Research Ethics Board (REB 4: Health Research Ethics Board - Biomedical Panel

The board reviews invasive health research involving patients, health information, AHS (Edmonton Region and North Region) or Covenant Health (province-wide) facilities and researchers.

This board deals with applications that involve invasive interventions and invasive measures, regardless of how significant a part the intervention or measure has in the overall project, for example: administration of drugs, vaccines, natural health products, use of an unlicensed device, surgical procedures, collection of blood or other specimens and work involving human stem cells. REB 4: HREB Biomedical reviews imaging studies, as well as studies involving the use of tissues, whether collected prospectively or previously collected for another purpose and now being used for research.

This board also holds a US Federal Wide Assurance (FWA00000077) and as such will be the board which must review research funded by the U.S. Department of Health and Human Services, for instance NIH.

Members of the board

The membership of the Health Research Ethics Board - Biomedical Panel complies with the membership requirements for research ethics boards as defined in Division 5 of the Food and Drug Regulations, the CGSB - 191.1 2013 and the Tri-Council Policy Statement. The HREB - Biomedical Panel carries out its functions in a manner consistent with Good Clinical Practices.

Members of the HREB - Biomedical Panel who are named as investigators do not participate in the discussion related to, nor vote on, such studies when presented to the committee. 

Meeting Dates

The "Submission Deadline" dates below reflect the date that the application must be received by the REB. Please allow time for your study to move through any required Internal and Departmental approvals, which could take several business days. As such, applications should be submitted in advance of the Submission Deadline date to ensure they are received by the REB by the Submission Deadline.

Preparing Your Application

When submitting to REB 4 - HREB Biomedical Panel, the following documentation must be attached to submissions (where applicable):

• Protocol - A formal protocol must accompany the ethics application. Protocol templates are available from QMCR.
• Project Budget (if funded)
• Data collection form (case report forms, data elements to be collected) - this information can be included within the Protocol or as separate documents
• Consent forms - Sample consent forms are available in the Forms Cabinet. Note that these are not intended to be used verbatim, but are provided as guides.
• Information regarding any drugs or device used (investigator's brochures, product monographs, etc.)
• Any documentation seen by (or read to) a participant including, but not limited to, recruitment advertisements; information sheets; pamphlets; forms/questionnaires; diaries; online material etc.
• Health Canada approval (No Objection Letter - NOL, Investigational Testing Authorization - ITA etc.) - if applicable.

REB Review of Application

Principal Investigators (or a named co-investigator) are required to attend the REB meeting at which their application will be reviewed. If a PI or a Co-Investigator delegate is unable to attend, review of the application will be deferred until the following meeting.

Please check the REB schedule prior to making your submission. If the PI will be unable to attend the upcoming meeting, then please wait to submit the application until closer to the deadline for the next meeting that PI is available to attend.

Shortly after the submission deadline, ARISE will generate an email notifying the PI of the time at which their application will be reviewed. Each application is scheduled for 15 minutes of discussion. The length of each REB meeting depends on the number of applications to be reviewed that day and may not be possible for PIs to request a specific time.

If an emergency arises on the day of the REB meeting and the PI is unable to attend, notify the Research Ethics Office ( reoffice@ualberta.ca).

Investigators can expect to hear back about requested revisions arising from the review of the study within 5-7 working days after an REB meeting. Once all outstanding issues have been addressed, the ethics approval letter will be generated and the study team will receive an email notification from the ARISE system that the study has been approved.

Students Applying to HREB

For the purposes of submission to the HREB (both REB 3 and REB 4) a "student or trainee" cannot be listed as the Principal Investigator. Medical Residents, Post-Doctoral Fellows or any post-graduate students are considered a "student" for the purposes of submission.

Student or Trainee researchers should list themselves on the application in the Co-investigator role (Section 1.1. - 9.0) and they should list their supervisor in the Principal Investigator role (Section 1.1 - 5.0). As the Co-Investigator an applicant can create the full application independently. A new application can only be submitted to the REB by the Principal Investigator. However, once the study is initially submitted, all requests for revision and subsequent re-submissions can be managed solely by the Co-Investigator (student or trainee).

For any questions about applying to the HREB please contact the Research Ethics Office or the Committee Specialists for REB 3 and REB 4.

Investigator Initiated Clinical Trails

An investigator-initiated clinical trial is defined as a research study:

• authored (or provided significant input into the conception and planning), initiated and conducted by a member of the University of Alberta and/or Alberta Health Services/Edmonton Area faculty or staff, and
• not primarily authored, wholly sponsored, nor subject to scientific review, by any for-profit outside entity including, without limitation, a pharmaceutical company or clinical research organization.

If you are conducting an investigator-Initiated Clinical Trial involving off-label use of a drug, device, or biologic, you may need to complete a Health Canada Clinical Trial Application (CTA; which will issue a No Objection Letter (NOL) or Investigational Testing Authorization (ITA), as applicable).

Contact Quality Management in Clinical Research ( QMCR) for further details and assistance with submitting a CTA.

Reporting Requirements

Following initial REB approval of your application, any changes to the study or approved documentation must be reviewed and approved by REB before implementation, except where necessary to eliminate an immediate hazard(s) to study participants (see Protocol Deviations below). Otherwise, throughout the conduct of the study, the following is to be reported to the REB via Reportable Events in the online system (as of July 22, 2019) .

Note: These reportable events typically apply to REB 4 studies, however they may be applicable to studies of the other REBs.

Category	Reporting Criteria/Description
Protocol Deviations / Violations	Investigators must report to the REB any protocol deviations/violations which: impact the rights, safety or well-being of a research participant (examples may include: incorrect dose of study medication, enrollment of participant that does not meet the inclusion/exclusion criteria of the protocol, consent violations, participant visits which occur prior to study approval, or after expiry of study approval); jeopardize the study efficacy or the data integrity (examples include significant variance from the protocol required study procedures, wrong diary or CRF in use, failure of sample storage conditions); OR constitute a breach of privacy. Deviations from or changes to the protocol to eliminate immediate hazards to the study participants must be reported to the REB within 7 calendar days of their discovery. All other deviations must be reported to the applicable REB within 15 calendar days of their discovery. Complete the Protocol Violation Form and submit via Reportable Events in the system.
Serious Adverse Events (SAEs) - Local	Local SAEs are adverse events experienced by research participants at the site(s) under the jurisdiction of the REB. Local SAEs must be reported to REB if the event is serious, unexpected, and considered to be related or possibly related to the study. Local SAEs that are fatal or life-threatening are to be reported to the REB within 7 calendar days of their discovery. All other local SAEs which are unanticipated problems must be reported within 15 calendar days of their discovery. Complete the Local SAE Report and submit via Reportable Events in the system.
Serious Adverse Events (SAEs) - Non-Local	Non-local SAEs are adverse events experienced by research participants at centres/institutions outside the REB's jurisdiction. A non-local SAE is reportable if the local PI believes it is an unanticipated problem (unexpected, related or possibly related to participation in the research and places research participants or others at a greater risk of harm) AND requires a change to the protocol and/or informed consent form or immediate notifications to participants for safety reasons. Otherwise, non-local SAEs may not need to be reported to REB. See SOP: Non-Local SAE for more details. Report within 15 calendar days of their receipt.
Progress Reports or Safety Reports	Written report or memorandum from sponsors, such as Periodic Safety or Progress Reports and Data Safety Monitoring Board (DSMB) Letters/Reports. Report within 15 calendar days of their receipt.
Audit	Should your site be selected for an audit, inspection, or inquiry by the sponsor, a university, provincial or federal agency, the REB MUST be notified that the audit is being conducted. A copy of the audit findings must also be submitted to the REB within 15 calendar days of receipt.
Suspension	Interruptions to the study or notification of study closure/termination by the sponsor, PI, REB or institution MUST be reported to the REB as information is received.
Participant Complaint	Complaints made by participants or others affected by the research concerning their well-being (psychological or physical) and/or respectful and fair treatment from the researchers. Describe the participant complaint and what, if any, action was taken to address the participant complaint.

How to Submit Reportable Events in ARISE

Statement of Compliance

The Health Research Ethics Board: Health Panel (REB 3) and Biomedical Panel (REB 4) are organized and operate in compliance with the TCPS2 (2022) Tri-Council Policy Statement: Ethical Conduct for Research Involving Human Participants, International Conference on Harmonization (ICH) E6, Good Clinical Practice (GCP), Part C Division 5 of the Canadian Food and Drug Regulations.

Where required, the Health Research Ethics Board complies with FDA regulations 21 CFR Parts 50 and 56, HHS regulations 45 CFR 46.  The Health Research Ethics Board (Health Panel) and (Biomedical Panel) are registered with OHRP/FDA; the Health Panel IRB registration number is IRB00010106 and the Biomedical Panel IRB registration number is IRB00000927.  The Federal Wide Assurance number for both Panels is FWA00000077.  

OHRP Compliance

United States Federal Wide Assurance (FWA)

Under the United States Department of Health and Human Services (DHHS) Code of Federal Regulations 45: Part 46 A Protection of Human Subjects Section 46.103, every institution engaged in human subjects research supported or conducted by any United States Federal Department or Agency must have assurance of compliance approved by the United States Office for Human Research Protections (OHRP). The Assurance formalizes the institution's commitment to protect human subjects.

OHRP Federalwide Assurance (FWA) and Institutional Review Board (IRB) assurance have been obtained for the REB 4: Health Research Ethics Board - Biomedical Panel (REB is the Canadian terminology for an IRB). Click on the type of assurance below for more information:

Type of Assurance	Policy Number
Federal Wide ( see details)	FWA00000077
Institutional Review Board ( see details)	IRB00000927

Individuals who contribute to the scientific development or execution of a project in a substantive, measurable way for NIH-funded human subjects research must fulfill the NIH education requirement. Any Senior/Key Person personnel listed on the local ethics application must attach their certificate of training on the protection of human subjects. This can be uploaded to Documentation Section of the application. The certificate of training will be considered valid for five (5) years from date of issue, after which time the training will have to be renewed and a new certificate uploaded if the study is ongoing.

The NIH does not endorse any specific programs to fulfill the requirement for education on the protection of human subjects. Training in fulfillment of this requirement can be obtained through completion of the ICH-GCP Training through the CITI program or by completing the NIH Office of Extramural Research Course.

Health Canada REB Attestation

It is the Health Research Ethics Boards' policy not to sign individual Health Canada REB Attestation Form. This letter serves as a substitute for this form and is to be taken into consideration along with any specific study approval that will be issued, as fulfilling the requirements set forth by Health Canada in regards to REB Attestation.

The Guidance for Clinical Trial Sponsors issued by Health Canada states that either the REB Attestation or similar documentation, meeting the requirements of Part C, Divisions 5 of the Food and Drug Regulations, is acceptable. To this end, the Health Research Ethics Board certifies that:

1. The membership of the Health Research Ethics Board complies with the membership requirements of Research Ethics Boards defined in Division 5 of the Food and Drug Regulations;

2. The Health Research Ethics Board carries out its functions in a manner consistent with Good Clinical Practices. Furthermore, members of the Health Research Ethics Board who are named as Investigators in research studies do not participate in discussions related to, nor vote on such studies when they are presented to the Committee.  

Use of Electronic Signatures in ARISE

ARISE (formerly called REMO) is compliant with US FDA 21 CFR Part 11 – Electronic Records. User-entered usernames and passwords are sent to a campus-wide LDAP server for authentication over https. When user roles are assigned with ARISE, each role is evaluated based on the user’s valid relationships with the University which are provided by an Identity-Management System.

ARISE uses a digital signature which means that the name of the signer is the name of the person who executed a particular action in ARISE. The digital signature is always printed in the History Log and, in the case of correspondence, in the letters themselves. The date and time when the signature was executed equals the data and time when the corresponding activity was executed, and the date and time are always indicated in the History Log.

Finally, the ARISE system uses Secured Sockets Layer for communication over network with appropriate SOPs for controlling physical access to the servers.  The system’s signature security has been validated by the University of Alberta. Validation documentation is available upon request.

If you have any questions or require evidence of validation, please contact the Research Ethics Office at reoffice@ualberta.ca.

REB Review Fees

The University of Alberta charges a $5000 CAD fee for the REB review of industry-sponsored or for-profit research (effective January 1, 2021).

Fee Criteria: Research Sponsored by Industry or For-Profit Organizations

The REB administration fee applies to research that receives its funding from an industry sponsor (i.e. pharmaceutical/biotech/medical devices company) or other for-profit organization. The administration fee is for the review of the application by the Health Research Ethics Board (HREB) administered by the University of Alberta and is payable after the REB review of the Protocol. The fee covers the initial ethics review of a Protocol and all subsequent REB activities, such as amendments, annual renewals, and ongoing monitoring. As such, it is payable regardless of the approval status of the Protocol.

Following initial approval of the lead site, participating sites using the REB Exchange will be charged a reduced fee of $2000 .

Fee Waiver Criteria

The following types of studies are excluded from the fee requirement:

• Studies funded by industry where the study is authored, initiated and conducted by a researcher from the University of Alberta where the intellectual property rests with the researcher, the researcher owns and can alter the research protocol without influence from the funder
• Grant funded studies from a public, charitable or not-for-profit organization, for example, CIHR, NIH or a disease-specific foundation
• Studies connected to Tri-Agency partnership grants involving matching funds from an industry partner
• Studies funded by University of Alberta internal grants
• Unfunded studies

Billing of REB Administration fees

REB administration fees will be billed directly to the Principal Investigator of the study. If an industry sponsor requests REB administration fee invoices be billed directly to them, it is the responsibility of the PI to create an invoice to submit to the Sponsor, using the University of Alberta generated invoice as back up documentation. Once fees are paid to the PI, they can then remit payment to the University from their study account. The University of Alberta will not issue invoices directly to industry sponsors/partners.

Direct questions related to the REB administration fee to reoffice@ualberta.ca