{"id":10,"date":"2018-04-16T23:39:51","date_gmt":"2018-04-16T23:39:51","guid":{"rendered":"https:\/\/www.iths.org\/rompethics\/?page_id=10"},"modified":"2018-12-27T15:27:29","modified_gmt":"2018-12-27T23:27:29","slug":"study-details","status":"publish","type":"page","link":"https:\/\/www.iths.org\/rompethics\/about-the-study\/study-details\/","title":{"rendered":"Study Details"},"content":{"rendered":"<div class=\"wpb-content-wrapper\"><p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text]<strong>We are conducting interviews and surveys with professionals who review research and with members of the public.<\/strong><\/p>\n<p>Our study will help policy makers to make recommendations about how to conduct Research on Medical Practices ethically and how to communicate with patients about it.<\/p>\n<p><strong>Main study questions:<\/strong><\/p>\n<ul>\n<li>What do people think about the risks and benefits of Research on Medical Practices?<\/li>\n<li>What do people think about different approaches to letting patients know this type of research is being conducted?<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][vc_column width=&#8221;1\/2&#8243;][vc_video link=&#8221;https:\/\/www.youtube.com\/watch?v=sW3M4_urt4E&#8221;][vc_empty_space height=&#8221;14px&#8221;]<div id=\"modal-trg-txt-wrap-1470\" class=\"ult-modal-input-wrapper ult-adjust-bottom-margin    \" data-keypress-control=\"keypress-control-enable\" data-overlay-control=\"overlay-control-enable\"><button  data-ultimate-target='#modal-trg-txt-wrap-1470 .btn-modal'  data-responsive-json-new='{\"font-size\":\"\",\"line-height\":\"\"}'  style=\"background:#333333;border-color:#333333;color:#ffffff; 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width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p>\n\t\t\t<\/div>\n\t<\/div>\n\t<\/div>\n\t<div class=\"ult-overlay-close top-right\" style=\"width:80px;height:80px; \"><div class=\"ult-overlay-close-inside\">Close<\/div><\/div>\n<\/div>[vc_empty_space height=&#8221;14px&#8221;][\/vc_column][\/vc_row][vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column][vc_separator type=&#8221;normal&#8221; thickness=&#8221;1&#8243; up=&#8221;16&#8243; down=&#8221;15&#8243;][\/vc_column][\/vc_row][vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column][vc_column_text]<strong>Study Progress<\/strong><\/p>\n<p>The ROMP Ethics Study began in October 2013. Completed and planned milestones are listed below.[\/vc_column_text][vc_empty_space][vc_tabs style=&#8221;boxed&#8221;][vc_tab title=&#8221;Completed Activities&#8221; tab_id=&#8221;bb978c50-56fd-7&#8243;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_column_text]<\/p>\n<h5>Completed Activities<\/h5>\n<p>[\/vc_column_text][unordered_list style=&#8221;circle&#8221; animate=&#8221;no&#8221;]<\/p>\n<ul class=\"checkmark primary\">\n<li>Conducted focus groups with IRB members at the University of Washington, Seattle Children\u2019s, and Stanford.<\/li>\n<li>Developed a survey for professionals who review research<\/li>\n<li>In collaboration with Public Responsibility in Medicine and Research (PRIM&amp;R), surveyed a sample of PRIM&amp;R members.<\/li>\n<li>In collaboration with Booster Shot Media, developed three informational videos for use in public surveys.<\/li>\n<li>Conducted focus groups with patients and parents at the University of Washington, Seattle Children\u2019s, and Stanford.<\/li>\n<li>Developed a survey for patients and the general public.<\/li>\n<li>In collaboration with Turner Research, surveyed a nationally representative population group<\/li>\n<li>In collaboration with Providence Health System, surveyed patients who receive specialty medical care in Spokane, Washington (Jan-April 2015).<\/li>\n<li>Further explored issues of risk, consent, and willingness to participate via phone interviews with 25 of the Spokane survey participants (May 2015).<\/li>\n<li>In collaboration with Survey Sampling International, conducted 45 cognitive interviews to evaluate and improve survey questions (Aug-Oct 2015).<\/li>\n<li>In collaboration with Survey Sampling International, developed a revised\u00a0population survey to evaluate impact of our\u00a0animated narrative video on knowledge and attitudes compared to illustrated narrative (comics),\u00a0informational video,\u00a0and text information (Oct-Nov 2015).<\/li>\n<\/ul>\n<p>[\/unordered_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][vc_tab title=&#8221;Planned Activities&#8221; tab_id=&#8221;1523926226626-2-9&#8243;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_column_text]<\/p>\n<h5>Planned Activities<\/h5>\n<p>[\/vc_column_text][unordered_list style=&#8221;circle&#8221; animate=&#8221;no&#8221;]<\/p>\n<ul class=\"arrow primary\">\n<li>Publish our finding to inform policy recommendations to the <a href=\"http:\/\/www.hhs.gov\/ohrp\/about\/index.html\" target=\"_blank\" rel=\"noopener\">U.S. Office for Human Research Protections<\/a> (OHRP).<\/li>\n<\/ul>\n<p>[\/unordered_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][vc_tab title=&#8221;Instruments&#8221; tab_id=&#8221;1523926269603-2-6&#8243;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_column_text]<\/p>\n<h5>Study Instruments<\/h5>\n<p>[\/vc_column_text][unordered_list style=&#8221;circle&#8221; animate=&#8221;no&#8221;]<\/p>\n<ul>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/IRB-Focus-Group-Guide.pdf\" target=\"_blank\" rel=\"noopener\">IRB Focus Group Guide<\/a><\/li>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/Patient-Focus-Group-Guide.pdf\" target=\"_blank\" rel=\"noopener\">Patient Focus Group Guide<\/a><\/li>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/Patient-Survey.pdf\" target=\"_blank\" rel=\"noopener\">General Population and Patient Survey<\/a><\/li>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/PRIMR-Survey.pdf\" target=\"_blank\" rel=\"noopener\">PRIM&amp;R Member Survey<\/a><\/li>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/ROMP-greenwall-survey-instrument.pdf\" target=\"_blank\" rel=\"noopener\">Greenwall Study Survey Instrument<\/a><\/li>\n<li><a href=\"https:\/\/www.iths.org\/rompethics\/wp-content\/uploads\/sites\/26\/ROMP-greenwall-plain-text.pdf\" target=\"_blank\" rel=\"noopener\">Greenwall Study \u2013 Plain Text<\/a><\/li>\n<li class=\"hide\"><a href=\"https:\/\/rompethics.iths.org\/study-details\/greenwall-grant-narrated-slideshows\/\">Greenwall Study \u2013 Narrated Slideshows<\/a><span class=\"highlight\"> &#8211; Links to page that doesn&#8217;t exist for reference: https:\/\/rompethics.iths.org\/study-details\/greenwall-grant-narrated-slideshows\/<\/span><\/li>\n<li class=\"hide\"><a href=\"https:\/\/rompethics.iths.org\/study-details\/greenwall-grant-comics\/\">Greenwall Study \u2013 Comics<\/a><span class=\"highlight\"> &#8211; Links to page that doesn&#8217;t exist for reference: https:\/\/rompethics.iths.org\/study-details\/greenwall-grant-comics\/<\/span><\/li>\n<\/ul>\n<p>[\/unordered_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][vc_tab title=&#8221;Publications&#8221; tab_id=&#8221;1523926310630-3-2&#8243;][vc_row_inner row_type=&#8221;row&#8221; type=&#8221;full_width&#8221; text_align=&#8221;left&#8221; css_animation=&#8221;&#8221;][vc_column_inner][vc_column_text]<\/p>\n<h5>Study Publications<\/h5>\n<p>[\/vc_column_text][unordered_list style=&#8221;circle&#8221; animate=&#8221;no&#8221;]<\/p>\n<ul class=\"arrow primary\">\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>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\" target=\"_blank\" rel=\"noopener\">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>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<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>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>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\" target=\"_blank\" rel=\"noopener\">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>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>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\" target=\"_blank\" rel=\"noopener\">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>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>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>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>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>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>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>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>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>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>[\/unordered_list][\/vc_column_inner][\/vc_row_inner][\/vc_tab][\/vc_tabs][\/vc_column][\/vc_row][vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column][vc_empty_space][\/vc_column][\/vc_row][vc_row css_animation=&#8221;element_from_fade&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221; el_class=&#8221;box&#8221; z_index=&#8221;&#8221;][vc_column][vc_column_text]<strong>References and Resources<\/strong><\/p>\n<ul>\n<li><a href=\"https:\/\/www.iths.org\/?p=16118\" target=\"_blank\" rel=\"noopener\">RoMP Study Assesses Public Acceptability of Research Policies<\/a> \u2013 ITHS News (May 22, 2014)<\/li>\n<li class=\"hide\"><a href=\"http:\/\/www.seattlechildrens.org\/research\/initiatives\/bioethics\/research\/assessing-public-attitudes-research-medical-practices\/\" target=\"_blank\" rel=\"noopener\">SUPPORT Trial Sparks National Debate on Risk to Research Participants<\/a> \u2013 Seattle Children\u2019s Hospital<span class=\"highlight\"> &#8211; Link no longer exists<\/span><\/li>\n<li><a href=\"http:\/\/med.stanford.edu\/news\/all-news\/2014\/09\/videos-explain-concepts-of-clinical-research.html\" target=\"_blank\" rel=\"noopener\">Videos explain concepts of clinical research<\/a> \u2013 Stanford Medicine (Sept. 19, 2014)<\/li>\n<li><a href=\"http:\/\/med.stanford.edu\/news\/all-news\/2015\/04\/recruiting-patients-for-research-needs-simple-queries.html\" target=\"_blank\" rel=\"noopener\">Recruiting patients for research? Simple explanations, queries from doctors are best<\/a> \u2013 Stanford Medicine (April 13, 2015)<\/li>\n<li><a href=\"https:\/\/www.iths.org\/?p=19782\" target=\"_blank\" rel=\"noopener\">Study Finds Public Support for Research on Medical Practices<\/a> \u2013 ITHS News (April 14, 2015)<\/li>\n<li><a href=\"https:\/\/www.iths.org\/?p=22191\" target=\"_blank\" rel=\"noopener\">ITHS Study Supports Policy Forum Article in AMA Journal of Ethics<\/a> &#8211; ITHS News (December 2, 2015)<\/li>\n<\/ul>\n<p>[\/vc_column_text][\/vc_column][\/vc_row]<\/p>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>[vc_row css_animation=&#8221;&#8221; row_type=&#8221;row&#8221; use_row_as_full_screen_section=&#8221;no&#8221; type=&#8221;full_width&#8221; angled_section=&#8221;no&#8221; text_align=&#8221;left&#8221; background_image_as_pattern=&#8221;without_pattern&#8221;][vc_column width=&#8221;1\/2&#8243;][vc_column_text]We are conducting interviews and surveys with professionals who review research and with members of the public. Our study will help policy makers to make recommendations about how to conduct Research on Medical Practices ethically and how&#8230;<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":188,"menu_order":10,"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-10","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/10","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=10"}],"version-history":[{"count":26,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/10\/revisions"}],"predecessor-version":[{"id":328,"href":"https:\/\/www.iths.org\/rompethics\/wp-json\/wp\/v2\/pages\/10\/revisions\/328"}],"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=10"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}