U.S. Health Insurance Portability and Accountability Act (HIPAA)
Order Instructions:
formed Consent
The concept of informing participants of what they participating in during a research study along with informing them of all possible side-effects, or outcomes, of their participation has only been in place for the last 50 years. The Declaration of Helsinki was the first documentation to state that any research involving humans needs to include informed consent of participants.
Review the historic perspective studies listed in this week’s reading. Then summarize one of the following explaining its role in the development of ethical research practices:
Nazi War Crimes and the Nuremberg Code
Thalidomide Disaster
Tuskegee Syphilis Study
Beecher’s article “Ethics and Clinical Research”
Declaration of Helsinki
The Belmont Report of 1979
U.S. Health Insurance Portability and Accountability Act (HIPAA)
Jesse Gelsinger – Gene Therapy Trial
Ellen Roche – Asthma Study
SAMPLE ANSWER
U.S. Health Insurance Portability and Accountability Act (HIPAA)
The following discussion will indulge in examining the role of U.S. Health Insurance Portability and Accountability Act (HIPAA) in the development of ethical research practices. One of the roles of HIPAA in the development of ethical research practices is enhancing education of health care researchers and patients. HPPAA suggests that the ability to share patient information across the continuum of health care increases the responsibility to protect that information. According to Nass, Levit, Gostin and Institute of Medicine (U.S.) (2009), not only should patients be informed about the practices for the use and disclosure of their information, but they must also be given written consent to use and disclose the information for treatment, payment and health care operations. Another role of HIPAA in development of ethical research practices is protection of patients involved in the research from harm and preserving their rights as an essential to ethical research practice (Nass, Levit, Gostin & Institute of Medicine (U.S.), 2009). This is because ethical health research is vital to improving human health and health care. Therefore, HIPAA requires research to obtain individual authorization in all situations where the individual to be studied may want to disclose information for the research.
HIPAA also has a role in developing ethical research practices by condemning discrimination and all other vices in conduction health care research. In fact, HIPAA provides that ethical research practice can only be felt if strict punishments are offered to those researchers who do not abide by the provisions of HIPAA and Privacy Rules (Grove, Burns & Gray, 2013). HIPAA dictates that failure to observe the set standards in research can lead to severe civil or criminal penalties, which can be as high as $250,000, and/or prison terms of 10 years for those who sell, transfer, or use individually identifiable health information for commercial advantage, malicious harm, or for personal gain.
Reference
Grove, S. K., Burns, N., & Gray, J. (2013). The practice of nursing research: Appraisal, synthesis, and generation of evidence. St. Louis, Mo: Elsevier/Saunders.
Nass, S. J., Levit, L. A., Gostin, L. O., & Institute of Medicine (U.S.). (2009). Beyond the HIPAA privacy rule: Enhancing privacy, improving health through research. Washington, D.C: National Academies Press.
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