The Kojo Nnamdi Show

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The panelists answer a caller's question about what might have happened to a mandatory DNA sample he had to give when he was incarcerated some years ago:

What Do You Think

• Have you participated in a medical trial or research study? Did you feel that you were adequately consulted and that your privacy rights were respected?
• Have you presented a research proposal to an Institutional Review Board?
• Should historians and anthropologists be subjected to the same review process as biomedical researchers?

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What Does "Ethical" Research Look Like in the 21st Century?

Today, most human research in the United States is subject to the Common Rule. Established in the 1970s, after revelations about the Tuskegee Syphilis study, the Common Rule requires institutions receiving federal-funding to establish policies that ensure ethical research protocols and protect human participants.

Revising the Common Rule: New Rules for a Changing Landscape
This year, the Office for Human Research Protections at the Department of Health and Human Services proposed major changes to the Common Rule. In July, proposed changes are aimed at reducing red tape and strengthening protections for participants. But experts in a variety of academic disciplines are worried the new rules will adversely affect their work.

Researchers complain that the current framework are inadequate for today’s technological and ethical landscape. In the two decades since The rules were last revised, major advances in DNA applications and digital record keeping have transformed biomedical research. But they have also raised thorny questions about privacy and consent.

From no consent to Informed Consent to “Re-Consent”
Henrietta Lacks died of cervical cancer in 1951. But the HeLa cell line—derived from cancer cells taken without her consent--- would serve as an important research tool in subsequent decades. By today's standards, those research practices raise serious ethical red flags.

Under the current system, researchers must acquire "informed consent" from trial participants, explaining the risks and benefits of participation and exactly how their blood, tissue and other data will be used. But what happens to all of that data after a study is completed? Researchers can often use old samples in new research without permission, if the identity of the donor cannot be determined. But controversies have emerged about whether “informed consent” should extend to these studies (re-consent).

Starting in 1990, members of the Havasupai Indian tribe participated in an Arizona State University study examining the genes associated with Type 2 diabetes. However, they later learned that researchers were using their blood samples for other studies. Their samples were used in a study exploring genetics and schizophrenia—a taboo subject within the tribe. Researchers also used the DNA to trace the tribe's geographic origins to Asia, contradicting traditional Havasupai origin stories. The case was settled in 2010.

Patients and Participants Want More Control
While no consensus currently exists around the consent / re-consent issue, patients and participants clearly favor more control over their data. A study in Journal of Empirical Research on Human Research Ethics found that the vast majority of donors want researchers to ask permission to use their data in other contexts: 90% of donors thought it was important that they were asked for permission before their data was shared. But a large majority of donors (86%) still opted to give consent for their data to be released.

Too Much or Too Little Consent?
Proposed changes to the Common Rule would strengthen informed consent protections involving "secondary use" of data and biospecimens. But researchers are divided about whether the rules impose too much or too little protection for participants. Some researchers and clinical trial administrators worry that the rule change could place unfair financial and logistical burdens on scientists. Dr. William E. Grizzle, a professor of pathology at the University of Alabama at Birmingham, told Clinical Trial Admnistrator:

• They're asking us to consent 30,000 to 50,00 patients a year... We estimate it would take three or four fulltime individuals who would do noth ng but informed consent, costing us up to $300,000 more to be able to continue the doing the research at the level we're currently operating" ("Common Rule tissue changes elicit objections" November 1, 2011-- paywall ).

Another researcher predicted that the medication pipeline would grind to halt without access to thousands of tissue samples.

On the other side, Krishanu Saha & J. Benjamin Hurlbut argue protections are too weak in the new proposed rules:

• The changes encourage blanket consent— asking donors to authorize virtually everything... telling donors next to nothing about how and for what purpose their donation will be used. Although this may reduce administrative complexity, we believe it will decrease, not increase public involvement in biobanks and fail to deliver on its ethical aim of better protecting participants’ rights.

Should Historians be Subject to the Same Rules as Pathologists?

The Common Rule framework was designed with drug trials and medical research in mind. But anthropologists, oral historians and other social scientists often have to submit their research proposals to Institutional Review Boards for approval. Many researchers complain the process has become a major obstacle to academic inquiry.

Social science organizations have raised concerns that the proposed rules could make things worse. They say important academic work-- like recent revelations that American research scientists deliberately infected research subjects in Guatemala with Syphilis in the 1940s-- would not come to light under new data collection and consent rules. The Guatemala abuses were uncovered when a historian accidentally came across notes in an archive.