Following 2 case reports about the potential for allopurinol to improve outcomes in patients with congestive heart failure, a research team plans a study to test this association. An investigation is undertaken at a hospital to systematically evaluate if patients taking allopurinol for gout are hospitalized less frequently for exacerbations of congestive heart failure. Community physicians are asked by the principal investigator to refer appropriate patients for the study.
Which of the following will help ensure protection of the patients' right to privacy with respect to their personal health information?

Question

Following 2 case reports about the potential for allopurinol to improve outcomes in patients with congestive heart failure, a research team plans a study to test this association.  An investigation is undertaken at a hospital to systematically evaluate if patients taking allopurinol for gout are hospitalized less frequently for exacerbations of congestive heart failure.  Community physicians are asked by the principal investigator to refer appropriate patients for the study.
Which of the following will help ensure protection of the patients' right to privacy with respect to their personal health information?

Quizplus · Accepted Answer

In 1996, the US Congress passed the Health Insurance Portability and Accountability Act (HIPAA), which regulates the use and disclosure of individually identifiable health care information. This protection extends to research subjects, and study designs must include measures to help safeguard the privacy of personal health information for study subjects. Research investigators must ensure that patient confidentiality will be protected and that patient identity will not be disclosed to third parties or appear in any study reports or publications. Avoiding the use of such information as actual names and social security numbers by using de-identified patient information (eg, assigning a unique study number to each patient) helps ensure patient privacy. (Choice A) A prospective, randomized, double-blind clinical trial is the most robust of all study designs as it avoids inherent biases encountered in observational studies, such as retrospective chart reviews. However, this study design will not ensure patient privacy. (Choices B and C) All study subjects should be allowed sufficient time to read the informed consent form, which details the risks and benefits of the study. They must be given the opportunity to ask questions, including those regarding confidentiality, and must be free and willing to participate. However, it is the responsibility of the research investigator to protect their personal health information. (Choice D) Although patients should be informed that data from their records is being used for study, they should be assured that their privacy will be maintained through de-identification. Educational objective: Patients have rights to privacy, and their personal health information is protected by the Health Insurance Portability and Accountability Act (HIPAA). In research studies, de-identifying patients by assigning a unique study number helps ensure confidentiality. __________ References: HIPAA compliance and patient privacy protection. (http://www.ncbi.nlm.nih.gov/pubmed/20841812) The importance of context: risk-based de-identification of biomedical data. (http://www.ncbi.nlm.nih.gov/pubmed/27322502)

Following 2 Case Reports About the Potential for Allopurinol to Improve