Research Ethics Board (REB) 3: Health Research Ethics Board - Health Panel

This board deals with applications that involve non-invasive health interventions and measures, or health research that concerns privacy, confidentiality and survey methods. Such research might include randomized trials of non-invasive interventions, interviews, chart reviews, surveys, questionnaires, observational or descriptive health research.

It's the designated REB to review applications from researchers enrolled at Royal Roads University who will be conducting research under the jurisdiction (ie. accessing patients, staff and/or their data) of the University of Alberta, Alberta Health Services (province-wide) or Covenant Health (province-wide) as part of the research. More information for Royal Roads Applicants

Members of the Board

The Board is constituted in accordance with the guidelines set forth in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2; ICH Guidelines; Guidelines for Good Clinical Practice and the Health Research Ethics Review Process Agreement and includes representation from the University of Alberta Health Sciences Faculties, Alberta Health Services and Covenant Health.

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.

Meeting Dates

 

Preparing Your Application

When submitting to REB 3 - HREB Health Panel, the following documentation must be attached to submissions:

• Research proposal
• Consent forms
• Any documentation seen by (or read to) a participant including, but not limited to, recruitment advertisements; information sheets; pamphlets; on-line information etc.
• All data collection forms such as surveys, questionnaires, diaries and interview guides.
• Where any part of the research involves the collection of information from medical records, the data collection sheet, with a complete list of variables, must be appended.

Where available, consider including the following documents:

• Project Budget
• Letters of support (i.e., from facilities)
• Evidence of peer review.

REB 3: HREB - Health Panel is the designated REB to review applications from researchers enrolled at Royal Roads University who will be conducting research under the jurisdiction (ie. accessing patients, staff and/or their data) of the University of Alberta, Alberta Health Services (province-wide) or Covenant Health (province-wide) as part of the research.
Information for Royal Roads Applicants

REB Review of Application

At the discretion of the Chair, HREB health protocols will be sent for either delegated or full-board review. Examples of applications that are typically reviewed by the full board include research with children or any other vulnerable population, research involving a novel intervention or research of a particularly sensitive topic matter.

Full Board Review

Estimated timeline: 2-6 weeks

Where a full-board review is required, Principal Investigators (or a named co-investigator) are required to attend the REB meeting. If a PI is unable to attend, review of the protocol will be deferred until the following meeting. Student investigators must attend with either their supervisor or a faculty member.

The Full Board Meeting Schedule is posted up to a year in advance. REB 3 meets on the first Friday morning of every month. Please check the schedule prior to submitting an application in order to ensure that the PI will be able to attend.

If you are invited to attend the meeting, approximately one week prior you will receive an email notification from ARISE advising you of the time and place. Generally, each study is allotted 20 minutes for discussion. Because all times are approximate, investigators should plan for a larger timeframe.

If the PI is unable to attend, notify the Research Ethics Office (reoffice@ualberta.ca).

Delegated Review

Estimated timeline: 2-4 weeks

Projects deemed to be minimal or below minimal risk will undergo a delegated review. Minimal risk is defined as research in which the probability and magnitude of possible harms implied by participation in the research is no greater than those encountered by participants in aspects of their everyday life that relate to the research. There are no submission deadlines for delegated reviews; these applications are processed as they are received by the office.

The delegated review process follows the path outlined below:

1. Submission received by the REB/REB Administrator ownership taken.
2. Preliminary review completed and changes requested. This step ensures the most complete application is forwarded to the delegated reviewer.
3. Upon receipt of changes the study is forwarded for delegated review (to either the Chair or another REB member). Any further change requests from the reviewer are forwarded through the administrator.
4. The second round of changes are reviewed and if satisfactory, the approval letter is drafted and forwarded to the Chair.

Examples of research eligible for delegated review:

• Examination of patient, medical or institutional records.
• Secondary analysis of data.
• Modifications of previously approved protocols.
• Surveys where the topic is not sensitive.

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 (2014) 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 and the Canadian General Standards Board (CGSB 191.1 2013).

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.

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 Electronics 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 the 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