Question

Select the statement that best describes HIPAA's stance in regard to human subjects' research and informed consent?

a. HIPAA does not addressed informed consent and human subjects research
b. HIPAA allows an organization's IRB to combine informed consent with authorization for use and disclosure of a research subject's health information
c. HIPAA requires only one informed consent to be used in human subjects research
d. None of the options are correct

Answer 1

HIPAA permits an organization's IRB to combine informed consent with HIPAA authorization for use and disclosure of a research subject's health information. HIPAA requires careful handling and documentation of informed consent, particularly when dealing with health information in research.

Step-by-step explanation:

The statement that best describes HIPAA's stance in regard to human subjects' research and informed consent is: HIPAA allows an organization's IRB to combine informed consent with authorization for use and disclosure of a research subject's health information. This means that an Institutional Review Board (IRB) may approve a consent form that includes both the general informed consent for research participation and specific authorization under HIPAA for the use and disclosure of the individuals' protected health information for research purposes.

HIPAA, or the Health Insurance Portability and Accountability Act, requires that especial care is taken when health information is used or disclosed for research purposes. This includes ensuring that the subject has been fully informed and has agreed, in writing, to how their health information will be used in the research context. Thus, the informed consent process is of critical importance and must be documented carefully.