Accordingly, the report proposes 12 recommendations across the following goals: (1) data protections simultaneous with data access and sharing; (2) data security and access to secure databases; (3) different consent models; (4) facilitating WGS progress; and (5) maximizing public benefit:
1.1 Various genomic medicine stakeholders should have clear policies for access to and permissible uses of WGS data. The policies should promote opportunities for data sharing.
1.2 Federal and state lawmakers should implement a “consistent floor of privacy protections” that would protect individual privacy and prohibit unauthorized access.
2.1 Various genomic stakeholders should ensure the security of WGS data and should be mindful of ethical standards for the use and disclosure of such information and held accountable for federal and state regulations for security breaches.
2.2 Various genomic stakeholders need to explain clearly to patients and donors of WGS information the permissible uses and disclosures of such information and, whenever possible, WGS data should be stripped of certain “traditional” identifiers to minimize the chances of linking this information to individuals.
2.3 Federal agencies should invest in efforts to ensure compliance with existing privacy regimes and to assist in the development of best practices.
3.1 Researchers and clinicians should develop and implement new consent policies and procedures tailored to genomic privacy and should seek to obtain up-front consent for future use.
3.2 OHRP or another federal agency should establish clear and consistent guidelines for informed consent forms for research.
3.3 Researchers, clinicians, and WGS commercial providers should explain the risks of incident findings and whether such findings will be communicated to the patient.
3.4 Funders of WGS should support studies that assess models for sharing incidental findings and that assess public expectations with respect to incidental findings.
4.1 Various genomic stakeholders should facilitate information exchange between researchers and clinicians while maintaining data protections.
4.2 Lawmakers should identify ways for the public to benefit from WGS research and for researchers and research subjects to collaborate on genomic research.
5.0 Federal government should facilitate access to WGS-generated advancements to the greatest number of people to ensure that everyone who can benefit does.
Overall, the Commission’s recommendations encourage stakeholders to look through genomic-colored glasses in order to leverage well-established ethical and legal principles in anticipation of the widespread adoption of WGS. As genomic information moves from the periphery to the center of medial practice, patients will increasingly undergo WGS. Accordingly, the privacy and data-sharing protections and incentives put in place for genomic information may well serve as a harbinger of the next-generation privacy and data-sharing framework generally.
The Commission’s Report, therefore, should be carefully considered as an early government effort to establish public policy in this important area, and WGS stakeholders should begin the process of reviewing their policies, practices, agreements, and other procedures and forms with an eye to tailored protections.