Genetic Research in Human Populations(Questions & Answers)2022
Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? - Answer Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
Under which of the following conditions is it appropriate to re-contact the individuals who
provided biological specimens? - Answer Original signed consent documents include provisions for recontacting subjects
Which choice is the best definition of "genetic determinism?" - Answer Genes are primarily responsible for human traits, including health, behavior, and disease
Which choice best describes the purpose of most pharmacogenomic research? - Answer To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
Which of the following statements is accurate in determining subject risk involved in a genetic study: - Answer Understanding the purpose and context of a specific study is critical in determining the risk involved
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: - Answer Health insurance and employment discrimination
Investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B's research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations? - Answer No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
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? - Answer Effects of findings on other family members
Which choice is the best definition of "genetic determinism?" - Answer Genes are primarily responsible for human traits, including health, behavior, and disease
Investigator A conducts research on emphysema using biospecimens from human subjects. The consent form indicates that the research will focus exclusively on emphysema. Investigator B wishes to use the biospecimens for research on lung cancer. Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? - Answer Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.
Under which of the following conditions is it appropriate to re-contact the individuals who
provided biological specimens? - Answer Original signed consent documents include provisions for recontacting subjects
Which choice is the best definition of "genetic determinism?" - Answer Genes are primarily responsible for human traits, including health, behavior, and disease
Which choice best describes the purpose of most pharmacogenomic research? - Answer To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs
Which of the following statements is accurate in determining subject risk involved in a genetic study: - Answer Understanding the purpose and context of a specific study is critical in determining the risk involved
Identify which types of discrimination the Genetic Information Non-Discrimination Act (GINA) protects individuals from: - Answer Health insurance and employment discrimination
Investigator A has biological specimens that are coded and linked to identifiers of the source individuals. Investigator A provides the specimens to Investigator B but does not provide the individual identifiers. Investigator B agrees not to re-identify the source individuals. Is Investigator B's research using the biospecimens human subjects research according to the definition of human subjects research in the federal regulations? - Answer No, because Investigator B cannot readily ascertain the identity of the source individual and Investigator B has agreed not to attempt re-identification.
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? - Answer Effects of findings on other family members
Which choice is the best definition of "genetic determinism?" - Answer Genes are primarily responsible for human traits, including health, behavior, and disease
