US Policy Developments and Points to Consider for Genomics Research Informed Consent

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1 US Policy Developments and Points to Consider for Genomics Research Informed Consent Marianna J. Bledsoe Independent Research Professional/Consultant Adjunct Assistant Professor George Washington University School of Medicine 2014 ISBER Annual Meeting

2 Overview Current Challenges Involving Genomic Research Current US Policy Developments Underway Related to Genomic Research Basic Points to Consider Regarding Informed Consent for Genomics Research Useful Resources and Tools

3 Current Challenges Related to Informed Consent for Genomics Research Genomics information can reveal predictive information about participants and their families that raise psychosocial risks Risks of inadvertent disclosure, such as loss of insurance or employment, stigmatization, etc. How to balance need to maximize value of research investments through broad data sharing vs. need to protect participants Expectations of sponsors and funding agencies for broad sharing Potential identifiability of genomic data

4 Current Challenges Related to Informed Consent for Genomics Research Considerable variability in relevant regulations and requirements Variation in US state laws Genetic testing, genetic privacy, ownership, etc. Variation in national laws and regulations, IRB, and health authority requirements nationally and globally Scope and specificity of consent for genetic research

5 Recent Policy Developments Presidential Commission for the Study of Bioethical Issues (PCSBI)

6 Presidential Commission for the Study of Bioethical Issues (PCSBI) Recommendations of the PCSBI addressed the following issues: Strong Baseline Protections While Promoting Data Access and Sharing Data Security and Access to Databases Consent Facilitating Progress in Whole Genome Sequencing Public Benefit

7 Presidential Commission for the Study of Bioethical Issues (PCSBI) Consent Recommendations: Recommendation 3.1 Researchers and clinicians should evaluate and adopt robust and workable consent processes that allow research participants, patients, and others to understand who has access to their whole genome sequences and other data generated in the course of research, clinical, or commercial sequencing, and to know how these data might be used in the future. Consent processes should ascertain participant or patient preferences at the time the samples are obtained.

8 Presidential Commission for the Study of Recommendation 3.2 Bioethical Issues (PCSBI) The federal Office for Human Research Protections or a designated central organizing federal agency should establish clear and consistent guidelines for informed consent forms for research conducted by those under the purview of the Common Rule that involves whole genome sequencing. Informed consent forms 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.

9 Presidential Commission for the Study of Bioethical Issues (PCSBI) Recommendation 3.3 Researchers, clinicians, and commercial whole genome sequencing entities must make individuals aware that incidental findings are likely to be discovered in the course of whole genome sequencing. The consent process should convey whether these findings will be communicated, the scope of communicated findings, and to whom the findings will be communicated.

10 NIH Draft Genomic Data sharing Policy Draft policy released for a 60 day public comment period on Sept. 20, 2013 Available for download at articles/2013/09/20/ /draft-nih-genomic-datasharing-policy-request-for-publiccomments 107 public comments received including those from ISBER page=scipolcomm

11 General Points to Consider Given the trend towards broad sharing and expectations and requirements of funding agencies, repositories should consider the likelihood that specimens will be used to generate genetic/genomic data that will be shared through publicly available databases for research and include appropriate language in the consents at the time specimens are collected.

12 General Points to Consider Repositories should try to avoid any language that may restrict broad sharing as long as permissible with local regulation and IRB requirements. Repositories should consider informed consent requirements of national laws of countries where specimens will be utilized.

13 Useful Resources and Tools NIH Points to Consider for GWAS Studies pdf National Human Genome Research Institute Webpage on Informed Consent for Genomic Research Presidential Commission for the Study of Bioethical Issues: Informed Consent in Privacy and Progress in Whole Genome Sequencing

14 Contact Information Marianna J. Bledsoe Independent Research Professional/Consultant Adjunct Assistant Professor George Washington University School of Medicine and Health Sciences