Monday, July 14, 2008

Informed consent essential to fostering trust in medical research
by Maggie De Pano

Researchers have been working for years to unlock the human genome and usher in an era of personalized medicine. High quality biological specimens and health information, collected and stored in biorepositories for researchers to study, are invaluable resources in this massive effort.

Biorepositories depend on the trust and goodwill of potential specimen contributors. According to the results of a study led by Dr. Laura M. Beskow, assistant research professor with the Duke Institute for Genome Sciences and Policy and Associate Director of the Duke Translational Medicine Institute’s Ethics, Law & Policy Core, privacy and confidentiality issues exert considerable influence on the willingness of people to contribute tissue samples. The study appeared in the June 2008 issue of Cancer Epidemiology Biomarkers & Prevention. It was co-authored by RTI International’s Elizabeth Dean.

Beskow and Dean emphasized that informed consent is an important part of maintaining trust in medical research. ”Informed consent” refers to the decision people make to take part in research only after learning the potential risks, benefits and other key facts related to participation. However, getting informed consent for the collection, storage and future use of specimens is challenging, since potentially complex and controversial information must be clearly expressed.

The authors studied how potential specimen contributors interpret information they receive in the process of giving consent and what they think about such information. They recruited 40 subjects from Durham, N.C., who are generally representative of people who might one day consider contributing specimens. They oversampled minorities and people with lower educational attainment, and screened potential subjects to achieve diversity by age and sex and to avoid habitual research participants.

Using a consent template developed for the Duke Biorepository, the authors looked into the subjects’ interpretation and opinion of the following:

• Overall trust in medical researchers;
• Purpose of biorepositories;
• Duration of specimen storage;
• Possibility of being contacted to update information and participate in future research;
• Access to participants’ medical information;
• Option to withdraw specimens anytime;
• Non-Duke researchers’ access to specimens;
• Risks and benefits associated with contributing specimens;
• Possibility that commercial products may be developed from research using specimens; and
• Participants’ access to research results.

The authors found that the subjects tended to have neutral feelings of trust or some level of trust, rather than distrust, in medical researchers. Considerably more than half of them were comfortable with the unlimited duration of specimen storage; periodic contact to update their information and to inform them of additional research opportunities; the prospect that commercial products could be developed from researching their samples; and that profits, if any, would not be shared among participants.

More than half of interviewees were willing to provide continuous access to their medical records, although this aspect was a primary concern for others. They generally accepted the concept of a variety of researchers having access to the biorepository as long as their samples and information are being put to “good use” and that their confidentiality was protected.

Additionally, more than two-thirds of participants were comfortable with not receiving individual research results as a matter of routine, but many thought that they should be informed of findings that have serious implications on their health.

On the other hand, participants cited potential loss of privacy as a primary reason for not wanting to contribute specimens. They cited the possibility of a confidentiality breach as a primary motivation for withdrawing specimens. Lack of trust in medical researchers also seemed to influence their decision to refuse additional contact for future research and continuous access to their medical records.

Beskow and Dean concluded that despite fears that the privacy and the confidentiality of information might be compromised, most people are nevertheless willing to participate in medical research. The authors encouraged biorepositories to honor this altruism by being transparent and accountable in their work. They wrote that biorepositories should not only adhere to rigourous processes that ensure that samples and data are protected and put to good use, they should also devise ways to communicate clearly about the research being conducted.

Read the full study here.