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Consent Templates

The REB provides templates and guidance relating to consent.

Important: Ensure that you are using the current version by returning to this page for templates as needed.

Templates & Guidance Version Date Comment
Informed Consent Form Checklist2015- DecemberFor applicants' reference and use - this is not required to be submitted to the REB
Letterhead & contact section2013-Oct-2 Revised For use with consent templates-contains BCCA logo, cover page and contact section
Consent-Main
(BC Clinical Common Informed Consent Template)

2014-July Revised

Click here for Summary of Changes since previous version
Consent - Optional
(see UBC CREB Forms & Templates)


2015 - January (v 2)Also see Mandatory Tissue Collection and Biobank Guidance in the Policies section in relation to consent for tissue collection or biobanking
CCTG Main and Optional Consent Template.docx

2016-Jun-1

May also be used for other cooperative groups or not-for-profit sponsored clinical trials
Consent - Addendum for Enrolled Participants2010-Dec-3Template for providing new information to already enrolled participants

Questions? email reb@bccancer.bc.ca or see Contacts page.

Date Formats: 
Please use date formats that spell out the month to differentiate the day, month, and year.

Please also ensure that the date you enter in the RISe system matches the date in the footer of the document. The date you enter in RISe is populated into the certificate of approval and must match the date in the document. Due to the security features of the system the REB cannot modify either date. Once approval is issued, any error/mismatch will require submission of an amendment.

 

(Effective May 27, 2003, Revised Nov 11, 2008, Nov 4, 2009, Feb 6, 2011, Mar 4, 2013)

The REB (RISe) Application Form must identify;
  • BCCA Principal Investigator (PI) responsible for the study (section 1.1) 
  • all co-investigators (Section 1.3) 
  • the lead PI (only one) for each additional participating "BCCA centre" (Section 11)
  • Note: Section 4.2B may be used to identify individuals or sites that must appear on the certificates of approval that will otherwise not appear (see below).

BCCA REB certificates will list;

  • the BCCA PI responsible for the study (Section 1.1 in RISe)
  • the lead PI (only one) for each additional participating "BCCA centre" (Section 11 in RISe)
  • any information entered into section 4.2B (in RISe) exactly "as entered" by the applicant on each certificate unless an amendment is submitted by the applicant.

BCCA REBcertificates do NOT list;

  • co-investigators (from section 1.3 in RISe)
  • study personnel from sections 1.2, 1.4 or 1.5 in RISe.
  • If an individual from one of these sections must appear on the certificate, the applicant may enter them in section 4.2B (in RISe) which will appear exactly "as entered" by the applicant on each certificate unless an amendment is submitted. 

The consent document(s) must identify;

  • the lead PI responsible for the study (this should match Section 1.1 in RISe).
  • the lead PI (only one) for each additional participating centre (covered by the REB approval)
  • the subject's study doctor if different from above
  • a 24/7 emergency contact
  • a non-emergency contact person other than the PI (i.e. Dept. Head) for concerns about the conduct of the study
  • the UBC Research Subject Information Line (noted in the BCCA REB consent template) 
  • Note: It is NOT a requirement of the BCCA REB to list all co-investigators in the consent document.
Permanent changes or a leave of absence of six months or longer of any investigator (including co-investigators) must be reported to the REB. If a PI or co-investigator is'relinquishing their responsibility' for six months or longer an amendment must be submitted to notify the REB of the change (even if there is a "designated coinvestigator with signing authority in RISe"). The consent document should be revised if the study is open to accrual so that subjects yet to be enrolled will be given the revised approved consent. For already enrolled subjects, the timing and mechanism for informing (or not informing) already enrolled subjects about this type of change should be determined by the principal investigator as to what is applicable and reasonable taking into consideration the status of the study and the status of already enrolled subjects. For example, notification may be verbal (in person or by phone and documented in the subject's file) or by mail, or by formal signed reconsent. It may be acceptable to not inform a subject(s) if a rationale is provided. A subject's participation status or health status may change from the time a notification plan is submitted to the REB and as a result notification may require a different approach, which may simply be documented in the subject's file with the rationale or in the overall study documentation if the change will apply to all enrolled subjects. If the investigator or sponsor requires it, a Request for Acknowledgment of the change to the notification plan for already enrolled subjects may be submitted to the REB but it is not required by the REB for this circumstance.

Designating Coinvestigators with Signing Authority: Once a study is approved, the PI should immediately designate up to 2 "Coinvestigators with Signing Authority" in RISe from the list of approved coinvestigators. These coinvestigators may submit applications in RISe on behalf of the PI. Only the PI can designate these individuals which can be done quickly in RISe (it does not require submission to the REB) and takes effect as soon as the PI adds their name. Note: If the PI or coinvestigator is relinquishing their responsibility for six months or longer (regardless of whether there is a designated coinvestigator with signing authority in RISe) submission of an amendment to notify the REB is still required, and if applicable, a revised consent document. See instructions to: 
 

(Effective March 8, 2004, hyperlinks updated November 13, 2013)


The BCCA Consent Document(s) signature page must state "Person Obtaining Consent", and include their signatureprinted namestudy role and date of signature. (Refer to BCCA Consent Templates )

The "Person obtaining Consent" must be a person sufficiently familiar with the study, the disease being treated and the process of informed consent to be able to obtain properly informed consent and, thus, will usually be the investigator or a designated research assistant, however, in accordance with the Tri Council Policy Statement (TCPS2) Chapter 3 which states "The head of the research team, also known as the principal investigator, is responsible for ensuring that the consent process is followed. This person is also responsible for the actions of any member of the research team involved in the consent process." (Also see UBC REB Guidance Article 13.3: Directions for Obtaining Consent and UBC REB Guidance: 10.2.1: Study Nurses or Research Coordinator)

Reminder for investigator: The investigator should independently document the obtaining of informed consent in the medical record, noting date, the subject's full understanding of the risks and benefits of enrollment and the voluntary nature of participation.

 

Behavioural Research may use the Consent-Main above and as needed, refer to UBC Behavioural REB Forms

 

SOURCE: Consent Templates ( )
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