邢唷��>� $��& !"#��'��<�)*+,-./0123456789:;��Root Entry�� Fy]7r�%€WordDocument��7B1Table��(>&SummaryInformation(��欹�k ��!bjbj:: 7BXu揵Xu揵��8�d@$��!jdz(��}}}=!?!?!?!?!?!?!$(#��%Pc!�}}}}}c!��x!��}j��=!�}=!��嗟x]7r��v�)!�!0�!�.&]�.&��.&� (}}�}}}}}c!c!��}}}�!}}}}��.&}}}}}}}}}BV: DEFERRED CONSENT GUIDELINES AND TEMPLATE Deferred consent is燼 strategy used in situations where an individual who requires urgent medical care is unable to provide consent for research due to loss of consciousness or decision-making capacity � and the delay to seek authorized third party consent could seriously compromise that individual抯 health. Certain types of medical emergency practices can be evaluated only when they occur, hence the need for this exception. Article 3.8 of TCPS2 (2022) outlines an exception to the general obligation of seeking consent from those participating in research. Article 3.8 Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves medical emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the following apply: A serious threat to the prospective participant requires immediate intervention. Either no standard efficacious care exists, or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care. Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant. The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project. Third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so. No relevant prior directive by the participant is known to exist. When a previously incapacitated participant regains decision-making capacity, or when an authorized third party is found, consent shall be sought for continuation in the project, and for subsequent examinations or tests related to the research project. It is the responsibility of researchers to justify to the REB the need for this exception. The underlying assumption of Article 3.8 is that participants could not receive any direct benefits of the research without setting aside the need for the researcher to seek the prior consent of participants, or of their authorized third party. This rationale should be outlined in the ethics application in Section 4.5 (1.2). To respect the autonomy of the participant,� HYPERLINK "https://ethics.gc.ca/eng/tcps2-eptc2_2018_chapter3-chapitre3.html" \l "8e" Article 3.8(e)爎equires researchers to undertake diligent efforts to contact authorized third parties, if practicable, and to document such efforts for the benefit of both the participant and the continuing ethics review functions of the REB. It also requires that participants who regain decision-making capacity be promptly afforded the opportunity to consent to their continued participation. When the REB has approved a participant can be enrolled without prior consent due to medical emergency' the site should outline in Section 4.5 (2.0) and develop a Standard Operating Procedure (SOP) for use in the study which includes predefined criteria for1) reasonable efforts/ steps that will be taken to obtain燾onsent;2) conditions and justification for if and when a full waiver may be requested (as an exceptional circumstance only); 燼nd3) a defined minimal data set to be retained if a full waiver were granted. � If the REB approves the use of deferred consent and a participant dies during the study where no consent has been obtained either from the participant and/or no substitute decision maker/family member is available on site or they refuse to give consent, any data or samples collected for study purposes will be destroyed (e.g.爄f爊o Substitute Decision Maker (SDM) is located燼nd the爌articipant doesn't regain capacity to燾onsent,� if爐he爌articipant爎efuses to燾onsent, if爐he participant is�'lost to follow-up'燽efore燾onsent爄s obtained). This is because the data was never collected with appropriate consent. Should researchers wish to retain any data or samples a request shall be made on a case by case basis to the REB, by submitting an amendment and outlining the circumstance specific to the participant and uploading the above noted site SOP. Deferred Consent for Research Participation Title of Project: Principal Investigator: Phone Number: The person named below is being enrolled in this research study by deferred consent. This has been fully outlined in the ethics application for this study and approved by the REB. When a previously incapacitated participant regains capacity, or when a substitute decision maker is found, consent shall be sought promptly for continuation in the study, and for subsequent examinations or tests related to the research study. Seeking consent prior to study participation is always preferable. If no substitute decision maker/family member is available on site or they refuse to give consent, any data or samples collected for study purposes will be destroyed. Patient抯 Name: _____________________________________________________ Date/time assessed for enrolment: _____/______/______ (dd/mm/yyyy) at ____ : ______ (time) Reason(s) deferred consent process is used (check all that apply): ____ At this time the patient is unconscious or lacks capacity to understand the risks, methods and purposes of the research study. ____ No next of kin/substitute decision maker is available to provide consent, or attempts to contact them have been unsuccessful despite diligent and documented efforts. ____ A substitute decision maker ___________________________________ (name and relationship) has been contacted by telephone, and the purpose, methods and risks of participation in this study have been explained to the third party. While the substitute decision maker has given verbal consent for participation, written consent must be still be obtained. ____ No relevant prior directive by the patient is known to exist. ____ Other: ___________________________________________________________________ _____________________________________________ ________________________ Signature of Investigator/designee Date and Time TO BE ON PI LETTERHEAD Version: April 18, 2023 (update to your version date) Page PAGE \* Arabic \* MERGEFORMAT 2 of NUMPAGES \* Arabic \* MERGEFORMAT 2 +?OR� � � 橛榈杦Y;$,h]JqB*OJQJ^JfHph333q� ��:h鋓�h]JqB*CJOJQJ^JaJfHph333q� ��:h鋓�h鋓�B*CJOJQJ^JaJfHph333q� ��=h鋓�h鋓�B*CJOJQJ\乛JaJfHph !$q� ��=h鋓�haV�B*CJOJQJ\乛JaJfHph !$q� ��:h鋓�haV�B*CJOJQJ^JaJfHph !$q� ��+h鋓�h��5丆JOJQJ^JaJmH sH +h鋓�haV�5丆JOJQJ^JaJmH sH *+] i ;�. � U� ��34$��gd鋓�gdvBgdaV� &F[$\$gdaV�きgdaV�gd]}�$a$gd�� \ ] i [\fl��馇⿴鈙X:�%)jh鋓�haV�CJOJQJU^JaJ:h鋓�hb�B*CJOJQJ^JaJfHph333q� ��4hb�B*CJOJQJ^JaJfHph333q� ��4h鋓�B*CJOJQJ^JaJfHph333q� ��4haV�haV�6丅*CJOJQJ^JaJmH ph333sH :haV�haV�5�6丅*CJOJQJ\乛JaJmH ph333sH 4h�_5�6丅*CJOJQJ\乛JaJmH ph333sH :h鋓�haV�B*CJOJQJ^JaJfHph333q� �� ./=>� %5V��镖黑渷fH�-乫�4h刣�B*CJOJQJ^JaJfHph"""q� ��:hJhvBB*CJOJQJ^JaJfHph"""q� ��4h詙�B*CJOJQJ^JaJfHph"""q� ��4hvBB*CJOJQJ^JaJfHph"""q� ��:h鋓�haV�B*CJOJQJ^JaJfHph333q� ��>h鋓�haV�0JB* CJOJQJ^JaJfHph)Svq� ��)jh鋓�haV�CJOJQJU^JaJ h鋓�haV�CJOJQJ^JaJ ��GP|}��c�馇獠馇鈷獠鈗獠馇S>(h鋓�haV�CJOJQJ^JaJmH sH :h鋓�haV�B*CJOJQJ^JaJfHph333q� ��@h�)�hvB6�>*B*CJOJQJ^JaJfHph"""q� ��>h]}�hvB0J B*CJOJQJ^JaJfHph"""q� ��)h]}�hvBB*CJOJQJ^JaJph"""4hvBB*CJOJQJ^JaJfHph"""q� ��:h]}�hvBB*CJOJQJ^JaJfHph"""q� �� 8CKpqsz|}€��栌簾簤簾簊篨簊熀焁熀熀熀X�5h]}�hKu0J CJOJQJ^JaJfHq� ��+hJCJOJQJ^JaJfHq� ��+h]JqCJOJQJ^JaJfHq� ��5h]}�hKu0JCJOJQJ^JaJfHq� ��1h]}�hKuCJOJQJ^JaJfHq� ��(hKu5�>*CJOJQJ^JaJmH sH .h鋓�haV�5�>*CJOJQJ^JaJmH sH ��24��"#$%'7胭遣澆賸俨u_I7#h鋓�h��5丱JQJ^JmH sH +h鋓�haV�5丆JOJQJ^JaJmH sH +h鋓�h65丆JOJQJ^JaJmH sH +h鋓�h �5丆JOJQJ^JaJmH sH "h詙�CJOJQJ^JaJmH sH (h鋓�h鋓�CJOJQJ^JaJmH sH (h鋓�haV�CJOJQJ^JaJmH sH "hw�CJOJQJ^JaJmH sH "hvBCJOJQJ^JaJmH sH (hKuhaV�CJOJQJ^JaJmH sH $&STgh��JK��/0y�� $dha$gd��$a$gd丩�gd礫m$$d��1$a$gd礫mgd��劙凱靆劙`凱靏dgd $dN��gd��gd��$a$gd�&�7RSTegh€��GK@��碹苫划‘�ttfXG6 h鋓�h��OJQJ^JmH sH h鋓�h礫mOJQJ^JmH sH h鋓�h礫m5丆J^JaJh鋓�h�:�5丆J^JaJh鋓�5丆J^JaJh鋓�h丩�5丆J^JaJ&h鋓�h��5�6丆JOJQJ^JaJh鋓�h��OJQJ^Jh鋓�hOJQJ^Jh鋓�h5丱JQJ^J#h鋓�h5丱JQJ^JmH sH #h鋓�h��5丱JQJ^JmH sH #h鋓�h丩�5丱JQJ^JmH sH �� ./0?y��-��镛镛锿华樛槅槅槅榯榗Uc狣 h鋓�h��CJOJQJ^JaJhvBCJOJQJ^JaJ h鋓�h�:�CJOJQJ^JaJ#h鋓�h 5丆JOJQJ^JaJ#h鋓�h丩�5丆JOJQJ^JaJ#h鋓�h礫m5丆JOJQJ^JaJ h鋓�h��CJOJQJ^JaJ#h鋓�h��5丆JOJQJ^JaJ h鋓�h礫mCJOJQJ^JaJ h鋓�h�:�OJQJ^JmH sH h鋓�h礫mOJQJ^JmH sH �J��B C � � � � � � � � � � � � � � !€!�!�� !Q'gdX�$a$gd鋓�gd�:�gd��$ �x��J勑�0�ゐ^勑`�0齛$gd ��!IJNPj%01��镛图殔p咃_镛锿颪�= h鋓�h�:�CJOJQJ^JaJ h鋓�h礫mCJOJQJ^JaJ h鋓�h] XCJOJQJ^JaJ(h鋓�hr'CJOJQJ^JaJmH sH (h鋓�h CJOJQJ^JaJmH sH h鋓�hr'CJOJQJ^JaJ h鋓�h��CJOJQJ^JaJ h鋓�h丩�CJOJQJ^JaJ h鋓�h;6�CJOJQJ^JaJ h鋓�hM(CJOJQJ^JaJ h鋓�h��CJOJQJ^JaJ��A B C � � � � � � � � � � 脍筛媬peWIW;Wp-h鋓�h�<�5丱JQJ^Jh鋓�h�0�5丱JQJ^Jh鋓�ha�5丱JQJ^Jh鋓�h$5丱JQJ^Jh鋓�5丱JQJ^Jh鋓�h��5丱JQJ^Jh鋓�h��OJQJ^Jh鋓�OJQJ^JmH sH h��CJOJQJ^JaJ h鋓�h礫mCJOJQJ^JaJ h鋓�h��CJOJQJ^JaJ h鋓�h] XCJOJQJ^JaJ h鋓�h�:�CJOJQJ^JaJ(h鋓�h�:�CJOJQJ^JaJmH sH � � � � � � � � � � � � � � � !! 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