Written by Dr. Erika E. Alexander, PhD
On August 27, 2014, the National Institute of Health (NIH) released an update to the current guidelines for scientists who receive NIH funding to study genomics. In the new policy, the NIH mandates that all funded data in genomics be posted online with the intent that the information be accessible to other researchers. Given the recent and heated debate about the ethics of sharing human biological and genetic material within the scientific community, it would appear that the NIH has chosen to bunk with the camp promoting rapid scientific discovery as being paramount over consent. However, you will also find that tucked very neatly within this update, are more specific guidelines for gaining informed consent of the participants who are contributing this genomic data.
As of January 25, 2015, all funding applications to the NIH proposing large-scale human and non-human projects must meet these requirements. Specifically, researchers are now required to tell study participants that their de-identified data (and thus genomic information) may be shared with the scientific community for future research, as well as with the general public. This requirement also applies to research using de-identified cell lines or clinical specimens.
This policy is groundbreaking because previously, researchers were simply required to discuss with potential participants the goals of the current work, and study subjects gave their consent to participate based on this discussion. Because of the vagueness of these requirements, there have also been many instances of human biological data being initially collected (with or without consent) for one study or clinical use, but being shared and used for a multitude of other unapproved applications. This lack of transparency has lead to widespread mistrust of both the medical and scientific professions, particularly by people of color.
One of the most famous examples of this is the case of Henrietta Lacks (1920-1951). Henrietta was an African-American woman whose cancer cells (denoted by HeLa cells) were used to generate a cell line that has served as the basis for a multitude of groundbreaking work in cancer research. However, Henrietta did not consent to, nor was she even informed of the possibility of the use of her biological material for scientific work before her death at age 31. Likewise, consent was not obtained from any of her family members before or after her death. In fact, for decades, the Lacks family were not even aware that Henrietta’s cells were used for research, despite its ubiquitous use in a variety of places, from molecular biology labs to medical school classrooms. The family of Henrietta Lacks made their vehement objections known to the public and to NIH in 2013, after two researchers sequenced her genome and published her genetic data in a 2012 paper, without the family’s consent. The Poston Collective has covered this story previously; for more information about Henrietta Lacks and the resolution of their case read here and here.
There have been other examples of the use of human biological material being solicited for specific research or clinical purposes, and actually being used for other undisclosed research. For example, in 2012, parents in both Minnesota and Texas sued the states because dried blood samples left over from newborn screening tests were used to create a DNA database, without parental consent. In the Texas case, the settlement required the destruction of 5 million dried blood samples, and in both Texas and Minnesota, resulted in more specific state-level laws requiring informed consent for blood samples retained for research. Read more about these cases here.
In 2010, Arizona State University settled a case brought by the Havasupai tribe of Arizona, paying out $700,000 to the tribe. The tribe alleged that blood samples originally collected for a study on diabetes were actually used in research on mental illness within the tribe and on population genetics. The Havasupai participants were not informed of this potential use of their genetic material and did not consent to their genetic information being published.
Naturally, these examples and others have inspired spirited debate within the scientific community regarding whether informed consent is really necessary with biological material, de-identified or not. Some argue that requiring informed consent is at best difficult to implement, and at worst unfeasible depending on the proposed work. They insist that it will slow down the pace of science, and may bar important research from being done.
I believe that in this day and age, with so many instances of past misconduct and exploitation of people of color, it is essential that the scientific community be seen as upholding certain values. These values include respect of human rights over scientific discovery. In my opinion, it may take a little extra work and time to gain consent from study participants, but it will go a long way to maintaining relationships and inspiring trust within the community. People choose to participate in scientific studies because of the reputation of scientists as honest, trustworthy and unbiased people. As such, it would be to the detriment of the scientific community to be thought of as being careless with biological material or genetic information, or even misleading subjects for their own benefit or agenda. This last point is probably why the NIH has been so proactive in resolving this dispute with the descendants of Henrietta Lacks.
The updated consent policy establishes the NIH as firmly on the side of informed consent and human right to choose what happens to their genetic and biological material, but still values sharing research findings with the rest of the scientific community. It allows the NIH to publicly recognize the humanity in human genetic and biological material. And in her own way, with the tireless advocacy of her descendants, the life of Henrietta Lacks played a role in not only advancing scientific research, but how science sees the subjects that it depends on: as human.
What do you think? Is informed consent really necessary for genetic material? What effects do you think the new NIH funding policy will have on science as a whole? Is this change enough?