Recent reports indicate that the Health Insurance Portability and Accountability Act (HIPAA) that went into effect in 2003 has adversely affected clinical trial conduct by (a) increasing researchers’ administrative burden; (b) increasing overall trial conduct costs; (c) delaying initial project approval; (d) hampering medical record and registry research, and most critical; (e) impeding clinical trial recruiting and retention,¹ which in turn has deterred locating patients lost-to-follow-up (LTFU).

Subsequent to our recent post that focused on these factors that hinder the conduct of clinical trials as a consequence of the HIPAA, this commentary will serve as the first of several that will discuss strategies to enhance recruitment, retention, and finding patients LTFU based on evolving interpretations of the HIPAA regulations.  

The first of these series will focus on initial procedural practices to facilitate participant recruitment–considered the most difficult aspect of the research process¹–and made even more difficult due to HIPPA.  Estimates reported in 2003, before HIPAA- impact, indicated that 85% of trials do not finish as scheduled because:

• There is low participant accrual.
• Sixty to eighty percent of clinical trials do not meet their chronological endpoints because of challenges in recruitment.
• Thirty percent of trial sites fail to recruit even a single participant.²

Despite the burden that the HIPAA privacy rule has placed on participant recruitment, retention and finding patients lost to follow-up (LTFU), deliberation of the seemingly logical intent of these regulations, along with prior planning, can facilitate clinical research efforts.  Consider one initial important process in study planning–preparatory research.  It is a necessity to identify potential sample populations available for recruitment and estimate those who will meet inclusion criteria.³   This task obviously requires the need to review individuals’ health information and the ability to subsequently contact these respective individuals.

Pre-HIPAA, these activities were not regulated by the Investigation Review Board (IRB), however, in the post-HIPAA era accessing this information– protected health information(PHI)–requires IRB or privacy board approval.⁴

Keeping in mind that logic must prevail, the initial fears of HIPAA caused institutes not to allow medical record access without patient consent.  This led to increased interruption in recruiting patients, and following the realization of no patients, no study interpretations, were adjusted to allow HIPAA waivers of authorization to facilitate this process.

Although logical interpretation can reign in situations of HIPAA non-clarification/guidance, abiding to regulatory standards such as completing a Preparatory to Research form and submitting to the local IRB or privacy board has been clearly confirmed.  The form must answer the following questions:   

• What is the purpose of the review?
• What PHI will be used or disclosed?
• Why is the PHI necessary for the research?
• Where is the information located?
• How will the information be assessed and by whom? ³

Only the minimal PHI from the covered entity (i.e., health plan, health care clearinghouse, or health care provider who transmits any health information in connection with a HIPAA transaction) is utilized to answer the questions on the form.  If no treatment relationship exists between the institute and prospective participants, the institute should work with the hospital or clinic staff to contact potential trial participants identified in the preparatory research. ³

Because the challenges imposed by HIPAA for recruitment, retention, and finding patients lost to follow-up (LTFU) are ambiguous, logical interpretation and processes must guide the clinical trial conduct process until further clarification and guidance are made available.

Our next post will focus on processes compliant to initial contact of participants and the consent process.

References:

1. Blanton, B. et al. Lessons learned in participant recruitment and retention: The EXCITE Trial. Physical Therapy. 2006; 86: 1520-1533.

 2. Nitkin R. Patient recruitment strategies. Training workshop conducted by National Institutes of Health, Bethesda, MD, 2003.

 3. 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.

 4. U.S. Department of Health and Human Services. (2004). Protecting personal health information in research: Understanding the HIPAA privacy rule. Retrieved March 15, 2006, from http://privacyruleandresearch.nih.gov/HIPAA_Booklet_4-14-2003.rtf

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Please share your thoughts regarding our post.  Also, please email or call us with any questions you have about our OmniTrace Corp. patient search and patient retention services:

dave@omnitrace.com (Dave Betz)
888-965-6696

THE CONTENT ON OUR OMNITRACE OWNED WEBSITES IS MERELY GENERAL INFORMATION OBTAINED BY ORDINARY PEOPLE AND NOT LEGAL ADVICE.  ONLY A QUALIFIED LAWYER CAN GIVE LEGAL ADVICE.  WE ARE NOT LAWYERS.