{"id":20,"date":"2018-04-16T23:42:12","date_gmt":"2018-04-16T23:42:12","guid":{"rendered":"https:\/\/www.iths.org\/rompethics\/?page_id=20"},"modified":"2018-12-27T15:09:58","modified_gmt":"2018-12-27T23:09:58","slug":"references","status":"publish","type":"page","link":"https:\/\/www.iths.org\/rompethics\/about-the-study\/references\/","title":{"rendered":"References"},"content":{"rendered":"<h2>Research\/Clinical Practice Integration\/Distinctions<\/h2>\n<ul>\n<li>Faden R, Kass N, Goodman S, Pronovost P, Tunis S, Beauchamp T. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.134\/full\" target=\"_blank\" rel=\"noopener\">An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics.<\/a> Hastings Center Report. 2013; 43: S16-S27.<\/li>\n<li>Grady C, Wendler D. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.137\/abstract\" target=\"_blank\" rel=\"noopener\">Making the transition to a learning health care system.<\/a> Hastings Center Report. 2013; 43: S32-S33.<\/li>\n<li>Kass N, Faden R, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.133\/full\" target=\"_blank\" rel=\"noopener\">The research-treatment distinction: A problematic approach for determining which activities should have ethical oversight.<\/a> Hastings Center Report. 2013; 43: S1-S15.<\/li>\n<li>Largent EA, Joffe S, Miller FG. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/j.1552-146X.2011.tb00123.x\/full\" target=\"_blank\" rel=\"noopener\">Can research and care be ethically integrated?<\/a> Hastings Center Report. 2011; 41: 37-46.<\/li>\n<li>Largent EA, Miller FG, Joffe S. Commentary. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.135\/full\" target=\"_blank\" rel=\"noopener\">A prescription for ethical learning.<\/a> Hastings Center Report. 2013; 43: S28-S29.<\/li>\n<li>Menikoff J. Commentary. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.136\/full\" target=\"_blank\" rel=\"noopener\">The unbelievable rightness of being in clinical trials.<\/a> Hastings Center Report. 2013; 43: S30-S31.<\/li>\n<li>Platt R, Grossmann C, Selker HP. Commentary. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.139\/full\" target=\"_blank\" rel=\"noopener\">Evaluation as part of operations: Reconciling the common rule and continuous improvement.<\/a> Hastings Center Report. 2013; 43: S37-S39.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>Ethical issues in Clinical Care<\/h2>\n<ul>\n<li>Braddock CH, Edwards KA, Hasenberg NM, Laidley TL, Levinson W. <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=192233\" target=\"_blank\" rel=\"noopener\">Informed decision making in outpatient practice: Time to get back to basics.<\/a> Journal of the American Medical Association. 1999; 282: 2313-2320.<\/li>\n<li>Modi N. <a href=\"http:\/\/www.bmj.com\/content\/346\/bmj.f3786\" target=\"_blank\" rel=\"noopener\">How not to reduce uncertainties in care.<\/a> British Medical Journal. 2013; 346: f3786.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>Ethical issues in Clinical Research<\/h2>\n<ul>\n<li>Fortune-Greeley AK, Hardy NC, Lin L, et al. <a href=\"http:\/\/www.researchgate.net\/publication\/42109055_Patient_reactions_to_confidentiality_liability_and_financial_aspects_of_informed_consent_in_cardiology_research\" target=\"_blank\" rel=\"noopener\">Patient reactions to confidentiality, liability, and financial aspects of informed consent in cardiology research.<\/a> Circulation: Cardiovascular Quality &amp; Outcomes. 2010; 3: 151-158.<\/li>\n<li>Gross CP, Krumholz HM, Van Wye G, Emanuel EJ, Wendler D. <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC1470665\" target=\"_blank\" rel=\"noopener\">Does random treatment assignment cause harm to research participants?<\/a> PLoS Medicine. 2006; 3: 800-808.<\/li>\n<li>Kirkby HM, Calvert M, McManus RJ, Draper H. <a href=\"http:\/\/www.plosone.org\/article\/info%3Adoi%2F10.1371%2Fjournal.pone.0076435\" target=\"_blank\" rel=\"noopener\">Informing potential participants about research: Observational study with an embedded randomized controlled trial.<\/a> PLOS ONE. 2013; 8: 1-8.<\/li>\n<li>Kraft SA, Constantine M, Magnus D, Porter KM, Lee SS, Green M, Kass NE, Wilfond BS, Cho MK. <a href=\"https:\/\/dx.doi.org\/10.1177\/1740774516669352\" target=\"_blank\" rel=\"noopener\">A randomized study of multimedia informational aids for research on medical practices: Implications for informed consent.<\/a> Clin Trials. 2017; 14: 94-102.<\/li>\n<li>Paris A, Brandt C, Cornu C, Maison P, Thalamas C, Cracowski JL. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/j.1365-2125.2009.03565.x\/full\" target=\"_blank\" rel=\"noopener\">Informed consent document improvement does not increase patients\u2019 comprehension in biomedical research.<\/a> British Journal of Clinical Pharmacology. 2009; 69: 231-237.<\/li>\n<li>Resnik DB, Patrone D, Peddada S. <a href=\"http:\/\/www.sciencedirect.com\/science\/article\/pii\/S1551714409001773\" target=\"_blank\" rel=\"noopener\">Evaluating the quality of information about alternatives to research participation in oncology consent forms.<\/a> Contemporary Clinical Trials. 2010; 31: 18-21.<\/li>\n<li>Shah A, Porter K, Juul S, Wilfond BS. <a href=\"https:\/\/dx.doi.org\/10.1080\/15265161.2015.1011007\" target=\"_blank\" rel=\"noopener\">Precluding consent by clinicians who are both the attending and the investigator: an outdated shibboleth?<\/a> Am J Bioeth. 2015; 15: 80-82.<\/li>\n<li>Vist GE, Bryant D, Somerville L, Birminghem T, Oxman AD. <a href=\"http:\/\/onlinelibrary.wiley.com\/store\/10.1002\/14651858.MR000009.pub4\/asset\/MR000009.pdf?v=1&amp;t=i16rn16s&amp;s=fb21b78ca4f88d1fc12f09ee52afcfef9f027d91\" target=\"_blank\" rel=\"noopener\">Outcomes of patients who participate in randomized controlled trials compared to similar patients receiving similar interventions who do not participate.<\/a> Cochrane Database of Systematic Reviews. 2008; issue 3, art. no. MR000009.<\/li>\n<li>Wilfond BS, Kraft SA. <a href=\"https:\/\/dx.doi.org\/10.1080\/15265161.2017.1388881\" target=\"_blank\" rel=\"noopener\">Attending to the Interrelatedness of the Functions of Consent.<\/a> Am J Bioeth. 2017; 17: 12-13.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>Ethical issues for Research on Medical Practices<\/h2>\n<ul>\n<li>Califf RM, Sugarman J. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/5\/436.long\" target=\"_blank\" rel=\"noopener\">Exploring the ethical and regulatory issues in pragmatic clinical trials.<\/a> Clin Trials 2015; 12: 436-441.<\/li>\n<li>Cho MK, Magnus D, Wilfond BS. <a href=\"https:\/\/dx.doi.org\/10.7326\/L15-5152-2\" target=\"_blank\" rel=\"noopener\">Informed Consent for Research on Medical Practices.<\/a> Ann Intern Med. 2015; 163: 725-726.<\/li>\n<li>Faden RR, Beauchamp TL, Kass NE. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMhle1313674\" target=\"_blank\" rel=\"noopener\">Informed consent, comparative effectiveness, and learning health care.<\/a> New England Journal of Medicine. 2014; 370: 766-768.<\/li>\n<li>Feudtner C, Schreiner M, Lantos JD. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp1309322\" target=\"_blank\" rel=\"noopener\">Risks (and benefits) in comparative effectiveness research trials.<\/a> New England Journal of Medicine. 2013; 369: 892-894.<\/li>\n<li>Kass N, Faden R, Tunis S. <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=1148159\" target=\"_blank\" rel=\"noopener\">Addressing low-risk comparative effectiveness research in proposed changes to US federal regulations governing research.<\/a> Journal of the American Medical Association. 2012; 307: 1589-90.<\/li>\n<li>Kim SYH, Miller FG. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMhle1312508\" target=\"_blank\" rel=\"noopener\">Informed consent for pragmatic trials\u2014the integrated consent model.<\/a> New England Journal of Medicine. 2014; 370: 769-772.<\/li>\n<li>Kim SY, Miller FG. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/6\/557.long\" target=\"_blank\" rel=\"noopener\">Ethical complexities in standard of care randomized trials: a case study of morning versus nighttime dosing of blood pressure drugs.<\/a> Clin Trials 2015; 12: 557-563.<\/li>\n<li>Kim SYH, Miller F. <a href=\"http:\/\/www.thehastingscenter.org\/Publications\/IRB\/Detail.aspx?id=7712\" target=\"_blank\" rel=\"noopener\">Waivers and alterations to consent in pragmatic clinical trials: respecting the principle of respect for persons.<\/a> IRB: Ethics &amp; Human Research 2016; 38: 1\u20135.<\/li>\n<li>Kraft SA, Porter KM, Shah SK, Wilfond BS. <a href=\"https:\/\/dx.doi.org\/10.1080\/15265161.2017.1328535\" target=\"_blank\" rel=\"noopener\">Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not.<\/a> Am J Bioeth. 2017; 17: 53-55.<\/li>\n<li>Kraft SA, Porter K, Wilfond BS, and the Research on Medical Practices Group. <a href=\"http:\/\/journalofethics.ama-assn.org\/2015\/12\/pfor2-1512.html\">Research on Medical Practices and the Patient-Physician Relationship: What Can Regulators Learn from Patients?<\/a> AMA Journal of Ethics. 2015; 17:1160-1165.<\/li>\n<li>Lantos JD. <a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/US-Research-Regulations-Do-They-Reflect-the-Views.pdf\" target=\"_blank\" rel=\"noopener\">U.S. Research Regulations: Do They Reflect the Views of the People They Claim to Protect?<\/a> Ann Intern Med. 2015 May 19;162(10):690-6.<\/li>\n<li>Lantos JD, D\u2019Angio C, Magnus D, Patrick-Lake B, Tyson J, and Wilfond B. <a href=\"http:\/\/www.thehastingscenter.org\/Bioethicsforum\/Post.aspx?id=7237&amp;blogid=140\" target=\"_blank\" rel=\"noopener\">OHRP\u2019s Dangerous Draft Guidance.<\/a> Bioethics Forum 12\/21\/2014<\/li>\n<li>Lantos JD, Wendler D, Septimus E, et al. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/5\/485.long\" target=\"_blank\" rel=\"noopener\">Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.<\/a> Clin Trials 2015; 12: 485-493.<\/li>\n<li>Magnus D, Wilfond BS. <a href=\"http:\/\/pediatrics.aappublications.org\/content\/135\/2\/208\" target=\"_blank\" rel=\"noopener\">Research on Medical Practices and the Ethics of Disclosure.<\/a> Pediatrics 2015; 135:2 208-210.<\/li>\n<li>Magnus D,\u00a0Wilfond B.\u00a0<a href=\"http:\/\/ctj.sagepub.com\/content\/12\/6\/564\" target=\"_blank\" rel=\"noopener\">Commentary on Kim Miller.<\/a>\u00a0Clin Trials. 2015 Dec; 12(6): 564-6.<\/li>\n<li>McKinney RE Jr,\u00a0Beskow LM,\u00a0Ford DE,\u00a0et al. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/5\/494.long\" target=\"_blank\" rel=\"noopener\">Use of altered informed consent in pragmatic clinical research.<\/a> Clin Trials\u00a02015; 12: 494-502.<\/li>\n<li>O\u2019Rourke PP, Carrithers J, Patrick-Lake B, et al. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/5\/449.long\">Harmonization and streamlining of research oversight for pragmatic clinical trials.<\/a> Clin Trials 2015; 12: 449-456.<\/li>\n<li>Platt R, Kass NE, McGraw D. <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=1848596\" target=\"_blank\" rel=\"noopener\">Ethics, regulation, and comparative effectiveness research: time for a change.<\/a> JAMA 2014; 311: 1497-1498.<\/li>\n<li>Sugarman J, Califf RM. <a href=\"http:\/\/jama.jamanetwork.com\/article.aspx?articleid=1871395\" target=\"_blank\" rel=\"noopener\">Ethics and regulatory complexities for pragmatic clinical trials.<\/a> JAMA 2014; 311: 2381-2382.<\/li>\n<li>Weiss EM, Joffe S. <a href=\"http:\/\/archpedi.jamanetwork.com\/article.aspx?articleid=2344552\" target=\"_blank\" rel=\"noopener\">Promoting informed decision making for comparative effectiveness randomized trials.<\/a>\u00a0JAMA Pediatr 2015; 169: 803-804.<\/li>\n<li>Wendler D. <a href=\"http:\/\/link.springer.com\/article\/10.1007%2Fs11606-014-3169-2\" target=\"_blank\" rel=\"noopener\">\u201cTargeted\u201d consent for pragmatic clinical trials.<\/a> J Gen Intern Med 2015; 30: 679-682.<\/li>\n<li>Whicher DM, Miller JD, Dunham KM, Joffe S. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/5\/442.long\" target=\"_blank\" rel=\"noopener\">Gatekeepers for pragmatic clinical trials.<\/a> Clin Trials 2015; 12: 442-448.<\/li>\n<li>Wilfond BS, Magnus DC. <a href=\"http:\/\/www.thehastingscenter.org\/Publications\/HCR\/Detail.aspx?id=7415\" target=\"_blank\" rel=\"noopener\">The potential harms and benefits from research on medical practices.<\/a> Hastings Cent Rep. 2015 May-Jun;45(3):5-6.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>The SUPPORT Trial<\/h2>\n<ul>\n<li>Drazen JM, Solomon CG, Greene MF. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMe1304996\" target=\"_blank\" rel=\"noopener\">Informed consent and SUPPORT.<\/a> New England Journal of Medicine. 2013; 368: 1929-1931.<\/li>\n<li>Lantos J. and Feudtner C. <a href=\"http:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hast.407\/abstract\" target=\"_blank\" rel=\"noopener\">SUPPORT and the Ethics of Study Implementation: Lessons for Comparative Effectiveness Research from the Trial of Oxygen Therapy for Premature Babies.<\/a> Hastings Center Report 45, no. 1 (2014): 30-40. DOI: 10.1002\/hast.407<\/li>\n<li>Macklin R, Shepherd L. <a href=\"http:\/\/www.tandfonline.com\/doi\/abs\/10.1080\/15265161.2013.849303#.VDhZedR4r68\" target=\"_blank\" rel=\"noopener\">Informed consent and standard of care: What must be disclosed.<\/a> American Journal of Bioethics. 2013; 13: 9-13.<\/li>\n<li>Macklin R, Shepherd L, Dreger A, et al. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/nejmc1308015\" target=\"_blank\" rel=\"noopener\">The OHRP and SUPPORT\u2014another view.<\/a> New England Journal of Medicine. 2013; 369: e3, 1-3.<\/li>\n<li>Magnus D, Caplan AL. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMp1305086\" target=\"_blank\" rel=\"noopener\">Risk, consent, and SUPPORT.<\/a> New England Journal of Medicine. 2013; 368: 1864-1865.<\/li>\n<li>Rich WD, Auten KJ, Gantz MG, et al. <a href=\"http:\/\/pediatrics.aappublications.org\/content\/126\/1\/e215.short\" target=\"_blank\" rel=\"noopener\">Antenatal consent in the SUPPORT trial: Challenges, costs, and representative enrollment.<\/a> Pediatrics. 2010; 126: 1-13.<\/li>\n<li>Wendler D. <a href=\"http:\/\/www.tandfonline.com\/doi\/abs\/10.1080\/15265161.2013.851578#.VDhZpdR4r68\" target=\"_blank\" rel=\"noopener\">What should be disclosed to research participants.<\/a> American Journal of Bioethics. 2013; 13: 3-8.<\/li>\n<li>Wilfond BS. <a href=\"http:\/\/www.tandfonline.com\/doi\/abs\/10.1080\/15265161.2013.851582#.VDrSEtR4r68\" target=\"_blank\" rel=\"noopener\">Quality improvement ethics: Lessons from the SUPPORT study.<\/a> American Journal of Bioethics. 2013; 13: 14-19.<\/li>\n<li>Wilfond BS, Magnus D, et al. <a href=\"http:\/\/www.nejm.org\/doi\/full\/10.1056\/NEJMc1307008\" target=\"_blank\" rel=\"noopener\">The OHRP and SUPPORT.<\/a> New England Journal of Medicine. 2013; 366: e36 1-3.<\/li>\n<li>U.S. Department of Health &amp; Human Services. <a href=\"http:\/\/www.hhs.gov\/ohrp\/newsroom\/rfc\/Public%20Meeting%20August%2028%2c%202013\/supportmeetingtranscriptfinal.html\" target=\"_blank\" rel=\"noopener\">Public Meeting: Matters Related to Protection of Human Subjects and Research Considering Standard of Care Interventions.<\/a> August 28, 2013.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>Regulations and Guidance<\/h2>\n<ul>\n<li>US Department of Health and Human Services. <a href=\"http:\/\/www.hhs.gov\/ohrp\/newsroom\/rfc\/comstdofcare.html\" target=\"_blank\" rel=\"noopener\">Draft guidance on disclosing reasonably foreseeable risks in research evaluating standards of care.<\/a> October 20, 2014.<\/li>\n<li>US Department of Health and Human Services. <a href=\"http:\/\/www.hhs.gov\/ohrp\/humansubjects\/regulations\/nprm2015summary.html\" target=\"_blank\" rel=\"noopener\">Notice of proposed rulemaking summary.<\/a> September 8, 2015.<\/li>\n<\/ul>\n<p>[vc_separator type=&#8217;normal&#8217; position=&#8217;center&#8217; color=&#8217;#eee&#8217; thickness=&#8217;2&#8242; up=&#8217;34&#8217; down=&#8217;33&#8217;]<\/p>\n<h2>Stakeholder attitudes about Research on Medical Practices<\/h2>\n<ul>\n<li>Anderson ML,\u00a0Califf RM,\u00a0Sugarman J;\u00a0participants in the NIH Health Care Systems Research Collaboratory Cluster Randomized Trial Workshop. <a href=\"http:\/\/ctj.sagepub.com\/content\/12\/3\/276.long\">Ethical and regulatory issues of pragmatic cluster randomized trials in contemporary health systems.<\/a> Clin Trials\u00a02015; 12: 276-286.<\/li>\n<li>Cho MK, Magnus D, Constantine M, Lee SS, Kelley M, Alessi S, et al. <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4776759\/pdf\/nihms743081.pdf\">Attitudes Toward Risk and Informed Consent for Research on Medical Practices: A Cross-sectional Survey<\/a> Ann Intern Med. 2015;162(10):731-732.<\/li>\n<li>Kelley M, James C, Kraft SA, Korngiebel D, Wijangco I, Joffe S, Cho MK, Wilfond B, Lee SS. <a href=\"https:\/\/dx.doi.org\/10.1080\/15265161.2015.1125967\" target=\"_blank\" rel=\"noopener\">The Role of Patient Perspectives in Clinical Research Ethics and Policy: Response to Open Peer Commentaries on &#8220;Patient Perspectives on the Learning Health System&#8221;<\/a>. Am J Bioeth. 2016; 16: W7-9.<\/li>\n<li>Kelley M, James C, Alessi Kraft S, Korngiebel D, Wijangco I, Rosenthal E, Joffe S, Cho MK, Wilfond B, Lee SS. <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/26305741\">Patient Perspectives on the Learning Health System: The Importance of Trust and Shared Decision Making.<\/a> Am J Bioeth. 2015 Sep;15(9):4-17.<\/li>\n<li>Kraft SA, Cho MK, Constantine M, Lee SS, Kelley M, Korngiebel D, James C, Kuwana E, Meyer A, Porter K, Diekema D, Capron AM, Alicic R, Wilfond BS, Magnus D. <a href=\"https:\/\/dx.doi.org\/10.1177\/1740774516648907\" target=\"_blank\" rel=\"noopener\">A comparison of institutional review board professionals&#8217; and patients&#8217; views on consent for research on medical practices.<\/a> Clinical Trials. 2016; 13: 555-565.<\/li>\n<li>Kraft SA, Porter KM, Korngiebel DM, James C, Constantine M, Kelley M, Capron AM, Diekema D, Lee SS, Cho MK, Magnus D, Wilfond BS. <a href=\"http:\/\/offcampus.lib.washington.edu\/login?url=http:\/\/search.ebscohost.com\/login.aspx?direct=true&amp;db=a9h&amp;AN=124037310&amp;site=ehost-live\" target=\"_blank\" rel=\"noopener\">Research on medical practices: Willingness to participate and the investigational misconception.<\/a> IRB: Ethics and Human Research. 2017; 39: 10-16.<\/li>\n<li>Lee SS, Kelley M, Cho M, et al. <a href=\"http:\/\/www.tandfonline.com\/doi\/full\/10.1080\/23294515.2016.1155674\" target=\"_blank\" rel=\"noopener\">Adrift in the gray zone: IRB perspectives on research in the learning health system.<\/a> AJOB Empirical Bioeth. 2016: 7.<\/li>\n<li>Nayak RK, Wendler D, Miller FG, Kim SY. <a href=\"http:\/\/annals.org\/article.aspx?articleid=2398906\" target=\"_blank\" rel=\"noopener\">Pragmatic randomized trials without standard informed consent?: a national survey.<\/a>\u00a0Ann Intern Med\u00a02015; 163: 356-364.<\/li>\n<li>Porter K, Cho MK, Kraft SA, Korngiebel DM, Constantine M, Lee SS, Kelley M, James C, Kuwana E, Meyer A, Diekema D, Capron AM, Magnus D, Wilfond BS. <a href=\"http:\/\/offcampus.lib.washington.edu\/login?url=http:\/\/search.ebscohost.com\/login.aspx?direct=true&amp;db=a9h&amp;AN=120590830&amp;site=ehost-live\" target=\"_blank\" rel=\"noopener\">Research on medical practices (ROMP): Attitudes of IRB personnel about randomization and informed consent.<\/a> IRB: Ethics &amp; Human Research. 2017: 39: 10-16.<\/li>\n<li>Whicher D, Kass N, Faden R. <a href=\"http:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Stakeholders%E2%80%99+views+of+alternatives+to+prospective+informed+consent+for+minimal-risk+pragmatic+comparative+effectiveness+trials\" target=\"_blank\" rel=\"noopener\">Stakeholders\u2019 views of alternatives to prospective informed consent for minimal-risk pragmatic comparative effectiveness trials.<\/a> J Law Med Ethics 2015; 43: 397-409.<\/li>\n<li>Whicher D, Kass N, Saghai Y, et al. <a href=\"http:\/\/jre.sagepub.com\/content\/10\/2\/132.long\" target=\"_blank\" rel=\"noopener\">The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight.<\/a> J Empir Res Hum Res Ethics 2015; 10: 132-144.<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Research\/Clinical Practice Integration\/Distinctions Faden R, Kass N, Goodman S, Pronovost P, Tunis S, Beauchamp T. An ethics framework for a learning health care system: A departure from traditional research ethics and clinical ethics. Hastings Center Report. 2013; 43: S16-S27. Grady C, Wendler D. Making the&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":188,"menu_order":20,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"class_list":["post-20","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/20","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/comments?post=20"}],"version-history":[{"count":11,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/20\/revisions"}],"predecessor-version":[{"id":326,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/20\/revisions\/326"}],"up":[{"embeddable":true,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/188"}],"wp:attachment":[{"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/media?parent=20"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}