NEW YORK (GenomeWeb News) - 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, according to a large group of genomics scholars, researchers, ethicists, and policy designers and watchers.
The ethical framework needed to encourage individuals to join whole-genome association studies, according to the report, should support good policies for consensual use of personal information, allow individuals freedom to withdraw from research, provide guidance for what type of information should be offered to participants, and should help guide and control the public release and storage of whole-genome association data.
The group of experts, led by Timothy Caulfield of the University of Alberta, published a statement of consensus this week in the journal 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.
Among their suggestions, the authors propose that before beginning participation in a whole-genome association study, participants should “be asked to provide consent for future use 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.”
This process should cover information about data security and about the governance structure and the mechanism for considering research protocols in the future. The right to withdraw consent “at any time, for any reason, and without repercussions is a central component of existing research ethics statements,” the group advised.
That right, which must include “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,” the group said. “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.”
Scientists also must look into the connection between how data and samples are collected, stored, and disseminated and the participant’s ability to withdraw from subsequent use. The authors said that this issue will need to be considered on a case-by-case basis per project.
In addition, the process of disclosing results to participants should provide them with sufficient interpretive information, said the authors. These results should be “scientifically valid, confirmed, and should have significant implications for the subject’s health and well-being.”
The studies also should be structured with plans to return other forms of significant non-health-related data as well. Data-release policies must balance the benefits and requirements of access and privacy interests, and the rationales for these policies must be explained, justified, and considered acceptable by an ethics review entity, they wrote.
For potential participants in whole-genome association studies, the implications of this data release must be disclosed, and the finality of the release process and its potential implications on privacy must be explained to the participant.
The authors concluded that while there is an immediate need for ethics guidance, the research communities also should “continue to explore the ethical, legal, and social implications of this rapidly evolving field.”