Community Research, Ethics, and the Impact of the Havasupai Case

The 2020 Advancing Ethical Research Conference (AER20) keynote address from Wylie Burke, MD, PhD, “Learning from Communities about Diversity and Justice”, discussed the implications of the lack of diversity in research. This is a real problem in genetic research: how can a full range of genetic variants be studied if a non-diverse population is assessed?

On the other hand, research on specific communities is also important. Community-based studies helped identify the sickle cell trait among African Americans and BRCA1 gene prevalence in the Ashkenazi Jewish population. Unfortunately, abuses in research, typically perpetrated on minority populations, have resulted in distrust of researchers and the research process by potential research participants.

Take, for instance, the breakdown in communications that occurred between the Havasupai Nation in Arizona and researchers at Arizona State University (ASU). Members of the Havasupai Nation, who had donated blood for genetic studies on type 2 diabetes, found out later that their samples had also been used in several other genetic studies concerning schizophrenia, alcoholism, and population inbreeding—all of which are taboo topics in the Havasupai culture. While these samples had been “de-identified” (whether something can be truly de-identified is a topic for another blog), the community from which the samples originated was known. As Dr. Burke stated in his talk, de-identification does not remove a group label.

The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research published the Belmont Report in 1979 to identify the minimum ethical principles required for human subject research. The three basic principles for research involving human subjects are respect for persons, beneficence, and justice.

Respect for persons mandates individuals receive adequate information so an informed consent might be given freely. Participants should enter into research voluntarily and with adequate information. Informed consent is fulfilled when a competent person agrees to take part in a study after having expressed a clear grasp of all relevant facts related to the activity in question. Not only can failure to adhere to informed consent protocols be harmful to a community, it can permanently harm the credibility of a researcher, an institution, and research as a whole.

Justice ensures the fair distribution of the benefits and burdens of research. Here, tribal oversight was meant to ensure the potential for benefit from the research, but neither oversight nor true informed consent can occur for research that is unknown to the participants. 

In community research, when obtaining consent, a researcher must make sure the community is fully informed about the extent of the research. IRBs must ensure that the basic tenets of human subjects research are not violated when overseeing community research. But how can we accomplish this?

We must ensure consent is obtained and respected. In addition to confirming the requirements for informed and broad consent are found in the consent document, the documents must be understandable. A “general description of the types of research that may be conducted with identifiable private information or identifiable biospecimens” must be added to broad consent documents. Notice the regulations specify a “general description” of the types of research that may be conducted is required. How can a reviewer assess this and ensure the supplied description is not too vague?

In community research, a discussion with community leaders would be appropriate. In the Havasupai case, members signed a broad consent document to “study the causes of behavioral/medical disorders.” All of the tribe members believed that they were donating blood solely for the purpose of looking for a link to diabetes to improve the health in their community. After ASU investigators determined that the genetic link to diabetes seen in the other tribe did not exist among the Havasupai, they continued their research into medical disorders without seeking further consent from the tribe. Should the IRB have requested a description that was narrower than “behavioral/medical disorders”, or would “endocrine disorders” have been more appropriate?

We must ensure ongoing communication between the IRB and researchers. We must also inform them about the regulations applicable to their study. After a study has been approved, how can an IRB follow the secondary use of these data and specimens? In addition to narrowing the focus of the proposed potential future research uses listed in the consent form, performing study audits might be appropriate. Additionally, study approval letters could reiterate what types of studies are permissible under the approved consent and mention the requirement of further IRB review of additional studies and the potential need for re-consenting.

We must also ensure appropriate communication between researchers and subjects or the community. Not only must researchers confirm information in a consent has been properly conveyed, investigators wanting to perform further studies using the original samples must return to the community to obtain new informed consent for the additional research. It is vital that a researcher recognize and respect the values and beliefs of the community under study.

Gretchen ParkerGretchen Parker, PhD, RAC, CIP, serves as co-chair for Pearl IRB and provides regulatory and clinical research support services for clients. Throughout her career, she has been deeply involved in regulatory affairs, clinical research, and medical writing for the pharmaceutical and medical device industries. She led the AAHRPP accreditation efforts at Pearl IRB and has assisted FDA inspectors on-site. She also led the efforts to update Pearl IRB institutional policies and procedures to comply with the revised Common Rule.

Dr. Parker began her career as a Regulatory and Compliance Analyst at a consulting firm, where she worked with clients, ranging from biotech start-ups to Fortune 500 companies, to plan and implement regulatory strategies, submissions, and research protocols. Her duties engaged her with several US governmental agencies, including FDA, USDA, and EPA.

Dr. Parker received a PhD in Molecular Endocrinology and Biochemistry from Purdue University, and completed her Post-Doctoral Fellowship in Biochemistry and Molecular Biology at the Indiana University School of Medicine Center for Diabetes Research. She has authored and published dozens of scientific articles in major peer-reviewed journals, holds a patent for a diagnostic assay, and is a member of PRIM&R and AAHRPP. She is Regulatory Affairs Certified (RAC) and a Certified IRB Professional (CIP).

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

PRIM&R’s next AER Conference takes place virtually—in conjunction with our Social, Behavioral, and Educational Research Conference—November 16–19, 2021. Browse the Advancing Justice and Equity track to find sessions on indigenous-centered approaches to the new Common Rule, leveraging community to strengthen research, and more. Learn more and register online!