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On Being a Doctor |

Tripping on the HIPAA Hurdle

Robert F. Schilling, MD
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From University of Wisconsin School of Medicine and Public Health, Madison, WI 53706.

Note: A list of references may be obtained from the author.

Requests for Single Reprints: Robert F. Schilling, MD, Department of Medicine, University of Wisconsin School of Medicine and Public Health, 1300 University Avenue, Room 4285, Madison, WI 53706; e-mail, rfsmd@medicine.wisc.edu.

Ann Intern Med. 2011;154(2):133-134. doi:10.7326/0003-4819-154-2-201101180-00015
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There can be no doubt that chart reviews, clinical experiences, and other forms of retrospective data-gathering over the past century have contributed significantly to progress in medical science and practice. But I have learned that HIPAA has been and will continue to be a significant deterrent to this type of clinical research.





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Comment on Tripping the HIPAA hurdle
Posted on February 11, 2011
John A Hermos
VA Boston
Conflict of Interest: None Declared

Dr. Robert Shilling, in his article, "On Being a Doctor: Tripping on the HIPAA Hurdle" (Ann Intern Med. 2011:154:133-134) expresses his frustration at the regulatory hurdles (Catch-22's) faced in collecting and reporting clinical data from an unusual group of cases, a process he began well before current regulations for informed consent and HIPAA authorization. We are sympathetic to what he has endured. Without judging his past actions as an investigator or the rulings of his Institutional Review Board (IRB), we believe that "the middle ground" he seeks, to facilitate certain clinical studies while complying with the rules governing informed consent, exists in the authority given to IRBs (Human Subjects Committees or other so authorized Privacy or Ethics Committees). That authority is to determine the appropriate consent process, including granting a waiver of informed consent, if conditions specifically cited in Federal Regulations (38 CFR16.116(d)) are met.

In summary, the current Federal Regulations give IRBs the authority to waive requirements for written or oral informed consent, and accordingly HIPAA authorization, if the research conveys no more than minimal risk to subjects, will not affect their rights and welfare, could not be practically carried out without a waiver and that, when appropriate, subjects are provided information about the research after participation. Importantly, investigators must demonstrate that they will utilize appropriate means to secure personal identifiers and protected health information. Such waivers for documentation of informed consent and HIPAA authorization are readily granted by IRBs for retrospective, observational studies using administrative databases, but they may also be justified in selected studies of clinical samples when these conditions are met.

To achieve this "middle ground", thoughtful and reasoned dialogs between investigators and IRBs are necessary. Investigators need to propose a workable consent process, perhaps including a request for consent and HIPAA waivers, which best suits their study design and the protection of their study participants. As final arbitrators of whether and how consent must be obtained, IRBs need to exercise wisdom, courage, and the full use of options provided within the regulatory guidelines, to make decisions that facilitate, and not hinder, worthwhile, carefully conducted, observational research.

Conflict of Interest:

None declared

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