Research Article

Journal of Medical Systems

, Volume 30, Issue 1, pp 65-69

First online:

Barriers of HIPAA Regulation to Implementation of Health Services Research

  • Jay J. ShenAffiliated withDepartment of Health Administration, College of Health Professions, Governors State University Email author 
  • , Linda F. SamsonAffiliated withCollege of Health Professions, Governors State University
  • , Elmer L. WashingtonAffiliated withAunt Martha’s Youth Service Center
  • , Phyllis JohnsonAffiliated withCollege of Health Professions, Governors State University
  • , Constance EdwardsAffiliated withDepartment of Nursing, Governors State University
  • , Amy MaloneAffiliated withDepartment of Physical Therapy, Governors State University

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Although many perspectives on the impact of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) on health services research have been wide spread, little empirical evidence has been reported about HIPAA-related barriers during the implementation of research projects. Using three cases of health services research projects, this study examined practical barriers created by HIPAA regulation. During the stage of implementation of the three projects, we experienced some HIPAA-related concerns, previously raised in the field of health services research. We found that technically complicated consent forms and privacy protection forms as well as socially-sensitive clinical conditions make patients less willing to participate in research projects; concerns about safety of patient medical information makes health organizations more hesitant to let researchers have access to the patient’s information, especially through electronic transfer; more restrictive IRB processes and challenging patient recruiting processes make health services researchers reluctant to go through the process; and as a result, they may compromise with the scientific soundness of the project. Overall, HIPAA complicates the research process and requires more resources and longer time to conduct research.


HIPAA Health Services Research IRB Consent form