What is informed consent?

A common thread to all of the ways in which a patient or healthy volunteer may be approached to donate (See “How Are Donors Approached”) is the process of “informed consent.” This means that someone will approach potential donors to give them information about why researchers are asking for their tissue and data to be put into a biobank, talk about any potential risks, and finally ask the potential donors for permission.

The informed consent process is also intended to clarify questions that a donor may have regarding the effects of his or her participation in a research study on personal medical treatment.

Today, almost every biospecimen in a biobank that is linked to information about the donor has been collected after an informed consent process. There are some exceptions however, in which donors may not have been approached for informed consent:

• Biobanks do collect specimens that are anonymous – that is, any possible linkage back to the donor has been broken and cannot be recreated – and in such systems it is considered both legal and ethical to bank without consent.
• Biobanks also contain materials from earlier times, in some cases approaching 100 years old, where the ethical and legal consensus was very different from what it is today. In these cases, use of the biobank typically also requires re-review by the institution’s ethics oversight board before those materials are used by researchers.

Federal regulations governing informed consent

The Federal Policy for the Protection of Human Subjects is known as the “Common Rule.” This document addresses the protection of human subjects in clinical research studies and outlines specific information that should be covered through an informed consent process¹:

• A statement that the study involves research.
• An explanation of the purposes, duration, and procedures of the study, and identification of any interventions that are experimental.
• Benefits to the participant or others.
• Reasonably foreseeable risks.
• The rules and safeguards to be followed to protect confidentiality.
• Whether there will be compensation and/or treatment for injuries from participation in studies involving more than minimal risk.
• A statement that participation is voluntary.
• Notification of the right to withdraw from a study at any time without penalty.

Additional information should be included in the consent process depending on the type of study and the population. With biomedical research, informed consent should also address issues such as linkable or identifiable genetics research, consent to future research, and risk of unauthorized disclosure and genetic discrimination.

Furthermore, the actual process of informed consent should not merely be validated by a donor’s signature; rather, there must be an extensive dialogue between the participant and the investigator in order to ensure that there is a thorough understanding of the research process.

¹ United State Department of Health and Human Services, “Title 45 Public Welfare: Part 46 – Protection of Human Subjects,” 23 June 2005, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm (Accessed 19 April 2006).