Selection Bias
The process of implementation of the HIPAA Privacy Rule affects considerably data that has been gathered at the result of researches. Selection bias is one of those outcomes of data collection when all important information is gathered from one population subset but not from the representative of the entire population. As a rule, selection bias may happen at the hospitals with different rates. Some other characteristics of selection bias have been studied by Dunlop and his team, as a result of which it was discovered that not many people were actually willing to participate and influence the development of the events. This is why the lack of important data is still a problem in the sphere of medicine.
Efficiency in Research
To achieve positive results in investigating the outcomes of the Privacy Rule, it is very important to pay much attention to its efficiency. In fact, research efficiency usually depends on 5 factors such as combination of cost and time, recruitment of research participants, evaluation of IRB and its constant interpretations, international cooperation between sophisticated people, and finally the analysis of agreements that have to promote proper implementation of the Privacy Rule. Each of these terms has its own peculiarities and significant points that have to taken into consideration, and when researchers try to change any of these items during the implementation of the Privacy Rule, it is necessary to consider the influence of these changes on other terms as well.
Recruitment
Recruitment is one of the items that influence the above-discussed research efficiency. It is necessary to admit that the Privacy Rule has already made this issue more difficult from several perspectives, and one of them is the obligatory modification of hospital protocols to improve participation rates. The conditions of recruitment also undergo certain changes considering gender differentiation: much is discussed concerning women recruitment and almost nothing is told about male recruitment. Many researchers make numerous attempts to investigate why the rates of recruitment worsen within a short period of time and what conditions may positively influence its development. The analysis of these attempts has to be renewed from time to time to achieve better results and improve human health by means of research.
Abandoned Studies
There are a great amount of abandoned studies which have a certain connection to the Privacy Rule and its outcomes on society. The peculiar feature of these studies is the inability to differentiate what aspects have been already covered and which aspects need to be investigated deeper. The activities which are described in San Francisco Chronicle or in Star Tribune demonstrate the vast majority of researchers were abandoned because of inability to authorize information and continue its analysis in a proper to the studies way. Even more, some researchers admit that they cannot represent new studies and make up the shortages of already abandoned studies because of the conditions introduced by the existed Privacy Rule.
Deidentified Information
One of the powerful sides of the Privacy Rule under consideration is the exclusion of any deidentified information. Though some researchers admit that the presence of such information cannot considerably influence this rule, some problems still appear and lead to the development of doubts. This deidentified information is usually characterized by poor quality or difficulties in searching and continuation of research. In fact, many difficulties may appear on the first stages on researches because it becomes impossible to gain the necessary access to deidentified information. This is why one of the most significant points of the Privacy Rule is the limitation of deidentified information use in order to be able to conduct the necessary investigations on a proper level.
Authorization Process
The importance of the authorization process is also discussed by the Privacy Rule. It is stated that if researchers are eager to take an active participation in improvement of the chosen sphere, they have to authorize their work. Though some people face considerable challenges with the authorization process, they cannot avoid it and have to learn its peculiarities. First, it is necessary to define what authorization form is better to use. Second, the readability has to be taken into consideration. And finally, even language issues have to be considered to pass the authorization process successfully. This is why it is not a surprise that many researchers who have not had a deal with such processes before are confused now.
Concerns about Potential Legal Consequences
Nowadays, the vast majority of research institutions put themselves under the risk of being punished from the legal side. This is why the Privacy Rule focuses on certain legal consequences and the influence of researchers’ work from the legal perspective. People are guided by their fears of civil suits and IRB’s participation in these activities. The representatives from IRB continue making attempts to work on the penalties that have to be introduced before people start their research. This team of people is responsible for making proper decisions in time and according to the established rules. Only in case all requirements are met, legal consequences can never disturb researchers.
Reference List
Armstrong, D., Kline-Rogers, E., Jani, S.M., et al. (2005). Potential Impact of the HIPAA Privacy Rule on Data Collection in a Registry of Patients with Acute Coronary Syndrome. Archives of Internal Medicine, 165 (10): 1125-1129.
Claus et al. (2004). Conforming to HIPAA Regulations and Compilation of Research Data. American Journal of Health-System Pharmacy, 61 (10): 1025-1031.
Dunlop, A., T. Graham, Z. Leroy, K. Glanz, and B. Dunlop. 2007. The Impact of HIPAA Authorization on Willingness to Participate in Clinical Research. Annals of Epidemiology, 17(11):899–905
IOM. 2002. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press.
Lydon-Rochelle, M., and V. L. Holt. 2004. HIPAA Transition: Challenges of a Multisite Medical Records Validation Study of Maternally Linked Birth Records. Maternal & Child Health Journal, 8(1):35–38.
Nass, S.J., Levit, L.A., Gostin, L.O. (2009). Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Washington, DC: National Academy of Sciences.
Russell, S. (2004). Dispute on Medical Record Access Settled: Cancer Researchers Wanted UC Data on New Cases Quicker. San Francisco Chronicle, B1.