ࡱ> WYV bjbj}} LD 666$ZZZPTlZ`'jL &&&&&&&$P),L'6 "  ''N!N!N! j86&N! &N!N!:%,3&Pntj% &0'0`'%RN,pN,3&N,63&  N!     ''N!   `'    N,          : consent addendum guidelines and Template The TCPS (2), the ICH-GCP, and the US Code of Federal Regulations (CFR) require that research participants be provided with any significant new findings developed during the course of the research which may relate to the participants willingness to continue participation. These significant new findings will be evaluated on a case-by-case basis by the REB. While the Belmont Report does not specifically address re-consenting, it does provide an additional ethical requirement that research participants should be notified of significant new findings that might affect their long-term health even after they have completed participation in the research study; Neither the TCPS (2), nor the regulatory documents provide guidance on the manner or extent of documentation required to satisfy these regulatory or ethical responsibilities. The following guidelines indicate the appropriate methods to use when providing significant new findings to research participants and the required documentation for notification. The format for disclosure will be dependent on the REBs review of the new information, the new risks identified and the overall risk of the research. REB approval will include specific information related to notification processes for re-consent based on their review of the new information. The Consent Addendum Template follows. Document(s) Required for Re-Consent or Provision of New InformationParticipant/ Study StatusBest Practice: Process for re-consent or provision of new informationRevised consent form amend original ICF to include new findings Open to enrolment at local study centre Participant to sign new (revised) consent form at enrolmentConsent Addendum Brief form containing ONLY new findings/changes and a discussion of these changes in the context of what the participant originally consented toParticipants on active treatment or intervention at local study centre Recall participant immediately to provide update and have consent addendum signed Contact participant with new information consent addendum to be signed at next visit At next visit, provide consent addendum and obtain signatureParticipants on follow up with occasional visitsContact participant with new information - consent addendum to be signed at next visitParticipants on follow up via phone contactMail updated form & document receipt at next phone contact. Enclose copy that participant can sign and mail back. Document in participant study record.Closed to follow-up. New findings affect the long term health of the participantContact participant with new information and mail updated form; contact again to ensure that updated form was received; document in participant study record if not archived. References: TCPS2 (2018) Chapter 11 45 CRF 46.116(6) (b); ICH GCP 4.8.2 21 CFR 50.25 (b) (5) LETTERHEAD ADDENDUM TO PARTICIPANT INFORMATION & CONSENT Title of Study: Principal Investigator: [include phone number] Research/Study Coordinator: Before beginning this research study, you signed an Information & Consent Form describing the study and your rights as a study participant. At that time, we explained that we would tell you about any new information that might affect your health, well-being or willingness to stay in the study. We recently learned of the information described below, which will also be explained to you by the researcher. After discussing the new information with the researcher, if you would like to continue in the study sign this Consent Form Addendum. Other information from the original consent that you signed at the beginning of the study still applies.  SHAPE \* MERGEFORMAT  INSTRUCTIONS: Describe all pertinent new information in this section in such a way that a participant can understandwhat has changedsince they originally joined the study.ONLY new information is to be included, with appropriate context so the information is understandable. Simply re-staing full sections from the previously signed consent form (such as the full risk section, or confidentiality section), will not be approved by the HREB. LETTERHEAD ADDENDUM TO CONSENT FORM Title of Study: Principal Investigator(s): Phone Number(s): Study Coordinator: Phone Number(s): I have read all of the new information in this addendum concerning the study I am currently participating in. I have been given the opportunity to discuss the information contained in this addendum. All of my questions have been answered to my satisfaction. This signature on this Information & Consent Form Addendum means that I agree to continue to take part in this study. I understand that I remain free to withdraw at any time. 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