Podcast
Questions and Answers
When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?
When conducting research that involves collecting biological specimens for genetic testing, which of the following issues is the most important for the IRB to consider?
- Effects of findings on other family members (correct)
- Timeframe of the study
- Funding sources
- Location of the research
Potential effects of research findings on family members is the least important consideration in genetics research.
Potential effects of research findings on family members is the least important consideration in genetics research.
False (B)
Can Investigator B use the biospecimens for cancer research without re-consent if the specimens are de-identified?
Can Investigator B use the biospecimens for cancer research without re-consent if the specimens are de-identified?
Yes
Research with de-identified specimens is not considered human subjects research under the regulations.
Research with de-identified specimens is not considered human subjects research under the regulations.
Which choice is the best definition of 'genetic determinism'?
Which choice is the best definition of 'genetic determinism'?
Current thinking supports the notion that genes function independently of environmental influences.
Current thinking supports the notion that genes function independently of environmental influences.
What types of discrimination does the Genetic Information Non-Discrimination Act (GINA) protect individuals from?
What types of discrimination does the Genetic Information Non-Discrimination Act (GINA) protect individuals from?
GINA addresses all forms of discrimination individuals may face.
GINA addresses all forms of discrimination individuals may face.
Is Investigator B's research using the biospecimens considered human subjects research according to federal regulations?
Is Investigator B's research using the biospecimens considered human subjects research according to federal regulations?
Investigator B must agree to attempt re-identification of the specimens according to OHRP guidance.
Investigator B must agree to attempt re-identification of the specimens according to OHRP guidance.
What is critical in determining subject risk involved in a genetic study?
What is critical in determining subject risk involved in a genetic study?
All genetic research poses the same level of risk.
All genetic research poses the same level of risk.
Flashcards are hidden until you start studying
Study Notes
Ethical Considerations in Genetic Research
- Importance of IRB considering the impact of genetic findings on family members.
- Potential effects on family members deemed the most critical issue in genetics research.
Use of Biological Specimens
- Investigator B can use de-identified biospecimens for lung cancer research without re-consent, as it no longer qualifies as human subjects research.
- Ethical concerns arise when using specimens in ways not aligned with the informed consent language.
Genetic Determinism
- Genetic determinism asserts that genes predominantly dictate human traits, including health and behavior.
- Current understanding emphasizes a complex interplay between genes and environmental influences, rejecting strict determinism.
Protections under GINA
- The Genetic Information Non-Discrimination Act (GINA) safeguards against discrimination related to health insurance and employment.
- GINA does not extend protection against all forms of discrimination.
Human Subjects Research Definitions
- Investigator B's research is not considered human subjects research as they cannot easily identify source individuals and have agreed not to re-identify.
- OHRP guidance supports that the agreement to refrain from re-identification relieves the research from human subjects classification, despite Investigator A's ability to identify.
Assessing Risk in Genetic Studies
- Understanding the specific study's purpose and context is essential for evaluating participant risk.
- Genetic research encompasses a wide range, from surveys to advanced gene transfer studies; each study must be individually assessed for risk.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
