Ethics Guidance2019-03-26T13:27:38+00:00

Ethics Guidance

Please use the following tabs below for information and guidance on preparing a submission to the RVH Research Ethics Board:

Does My Research Require Ethics Review?

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, and include the following requirements for ethics review:

Article 2.1:

The following requires ethics review and approval by an REB before the research commences:

  1. Research involving living human participants;
  2. Research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals.

Article 2.2:

Research that relies exclusively on publicly available information does not require REB review when:

  1. The information is legally accessible to the public and appropriately protected by law; or
  2. The information is publicly accessible and there is no reasonable expectation of privacy.

Article 2.3:

REB review is not required for research involving the observation of people in public places where:

  1. It does not involve any intervention staged by the researcher, or direct interaction with the individuals or groups;
  2. Individuals or groups targeted for observation have no reasonable expectation of privacy; and
  3. Any dissemination of research results does not allow identification of specific individuals.

Article 2.4:

REB review is not required for research that relies exclusively on secondary use of anonymous information, or anonymous human biological materials, so long as the process of data linkage or recording or dissemination of results does not generate identifiable information.

Article 2.5:

Quality assurance and quality improvement studies, program evaluation activities, and performance reviews, or testing within normal educational requirements when used exclusively for assessment, management or improvement purposes, do not constitute research for the purposes of this Policy, and do not fall within the scope of REB review.

Article 2.6:

Creative practice activities, in and of themselves, do not require REB review. However, research that employees creative practice to obtain responses from participants that will be analyzed to answer a research question is subject to REB review.

What Kind of Review Does My Research Require?

The RVH REB adopts a proportionate approach to research ethics review in accordance with Article 6.12 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2). 

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
  • 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
  • Examples include surveys, focus groups, retrospective chart review
  • 30 day turn-around for review
  • Reviewed by a single REB member or group of REB members

Reviewed studies will be given one of the following designations: Approved, Conditionally Approved (approval dependant on fulfillment of revision requirements), or Denied.

Education and Training

Mandatory Training

As part of the RVH Research Institute’s commitment to Accelerate Teaching and Research, Value People, and Drive Clinical Excellence, and to ensure compliance with relevant research regulations and guidelines, investigators wishing to conduct research at RVH are required to provide evidence of ethics training through online certification. Investigators are responsible for ensuring their research team complies with the qualification and training. All clinical study staff are responsible for participating in all required training, and for understanding and utilizing the training, as dictated by study protocol requirements.

Research Ethics Certification

Online research ethics certification must be completed prior to submitting an application to the Research Ethics Board. Certificates are provided upon completion of each course and should be submitted as part of the ethics application. The following information

Type of Research Study Role Required Training and Weblink
High Risk (e.g., RCT involving drug/device intervention) PI, Co-PI(s), Staff delegated study responsibilities CITI Canada GCP; CITI Canada Biomedical; CITI Canada -Health Canada Division 5
Moderate Risk (e.g., RCT with no drug/device intervention) PI, Co-PI(s) CITI Canada GCP
Staff delegated study responsibilities TCPS2 CORE
Low Risk (e.g, research eligible for expedited review; observational studies; chart reviews) PI, Co-PI(s), Staff delegated study responsibilities TCPS2 CORE

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)

REB initial approval of new submissions and annual renewal approvals of ongoing studies will only be granted to those investigators who have appropriate certification of training for themselves and all of their research staff.

Institutional 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 applicable clinical research personnel should familiarize themselves with the N2 set of SOPs, which are made available to all RVH investigators through RVH Policies and Documents intranet site (https://rvrhc.sharepoint.com/Policies/SitePages/Policies%20and%20Documents.aspx) or in the RVH Research Office.

REB Fees

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.

Service

Fee (CDN)

RVH-Investigator Initiated Study (All Review Types)
$0
Application Fee – Industry Sponsored Studies $3000
​Application Fee – Non-Industry External Study (Service Only) $500
Annual Re-Approval – Industry Sponsored Studies $500
Annual Re-Approval Non-Industry External Studies (Service Only) $100
​Penalty for Lapsed Approvals $250
Protocol Amendments Requiring Full Protocol Review $500

Invoicing and Payment

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.

RESEARCH STUDIES vs. THE USE OF INNOVATIVE THERAPIES

Medical professionals have an obligation to set standards and improve quality. Research Ethics Boards are not responsible to protect patients within a clinical practice. Studying quality and outcomes does not always equal research. Innovative therapy refers to new medical and surgical techniques or interventions that have not yet been introduced at the hospital as standard treatment but may have been validated elsewhere. The Declaration of Helsinki confirms the importance of innovation in medicine:

The Declaration of Helsinki Article C5:

In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic methods do not exist or have been ineffective, the physician, with informed consent from the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic measures, if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering. Where possible, these measures should be made the object of research, designed to evaluate their safety and efficacy. In all cases, new information should be recorded and, where appropriate, published. The other relevant guidelines of this Declaration should be followed.

If the intention is strictly therapeutic, innovative interventions 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 it 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 used for 3 or more patients, it should become the object of a research protocol and therefore recommended that it be submitted for REB approval. Use of the therapy shall be discontinued until it receives REB approval.

Innovative therapy may also be proposed for the use of an off-label drug, an untested or non-validated drug, or a validated drug for a new indication in which the intent is strictly clinical and without a research component. In such circumstances, the V.P. and Chief Medical Executive, the Clinical and Administrative Directors of the Department involved must first give approval for the therapy. In the absence of the V.P. and Chief Medical Executive, the Chair of the Medical Advisory Committee may grant this approval. The treating physician may also consult the Director of Pharmacy for objective opinions about the innovative therapy.

Introducing an Innovative Therapy/Procedure/Device

Physicians who wish to introduce an innovative procedure/therapy/medical device for strictly clinical reasons must submit an “Enabling Innovation Letter” to the Chief Medical Executive (copied to the Clinical and Administrative Directors of the impacted departments, as well as the Research Ethics Board Chair). The letter should:

  1. Explain the risks of the procedure/device/therapy;
  2. Describe the benefits of the procedure/device/therapy;
  3. Outline the costs;
  4. Be co-signed by two informed peers who are in support of the procedure/device/therapy;
  5. State who is responsible for oversight and how it will be achieved;
  6. Describe a plan for oversight.   The greater the risk, the greater the oversight required;
  7. Stringent oversight is required when:
    • The procedure is so novel that risks and benefits are unknown
    • the procedure affects the allocation of resources
    • the procedure/therapy/device carries greater risk than the alternative approaches
  8. State that Informed Consent is required.
  9. Fully describe the procedure/device/therapy
  10. Contain a clause informing the patient this is a new procedure in the hospital and that the patient is one of the first persons to receive it;

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 12 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.

Do I need to include a TCPS2 CORE Certificate or CITI-Canada GCP Certificate, with my submission for ethics review?2019-02-01T14:08:37+00:00

Yes. Investigators wishing to conduct research at RVH must submit evidence of ethics training for each new REB submission. Please visit http://www.rvhresearchinstitute.ca/ethics/how-to-apply/ to learn more about which ethics certifications are required based on the type of research being performed.

Can submissions be made using paper copies?2019-02-01T14:16:20+00:00

All applications submitted on or after October 15, 2018 should must be submitted electronically through the REO portal.

Is the submission deadline for full board review flexible?2019-02-01T14:23:42+00:00

Permission from the REB Chair must be obtained to consider the review of submissions after the deadline for the upcoming full board meeting. Please contact the REB Coordinator, Romaine Miller, at 705-728-9090 Ext. 43318 to inquire about submitting after the deadline.

How long does ethics review take?2019-02-01T14:40:22+00:00

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.

I am an external researcher. Who would I contact at RVH to help obtain departmental impact signatures?2019-02-01T15:34:47+00:00

If you require assistance with obtaining departmental impact signatures, please contact RVH Research Manager, Dr. Jesse McLean, at (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?2019-02-01T15:43:50+00:00

Yes. 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
How do I know if my research requires REB review?2018-05-22T16:56:48+00:00

Research involving the use of human subjects and/or information about them generally requires REB review and approval.  Use of human subject information for quality improvement purposes only may not need REB review and approval.  The final decision lies with the REB who will provide clarification on a case by case basis.  The Research Office is available to review your project/idea/study and facilitate a clarification from the REB.   It is strongly recommended that you obtain clarification and confirmation in advance of beginning your project if you believe it does not need REB approval. 

I’m ready to submit my REB application – what do I do?2018-05-22T16:58:39+00:00

All research with the exception of Oncology and FMTU resident projects (which undergo a similar review) must be referred to the Research Office prior to REB submission.  The Research Office ensures submissions are complete (approvals, paper/electronic versions, training certificates, CV’s, etc.), that necessary agreements or other administrative components are done or in process and privacy review and sign off is facilitated. 

I am an experienced researcher – do I still need to submit my project to the Research Office prior to the REB?2018-05-22T16:59:20+00:00

Yes, unless you are submitting your project through Oncology or as a FMTU resident project.   The Research Office assigns a unique number to all research studies and enters information about all research projects into the RVH study database.  To assist in the process completion of an intake form is recommended. 

Does RVH have policies related to conducting clinical trials research?2018-05-22T18:40:19+00:00

Yes, RVH is a member of the Network of Networks N2 a pan Canadian organization committed to facilitating clinical trials at the highest level and has adopted their standard operating procedures (SOPs).  Importantly, these SOPs have passed Health Canada inspection.  D

isclosure – As there can be a brief time lapse between the introduction of a new or revised SOP from N2 and its adoption at RVH please confirm with the Research Office the most current versions in use at RVH.  The N2 SOPs are currently available in the Research Office as well as the Cancer Program Clinical Trials Office.

Does my quality improvement (QI) project require REB approval?2019-02-01T16:17:06+00:00

In general, projects that are considered quality improvement/assurance (QI/QA) or program evaluation do not require ethics approval. However, when there is doubt as to whether or not the activity does or does not meet the definition of research involving humans, the researcher must confirm with the REB 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 are often published. 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 click HERE.