Genetic Research in Human Populations (ID 6)

Genetic Research in Human Populations (ID 6) Important Considerations in Genetic Research 1. Effects on Family Members - IRB Consideration: - ️ When conducting research that involves collecting biological specimens for genetic testing, the effects of findings on other family members is the most important issue for the IRB to consider. - Rationale: - While all issues are significant, the potential impact of research findings on family members takes precedence. 2. Biospecimen Use and De-Identification - Research Focus by Investigator A: - Conducts research on emphysema using biospecimens. - Consent form specifies research will focus exclusively on emphysema. - Use by Investigator B: - Wishes to use de-identified specimens for lung cancer research. - Can Investigator B proceed without re-consent? - ️ Yes, if the biospecimens are de-identified, then the research is no longer considered human subjects research. - Ethical Concerns: - Many commentators find it ethically problematic to use specimens in ways inconsistent with the informed consent language, despite regulations allowing de-identification. 3. Definition of Genetic Determinism - Best Definition: - ️ Genes are primarily responsible for human traits, including health, behavior, and disease. - Current Understanding: - Genetic determinism suggests genes control health and behavior; however, current thinking emphasizes the complex interplay between genes and environmental factors. 4. Protection Under GINA - Discrimination Types Covered: - ️ GINA protects individuals against health insurance and employment discrimination. - Limitations: - GINA does not address other forms of discrimination. 5. Human Subjects Research Determination - Scenario Involving Coded Specimens: - Investigator A provides coded specimens without identifiers to Investigator B, who agrees not to re identify individuals. - Is this considered human subjects research? - ️ No, because Investigator B cannot readily ascertain the identity of the source individual and has agreed not to pursue re-identification. - OHRP Guidance: - Investigator B is not conducting human subjects research, although the original investigator can identify individuals. OHRP guidance states such agreements are not subject to IRB oversight. 6. Assessing Subject Risk in Genetic Studies - Accurate Statement: - ️ Understanding the purpose and context of a specific study is critical in determining the risk involved. - Risk Assessment: - Genetic research encompasses a wide range of study types, so assumptions about risk are unsuitable; each study should be evaluated independently.