0

The full content of Annals is available to subscribers

Subscribe/Learn More  >
On Being a Doctor |

Tripping on the HIPAA Hurdle

Robert F. Schilling, MD
[+] Article and Author Information

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
Text Size: A A A

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.

Figures

Tables

References

Letters

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Comments

Submit a Comment
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

Submit a Comment

Summary for Patients

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

Toolkit

Buy Now

to gain full access to the content and tools.

Want to Subscribe?

Learn more about subscription options

Advertisement
Topic Collections
Forgot your password?
Enter your username and email address. We'll send you a reminder to the email address on record.
(Required)
(Required)