{"id":4466,"date":"2024-01-08T14:12:19","date_gmt":"2024-01-08T19:12:19","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4466"},"modified":"2026-09-09T17:30:11","modified_gmt":"2026-09-09T21:30:11","slug":"key-information","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/key-information\/","title":{"rendered":"Key Information"},"content":{"rendered":"<p>One of the general requirements for informed consent defined by <a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.116\">45 CFR 46<\/a> is the presentation of \u2018key information\u2019 at the start of the consent form; the regulations state:<\/p>\n","protected":false},"excerpt":{"rendered":"<p>One of the general requirements for informed consent defined by 45 CFR 46 is the presentation of \u2018key information\u2019 at the start of the consent form; the regulations state:<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":4386,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-4466","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Key Information and Informed Consent","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"","card_text":"\u201c<em>Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.\u201d<\/em>","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0","title":"","content":"While <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/requests-for-comments\/draft-guidance-key-information-facilitating-understanding-informed-consent\/index.html\">draft guidance<\/a> from the Department of Health and Human Service\u2019s Office for Human Research Protections (OHRP) on this requirement is currently under review, the <a class=\"u-link-external\" href=\"https:\/\/www.govinfo.gov\/content\/pkg\/FR-2017-01-19\/pdf\/2017-01058.pdf\">preamble to the final rule<\/a> indicates that this requirement can be satisfied by including a brief description of the following at the beginning of a consent form:\r\n<ul>\r\n \t<li>\u201cthe fact that consent is being sought for research and that participation is voluntary;<\/li>\r\n \t<li>the purposes of the research, the expected duration of the prospective subject\u2019s participation, and the procedures to be followed in the research;<\/li>\r\n \t<li>the reasonably foreseeable risks or discomforts to the prospective subject;<\/li>\r\n \t<li>the benefits to the prospective subject or to others that may reasonably be expected from the research; and<\/li>\r\n \t<li>appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.\u201d<\/li>\r\n<\/ul>\r\nBased on this recommendation, the <a href=\"https:\/\/www.rochester.edu\/ohsp\/templates\/#consent\">IRB\u2019s consent templates<\/a> include \u2018key information\u2019 bullet points.\u00a0<strong>The key to utilizing the \u2018key information\u2019 template is to bear in mind that the bullet points are guidance only<\/strong>; bullet points may be added or removed as necessary based on the nature of the research.\r\n\r\nWhen drafting consent forms, study teams should strive for a \u2018happy\u2019 balance between meeting the additional requirements, without creating significant duplication or making the consent form unnecessarily long or more complex. <strong>The goal of the \u2018key information\u2019 is to facilitate decision-making by providing critical information to the subject \u2018up front\u2019.<\/strong>\r\n<h4>higher risk or more involved research<\/h4>\r\nFor higher risk or more involved research, the \u2018key information\u2019 should be relatively brief, concise and focused, providing a short summary of crucial elements of information that are further explained in the consent form (e.g., identifying the most important or the most severe risks instead of all risks).\r\n<h4>simple research with limited requirements<\/h4>\r\nFor simple research, with limited procedures, the \u2018key information\u2019 may be quite minimal as highlighting multiple benign points in an already brief document will not likely aid in the decision-making process. In some cases, as stated in the preamble to the final rule, \u201cif the information included at the beginning of the consent form satisfies both [key information requirements and the elements of consent]\u2026 more generally, the information in the beginning need not be repeated later in the body of the informed consent.\u201d\r\n\r\nFor example, for a minimal risk study requiring only a short interaction with the subject (e.g., brief interview or survey completion), it may not be necessary to duplicate a concise statement of duration of participation (e.g., \u2018your participation in this study will last about 30 minutes\u2019) and\/or benefit statement (e.g., \u2018you will not benefit from being in this study\u2019), as this would not require further explanation in the body of the consent document, provided the statement(s) is provided as a \u2018key information\u2019 bullet.\r\n<h4>additional considerations<\/h4>\r\nAdditional considerations to bear in mind when drafting \u2018key information\u2019 include the following:\r\n<ul>\r\n \t<li>The University of Rochester only applies the revised Common Rule (including the provisions for key information) to <em>new<\/em> research approved on or after January 21, 2019. All studies approved prior to that date remain under the old, pre-2018 Common Rule requirements, and do not require \u2018key information\u2019 in the consent form.<\/li>\r\n \t<li><strong>\u2018Key information\u2019 requirements do not apply to research deemed exempt<\/strong>; \u2018key information\u2019 does not need to be included in consent documentation (e.g. information letters) for such research.<\/li>\r\n \t<li>In the event, a consent template is provided by a sponsor or coordinating center for local IRB review and approval, study teams may defer to the \u2018key information\u2019 identified by the sponsor or coordinating center. <strong>Do not insert duplicative \u2018key information\u2019 bullets<\/strong> merely because these bullets are included in the IRB consent templates. Providing two sets of \u2018key information\u2019 defeats the goal of facilitating subject understanding.<\/li>\r\n<\/ul>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Related resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"3","cards":[{"card_title":"<h5>OHSP Policy 701: Informed Consent<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_701_Informed_Consent.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>OHSP Guideline on Informed Consent<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/701_GDL_Informed_Consent.pdf","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Consent templates<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/#consent","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Documentation of informed consent<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Documentation","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/documentation\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Who's my IRB Coordinator?<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Who\u2019s My IRB Coordinator?","url":"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Key Information for Informed Consent - Office for Human Subject Protection - University of Rochester<\/title>\n<meta name=\"description\" content=\"Understand what &#039;key information&#039; requirements are in consent forms for human subject research. 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