Genomic Research, Informed Consent and Understanding Culture

The issue of what is required to obtain consent that is informed consent —consent that is obtained because the person or group providing consent truly understands what is encompassed by the consent—is at the heart of the issues that were raised in the lawsuit by the Havasupai peoples regarding blood they donated for research [More information on the background of the case, the legal case and its settlement can be found here].

This is as much, if not more, an issue for the medical research committee as it is for lawyers. A 2010 article by Jacobs, et al in the Journal of Law, Medicine and Ethics (article available at this link) comments that if researchers involved with the Havasupai had “practiced the processes of consultation, consent and collaboration here outlined [within the article], the dispute may never have started.” The point being, legal issues are unlikely to arise if meaningfully informed consent is obtained. The article by Jacobs et al points to the need for several steps to be taken to ensure that meaningfully informed consent is obtained, including an important step of consultation with the specific indigenous community from which researchers are interested in obtaining consent and doing genomic research.

An article by Roderick McInnes (available at this link) that was his 2010 Presidential Address to the American Society of Human Genetics underscores that understanding culture is a two-way exchange in the process of obtaining informed consent. It is not only important for the indigenous community and individuals to understand fully what research would be undertaken should they give consent. It is important as well for the researchers to understand the culture of the indigenous community itself. McInnes comments in his article “that the culture, priorities, values and jurisdiction of the indigenous community must be respected and that, in successful studies, it is.”

Two further points should be taken from this:

• Firstly, the important task of understanding culture should not be ignored in genomic research and is a vital part in obtaining meaningfully informed consent. Nor is understanding culture a need limited to medical research. It is very much a required ingredient in legal education. Understanding culture is not restricted either to an indigenous sphere—it is potentially an issue anywhere that there are legally pluralistic jurisdictions. The place of culture in legal education will be the topic of a future blog post. An article by Professor Aliza Organick ( available at this link) provides important insight into the necessity and challenges of the inclusion of the idea of culture into legal education.
• Secondly, indigenous groups themselves have established research boards whose standards scientists must meet as part of the requirements to obtain informed consent. One example is the Navajo Nation Human Research Code (available here).

Self-determination and autonomy means that many indigenous groups have their own laws, and certainly this can extend into requirements for human subjects research. Yet so often, legal education neglects to provide this understanding of indigenous groups and communities, as addressed in this article by Professor Tonya Kowalski, http://washburnlaw.edu/faculty/kowalski-tonya-fulltext/2009-36floridastateuniversity765.pdf.

These points will be further discussed in future posts on this blog.

Written by Sarah Sargent.

Do Genes Matter?

Sarah’s last blog (here) on bioethics, medical research and indigenous peoples raises a number of interesting points. As a relatively new blogger it allows me to discuss an area I am familiar with. My research concerns the restitution of ancient indigenous human remains, ancient indigenous DNA and property rights. What you may ask has this got to do with medical research and bioethics.

The collecting of indigenous human remains in the past has been compared with the new interest in the genes of indigenous peoples. Indigenous peoples are particularly vulnerable to bio-prospecting and in turn bio-piracy. In many cases although not in all, indigenous peoples have remained geographically and socially isolated and therefore are particularly interesting for scientists interested in genetic information. There are a number of examples and Sarah mentions the Havasupai Tribe case where genetic material or blood samples in the case of the Havasupai Tribe were used in a way that was ‘culturally inappropriate’ in the indigenous sense but may have been ‘culturally appropriate’ for the researchers. Sometimes consent has been given but the implications of that consent have not been fully explained to the indigenous group giving consent.

The following statement concerns the collection of the genes of the living by the Human Genome Project a project set up in 1990. The statement although made in 1994 still resonates today.

‘The issue relating to the Human Genome Project and others relating to our genes, is a serious violation of our peoples’ rights. Without consultation with the indigenous communities, several projects are now taking blood, hair, tissue and other samples for purposes that are not clear. The practice of collecting samples without our approval is very dangerous because in this way our genetic material can be patented or used for other purposes. Such practices not only violate ethics and human rights, but also violate nature, our spirituality and our knowledge of creation that connects us with all forms of life.’

Geneva Intellectual Property Rights Workshop, August 1994

Over the coming weeks I will draw out the rights and human rights implications of this debate; such rights as non-discrimination, Free, Prior, Informed Consent (FPIC), consultation, participation, benefit-sharing and a right to culture. This discussion has wider ramifications and can be applied to other indigenous ‘resources’ as it seems to me indigenous genes are viewed through a proprietary prism and sit alongside other vulnerable resources such as land, minerals, water and indigenous traditional knowledge (TK) to name but a few.

Written by Fiona Batt.