Home Ethical Issues Informed Consent Tiered Consent

What is tiered consent?

Tiered consent refers to a set of choices available in informed consent. Rather than simply being asked to participate, a tiered consent process allows donors to select some choices over others giving them some control over the direction of their excised tissue.

The common set of choices offered in tissue collection is that of linked, unlinked, and anonymous tissue.

Other choices may be included in tiered consent as is suggested by The Tissue Access Working Group, (TAWG) (2003). TAWG is part of the National Dialogue on Cancer Research Team and includes cancer researchers in the profit and non-profit sectors with the common objective of establishing "a national, pre-competitive, regulatory compliant and genetic privacy protected, standardized , inclusive, highest quality network of biological sample(s) banks; developed in partnerships with and supported by cancer survivors/advocates; shared, readily accessible, and searchable using appropriate informatics systems."

The following options are listed in the TAWG consent form for NCI databases:

1. My tissue may be kept for use in research to learn about, prevent, or treat cancer.
2. My tissue may be kept for use in research to learn about, prevent or treat other health problems (e.g., diabetes, Alzheimer's disease, or heart disease).
3. Someone from xyz may contact me in the future to ask me to take part in more research.

As TAWG (2003) notes, this model favors donor choices while presenting some difficulties for researchers when research in the first two categories overlap or one leads to the other. For this reason, critics might suggest that choices of type of research are not valid choices given the array of diseases and conditions that may be associated with for instance, cancer in general, or even a specific type of cancer. Further, critics contend that the third statement might suggest that IRB approval would not be needed for further research if donors answered this question affirmatively.

Does TAWG go far enough? Should donors also be allowed additional choices such as:

• [type of sample (anonymous, linked, unlinked)]
• [type of research]
• type of specimen to be donated (blood, urine, tissue, etc.)
• type of researcher (public or private)
• duration of storage time (5 years, 10 years, indefinitely)
• type of products, if any, to be derived from the tissue

Of course, the more choices donors are given in tiered consent the more challenging it is to devise an appropriate database system to track the various options linked with each sample.