The issue of informed patient consent is a top priority for virtually every biobank review committee these days.
In general terms, biobankers use informed consent aims to accomplish two goals. Informed consent helps:
- Ensure biobank donors are well-informed about possible risk, benefits and other factors associated with their involvement in biobanking and
- Acquire voluntary consent of research participants.
Most biobankers follow either the broad consent or dynamic consent model to achieve these goals.
In the broad consent model, a donor consents to his/her sample(s) being used once at the beginning of a research experiment. If additional analyses need to be performed or new experiments are designed, the donor isn’t contacted again, provided the new research isn’t a significant deviation from what was agreed to initially. In the dynamic consent model, donors are asked to re-consent to every new experiment or slight change in research.
In theory, a consent model should balance the ethical responsibility of keeping donors informed about the research they’re enabling with the need for researchers to continually explore new frontiers. Unfortunately, though, neither the broad nor dynamic consent model fully achieves that objective, and so biobankers must carefully weigh the advantages and disadvantages of each one. For example, here are a few key points to consider:
- The dynamic consent model keeps participants up-to-date. Frequent contact between the biobank and donors helps ensure participants are informed and involved in the research they’re enabling. By contrast, under the broad consent model, continual communication between the biobank and donors is not required.
- Re-obtaining consent is not necessarily easy. Although modern communication methods allow biobankers to reach out to study participants quicker and more reliably than ever before, re-obtaining consent from dynamic consent donors can still be a difficult process. Some donors may agree in concept to the continued use of their samples and yet still fail to respond, shrinking the amount of samples available for future studies.
- Ethical review boards are fundamental to the broad consent model. As mentioned above, under broad consent, donors are only contacted if new research represents a “significant deviation” from what they initially agreed to. Any biobank following the broad consent model must have an ethics committee review new research, and that process can be expensive and time-consuming.
For a more in-depth look at the differences between broad and dynamic consent, read “Broad consent versus dynamic consent in biobank research: Is passive participation an ethical problem?” published in the European Journal of Human Genetics.