PCSBI makes these 12 recommendations
Focus is on informed consent
The Presidential Commission for the Study of Bioethical Issues (PCSBI) has made these 12 recommendations for how to better develop public trust and protect privacy in the era of whole genome sequencing in research:
1. Establish clear policies regarding data access.
Sponsors, research institutions, database owners, and policy makers should make clear policies defining what type of access is acceptable in using whole genome sequence data. Strong baseline privacy protections are necessary to ensure safe sharing of genetic data.
2. Federal and state governments should ensure a consistent floor of privacy protections.
Policies should prohibit whole genome sequencing without the consent of the individual from whom the sample came. Full informed consent should be obtained at the outset of diagnostic testing or research.
3. Funders of genome research, database managers, and policy makers should ensure data protection.
Data protection would be enhanced by having all persons who work with whole genome sequence data to do the following:
- be guided by professional ethical standards related to privacy and confidentiality;
- held accountable to laws and regulations that require specific remedial or penal measures in the case of lapses in data security.
4. Funders, research managers, database owners, and policy makers must outline acceptable access to identifiable whole genome sequence data.
Whole genome sequence data should be stripped of traditional identifiers whenever possible. Exceptional circumstances might permit law enforcement or defense and security to gain access to biospecimens for non health-related purposes without consent.
5. Federal agencies should invest in initiatives to ensure all parties with access to whole genome sequence data comply with regulatory and other data privacy and security requirements.
6. Use robust and workable consent processes.
The IC process should provide research participants with information about who has access to their whole genome sequences and how these data might be used in the future. Their specific preferences should be noted when the samples are obtained.
7. OHRP or another federal agency should write clear and consistent guidelines for IC forms in genetic research.
The PCSBI recommends that IC forms contain:
- descriptions of whole genome sequencing and analysis;
- information about how data will be used in the present study and how data might be used in the future;
- explanation of how much control the individual will have over future data uses;
- definition of benefits, potential risks, and a statement that acknowledges unknown future risks;
- statement of what data and information — if any — might be returned to the individual.
8. Make individuals aware of likely incidental findings.
Researchers, clinicians, and sponsors should make individual participants aware of any incidental findings that are likely to be discovered during the whole genome sequencing. The IC should specify how and to whom to communicate these findings.
9. Genetic research funders should support studies to evaluate frameworks for offering the return of incidental findings.
Funders should investigate genetic material contributors' preferences and expectations.
10. Funders, clinical entities, and others in the commercial sector should facilitate a safe exchange of information between genomic researchers and clinicians.
Information exchanges must maintain data protection safeguards to facilitate whole genome sequence and health data sharing.
11. Policy makers should promote opportunities for the public to benefit from the research.
The research community and policy makers should promote opportunities for the exploration of alternative models of the relationship between researchers and participants, including participatory or collaborative relationships.
12. The federal government should invest in whole genome sequencing to benefit all people.
Government investment in genomic research has provided ample public benefit through improved health care, and this work should continue to benefit all members of society. Researchers should include individuals from all parts of society in their studies.
The Presidential Commission for the Study of Bioethical Issues (PCSBI) has made these 12 recommendations for how to better develop public trust and protect privacy in the era of whole genome sequencing in research:You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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