The BCCA REB considers focus groups to be ordinarily of minimal risk and, thus, research projects including focus groups may be considered for expedited review provided all other criteria for expedited review are met and the informed consent clearly indicates that the subject agrees to consider all information about other members in the group confidential.

• The REB (RISe) Application Form m
ust 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 REB certificates 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.  Already enrolled subjects may be verbally informed about the change of an investigator (this should be documented in the subject's file), or they may be reconsented with the revised approved consent if the PI deems it necessary based on the status of the study and already enrolled subjects.
  
  
• Changing the PI:  If you need to change the PI permanently or temporarily (as noted above), submit an Amendment to the REB using the RISe system. This involves completing the "change of PI form" located in the Amendment PAA Coversheet in RISe. The form requires the signature of the following and to then be reattached in the PAA Coversheet as a .pdf file; 
       -the current PI
       -the new PI
       -the new PI's Department Head.
  If the PI is not available to sign the form then provide an explanation on the form as to why they are not available to sign it.
  If the PI is not available to submit the amendment; a coinvestigator with signing authority listed in RISe can submit the amendment.  The PI can access RISe from any location where they can access the internet.  If the PI cannot access the internet to either submit the amendment or designate a coinvestigator with signing authority (see below), then contact the REB by email for instructions (reb@bccancer.bc.ca ).
  
  
• 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: Designate Coinvestigators with Signing Authority in RISe

The BCCA Consent Document(s) signature page must state "Person Obtaining Consent", and include their signature, printed name, study 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 D1 Article 2.4 which states "In a research team, the principal researcher is ultimately responsible for the actions of those acting with delegated authority"  (Also see UBC CREB Guide 39.8.4 )

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.

A protocol deviation is an unanticipated or unintentional divergence or departure from the expected conduct of an approved study that is not consistent with the current research protocol, consent document or study addenda.

Examples of protocol deviations include:

i) changes in procedures initiated to eliminate immediate hazards to study subjects;

ii) enrolment of subjects outside protocol inclusion/exclusion criteria, whether agreed to or not by the sponsor;

iii) medication/intervention errors [i.e. incorrect drug/intervention, incorrect dosage of the drug];

iv) inadvertent deviation in specific research intervention procedures or timing of the research intervention which could impact upon the safety or efficacy of the study-related intervention or upon the experimental design [n.b. this would not include appointment deviations usually];

v) breach of confidentiality or privacy whereby confidential information about a subject is revealed in inappropriate settings, or to persons without a need to know, or by data exposure (computer security breach, documents left unsecured), and;

vi) significant deviation from the consenting process.

Furthermore, it is the responsibility of the Principal Investigator to notify the REB of all protocol deviations that:
1) expose subjects to potential increased risk;
2) compromise the integrity of the entire study;
3) are repetitive in nature;
4) alter subject eligibility, or
5) affect the privacy of the subject.

Timeframes for Reporting Protocol Deviations

1)  A deviation from, or change of, the protocol to eliminate immediate hazards to the study subjects must be reported to the REB within 5 days of its discovery.

2)  All other deviations must be reported to the REB within 15 days of their discovery.

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Registration for Publication  (Expanded Definition Includes Phase I Clinical Trials)

Update posted: September 19, 2008; revised Oct. 23/08; revised Nov 12, 2009

Publication of the results of research studies, whether positive or negative, is of obvious value to society and an ethical obligation of investigators to the subjects who voluntarily participated. In recognition of this ethical obligation the journals represented by the International Committee of Medical Journal Editors (ICMJE) require that research studies initiated after June 2005 be registered before the research starts or they will not be considered for publication. Ongoing studies that started prior to June 2005 were required to have been registered by September 2005. The ICMJE provides a "definition" of studies that require registration and a list of acceptable registries. This is summarized below showing the change between the previous and current definition.

The International Committee of Journal Editors (ICMJE) recently implemented an expanded (2007) definition of research studies that must be registered and extended the list of acceptable registries.

If there is any possibility of the intent to publish results of a research study, it must be registered BEFORE the research starts. Principal Investigators must ensure that a study is registered and appropriately updated when the study is complete or results are published.

This applies to all research studies of healthcare interventions that involve prospective enrollment of subjects that began enrollment on or after July 1, 2008.

Previous: International Committee of Journal Editors Definition (2005)
“Any research project that prospectively assigns human subjects to intervention and comparison groups to study the cause-and-effect relationship between a medical intervention and a health outcome. The trial must have at least one prospectively assigned concurrent control or comparison group in order to trigger the requirement for registration.”
This definition previously excluded Phase I trials.

Requirement for Informing or Re-Consenting Subjects When There Is an Update to an Investigator Brochure (IB).

The REB considers it to be the responsibility of the study sponsor, the accountable investigators and the study team, to practice due diligence and oversight for clinical trials, including the safety of subjects.

Therefore, the REB relies on the study investigators and the sponsoring agency to use their best judgment in determining when new information, or changes to an IB warrants disclosure to subjects, or re-consenting.

The REB requires that any new information obtained and documented in an IB or other document be submitted to the REB, together with an explanation of what changes were made, and the decision of the study sponsor/team as to the actions to be taken in light of the new information. The REB reserves the right to request an alternate action be taken if deemed necessary.

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Use of the term "Subject" vs "Participant" vs "Patient" (Effective January 13, 2004)
The individual participating in a study should be referred to as the "subject" or, if for some special reason that is not thought appropriate, "participant". The chosen term must be used consistently in the title of the study and throughout the document.

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