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Disclosures for "informed consent"

The concept of informed consent relies on an informed person. The more complex medical research becomes, the more challenging it is to explain to prospective donors in the consent process. For instance, while people might easily understand a drug dosage trial (e.g., that research subjects will be given a new drug in doses that double every week), research on excised tissue is more elusive. In designing informed consent processes for tissue donation, the goal is to strike a balance between accurately representing the research and explaining it in language that the typical person can understand. Details that are important but that people cannot understand do not fulfill the "informed" aspect of consent. Similarly, information that is easily understandable but so basic that some of the important and more controversial aspects of the research go unmentioned, is misleading and violates the principles of informed consent.

Informed consent discussion for tissue collections, should be a dialogue between the prospective donor and a collection nurse. In addition, written materials (e.g., informational brochures) should be provided to prospective donors that review (usually in more detail) common questions and answers about the research. The culmination of the research process is the informed consent document. Disclosures are discussed below.

The first set of disclosures should be a description of the tissue collection protocol:

• the nature of a tissue repository
• general research goals of end-users (as specific as one can be)
• typical end-users (e.g., public, private, international, commercial, including pharmaceutical companies, etc.)
• maximum storage time (Some repositories agree to store tissue for 5 or 10 years and then destroy it if it has not been used. Other repositories have no maximum storage time.)
• the commercial nature of the repository

The second type of disclosure should be the commercial nature of the repository.

There is a common perception that commercial repositories may be driven by profit motives and only secondarily motivated by the collective good. This perception is enhanced when the typical users of commercial repositories are large pharmaceutical companies. Aggressive marketing campaigns for new expensive drugs while news reports continue to declare a health care crisis do not counter this perception. Many people are distrustful of commercial healthcare businesses in general, and pharmaceutical companies in particular. They may decide to donate tissue to a public repository but never a commercial one. Whether or not there is an ethical difference between a particular profit or non-profit repository, of course, depends on a critical assessment of the business practices and goals of each. If the medical center is collaborating with more than one commercial repository, this should be disclosed in the consent discussion. If the same tissue collection protocol may direct tissue to both profit and non-profit repositories, that too should be disclosed.

In addition to disclosing the commercial aspect of the repository, it is important to disclose in general terms how, if at all, the medical center will profit or benefit from tissue collection.