Can Investigator B use biological specimens for cancer research without re-consent if they are de-identified?

Study for the CITI Program Biomedical Research Exam. Utilize our resources with flashcards and multiple-choice questions, complete with hints and explanations. Prepare with confidence!

The correct answer highlights that if biological specimens are de-identified, they are no longer considered human subjects in the context of research ethics and regulations. When biospecimens are properly de-identified, this means that any identifying information has been removed or obscured to the extent that the individuals from whom the specimens were obtained cannot be readily ascertained. As a result, this means the research does not involve human subjects as defined by regulatory standards.

Because the specimens cannot be linked back to the individuals, there are no privacy concerns or risks of harm that would otherwise trigger the need for re-consent. This allows Investigator B to utilize these de-identified specimens in cancer research without the requirement of obtaining additional consent from the original donors.

Understanding this concept is crucial for compliance with ethical guidelines and regulations governing research involving human subjects. The implications of this answer emphasize the importance of maintaining anonymity and privacy in research to facilitate scientific inquiry while respecting individuals' rights.

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