Women's Network—Diverse Populations in Clinical Trials: Past, Present, and Future

• May 01, 2024

• Heather Butts , Columbia University Mailman School of Public Health
• Rebecca Dahl , Stony Brook University
• Andria Adigwe , Buchanan Ingersoll Rooney PC

The American Health Law Association’s Women’s Leadership Council (WLC) has recently hosted panel discussions addressing disparities in health care. During the WLC’s February event, Dr. Heather Butts and Dr. Rebecca Dahl discussed some of the causes behind the lack of diverse populations in clinical trials and addressed how failure to obtain informed consent from participants in the Tuskegee¹ and the Havasupai Studies led to hesitancy in clinical trial participation. This hesitancy can skew population demographics, including underrepresentation of women, resulting in the production of ineffective or even harmful drugs or devices for certain populations. As we saw during the COVID pandemic where there was a significant lack of vaccine trial participants from underrepresented communities, the medical world has a long way to go.

The history of research ethics and clinical care are intertwined, with much of the early work around clinical trials and ethics being linked to individual decision making on the part of the health care provider. The Hippocratic oath, “first do no harm,” was a guiding light for health care professionals in an era of little formalization of rules or regulations.

In 1932, the syphilis study at Tuskegee enrolled several hundred African American male sharecroppers without proper informed consent. For 40 years, researchers observed the impact of untreated syphilis on the body. Several research studies have been done on the legacy of Tuskegee, and researchers have noted that “Blacks were 1.8 times as likely as Whites to have a higher fear of participation in biomedical research.”² This study and several others led to the ethical and regulatory framework that we have today, which includes diversity for clinical trial participants.

The National Institutes of Health (NIH) states that “clinical trials did not always recruit participants who represented the individuals most affected by a particular disease, condition, or behavior. Often, these clinical trials relied almost exclusively on White male study participants.”³ NIH posits that this lack of diversity in studies created “gaps” in the way we perceive and understand illnesses, which has an impact on the way various populations receive care, medication, and health care advice.

In 2003, Havasupai tribal members discovered that their DNA samples collected over four years for genetic studies on Type II diabetes had been used for studies on schizophrenia, migration, and inbreeding without their consent. Tribal members were informed during the consenting process that their samples would only be used for genetic studies on diabetes. Following collection, the blood samples were stored and subsequently used for studies on schizophrenia although no additional consent was obtained.⁴ Samples were also used for studies on migration and population inbreeding both of which are taboo topics among the Havasupai culture^.

The resulting lawsuit brought by the Havasupai reached a settlement in which tribal members received monetary compensation but more significantly for the tribe, the return of DNA samples. According to Dr. Frank Dukepoo, who grew up on First Mesa in Arizona:⁵

My people wonder, what is really going on here. To us, any part of ourselves is sacred. Scientists say it’s just DNA. For an Indian, it is not just DNA, it is part of a person, it is sacred, with deep religious significance. It is part of the essence of a person.

Tribes have been taken advantage of and exploited in research. Decisions about research involving indigenous people have been made without their input or agreement.⁶ Studies have tried to enroll indigenous people outside of tribal lands to avoid tribal rules and requirements. However, it is important to work with tribal governments and tribal Institutional Review Boards (IRB). Debra Harry, a Northern Paiute said:⁷

The genome diversity project asks such questions as who are we and where do we come from? That’s not a priority question for us. What benefit can this possibly do us?

Obtaining tribal permission is easier said than done. There exists an inherent distrust in research conducted by non-tribe members.⁸ Having the tribal IRB review the study can take months. However, if there is not an agreement to the study by these IRB members, the study does not move forward.

Studies may partner with tribal members to find issues relevant to the tribe and work toward the goal of conducting research in those areas and/or make the outcome of the research a permanent part of the culture. If the focus of the research is on diabetes education, include a permanent clinic on the tribal land that continues beyond the conduct of the study.

Many people are unaware of clinical trials for which they are qualified and how they can get involved. It is customary for patients to be made aware of those trials by their doctors, but some patients may not have a doctor, and doctors are often unaware of relevant clinical trials. Moreover, promotion of clinical trials does not always make it to neighborhoods or communal areas that would result in a more representative sample of the United States. The health care community needs to be more intentional about its outreach efforts and think outside the box.

Heather Butts, is an Associate Professor in the Department of Health Policy and Management at Columbia University Mailman School of Public Health.

Rebecca Dahl, Assistant Vice President for Research Compliance at Stony Brook University.

Andria Adigwe, regulatory health law and data privacy attorney at Buchanan Ingersoll Rooney, PC, and a member of AHLA’s Women’s Leadership Council.

ARTICLE TAGS

• Women's Leadership
• Diversity, Equity, and Inclusion in Health Care Hub