It is still unclear what kind of consent should be used when collecting biological samples for future research. Different forms of consent are practiced, which creates another uncertainty: which research is actually permitted with the collected samples?
This haphazard situation leads to unintended constraints on research. But it also leads to research sometimes being carried out without consent.
Against this background, the US National Institutes of Health (NIH) organized a workshop to discuss whether it is ethically reasonable to manage these uncertainties by using broad consent for future research when collecting biological samples.
The group of bioethicists who attended the workshop, including Mats G. Hansson, recently published their thoughts and conclusions in the American Journal of Bioethics:
The group’s proposal is that broad consent is ethically reasonable and often the best option, if it has three components:
- Consent is conducted initially, in connection with sample collection.
- There is a system for oversight and approval of future research.
- As far as possible, there should be ongoing communication with, and information to, donors.
Biological samples are collected in a variety of contexts. It is here that the haphazard situation arises, if different forms of consent are used, or perhaps no consent at all. By initially informing potential donors of the wide range of research that can be carried out, they can take a position on risks and benefits of donation (given the oversight and the general conditions of the future research that they are informed about).
The group emphasizes that broad consent gives donors control over the use of samples, while minimizing costs and burdens for both donors and researchers.
They also point out that empirical studies show that most people want to decide if their samples may be used for research. Most respondents also say that the decision is not influenced by the specific details of the future research (e.g. what diseases are studied, what techniques are used, or which parts of the sample are studied).
Of course there are examples of research that can be perceived as controversial, such as human cloning. But broad consent can be combined with specific restrictions. Oversight moreover considers whether research proposals can be said to comply with the donors’ values.
If donors still hesitate, they are free to choose not to donate the sample.