by Joan Rachlin, executive director

I’ve long admired a bioethicist from McGill named Bartha Maria Knoppers, PhD.

At the last week’s CAREB conference in Montreal, Dr. Knoppers spoke about a population genomics research project on which she and collaborators have been working. Genomics is the study of genomes, and the aim of Dr. Knoppers’ work is to build a longitudinal infrastructure (i.e., a database and a biobank) for future research. Population genomics research is increasingly being submitted to IRBs and/or to research ethics boards (the name by which IRBs are known in Canada), so I wanted to share some of the highlights of her presentation.

The primary goals of the project Dr. Knoppers described are twofold: First, to create a platform that is neither disease-specific nor clinical or interventionist; and secondly, to foster the adoption of an ethos that recognizes and encourages solidarity and common good with no immediate personal benefits for contributing citizens.

The Canadian Public Population Project in Genomics (P3G) will enable data sharing in the future among the 40+ countries that are currently involved. In late April, there was “proof of concept” when the P3G members put together 220 comparable variables and created a resultant data set of 6,000,000 people from around the world.

Dr. Knoppers argued that a different type of ethics review is needed for this kind of science, and that transparency in the process, including in the drafting of the consent documents, is key. In P3G, broad consent is obtained, but recontact is provided (e.g. “ If you participate, you agree to the use of your samples over time and you also agree to be recontacted.”) In this model, the provision for recontact is thought to balance the risk of the initially broad consent.

It is important to note that there is no return of research results/incidental findings to those who participate in P3G. In fact, Dr. Knoppers indicated that she finds the term “return of research results” a misnomer, in that if it’s research, that per se means you’re still looking for results, and there will thus not be any individual results. Among the distinct characteristics of P3G are:

1. It permits unspecified future research.
2. There are many sites, and the project collaborates with other countries.
3. Participants agree that their samples can be used after their death (unless they specify otherwise in their wills, etc.).
4. Researchers must return their enriched results to the database so that the next generation of researchers will benefit from the data; this is part of the access agreement.
5. There are several communication strategies. Participants can visit the P3G website and see what research is being done. Researchers are required to prepare and post a summary of the research in which they’re involved in lay terms so that participants can see what’s going on. Thus, there is a lot of reciprocity even though there is no direct benefit.

Dr. Knoppers provided plenty of food for thought about the ethical underpinnings of, and distinct ethical issues in, this type of research. She encapsulated one of the key ethical issues in research by posing the question, “What happens to individual privacy/autonomy concerns when the main emphasis is on security and governance?” and she suggests that is the crux of the decision prospective participants must consider before they consent to contribute to a this type of database. Finally, she talked about the safe harbor and the matter of equivalent protections. Rather than going through her entire talk, please view her slides so that you can have a look for yourselves. Dr. Knoppers is a “shero” of the bioethics field and a global good citizen. It was a privilege to hear her speak. Thank you, Dr. Knoppers for sharing your ideas and time with CAREB and for sharing your slides with PRIM&R!