Outsourcing Clinical Research: Alternative Ethical Paradigms
This past Saturday afternoon I was part of a panel discussion at the Annual Meeting of CAREB (the Canadian Association of Research Ethics Boards) in Vancouver.
The hopefully-provocative title of my talk was “Outsourcing Research to Developing Countries: Exploitation or International Trade?” The main goal of the talk was to point out, to an audience with background mostly in bioethics, that not all ethical reflection goes on from a bioethics point of view. That wouldn’t be news to everyone, but to some it would.
I pointed out that bioethics and business ethics are kindred disciplines that have different histories and that focus on different problems. I suggested that a single ethical issue could look quite different when examined from a business ethics point of view as opposed to a bioethics point of view. I further suggested that neither ‘lens’ can really claim to “trump” the other, in general. But it’s useful for people working from one perspective to understand that things might look different to people working from the other.
Then I pointed out that commercial pharmaceutical research lies at the intersection: it’s of interest both to people who study bioethics, and to people who study business ethics:
To illustrate my point, I talked a bit about the outsourcing of clinical trials to developing nations. I suggested that the 3 key worries with regard to outsourcing (as outlined in this NEJM article) are:
- Oversight, rigour, safety;
- Exploitation of research subjects; and
- International Justice.
I then sketched briefly how each of those issues might look from a business ethics point of view, one aimed at getting pharmaceutical companies to find the right way to balance their legitimate desire to make a profit against both the economic development interests of developing nations and the employment interests and human rights of potential research subjects.
I finished by suggesting that while the bioethics lens — the lens that focuses on the protection of human subjects and the integrity of the research enterprise — must absolutely be the primary lens through which ethics boards look at outsourcing, it’s still useful for ethics boards to understand the alternative ethical framings that might be applied by other people looking at the same issue.