1.0Public Citizenhttps://www.citizen.orgDiane Krauthamerhttps://www.citizen.org/author/dkrauthamer/rich600338<blockquote class="wp-embedded-content" data-secret="p8SU1g9uTG"><a href="https://www.citizen.org/article/letter-opposing-draft-guidance-regarding-use-of-exculpatory-language-in-informed-consent-for-research/">Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research</a></blockquote><iframe sandbox="allow-scripts" security="restricted" src="https://www.citizen.org/article/letter-opposing-draft-guidance-regarding-use-of-exculpatory-language-in-informed-consent-for-research/embed/#?secret=p8SU1g9uTG" width="600" height="338" title="“Letter Opposing Draft Guidance Regarding Use of Exculpatory Language in Informed Consent for Research” — Public Citizen" data-secret="p8SU1g9uTG" frameborder="0" marginwidth="0" marginheight="0" scrolling="no" class="wp-embedded-content"></iframe><script type="text/javascript"> /* <![CDATA[ */ /*! This file is auto-generated */ !function(d,l){"use strict";l.querySelector&&d.addEventListener&&"undefined"!=typeof URL&&(d.wp=d.wp||{},d.wp.receiveEmbedMessage||(d.wp.receiveEmbedMessage=function(e){var t=e.data;if((t||t.secret||t.message||t.value)&&!/[^a-zA-Z0-9]/.test(t.secret)){for(var s,r,n,a=l.querySelectorAll('iframe[data-secret="'+t.secret+'"]'),o=l.querySelectorAll('blockquote[data-secret="'+t.secret+'"]'),c=new RegExp("^https?:$","i"),i=0;i<o.length;i++)o[i].style.display="none";for(i=0;i<a.length;i++)s=a[i],e.source===s.contentWindow&&(s.removeAttribute("style"),"height"===t.message?(1e3<(r=parseInt(t.value,10))?r=1e3:~~r<200&&(r=200),s.height=r):"link"===t.message&&(r=new URL(s.getAttribute("src")),n=new URL(t.value),c.test(n.protocol))&&n.host===r.host&&l.activeElement===s&&(d.top.location.href=t.value))}},d.addEventListener("message",d.wp.receiveEmbedMessage,!1),l.addEventListener("DOMContentLoaded",function(){for(var e,t,s=l.querySelectorAll("iframe.wp-embedded-content"),r=0;r<s.length;r++)(t=(e=s[r]).getAttribute("data-secret"))||(t=Math.random().toString(36).substring(2,12),e.src+="#?secret="+t,e.setAttribute("data-secret",t)),e.contentWindow.postMessage({message:"ready",secret:t},"*")},!1)))}(window,document); /* ]]> */ </script> Public Citizen strongly opposes the proposed draft guidance on exculpatory language in informed consent because, contrary to the Federal Register notice announcing the availability of this draft guidance document for comment (76 FR 55390) – which states that the Office for Human Research Protections and the Food and Drug Administration are seeking to “enhance human subjects protection” by “actively working to harmonize the agencies’ regulatory requirements and guidance for human subjects research” – the proposed guidance would weaken protections for human subjects.https://www.citizen.org/wp-content/uploads/public_citizen_shared_link.jpg1200628