The Havasupai Case and How to Make Consent Forms Better

In the 1990’s researchers at  Arizona State University began collecting DNA samples from members of the Havasupai tribe. Of the 650 members of the Havasupai tribe, located on the western floor of the Grand Canyon, roughly 100 members gave blood to the researchers between 1990-4. The researchers intended to look for gene variants associated with diabetes, a common and serious disease among the tribe’s members. Although to the Havasupai blood has a spiritual significance, participants consented to give blood to the researchers because they believed they “might get a cure” for diabetes.

In 2003, the Havasupai learned that the analysis of their blood samples had not been limited to diabetes research. The samples were also used to study schizophrenia, the tribe’s origin, and their degree of inbreeding. The Havasupai filed a lawsuit alleging that these additional studies exceeded their informed consent. On Tuesday, the ASU Board of Regents agreed to pay $700,000 to 41 members of the Havasupai tribe and return the blood samples.

Although the Havasupai believed their DNA would only be used to study diabetes, the written consent form they signed included a very broad statement about how the DNA samples would be used (to “study the causes of behavioral/medical disorders”). The language in the forms would permit the additional studies, but the written consent form is only one part of the consent process. It is evidence of what the parties agreed to but is not itself the final agreement.

In general, however, if researchers (especially those not privy to the oral portions of consent and surrounding circumstances) are unable to rely on the text of the consent form, then determining whether a DNA sample could be used in a specific study will be much more difficult. Is there a way to make the consent form stronger evidence of the participants’ agreement to be part of specific research? Is there a type of written consent that could be taken at face value?

One way to make the written consent form better evidence of the researcher/participant agreement is to give the participant choices about how their DNA will be used and with whom it will be shared. Allowing the participant to choose between options for how their data will be used (for example: any research, or only diabetes research, or no other research beyond this study) would indicate that the form more accurately reflects the participant’s wishes. And selecting between the options creates the structured opportunity for participants to ask questions and to give input into the consent process. According to preliminary research Amy McGuire presented at Stanford last month, participants prefer to be given choices about what will happen with their DNA. And when they are given options, they better understand what they have agreed to.

Giving participants options about what happens with their DNA is not legally required, but it is good policy for a few reasons. It should make the written consent form more compelling evidence that the person agreed to a particular use of her DNA. Giving people more control over what happens to their DNA is respectful to the participants. And participants who feel respected are more likely to trust researchers and to participate in genetic research, something the Havasupai are unlikely to do again anytime soon.

– Kelly Lowenberg