{"id":748,"date":"2018-05-04T11:48:09","date_gmt":"2018-05-04T11:48:09","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/seeking-reconsent-research-participants\/"},"modified":"2026-04-08T10:09:20","modified_gmt":"2026-04-08T14:09:20","slug":"seeking-reconsent-research-participants","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/seeking-reconsent-research-participants\/","title":{"rendered":"Seeking Reconsent from Research Participants"},"template":"","categories":[24],"tags":[],"content-type":[41],"topic":[26,66],"update-type":[],"class_list":["post-748","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","content-type-guidance","topic-informed-consent-assent","topic-investigator-study-team-responsibilities"],"acf":{"use_legacy_editor":true,"updated_date":"2020-07-29 14:00:00","update_notice":false,"author":"IRBMED","summary":"<a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/informed-consent-assent-templates\">Informed consent<\/a> is an ongoing, interactive process throughout a participant\u2019s study involvement, rather than a one-time information session. In addition to encouraging subjects to ask questions and raise concerns, it may become necessary to seek renewed informed consent from a participant when aspects of a research study are altered during their participation.\u00a0 The circumstances that may warrant participants\u2019 reconsent, as well as the available methods employed to obtain it, will be the subject of this guidance.","button_links":null,"related_content":[730,733,740,775,734],"legacy_path":"seeking-reconsent-research-participants","legacy_node_id":289,"legacy_related_nids":"259, 262, 278, 317, 263","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Substantive Changes","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Any change that may change a participant\u2019s willingness to continue in the study requires reconsent. However, it is not changes that modify the risk\/benefit ratio that <em><u>only<\/u><\/em> warrant reconsent. Federal regulations from OHRP (45 CFR 46.116 (b) (5)) and FDA (21 CFR 50.25 (b) (5)) state that, when appropriate, the <a href=\"https:\/\/research.medicine.umich.edu\/our-units\/institutional-review-boards-irbmed\/informed-consent-assent-templates\">informed consent document<\/a> must include a statement that \u201csignificant new findings developed during the course of the research which may relate to the participant\u2019s willingness to continue participation will be provided to the participant.\u201d\r\n\r\nExamples:\r\n<ul>\r\n \t<li>increasing the <a href=\"\/medschool\/guidance\/evaluating-risks-participants\/\">risks<\/a>, for instance the identification of new risks or a change in the magnitude of known or\r\nsuspected risks<\/li>\r\n \t<li>decreasing the potential for benefit<\/li>\r\n \t<li>availability of new alternative treatments<\/li>\r\n \t<li><a class=\"gtip\" href=\"\/medschool\/glossary\/food-and-drug-administration-fda\">FDA<\/a> approval of an <a class=\"gtip\" href=\"\/medschool\/glossary\/investigational\">investigational<\/a> drug (so that the drug is available outside the research context)<\/li>\r\n \t<li>adding study procedures; and<\/li>\r\n \t<li>modifying or removing study procedures when this can affect risk or potential\r\nbenefit.<\/li>\r\n<\/ul>\r\nPlease note: Changes to study procedures that do not affect risk or potential benefit still warrant a reconsent process if already enrolled participants need to agree to those additional procedures.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Changes to Previously Approved Application via an Amendment","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"The <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\/\">eResearch Regulatory Management<\/a> application asks for each <a href=\"https:\/\/documentation.its.umich.edu\/node\/1263\">Amendment<\/a> submission (\u201cEdit Amendment Forms,\u201d also known as \u201cAmendment Cover Sheet\u201d) whether participants\u2019 reconsent will be sought as a result of the changes being made. In 1.3, a checkmark should indicate that section 10 (Informed Consent) has been updated; then 1.5 must be completed.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":1445,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed_ame-cover-sheet-consent.png","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"When Children Turn 18","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"When minors turn age 18, and if they are continuing as research participants, they must provide consent using the adult informed consent document.\u00a0 <a href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/guidance\/faq\/children-research\/index.html\">OHRP Research with Children FAQ<\/a> states that \u201cunless the Institutional Review Board (IRB) determines that the requirements for obtaining informed consent can be waived, the investigators should seek and obtain the legally effective informed consent, as described in <a href=\"https:\/\/www.ecfr.gov\/current\/title-45\/subtitle-A\/subchapter-A\/part-46\">45 CFR 46<\/a>.116, for the now-adult participants for any ongoing interactions or interventions with the participants.\u201d\r\n\r\nThis includes ongoing use of data or biospecimens collected for a research <a href=\"\/medschool\/guidance\/repository-overview\/\">repository<\/a>.\r\n\r\nThe <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\/\">eResearch Regulatory Management<\/a> application asks for each study enrolling minors (section 10.2 Informed Assent) a participant\u2019s status as a child may change during the study (e.g., reaching the age of majority), and what the plans are for seeking the individual\u2019s consent.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":1446,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed_HUM-10.2-change-in-child-subject-status.png","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Intermittent Cognitive\/Decisional Impairment","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"When study participants who were temporarily <a class=\"gtip\" href=\"\/medschool\/glossary\/cognitively-impaired\">cognitively impaired<\/a> regain <a class=\"gtip\" href=\"\/medschool\/glossary\/competence\">consent capacity<\/a>, they should be undergo a full consent process.\u00a0 If participants who regain consent capacity decide that they do not wish to continue to participate in the study, their decision must be respected. This would involve withdrawing the participant and\/or\r\ntheir data\/specimens. This situation arises in research conducted in critical or emergency situations, where the initial consent may have been provided by a <a class=\"gtip\" href=\"\/medschool\/glossary\/legally-authorized-representative-lar\">legally authorized representative (LAR)<\/a>.\r\n\r\nThe <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\/\">eResearch Regulatory Management<\/a> application asks for each study enrolling adults with impaired cognition or <a class=\"gtip\" href=\"\/medschool\/glossary\/diminished-decision-making-capacity\">decision-making capacity<\/a> (sections 10.1 Informed Consent, and 37) whether the cognitive capacity of the subjects is expected to change significantly during the study, and what the plans are for seeking such individuals\u2019 consent.","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":1447,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed_HUM-10.1-change-in-capacity-to-consent.png","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Improperly Obtained Consent","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Situations where participant may need to be asked to reconsent:\r\n<ul>\r\n \t<li>When informed consent was obtained improperly. For example, if the person who obtained consent was not authorized to do so. (e.g. not listed in section 1.3 of the eResearch application as study personnel).<\/li>\r\n \t<li>When the wrong version of the Informed Consent Document has been used and the consent form varies by more than the version date (e.g. the content is not the same).<\/li>\r\n \t<li>The study team utilized version of the consent document that was not watermarked (approved) by IRBMED.<\/li>\r\n<\/ul>\r\nAlso submit a \u201cProtocol deviation\u201d <a href=\"\/medschool\/guidance\/other-reportable-information-or-occurrence-orio\/\">ORIO (Other Related Information or Occurrence)<\/a>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Permissible Methods for Seeking Reconsent","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Study teams may use various methods of reconsent:\r\n<ul>\r\n \t<li>A fully revised consent document<\/li>\r\n \t<li>Written consent document addendum<\/li>\r\n \t<li>A telephonic re-consent process for specific study activity<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"heading","legacy_heading":"Examples of When Reconsent May Not Be Necessary","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Sometimes notifying participants of changes made is enough and a formal reconsent process isn\u2019t necessary.\r\n\r\nPlease note: Final decisions for individual studies are up to the board reviewer(s).\r\n\r\nExamples:\r\n<ul>\r\n \t<li>Key study team member changes <em>without<\/em> contact information changing<\/li>\r\n \t<li>The wrong version of the informed consent document was used, <em>but<\/em> the only difference is the version date<\/li>\r\n \t<li>Formatting or typographical errors in the informed consent document that do <em>not<\/em> change the meaning, understandability, or contact information<\/li>\r\n \t<li>Removing questions on a repeated survey that do <em>not<\/em> change the scope or sensitivity of the survey<\/li>\r\n \t<li>Decreasing the number or frequency of repeated procedures, if this does <em>not<\/em> affect data needed to ensure participant safety<\/li>\r\n<\/ul>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[],"update_notice_start":"2020-07-30 03:15:00","update_notice_end":"2020-09-30 19:15:00","update_notice_text_blocks":[{"update_notice_text":"<p>This page has been extensively revised and expanded. Please contact IRBMED with any questions about the new content.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\n<p>A <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.<\/p>\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 8, 2026 10:10AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/748","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/748\/revisions"}],"predecessor-version":[{"id":1952,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/748\/revisions\/1952"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/734"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/775"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/740"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=748"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=748"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=748"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=748"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=748"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=748"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}