Ethical guidelines for whole genome studies

It’s been quite a month for genetics and ethics!  There has been much commentary on GINA (Genetic Information Non discrimination Act) and now an influential academic group have developed an ethical framework of recommendations to encourage individuals to join whole-genome association studies.

According to a large group of genomics scholars, researchers, ethicists, and policy designers and watchers, in order to live up to its potential, whole-genome research in the future should be built upon some ETHICAL foundation that will give people the confidence and trust they will need in order to become volunteers.

The group of experts published a statement of consensus this week in PLoS Biology that is intended to serve as practical guidance for scientists involved in whole-genome association research and for ethics boards. The statement proposes eight recommendations aimed at creating more secure and consensual practices for research institutions involved in whole-genome association studies.

In summary, they are:

1. Detailed consent from volunteers for future use of their genetic material that includes as much detail as possible, including information about the sampling and sequencing process, associated commercialization activities, possible risks, and the nature of likely future research initiatives. Option for volunteers to re-consent for specific projects.

2. The right to withdraw consent, including the destruction of tissue samples and written information, must, so far as possible, be respected and be part of the whole-genome research ethics process. In addition, the fact that this right may be severely limited once data are disseminated must be clearly communicated as part of the initial informed consent process.

3. The design of personal genome projects and ethics review should explicitly consider how the ability to withdraw from subsequent use is enhanced or diminished by how data and samples are collected, stored, and disseminated. The appropriate balance will need to be considered for each project on a case-by-case basis.

4. Personal genome research projects should have an established process, approved by a research ethics review entity, for evaluating whether findings (incidental or otherwise) meet criteria for offering to individual participants. This process should be highlighted in the initial consent and should acknowledge the participants’ right not to know certain results.

5. The process of identifying and disclosing research results should involve professionals with the appropriate expertise required to provide the participant with sufficient interpretive information.

6. Data release policies must be designed to appropriately balance the benefits and requirements of access against the privacy interests of research participants. The rationale for the proposed data release policy needs to be clearly explained, justified as necessary for the goals of research, and deemed acceptable by the relevant ethics review entity.

7. The implications of data release must be adequately disclosed to the potential participants in the consent process. This disclosure should include a discussion of the likely finality of the release process and the implications that this may have on privacy and the future right to withdraw.

8. As part of the consent and ethics review process, the issues associated with family members and relevant groups and populations should be considered (this may, for example, involve encouraging/requiring discussions with family members).

For further information, please click on the following link:

http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pbio.0060073

Elaine Warburton  www.geneticsandhealth.com