In mid-October, after studying the issue for more than a year, the Presidential Commission for the Study of Bioethical Issues issued its report on whole genome sequencing. The introduction gets right to the point:
Collections of whole genome sequence data have already been key to important medical breakthroughs, and they hold enormous promise to advance clinical care and general health moving forward. To realize this promise of great public good ethically, individual interests in privacy must be respected and secured.
The report expresses concern that the current patchwork of state and federal safeguards does not go far enough to ensure privacy for people who participate in genomic research (knowingly or otherwise) or for their relatives who may be secondary subjects of such studies. The Commission developed five basic ethical principles it believes should inform the collection, handling and sharing of large-scale genetic and genomic data:
- Public beneficence
- Responsible stewardship
- Intellectual freedom and responsibility
- Democratic deliberation
- Justice and fairness
In formulating these principles, the Commission took inspiration from the Belmont Report, particularly the Belmont principle of respect for persons. All of the specific recommendations outlined in the report flow from these five concepts.
Regarding consent, the Commission states that consent forms for research involving whole genome sequencing should “1) briefly describe whole genome sequencing and analysis; 2) state how the data will be used in the present study, and state, to the extent feasible, how the data might be used in the future; 3) explain the extent to which the individual will have control over future data use; 4) define benefits, potential risks, and state that there might be unknown future risks; and 5) state what data and information, if any, might be returned to the individual”. This recommendation does not expand the elements of consent already required by the Common Rule; it merely interprets the basic principles of informed consent within the specific context of whole genome sequencing.
The full report includes a summary of US and international privacy regulations, a glossary and a brief primer on genetics and genomics.