1. GENOMIC RESEARCH: INFORMED CONSENT

2. Genomics- a branch of genetics that sequences DNA to analyze the structure and function of genomes (the complete set of DNA within a single cell of an organism). Genomic Research- studies the information gathered from genomes and compares them to find variations which may help predict inheritance of diseases, diagnosis, treatment, etc. Learning Goal: Understand what genomic research is and understand that there has been widespread benefits to human health as a result of samples collected through genomic research, but there has also been some significant abuses of how specimens were collected.

3. Advances due to Genomic Research 1. Cancer medicine 2. Link between HPV and Cancer 3. Prenatal Care 4. 5,000 known conditions 5. Change in prescriptions 6. Infection method of HIV and other infectious diseases In the News

4. Who is HeLa? Henrietta Lacks was an African- American woman who was the unwitting source of cells which were cultured by George Otto Gey to create the first known human immortal cell line for medical research.  Her cells are now known as the HeLa cell line; they have been used in medical research since the 1950s.  HeLa HeLa

5. Ethical and Legal Implications 1. Research specimens are obtained from the following four sources:  Tissues collected prospectively for a research project  Excess tissue from samples taken specifically for clinical purposes (such as diagnosis or treatment) which are subsequently recognized as valuable for research  Cadaveric tissues  Tissues with reproductive or “human” potential, including eggs, sperm, zygotes, embryos, and fetal tissues, which are also often collected for clinical purposes.

6. 2. Historically, researchers and institutions have assumed that they can retain the right to collect, study, store, transfer, or dispose of tissue specimens and the associated patient data.  Physicians and researchers have assumed that they can use patient tissues and other bodily substances to develop cell lines, genetic sequences, and other biologic products that may be financially rewarding.

7. 3. The Code of Medical Ethics of the American Medical Association prohibits the use of human tissue and its products for commercial purposes without the informed consent of the donor.  Any biological sample can only be taken and stored for use in genomic research if the patient has been informed and provided consent; otherwise it must be discarded.

8. Informed Consent- permission granted (consent) by a patient to a surgical or medical procedure or for participation in a clinical study or blood/tissue collection with the understanding of its use or risks involved.  Informed consent provides research subjects a mechanism to protect themselves

9. Informed Consent vs. The Capacity to Consent Critical care research presents special ethical challenges largely due to the potential for exploitation stemming from the vulnerability of the critically ill patients who are solicited for enrollment.  The presence of vulnerability makes the achievement of a valid, informed consent problematic. (Protection of the Vulnerable)

10. Recent Court Cases 1. Arizona, 2004 The Havasupai Case Blood Journey 2. The Catalona Case, 2001 3. Texas, 2009 Minnesota Case