The unit of legal responsibility. Global? Community? Tribal? Family? Individual? Corporate?

1. When Enough is TOO Much: Community Consent and BiospecimenBanking Brenda F. Seals, PhD, MPH, MA and Greg Seals, PhD, MA* Rides Over Mountains Consulting; *Also at Department of Education, College of Staten Island, Staten Island, NY Genetics and Biomarkers Conclusions Background Confidentiality • The proliferation of information undermines community consent as a viable solution to protecting groups from stigma, liability and private control of genetic information. • Family rights to consent seem promising but do not take into account the “past, present, future” of changing relations between families and research. • Families also lack a consensus basis. • Ownership over genetic information must consider macro (global) and micro (individual) concerns. • Ethic and research must explore these issues and develop policy to cover legal and liability issues. • Pharmacogenetic vs. pharmacogenomic • Neurogenetics • Daily innovations • Claims to ownership becoming a corporate model. • Corporations like insurance companies with a “right to know” medical information may be positioned to determine risks even when the “patient” does not “know” about their risk, especially in the case where they have “chosen” not to know. • Community consent and CBPR groups have not made bridges into these levels of health care to offer confidentiality protection. Picture courtesy of en.wikipedia.org • Mapping of the human genome slides to estimating individual, family, race/ethnicity, and communities in unending quest for more knowledge • Genetic testing evolves from testing for select disorders to the potential for calculating risks of propensities (e.g. mental health or substance abuse) • CBPR offers hope for some protection or control over “right to know” yet the “leaky” dissemination of information undercuts such efforts • Policy and legal issues abound Legal Issues Individual vs. Community Consent • Ownership or property rights to biospecimensamples • Insurance companies? Researchers? Communities? • Liability • Suing for wrongful disclosure • Suing for failure to notifyObligation to notify varies by • Potential for early detection • Potential for treatment/altered outcomes • Many confidentiality issues remain unresolved including • Parents who must decide to tell or not tell children with potentially poor future prospects • Need to disclose to family members who do not know or choose not to know health risks • Application of “do no harm” is unexplored when community consent overrides individual concern • Intermediary groups claiming decision rights such as tribes, race and ethnicity and other agencies blur the lines between individual and community • Individuals and families will always have avenues for self-testing. When pedigree information becomes public like family trees, consent is meaningless. . Human Chromosomes Picture courtesy of en.wikipedia.org • Consent processes must cover family, tribal and community issues • Consenting for future generations remains unresolved. Future Directions Ultimately family consent must be taken seriously by the courts. Courts are going to need to consider the next level which is tribal groups, races. Unfortunately social network theory and research demonstrates that underlying all racial categories is the form homo sapiens. In that context, all mankind may be equal, related, all one family. If global genetics unites the genome to a common definition of human, legal entities may need to consider that we all own each others’ genetics. At that level, ownership does apply except where people share economics, food sources, air, water and all resources necessary for life as a human. The final question remains, “Have we courage to create a legal apparatus that can treat genomic information as a common interest of the human family?” MitakuyeOyasin • The unit of legal responsibility. • Global? • Community? • Tribal? • Family? • Individual? • Corporate? • Government? • Advocacy group? • Are there any parties without conflicts of interest or ownership? Biospecimen Banking • NIH and other health organizations promote biobanking, especially in select diseases. • The corporate nature of many biobanks, health care systems undercuts conflicts of interest. Family Consent • Consider Grace Rock’s Consent • Study consent led the family to believe they would be informed of BRCA1 and of the right to be informed. • Pediatric cases blur requirements: • family courts, child advocates, civil rights • Yet family consent remains a most viable option. CBPR • CBPR research has recently entered the debate on genetic screening for tribal and racial groups and, more generally, populations. • Unfortunately, the ability of communities to control information both undermines legal approaches favoring families and individuals and ignores precedents and liability issues. • The Havasupai v Arizona state case tells all: • (http://www.nytimes.com/2010/04/22/us/22dna.html?pagewanted=all&_r=0) Insurance and liability Pedigree Research Contact Information • Economists point out that premiums inflate even for deaths, like sudden heart attacks, usually cost little for health care; however, risks for such deaths inflate costs. • Liability for “not knowing” or “not wanting to know” favor disclosure. • In the age of shared information and the increase in diagnosable disorders, at some point everyone “has” risk. • Primarily conducted within family groups. • Probability predictive models for mental health and health risks like obesity or substance abuse increase concerns about confidentiality and the stigmatization of those with disease. • Siblings with Ischemic Stroke Study (SWISS) • Podoconiosis “mossy feet”, Achondroplasia, p.C 282Y, FMR1, Lynch syndrome, Huntington’s Disease court cases Rides Over Mountains, LLC Public Health evaluation consulting www.ridesovermountains.com brendas@ridesovermountains.com Thanks to Carol Thiel, Design and Layout. • “The constitution of a genetic group: • Each is mirrored in the other. If it appears in one mirror, it appears in them all. Mapping the human genome has created halls and halls of mirrors.”