Lawsuit challenges use of blood samples
Indian tribe claims other studies done
The Havasupai Indian tribe of northwestern Arizona, and some of its individual members, have filed two federal lawsuits seeking a total of $75 million in damages against Arizona State University (ASU), the Arizona Board of Regents, and three university researchers, claiming that blood samples taken from tribe members as part of a diabetes study were destroyed, lost, or used in studies of schizophrenia, inbreeding, and population migration without the donors’ consent.
The tribe alleges that nearly 400 blood samples were collected from more than 180 donors between the years 1990 and 1994 as part of a larger study of the incidence of diabetes among its members.
According to the lawsuit, the tribe was told the study consisted of three parts: diabetes education, collecting blood samples from members for research, and genetic testing to identify which genes in the Havasupai caused diabetes.
However, researchers later used their access to Havasupai medical records, in addition to the blood samples, to initiate studies of schizophrenia and inbreeding. They also transferred some of the samples to researchers at other institutions across the country, some of whom used the samples in research into theories of population migration.
"The material went from university to university, lab to lab,’" the tribe’s attorney, Robert Rosette, JD, of the Sacramento, CA, law firm Monteau & Peebles told The Arizona Republic in March. "There were 23 different academic papers written."
The lawsuit also alleges that researchers misled the tribe about their intent to use the information in studies not related to the diabetes project.
They have evidence that there was never intent to strictly do diabetes research, Rosette said. For example, the tribal lawsuit contends that researchers collected handprints from some members in 1992, claiming that they would be used in diabetes research when they were actually used in a project to study inbreeding.
The additional use of the samples came to light, the attorney claims, when a tribal member read some of the published studies and realized it was her tribe they were talking about.
University officials have disputed that account, claiming that another researcher discovered the mishandling of the blood samples and reported it to university officials who initiated an investigation.
Lawsuit alleges IRB failures
The lawsuit also alleges that ASU’s institutional review board failed to stop the mishandling and transfer of the samples to other laboratories and research institutions. Information about tribal members was eventually published in 23 separate papers in 15 publications, Rosette said.
The tribe finds the studies of theories of population migration particularly offensive because their religion and culture is based on the belief that they originate from the Red Butte area of the Grand Canyon.
Without knowing the facts of the case, the allegations themselves raise interesting questions for IRBs examining protocols involving studies of whole populations, says Dale Hammerschmidt, MD, and associate professor of medicine at the University of Minnesota School of Medicine and director of Education in Research Ethics and Compliance at the school.
Discussions about protection of human subjects, and the federal regulations governing human research protections, have focused on the potential benefits and harms to the individual, and have been more cautions in their consideration of whole populations as units, he says.
"From a regulatory perspective, samples obtained for one purpose may be used for another purpose. If they are completely anonymized, the original sources won’t even meet the federal regulatory definition of human subjects," Hammerschmidt tells IRB Advisor. "If they are not completely anonymized, but the code is quite secure, an IRB could, under certain defined circumstances, waive the consent requirement."
In order for the IRB to consider a waiver of informed consent for additional research using the samples, the investigators should have to demonstrate that either the donated samples were anonymized (any identifying linkages to the donor were permanently removed), or, if the samples were not anonymized, that identifying information was protected by a secure code.
The IRB might then review another study protocol and stipulate under what circumstances a waiver of consent could be applied.
Federal regulations stipulate that investigators can seek a waiver of some or all of the informed consent requirements for the following reasons:
- The research or demonstration project is to be conducted by, or subject to the approval of, state or local government officials, and is designed to study, evaluate, or otherwise examine: i) public benefit or service programs; ii) procedures for obtaining benefits or services under those programs; iii) possible changes in or alternatives to those programs or procedures; or iv) possible changes in methods or levels of payment for benefits or services under those programs; and the research could not practicably be carried out without the waiver or alteration.
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- The research could not practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation.
"My question then would be whether the criteria for such a waiver were appropriately documented and applied," he says.
However, even if all of the regulatory requirements are met, it still can be argued that use of the samples for research that the Havasupai would find culturally problematic, and which still identified them as a group, constituted an inappropriate breach of their right to informed consent, he adds.
"Was there, in fact, an understanding that the samples would not be used for something else?" he wonders. "Was information sought or generated that could itself be problematic? For example, did they discover health risks or problems for which there would normally be an intervention?"
Even if the individual members could not be identified in the data or in publications, the group might be identified in a way that created breach of confidentiality or other informational risks, Hammerschmidt says. "In other words, is this a case where proper adherence to the regs was an insufficient protection?"