Author Question: Which of the following statements are true? (Select all that apply.) a. HIPAA regulations were ... (Read 74 times)

madam-professor · **on:** Jul 8, 2018

Which of the following statements are true? (Select all that apply.)

a. HIPAA regulations were formulated to address ethical treatment of research subjects.
b. If electronic medical records had not been invented, HIPAA would not have been necessary.
c. Data held by health insurance companies sparked the emergence of HIPAA.
d. Ethics and HIPAA regulations overlap in the area of justice.
e. Ethics and HIPAA regulations overlap in the area of anonymity.

Question 2

Monica is a nurse researcher. She completes her paperwork for an institutional review board (IRB). Her application for approval is returned to her, with comments as to how it should be revised and resubmitted.

Which of the following comments are within the scope of the IRB? (Select all that apply.)
a. You have failed to provide a copy of your survey. Please do so.
b. Your study protocol does not provide information on potential risks to anonymity. Please indicate this in Section 1g.
c. Because of inexperience in this area, the IRB invites you to meet with us as one of the reviewers of this protocol.
d. We can only provide provisional approval of your study.
e. You have not included information about the risk-to-benefit ratio of this research. Please do so.

bulacsom · **Reply #1 on:** Jul 8, 2018

Answer to Question 1

ANS: B, C, E
One of the more recent regulations, the Health Insurance Portability and Accountability Act (HIPAA), was enacted in 2003 to protect the privacy of an individual's health information and was necessitated by the electronic storage and exchange of health information. The principle of justice holds that human subjects should be treated fairly. Anonymity exists if the subject's identity cannot be linked, even by the researcher, with his or her individual responses.

Answer to Question 2

ANS: A, B, E
An institutional review board (IRB) is a committee that reviews research to ensure that the investigator is conducting the research ethically. Universities, hospital corporations, and many managed care centers have IRBs to promote the conduct of ethical research and protect the rights of prospective subjects at these institutions. Each IRB has at least five members of various backgrounds (cultural, economic, educational, gender, racial) to promote a complete, scholarly, and fair review of research that is commonly conducted in an institution. If an institution regularly reviews studies with vulnerable subjects, such as children, neonates, pregnant women, prisoners, and mentally disabled persons, the IRB should include one or more members with knowledge about and experience in working with these individuals. The members must have sufficient experience and expertise to review a variety of studies, including quantitative, outcomes, intervention, and qualitative research (Munhall, 2012b). The IRB members must not have a conflicting interest related to a study conducted in an institution. Any member having a conflict of interest with a research project being reviewed must excuse himself or herself from the review process, except to provide information requested by the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB such as require revision of a study protocol or study documents and disapproval of the research. The IRB reviews research in progress at least yearly.