Clinical Trial Conduct

Assuring full compliance of guidelines mandated by governing authorities is critical to conducting successful clinical trial research and to subsequent product approval.  The federal government’s medical privacy rule, the Health Insurance Portability and Accountability Act (HIPAA), that went into effect in 2003 is such a mandate.  It has greatly impacted the conduct of clinical trials, however, not in a favorable way.  The focus of this post is to highlight various factors that have hindered the conduct of clinical trials as a consequence of rules imposed by HIPAA.

HIPAA of 1996 included a major provision that required covered entities (hospitals, physicians, health plans, and other entities that handle patient information) to obtain confidentiality documentation from researchers before disclosing health data.  This section of the law, which took effect as part of the overall medical privacy law in April 2003, was intended to ensure that patients’ protected health information (PHI) would not be inappropriately disclosed or used during the course of a research trial.¹

In the wake of implementation of this rule, researchers have reported that HIPAA is hindering research by increasing administrative burden so that the additional paperwork required to obtain a patients’ consent to participate in clinical research trials has caused enrollment to plummet by as much as 50% in one research institute alone.  Several different research institutions have report similar situations.¹  In fact, nearly three quarters (72%) of 331 U.S. investigators polled by the Association of American Medical Colleges reported that HIPAA was having an adverse effect on clinical research during the first six months after its implementation.  Negative effects on patient recruitment, data access, and data acquisition were cited by more than 68% of the respondents.¹

Recent reports have indicated that HIPAA has not only adversely affected clinical trial recruiting but also retention, ² which in turn has thwarted finding patients lost to follow-up (LTFU).  As recruiting and retaining an adequate sample is critical to the success of clinical research trials, the fact that HIPAA has adversely affected this research is discouraging.  However, even more daunting is that few resources are available to assist researchers in delineating the challenges imposed by HIPAA for recruitment and retention, and there is a lack of guidance by the U.S. Department of Health and Human Services (HHS) on how to interpret this provision and the resulting variability in approaches by research institutions.²  

Further, it is unclear when and how researchers can access and use data concerning an individual who drops out of a clinical study and becomes LTFU.  This is particularly important for pharmacovigilance initiatives if the withdrawal relates to an adverse event or other development affecting the safety or efficacy of a drug under study.¹

 While these issues have been brought to the attention of the HHS and advisory committees have been put into place, currently there has been no public clarification.  As the aim in clinical research is to protect individual privacy, researchers have urged the HHS to design policies that that will encourage clinical trial investigators to protect confidentiality by educating on how to appropriately record and publish data versus developing so many detailed rules that make critical research excessively costly and burdensome to undertake. ¹

1. Nosowsky, R.et al.  Ann Epidemiol. 2005; 57: 15:85-86

2. Wipke-Tevis, D. Impact of the Health Insurance Portability and Accountability Act on participant recruiting and retention. Western Journal of Nursing. 2008;30: 399-53.

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