the characteristics of each subject seems ethical, I believe that in practice, researchers must pay careful attention to the individuals’ socioeconomic/demographic/ethnic backgrounds.

Let us take a look at how the socioeconomic disparities in our society challenges researchers in recruiting a diverse population. Generally, participation in a clinical trial study is available to those who have access to healthcare. According to a study conducted by the Hadassah-Hebrew University Medical Center, “40 percent of those who have not graduated from high school are uninsured, compared with only 10 percent of college graduates; more than 60 percent of the uninsured are in low-income families”. Dr. Gross, who leaded the study, further noted that people who “lack insurance receive less medical care” (Gross). Our current healthcare system places immense burden on the low-income population, suggesting that there is less chance for these individuals to be exposed to clinical trial opportunities, making fair subject selection rather difficult.

Furthermore, ethnic groups, including but not limited to, African Americans, Hispanics and Native Americans, have long struggled with underrepresentation on the clinical field. In 1993, Congress passed the National Institutes of Health Revitalization Act, requiring agencies to include more women and POCs in their research study. While the percentage of women in clinical trials has grown significantly since then, participation by racial minorities has not shown the same growth. A study done in 2014 found that “fewer than 2 percent of more than 10,000 cancer clinical trials funded by the National Cancer Institute focused on a racial or ethnic minority. And even if the other trials fulfilled those goals, the 1993 law regulates only studies funded by the NIH, which represent a mere 6 percent of all clinical trials,” (Feng). This underrepresentation shines light upon concerns that while certain diseases particularly affect marginalized racial and ethnic groups, these very people are being underrepresented. For example, African Americans are more likely to suffer from respiratory ailments compared to white Americans. However, according to a 2015 study, only “1.9 percent of all studies of respiratory disease included minority subjects, and fewer than 5 percent of NIH-funded respiratory research included racial minorities.”

I did previously mention that it is important for researchers to be attentive of their subjects’ backgrounds. However, I also recognize that the problem doesn’t necessarily lie in a researcher’s unwillingness to diversify their studies, but the fact that members of various minority groups are reluctant to participate, often out of fear of discrimination by medical professionals. There is also the fact that, as previously mentioned, many ethnic, racial and/or socioeconomic minorities do not have access to care centers that recruit subjects for clinical trials.

Ultimately, these unresolved issues leave me to believe that fair subject selection is one of the most important issues we must give our attention to.

Sources

Editors, The. “Clinical Trials Have Far Too Little Racial and Ethnic Diversity.” Scientific American, Scientific American, 1 Sept. 2018, http://www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/.

“Ethics in Clinical Research.” NIH Clinical Center, U.S. Department of Health and Human Services, clinicalcenter.nih.gov/recruit/ethics.html.

Gross, D J, et al. “Out-of-Pocket Health Spending by Poor and near-Poor Elderly Medicare Beneficiaries.” Health Services Research, U.S. National Library of Medicine, Apr. 1999, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1088998/.

Pinnow, Ellen, et al. “Increasing Participation of Women in Early Phase Clinical Trials Approved by the FDA.” Women’s Health Issues, Elsevier, 9 Mar. 2009, http://www.sciencedirect.com/science/article/abs/pii/S1049386708001412?via=ihub.

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