Genetic Research in Human Populations

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?

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?

Original signed consent documents include provisions for recontacting subjects

Which choice is the best definition of "genetic determinism?"

Genes are primarily responsible for human traits, including health, behavior, and disease

Which choice best describes the purpose of most pharmacogenomic research?

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:

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:

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?

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?

Effects of findings on other family members

Which choice is the best definition of "genetic determinism?"

Genes are primarily responsible for human traits, including health, behavior, and disease