Home Ethical Issues Informed Consent Open-Ended Consent

Is open-ended consent ethical?

The issue of open-ended (sometimes called "blanket") consent is often a controversial aspect of tissue collection for repositories, particularly when considered from the perspective of IRB objectives. Much of the controversy stems from confusing tissue collection with human subject research. If one assumes that tissue collection for research is human subject research, then the challenge is to apply the same criteria for informed consent in tissue collection that is applied in human subject research. Immediately, there can be difficulty. The usual practice of informed consent in research is tailored to the specificities of a particular experiment or set of experiments. A person is asked to participate in a particular research protocol as opposed to another. The specificity is necessary because there may be physical risks or benefits for human subjects. By contrast, tissue collection for banking involves no physical risks or benefit to donors. Some repositories seek end-users for a range of research areas and hence, consent procedures are usually open-ended.

When obtaining consent from donors for tissue collection for research repositories, it is not possible to inform potential donors in advance of many aspects of informed consent outlined in the Common Rule:

• the nature of the experiments is variable (which may range from standard medical trials to experiments in genetics, or data-mining in genomics and proteomics research) and include genomic and more "conventional" projects that involve long-term follow-up data, and situations where linking back might be deemed important
  
  
• the duration of their participation is unknown (their tissue may be stored for years or derivative DNA products may be made from it that are used in the future for experiments)
  
  
• the number of researchers or experiments that may be conducted on their tissue is unknown (most repositories cannot even estimate this)
  
  
• it is not possible to describe future sorts of research that could employ techniques not currently existing

In addition, critics of open-ended consent ask if donors can actually comprehend the nature of a research repository and the array of genetic and clinical research studies that might be run on their tissue samples. Add to this the open-ended nature of genetic findings, the possibility of storing samples for generations, and the prospect of researchers making derivative DNA products including immortalized cell lines and one can assume to exceed the comprehension level of many donors.

Others might point out that people may differ in the degree to which it matters how their tissue may be used in research. Some may only donate tissue or organs to a disease-specific repository, for instance, a breast cancer repository or a brain bank that conducts research only on schizophrenia. Others may not care what researchers do with their tissue as long as it is anonymized. Still others might want some assurances that potential research on their tissue excludes certain areas: e.g., behavioral genetics.