Ethics Guidance

Is Ethics Review Required?

Education & Training 

Fee

Schedule

Frequently Asked Questions (FAQs)

 

Is Ethics Review Required?

Generally, all research that involves human subjects requires review and approval by a Research Ethics Board (REB), also know as an Institutional Review Board (IRB).

The RVH REB  must review and approve research that meets any of the following criteria:

  • The research involves living human participants at RVH;

  • The research involves the collection, storage, or transport of human biological materials at RVH (e.g., blood, urine, human embryos, fetuses, fetal tissue, reproductive materials, and stem cells). This applies to materials derived from living and deceased individuals;

  • The research is conducted fully or partially on RVH property;

  • The research involves testing an experimental drug or medical device at RVH;

  • The research involves reviewing patient medical records; and/or

  • The research utilizes RVH resources, including, but not limited to:

    • Electronic medical records (e.g., Meditech, ARIA);

    • Imaging or diagnostic services;

    • Laboratory services;

    • Pharmacy services;

    • Surgical services;

    • Emergency services; and/or

    • Other departmental services

 

If you are uncertain as to whether REB review is required, please contact the RVH REB to obtain the written opinion of the REB Chair. 

Research proposals must be approved by the REB before you can begin the research.

Additional information regarding the scope of research ethics review can be found in the Tri-council Policy Statement (TCPS2): Ethical Conduct for Research Involving Humans

 

Education & Training

Research Ethics

Research ethics certification must be completed prior to submitting an application to the RVH REB. Certificates are provided upon completion of each course and should be appended to the REB submission. Approvals of new submissions and ongoing studies will only be granted to those investigators who have appropriate certification of training for themselves and their research staff. The RVH REB stratifies research ethics training requirements based on study risk; please consult the table below to determine the ethics certifications required for your study.

Acronyms: CITI, Collaborative Institutional Training Initiative; GCP, Good Clinical Practice; N2, Network of Networks; PI, Principal Investigator; RCT, Randomized Controlled Trial; TCPS2, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 2 ed. (TCPS 2)

Standard Operating Procedures

Regulatory authorities require that clinical research sites utilize standard operating procedures (SOPs) to protect the rights and safety of human participants and integrity of the data collected.

RVH is a member of the Network of Networks (N2 Canada), a not-for-profit Canadian organization and an alliance of Canadian research networks and organizations that work towards enhancing national clinical research capability and capacity. RVH has adopted N2 Canada’s national standardized set of operating procedures, which are applicable to any therapeutic area and are compliant with Health Canada and U.S. Food and Drug regulations, ICH-GCP guidelines, and TCP2. The purpose of having documented SOPs is to:

  • provide written guidelines for the performance of all aspects of clinical research

  • promoted quality and consistency in clinical research processes

  • ensure compliance with applicable regulations and guidelines

  • facilitate training of new personnel

 

All researchers* participating in regulated, interventional research at RVH are required to self-train and attest to their knowledge and understanding of the N2 SOPs. Forms 

It is strongly recommended that non-regulated, interventional researchers also complete the N2 SOP self-training and attestation prior to the start of any research activity.

The N2 set of SOPs and attestation form is made available to all RVH researchers through RVH Policies and Documents intranet site (https://rvrhc.sharepoint.com/Policies/SitePages/Policies%20and%20Documents.aspx) or through the RVH Research Office.

*Researchers are defined as Principal Investigators, Co-Investigators, and/or any staff listed on the study delegation log.

 

REB Fee Schedule

Fees for ethical review support the RVH REB in fulfilling its responsibility to ensure the ongoing protection of the rights, safety, and well-being of human participants involved in research at RVH.

REB fees are applied to clinical research that is partially or fully supported by industry sponsors, as well as to research from external investigators that require the services of the RVH REB but who are not collaborating with RVH employees or professional staff. The RVH REB does not charge REB fees for RVH-investigator initiated studies.

The Principal Investigator remains responsible for communicating REB fee requirements to the sponsor and for providing the sponsor’s billing information. To streamline the fee payment process, contract reviewers at RVH will make efforts to negotiate REB fees into agreements with industry sponsors. When the contract reviewer is unable to negotiate REB fees into the agreement, the RVH Department of Finance will issue an invoice directly to the sponsor. The sponsor is expected to pay the REB fee within 30 days of receipt of the invoice.

 

How long does ethics review take?


Minimal risk studies that qualify for delegated review (formerly known as expedited review) are reviewed within 30 days. Greater than minimal risk studies that require full-board review will be reviewed within 30-90 days, depending upon the complexity of the study, the number of clarifications and/or modifications required by the REB, and the time taken by the Principal Investigator to respond.




Who do I contact if I require assistance obtaining departmental impact signatures.


If you require assistance with obtaining departmental impact signatures, please contact Dr. Jesse McLean, RVH Research Manager, at mcleanje@rvh.on.ca or (705) 728-9090 Ext. 41350




I have ethics approval from another REB. Do I still need to obtain approval from the RVH REB for my study?


Yes. The RVH REB must review and approve all research that is conducted using on RVH property or require RVH resources. The RVH REB permits Clinical Trials Ontario qualified REBs to act as the Board of Record for select multi-centre clinical trials.




Does RVH have policies related to the conduct of clinical trials?


Yes, RVH is a member of the Network of Networks (N2) a pan Canadian, non-profit organization dedicated to helping member sites conduct clinical trials at the highest level. RVH has adopted N2 Standard Operating Procedures (SOPs) for all research activities; these SOPs are approved by Health Canada.




Does my quality improvement project require review?


In general, projects that are considered quality improvement/quality assurance (QI/QA) or are for program evaluation do not require ethics approval. However, when there is doubt as to whether or not the activity meets the definition of research involving humans, the researcher must confirm with the RVH REB Chair as to whether ethics approval is required. The intent to publish does not necessarily distinguish an activity as research, since findings from QA/QI and program evaluation projects may be published. Please note, the REB will not provide ethics approval retroactively; the onus is on the researcher to obtain the necessary approvals. For more information about differences between QA/QI and research, please contact Jesse McLean, RVH Research Manager, at mcleanje@rvh.on.ca or (705) 728-9090 Ext. 41350.




Is the submission deadline for full board review flexible?


Permission must be obtained from the RVH REB Chair in order for the REB to review any submissions after the deadline for the upcoming full board meeting. Please contact REB Coordinators Romaine Miller or Debra Pietersen at research@rvh.on.ca to inquire about submitting after the deadline.




Do I need to include a copy of my ethics certification and curriculum vitae with my REB submission?


Yes. Investigators wishing to conduct research at RVH must submit a copy of their ethics certification and curriculum vitae for each new REB submission.




Are there different types of ethics review?


Yes. The RVH REB adopts a proportionate approach to research ethics review in accordance with TCSP2 Article 6.12. Based on the outcomes of a risk analysis that takes into consideration the study population, the extent and likelihood of a participant experiencing harm, and the type of risk, research submissions will be stratified into those requiring full board review and those that may be delegated: 1. Full-Board Review -greater than minimal risk studies -30-90 day turn-around for review -reviewed by all REB members at monthly full-board meeting -full-board review is the default requirement unless delegated review is authorized by the Chair 2. Delegated Review (formerly known as Expedited Review): -acceptable level of minimal risk -no therapeutic intervention (e.g., surveys, focus groups, retrospective chart review) -30 day turn-around for review -reviewed by a single REB member or group of REB members All reviewed studies will be given one of the following designations: Approved, Conditionally Approved (approval dependant on fulfillment of revision requirements), or Denied.




I would like to try a new clinical procedure that is not standard treatment. Do I need ethics approval?


Medical professionals have an obligation to set standards and improve quality of care. Research Ethics Boards do not have the capacity to oversee the protection of patients that are not participants in research. Studying quality and outcomes does not always equal research. Innovative Therapy refers to new medical and surgical techniques, procedures, or interventions that have not yet been introduced at the hospital as standard treatment but may have been reported elsewhere. If the intention of the procedure is strictly therapeutic, Innovative Therapies may be employed when: 1) Standard approaches have failed; or 2) When no standard treatment is known; and 3) There is evidence elsewhere that the novel therapy may have efficacy or benefit to the patient. In such cases the procedure may be administered on an emergency basis only and may be attempted with only one or two patients (often referred to as “compassionate” treatment). If the Innovative Therapy is used on 3 or more patients, the procedure should become the object of a research protocol and, therefore, subject to REB review. Use of the therapy shall be discontinued until it receives REB approval. Physicians who wish to introduce an Innovative Therapy strictly for clinical reasons must submit an “Enabling Innovation Letter” to the Chief of Staff (copied to the Clinical and Administrative Directors of the impacted departments, as well as the Research Ethics Board Chair). The Enabling Letter should be shared with the REB Chair, who will advise if research ethics review is required. Innovative Therapy Requests that are deemed to be “research” will be referred to a full-board of the REB for ethics review, by the REB Chair. Where the Chief Medical Executive determines that the therapy described in the Enabling Letter is in fact innovative, he or she may do one of the following: 1) Approve the innovative use with or without restrictions; 2) Grant clinical evaluation status for six to twelve months; 3) Request that the innovative use be continued only through a study protocol approved by the REB; or 4) Deny the request as submitted. Requests for Innovative Therapy that are approved by the Chief Medical Executive shall be conducted in accordance with the Enabling Letter and be subject to any requirements placed upon the Innovator by the Chief Medical Executive. All innovative outcomes shall be reported to the Chief Medical Executive, the Clinical and Administrative Directors of the impacted department and the REB Chair, without delay.





Frequently Asked Questions (FAQs)

  • White Instagram Icon

Contact Us

Address

© Copyright 2016 - 2020

Royal Victoria Regional Health Centre 

All Rights Reserved

Tel: 705-728-9090

Email: research@rvh.on.ca

Royal Victoria Regional Health Centre

Centre for Education & Research

201 Georgian Drive

Barrie, ON L4M 6M2