Tuesday, January 27, 2009

The Ethics Of Genetic Research

This guest post was written by J.C. McElveen, of Jones Day. We thank him for the contribution:

In the late 1980s, members of the Havasupai tribe, an Indian tribe that lives at the bottom of the Grand Canyon, approached an Arizona State University anthropologist with whom the tribe had been working for several decades and asked if he could help shed some light on what the tribe members perceived to be an “epidemic” of diabetes within the tribe. Suspecting that genetics might be playing a role, the anthropologist got an ASU genetics professor involved, and, pursuant to several agreements and informed consents, the blood of over 200 tribal members was collected, in the early 1990s, to evaluate the genetics of diabetes among the Havasupai. Rather quickly, the researchers found that diabetes was occurring too frequently, and there was too little genetic variability among the tribe members, to conclude that the diabetes was related to genetics, and a paper to that effect was published in 1991.

However, the research did not stop there. From the early 1990s until the early 2000s, research using the blood continued, without the knowledge of the Havasupai. That research included research on schizophrenia and research on theories about population migrations from Asia to North America in ancient times, over the Bering Strait land bridge. The latter research conflicts with the Havasupai belief that, as a people, they originated in southwestern North America.

Once the Havasupai learned of this additional research, they banished ASU teachers and employees from the reservation and, ultimately, the tribe and certain tribal members sued the Regents of the University of Arizona. The most recent decision in this case, Havasupai Tribe of the Havasupai Reservation v. Arizona Board of Regents, 2008 WL 5047641 (Ariz. App. Div. 1) (Nov. 28, 2008), decides only issues having to do with whether certain procedural requirements were satisfied by the tribe and tribal members, before filing suit. However, the allegations in the suit raise very real issues regarding the extent to which genetic material can be used. Basically, the Havasupai claim that they provided blood samples only to ASU researchers, and only for the purpose of studying diabetes among tribal members. Instead, the tribe alleges, the blood was given to people outside ASU, was used for research having nothing to do with diabetes, and was even used (as the decision says) for “evolutionary genetics” research rather than “medical genetics” research. The tribe’s and tribal members’ causes of action included negligence, fraud, and breach of fiduciary duty, trespass and invasion of privacy. As to this last cause of action, the individual tribal members alleged invasion of personal privacy, and the tribe alleged invasion of cultural and religious privacy.

This case presents many interesting issues, one of which is: “Is this ‘injury’ compensable?” The court did address that issue, in the context of ruling on whether the tribe and the tribal members had made claims which “contain[ed] facts sufficient to permit [the defendant] to understanding the basis upon which liability is claimed and . . . [which set out] a specific amount for which the claim can be settled, and the facts supporting that amount,” as the Arizona statute permitting claims against public entities or public employees requires. A.R.S. 12-821.01(A) (The Arizona Notice of Claim Statute).

The court said that invasion of privacy by testing blood or urine samples beyond the consent given is a well-recognized cause of action (citing Norman-Bloodsaw v. Lawrence Berkeley Laboratory, 135 F.3d 1260 (9th Cir. 1998), and Doe v. High-Tech Institute, Inc., 972 P.2d 1060 (Colo. App. 1998). Similarly, “dignitary torts,” such as those alleged by the tribe, do not require proof of physical manifestations of injury (citing to Rumbauskas v. Cantor, 266 N.J. Super. 39, 629 A.2d. 1359 (N.J. App. 1993), rev’d on other grounds, 138 N.J. 173, 649 A.2d. 853 (N.J. 1994)), and Snakenberg v. The Hartford Casualty Insurance Co., Inc., 299 S.C. 164, 383 S.E.2d (S.C. App. 1989).

This case is far from over. The majority opinion drew a sharp dissent, and it will either be appealed to the Arizona Supreme Court, or go back to the Maricopa County, Arizona Superior Court for further proceedings (or, of course, it may be settled).

Is this type of case just an “informed consent” case: i.e., if the “informed consent” had been broader, there would be no viable claims? Or, does this case have broader implications?

In many way, this case is similar to Moore v. Regents of the University of California, 271 Cal. Rptr. 146, 793 P.2d. 479 (Cal. 1990). In that case, a patient’s leukemia cells were turned into a cell line and patented by his physicians without his knowledge or consent. The patient was allowed to sue for breach of fiduciary duty to disclose facts material to the patient’s consent, or performance of a medical procedure without first having obtained the patient’s consent.

At the very least, the Havasupai case expands this concept to a broader range of scientific research than just medicine. In all likelihood, as individual’s genes become more available, and more commercial opportunities arise as a result of discoveries about them (think about a gene in an individual, or in a group of people, that protects against a type of cancer), the law in this area is going to become much more complex.


Soronel Haetir said...

Okay, I can see serious ethical issues where a contract exists between the researcher and involved people. I have in fact crossed out clauses from medical care waiver forms and had my altrations accepted.

What I think would be a more interesting case, genetic material collected without knowledge or consent. Given that there is apparently nothing wrong with collecting things like tissue and other discarded items, what sorts of ethical issues would be raised by a university collecting the trash from the reception area and performing this same sort of analysis? (Other than an obvious problem of not being able to link a particular sample to particular person.) That problem might not even be a problem where your research is into group origin of a reasonably small community.

jc said...

That is an interesting issue, and I thought some about that. One of the problems would, of course, be that your sample would only consist of those whose DNA could be obtained by such collection methods, and the information obtained would be pretty random. I doubt any journal would publish results based on data so collected. If it were published, it would certainly be attacked.

MedInformaticsMD said...

Interesting post. An excerpt from my posts over the past few years regarding academia and genome studies (links are below):

Should academia alone be entrusted to collection and stewardship of indigenous populations’ genomic data and of the inventions discovered as a result of such possession?

Academics, especially those with tenure, are less accountable than even industry and governmental officials (as, for example, FDA’s and Merck’s trials and tribulations illustrate). Of all people, genome information is perhaps least safe in the hands of academics. A significant portion the public in the U.S., let alone indigenous people, is not entirely trusting of the potential for misuse of clinical and genetic data. At least in profit-driven industry those in possession of the data face the threat of litigation and financial ruin for misuse of such data.

Academia itself lacks a pristine reputation on handling of intellectual property matters. For example, several years ago bitter authorship disputes were found to be increasingly frequent by the Ombud of Harvard Medical School and felt to affect other academic institutions as well. Even worse, the Harvard Ombud wrote that “it is unreasonable for institutions to promise that they can protect individuals from retaliation for coming forward to complain through formal grievance procedures.” In my response in JAMA I indicated alarm at the latter opinion. If universities admittedly cannot protect their own, I ask, how can they possibly protect their research subjects’ interests when disputes arise?

... Does Ivy-League academia intrinsically respect the notion of individual or collective intellectual or genetic-information property? The Free software movement began in the "hacker" culture of U.S. computer science laboratories (Stanford, Berkeley, Carnegie Mellon) and is an academic concept designed to block corporations from capitalizing on the advantages of intellectual property ownership. This movement considers free software a matter of “liberty” as in "free speech".While trying to deny Bill Gates and Microsoft the benefits of intellectual property protection may not seem like a bad idea to some, and while free software such as the Linux operating system has enabled a lot of useful research, disrespect towards the property rights of indigenous populations via such widespread academic ideologies would be, quite frankly, a risk of a renewed Genome project under any name. It would be an atrocity if harm actually occurred.

... Has it ever been possible to hold academia accountable for anything in front of any authority? Some in academia make the most outlandish of statements or engage in questionable activities and rights abuses, often without significant loss of career or income.

Also see:

Informed consent, exploitation and "Developing a SNP panel for forensic identification of individuals" at:



New book: Analysis of the Commodification & Ownership of Life at:



Academic abuses in biomedicine vs. Indigenous Peoples: The Genographic Project at: