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Journalists, district attorneys and researchers: why IRBs should get in the middle
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. fe...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4392736/ https://www.ncbi.nlm.nih.gov/pubmed/25889147 http://dx.doi.org/10.1186/s12910-015-0015-y |
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author | Chodos, Anna H Lee, Sei J |
author_facet | Chodos, Anna H Lee, Sei J |
author_sort | Chodos, Anna H |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-4392736 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-43927362015-04-11 Journalists, district attorneys and researchers: why IRBs should get in the middle Chodos, Anna H Lee, Sei J BMC Med Ethics Debate 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. BioMed Central 2015-03-29 /pmc/articles/PMC4392736/ /pubmed/25889147 http://dx.doi.org/10.1186/s12910-015-0015-y Text en © 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. |
spellingShingle | Debate Chodos, Anna H Lee, Sei J Journalists, district attorneys and researchers: why IRBs should get in the middle |
title | Journalists, district attorneys and researchers: why IRBs should get in the middle |
title_full | Journalists, district attorneys and researchers: why IRBs should get in the middle |
title_fullStr | Journalists, district attorneys and researchers: why IRBs should get in the middle |
title_full_unstemmed | Journalists, district attorneys and researchers: why IRBs should get in the middle |
title_short | Journalists, district attorneys and researchers: why IRBs should get in the middle |
title_sort | journalists, district attorneys and researchers: why irbs should get in the middle |
topic | Debate |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4392736/ https://www.ncbi.nlm.nih.gov/pubmed/25889147 http://dx.doi.org/10.1186/s12910-015-0015-y |
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