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      Journalists, district attorneys and researchers: why IRBs should get in the middle

      research-article
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      BMC Medical Ethics
      BioMed Central

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          Abstract

          Background

          Federal regulations in the United States have shaped Institutional Review Boards (IRBs) to focus on protecting individual human subjects. Health services research studies focusing on healthcare institutions such as hospitals or clinics do not have individual human subjects. Since U.S. federal regulations are silent on what type of review, if any, these studies require, different IRBs may approach similar studies differently, resulting in undesirable variation in the review of studies focusing on healthcare institutions. Further, although these studies do not focus on individual human subjects, they may pose risks to participating institutions, as well as individuals who work at those institutions, if identifying information becomes public.

          Discussion

          Using two recent health services research studies conducted in the U.S. as examples, we discuss variations in the level of IRB oversight for studies focusing on institutions rather than individual human subjects. We highlight how lack of IRB guidance poses challenges for researchers who wish to both protect their subjects and work appropriately with the public, journalists or the legal system in the U.S. Competing interests include the public’s interest in transparency, the researcher’s interest in their science, and the research participants’ interests in confidentiality. Potential solutions that may help guide health services researchers to balance these competing interests include: 1) creating consensus guidelines and standard practices that address confidentiality risk to healthcare institutions and their employees; and 2) expanding the IRB role to conduct a streamlined review of health services research studies focusing on healthcare institutions to balance the competing interest of stakeholders on a case-by-case basis.

          Summary

          For health services research studies focusing on healthcare institutions, we outline the competing interests of researchers, healthcare institutions and the public. We propose solutions to decrease undesirable variations in the review of these studies.

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          Most cited references5

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          Access to subspecialty care for patients with mobility impairment: a survey.

          Adults who use wheelchairs have difficulty accessing physicians and receive less preventive care than their able-bodied counterparts. To learn about the accessibility of medical and surgical subspecialist practices for patients with mobility impairment. A telephone survey was used to try to make an appointment for a fictional patient who was obese and hemiparetic, used a wheelchair, and could not self-transfer from chair to examination table. 256 endocrinology, gynecology, orthopedic surgery, rheumatology, urology, ophthalmology, otolaryngology, and psychiatry practices in 4 U.S. cities. None. Accessibility of the practice, reasons for lack of accessibility, and planned method of transfer of the patient to an examination table. Of 256 practices, 56 (22%) reported that they could not accommodate the patient, 9 (4%) reported that the building was inaccessible, 47 (18%) reported inability to transfer a patient from a wheelchair to an examination table, and 22 (9%) reported use of height-adjustable tables or a lift for transfer. Gynecology was the subspecialty with the highest rate of inaccessible practices (44%). Small numbers of practices in 8 subspecialties in 4 cities and use of a fictional patient with obesity and hemiparesis limit generalizability. Many subspecialists could not accommodate a patient with mobility impairment because they could not transfer the patient to an examination table. Better awareness among providers about the requirements of the Americans with Disabilities Act and the standards of care for patients in wheelchairs is needed. None.
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            Availability of consumer prices from US hospitals for a common surgical procedure.

            Many proposals for health care reform incentivize patients to play a more active role in selecting health care providers on the basis of quality and price. While data on quality are increasingly available, availability of pricing data is uncertain.
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              Debriefing and accountability in deceptive research.

              Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception.
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                Author and article information

                Contributors
                anna.chodos@ucsf.edu
                sei.lee@ucsf.edu
                Journal
                BMC Med Ethics
                BMC Med Ethics
                BMC Medical Ethics
                BioMed Central (London )
                1472-6939
                29 March 2015
                29 March 2015
                2015
                : 16
                : 19
                Affiliations
                [ ]Division of General Internal Medicine, San Francisco General Hospital, Department of Medicine, University of California, San Francisco 1001 Potrero Avenue, San Francisco, CA USA
                [ ]Division of Geriatrics, University of California and San Francisco VA Medical Center, 4150 Clement Street, San Francisco, CA USA
                Article
                15
                10.1186/s12910-015-0015-y
                4392736
                680e1a5a-f574-4951-aa7b-0ec332543fb7
                © Chodos and Lee; licensee BioMed Central. 2015

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 7 February 2014
                : 17 March 2015
                Categories
                Debate
                Custom metadata
                © The Author(s) 2015

                Medicine
                Medicine

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