Bioethics in Daily Life

1. Bioethics in Daily Life Day 13 Prof. Connie J. Mulligan Department of Anthropology

2. This week Sample collection for research Informed consent issues Collection of samples from impoverished people/people from developing countries Return of samples Return of skeletal remains/archaeological artifacts Right/responsibility to participate in research Reading DNA returned to tribe, raising questions about consent, Science, April 30, 2010 Researchers to return blood samples to the Yanomamo, Science, June 4, 2010 Iceland: The case of a national human genome project, Anthro Today, Oct, 1999 Grave disputes, Science, Oct 8, 2010, 330:166 Science education: Research on the reservation, Nature, March 2, 2011, 471:25-26 Of HeLa and human lives, Science, Feb 26, 2010, 327:1081 Taking the least of you, The New York Times, April 16, 2006 Video – Gene Hunters Oral presentations (animal cognition/animal rights) For/Against vegetarianism Huge/small difference between us and other animals

3. Next week (last class) Evolution/Intelligent design Scientific basis of evolution and creationism/intelligent design Should evolution/creationism/intelligent design be required subjects to teach? In what classes? Reading Talbot M. 2005. Darwin in the Dock. The New Yorker, pp66-77 BerkmanMB et al. 2008. Evolution and Creationism in America’s Classroom: A National Portrait. PLoS Biology, 6:0920-0924 Oral presentations (evolution/intelligent design) For/Against evolution For/Against intelligent design Mulligan lab tour – 415 Cancer Genetics Research Complex Southwest corner of Mowry Rd and Gale LemerandDr Meet in the lobby Paper due April 25 – best to put hard copy in my mailbox

4. Final paper • Paper – 100 pts • In-depth analysis of a bioethical issue of your choice • There must be a clear biological aspect to the issue and you must explain the science and how it relates to your chosen bioethical issue, in addition to developing the bioethical issue • Class is Bioethics in Daily Life • Could be more broadly technological, but be sure to say you know this is not biological content • I gave ideas for biological content in some of last week’s group projects so you know what I’m talking about. Feel free to email me if you’re unsure about the biologically scientific content of your paper. • You must include at least 3 scientific peer-reviewed articles • The expected length ~3000 words, or ~5-7 single-spaced pages.

5. Review of research involving human subjects • Federal regulations require that all research involving human subjects be approved by an IRB prior to the research • Institutional review board = IRB • Virtually all universities and research institutes have their own IRBs • Composed of professors/scientists who volunteer their time • Must be research – anything commercial is not subject to same regulations, e.g. if someone pays to have genetic typing performed • Also excludes general medical practice, i.e. distinction between accepted and experimental therapy

6. What is a human subject? • A human subject is a living individual about whom a researcher obtains: • Data through intervention or interaction w/ the individual • Identifiable private information • IRB regulations do not cover: • Dead persons – no protection for the sample of someone who has died • Tissue samples taken from a live person • Samples that are already collected and that have no identifying information (i.e., are anonymous) • New snag – It has become so easy to generate lots of genetic data on individuals, that everyone is identifiable through genetics and a little bit of personal info, i.e. no such thing as anonymity

7. Goal of IRB review • To safeguard the rights and welfare of human subjects participating in biomedical and behavioral research • Guided by the Belmont Report • The Belmont ReportEthical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchApril 18, 1979 • Written in response to past abuses of human subjects in biomedical research • WWII • Abuses of concentration camp victims • Tuskogee Syphilis Project • Gov’t sponsored study (1932-1972) that denied effective treatment for syphilis to 399 African-American men in order to document the natural history of the disease

8. Three basic principlesBelmont Report • Respect for persons • Subjects must be given the opportunity to choose what will or will not happen to them • Principle of informed consent and the consent process (information, comprehension and voluntariness) • Beneficence • “do no harm” • “maximize possible benefits and minimize possible harms” • Extends to both investigator and society • Justice • Requires that there be fair procedures and outcomes in the selection or subjects, both individually and socially (no one asked to unfairly bear burdens)

9. Projects in which the study populations are intimately involved with the project • Iceland – National human genome project • deCode Genetics, an Icelandic start-up genomics company, spearheaded a project to map the genome of the Icelandic people as part of a larger medical database • African Ancestry project • Provides DNA testing to determine indigenous African paternal and maternal lineages among African Americans

10. deCode Genetics • Iceland is ideal location for a genetic disease association study • Historically small population (~50,000 19th century & ~275,000 today) • Relatively homogeneous and comparatively isolated • Disease candidate genes may be easier to identify • Detailed genealogical records for generations • Detailed medical records dating back to 1915 • In 1998 Icelandic parliament passed a bill authorizing the construction of a national medical database • Lots of controversy, some detractors, but general Icelandic public seems to be in favor of project • Informed consent as far as medical records goes was based on the principle of presumed, rather than informed, consent, i.e. people had to specifically request that their medical records not be used • First paper purporting to find a gene involved in schizophrenia • Working on heart attacks, asthma, pain, vascular disease, diabetes, etc • What do you think about the project and how it has developed?

11. African Ancestry project • Motivated by African-Americans’ desire for more information about their ancestry • There is only limited historical info available for African-Americans prior to their enslavement • From 1619-1850, millions of indigenous west and central Africans were enslaved • Primarily from Senegal through the Cape of Good Hope and north along eastern Africa to Cape Delgado

12. African Ancestry project, cont • Spurred by African Burial Ground project • In 1991, human remains were uncovered from an 18th century burial ground of enslaved African in lower Manhattan • African American community became a major contributor (both financial and intellectual) to a research project with these aims: • What are the origins of the population? • What was the physical quality of life in 18th century NYC? • What can the site reveal about the biological and cultural transition from African to African American identities?

13. Different responses to genetic research • There is no single response to genetic research • Individual responses within a community can differ • Different communities have different responses • Two types of research relevant to a discussion of human genetics and informed consent • population history or genetic ancestry • cause of disease

14. General community responses to genetic research • African American community • Genetic ancestry – Positive, apprehensive, skeptical • Disease – Concerns about possible abuse and/or stigmatization • Native American • Generally negative for both b/c they don’t view genetic data as something they need to understand their ancestry and b/c they would rather focus on improving social, economic, and environmental conditions as a means of improving health • Recently, increasing #s of Native American PhDs/researchers • European • Generally positive for both types of research • Lots of interest in genetic typing companies (National Genographic, etc) • Lots of interest in disease studies (deCode project) • Asian • Generally positive for both types of research • Very interested in genetic genealogy, e.g. Japanese emperor • 2/4 countries involved in HapMap (derived from Human Genome sequencing project) were China and Japan

15. Native American cases • Havasupai case • Yanomamö case • NAGPRA – Native American Graves Protection and Repatriation Act

16. Video

17. Discussion questions • IRBs and informed consent • IRBs are intended to protect universities or institutions from litigation brought by research participants • Assumption is that research is harmful and institutions/individuals should be protected from such research • Is there anything other than full disclosure that can guide decision-making when it comes to consent-giving? • Is it possible to be fully informed?

18. Discussion questions • Scientists and the general public • Do scientists/the general public have a “right” to learn about the human past? • Do scientists/the general public have a “responsibility” to learn about the human past? • Individuals • Do individuals have a “responsibility” to participate in research for the common good? • Do individuals have a “right” to participate in research for the common good?

19. Bottom line • Best research involves research participants from the beginning and throughout project • Best research honors the beliefs and goals of the research subjects • Don’t expect them to buy into “greater good” argument because that reflects the scientific community’s beliefs, not their beliefs • Best research assumes that research participants can be educated about the research as long as you put yourself in their position

20. Next week’s oral presentations • Oral presentations (evolution/intelligent design) • For/Against evolution • For/Against intelligent design