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Application must be made to the Ottawa Health Science Network Research Ethics Board if you are planning any research that will involve human subjects. The following list will provide you with basic information on the various applications and forms available.

Request for Ethics Review

An   OHSN-REB Electronic Application  must be submitted for review and approval by the Ottawa Health Science Network Research Ethics Board. An approval letter must be obtained before the research begins.

Types of Review

Chart Review / Database Research
To qualify for chart review, your project must only involve the use of hospital charts (paper, vOacis, PACS, etc.) and must be retrospective in nature.

Or if you are doing database research, provide evidence of database registration from the TOH/UOHI Privacy Office if database was initially developed for clinical/administrative purposes or a completed request to the Decision Support Office to use TOH Data Warehouse information. Evidence of approval from the REB if the database was initially developed for research purposes.

OHSN-REB approval must be received before the research begins.

An  OHSN-REB Electronic Application  must be submitted for review and approval by the Chairperson of the Ottawa Health Science Network Research Ethics Board or their delegate.

Delegated Review

To qualify for delegated review, research must involve no more than minimal risk to human subjects, and fall within one of the categories established by the Tri-Council Policy Statement Ethical Conduct for Research Involving Humans (TCPS 2 (2014); chapter 6, Article 6.12).

An OHSN-REB Electronic Application  must be submitted for review and approval by the Chairperson of the Ottawa Health Science Network Research Ethics Board or their delegate. If the Chairperson does not agree that the research qualifies for expedited review, the investigator will be asked to submit the application to the Ottawa Health Science Network Research Ethics Board for full review.

Full Board Review

A completed  OHSN-REB Electronic Application  must be submitted to the Ottawa Health Science Network Research Ethics Board for review by the full Board. The submission deadlines and meeting dates can be found on our website by clicking on the Meeting Dates tab. OHSN-REB approval must be received before the research begins.

The Board’s responses to applications for full Board review are typically distributed one to two weeks following the meeting date.

Duration of Approval

Maximum duration of approval is one year. The OHSN-REB may specify a briefer period. Annual renewal of protocols is a minimum frequency.

Continuing Review

If research is ongoing, it is the responsibility of the investigator to ensure that approval of the study does not lapse. An  Annual Renewal Form  should be provided to the Ottawa Health Science Network Research Ethics Board approximately two months prior to the expiry date. This will allow the Chairperson or their delegate sufficient time to contact the investigator if there are any questions or concerns about the progress of the study.

The REB may determine that the research requires continuing review more frequently than once per year by considering the following:

  • The nature of any risks posed by the research,
  • The degree of uncertainty regarding the risks involved,
  • The vulnerability of the participant population,
  • The projected rate of enrolment and estimated research closure date,
  • Whether the research involves novel interventions,
  • The REB believes that more frequent review is required.

IMPORTANT:   Research participants cannot be enrolled into a study if ethics approval has lapsed.

The Researcher must document the reasons for the lapse and identify the steps taken to prevent future lapses.

Amendments

If there are any changes to the original Ethics application or company protocol, the investigator must notify the Ottawa Health Science Network Research Ethics Board as soon as possible. An  Amendment Form should be completed, and an approval letter obtained prior to implementing any changes.

If the proposed change represents more than minimal risk, it must be reviewed by the REB at a Full Board meeting. Amendments that may be classified as more than minimal risk may include:

  • Addition of genetic testing, new genetic tests, or tissue banking where genetic testing may or will be performed,
  • Addition of an open label extension phase following a randomized trial,
  • Emergency amendments that arise because of participant safety and may include, but are not limited to:
    1. A change in drug dosing/duration of exposure,
    2. A change in recruitment that may affect confidentiality or the perception of coercion,
    3. A change in experimental procedure or research population;

Changes to the Informed Consent Form and/or Other Participant Documents

Any change to an approved informed consent form and/or participant document (e.g. poster or questionnaire, etc) must be submitted for review and approval by the Ottawa Health Science Network Research Ethics Board. The investigator may only use the revised forms once they have received an approval letter from the Ottawa Health Science Network Research Ethics Board.

PLEASE NOTE:   The OHSN-REB no longer requires that a �valid until� date to be added to the bottom of all approved informed consent forms. Each initial approval, continuing review and consent form amendment approval letter will indicate the name and version date of the consent form(s) currently approved for use.

In addition, copies of the OHSN-REB approved informed consent form(s) will no longer be sent back with the approval letters.

Adverse Event Reporting

Internal Adverse Events

  • The QI/PI is required to report to the REB only those local AEs/ADRs that are deemed to be unexpected, related/possibly related and involving greater risk.
    • Upon becoming aware of a local AE/ADR, the investigator should assess whether the AE/ADR meets the reporting criteria above.
    • If the investigator determines that the AE/ADR meets the criteria for reporting to the REB, the investigator must report it to the REB within seven days of the incident, occurrence, outcome event, or when the Investigator becomes aware of the event or the new information.
    • If the investigator determines that an AE/ADR is does not meet the criteria, but the sponsor subsequently determines that it does, the sponsor should report this determination to the QI/PI, and such reports must then be submitted to the REB.
    • The following local AEs/ADRs ordinarily should NOT be reported to the REB:
      • SAEs/SADRs that are considered expected as defined by the protocol and/or IB or PM.
      • SAEs that are considered not related to the investigational product or research procedures, whether the event is expected or not.
      • AEs/ADRs that are non-serious, whether expected or not.

External (non-local) Adverse Events

External (non-local) serious AEs/ADRs should only be reported to the REB in the form of periodic safety update reports accompanied by information that is meaningful and useful to the REB. The content of the safety report should include at a minimum a sponsor analysis of the significance of the event or an analysis from the DSMB, with (where appropriate) a discussion of previous similar events, and a position statement as to whether any changes are required to the approved documents. These periodic reports should be submitted to the REB no later than fifteen days after receipt by the investigator.

Other Reportable Events

The REB must receive and review any new information generated throughout the course of the research that might affect the rights, safety and well-being of research participants.

Such information may include:

  • Modifications or changes to the previously approved research,
  • Reports of unanticipated problems involving risks to participants or others,
  • Reports of any serious or continuing non-compliance,
  • Reports of any changes significantly affecting the conduct of the research or increasing the risk to research participants,
  • Results of any interim analysis or Data and Safety Monitoring Board (DSMB) assessments,
  • Deviations to the previously approved research,
  • Adverse events that meet the reporting criteria,
  • Reports of any privacy breaches,
  • Summary reports of any audits and inspections,
  • Any other new information that may affect adversely the safety of the research participants or the conduct of the research

Terminations

Upon completion of the research, the investigator must submit a Termination Form to the Ottawa Health Science Network Research Ethics Board for review. This instructs the OHSN-REB to close the file. 

The ICH Guideline for Good Clinical Practice (1996) clearly indicates in section 14.3 – Final Report(s) by Investigator that “upon completion of the trial, the investigator, where applicable, should inform the institution; the investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome, and the regulatory authority (ies) with any reports required” (p. 20).

Prior to submitting a termination report, please ensure that this is your FINAL submission to the OHSN-REB for your protocol, i.e. all participant follow-up is complete, the sponsor has confirmed (where applicable) the database has been locked, all queries have been resolved.  Termination reports should not be submitted unless the study is finished at all centres (where applicable).

Advertisements, Letters to Physicians

Promotional material for studies, including letters and advertisements must be approved by the OHSN-REB prior to use. This includes print and electronic (e.g., radio, TV, Email, web-based) communication.
Newspaper advertisements and posters should include the OHSN-REB logo if you are recruiting across sites (e.g. at both TOH and UOHI). If you are recruiting from only one institution (e.g. TOH only) you may use the new OHSN-REB letterhead or your institution's letterhead. The following statement should also be included "This research study has been approved by the Ottawa Health Science Network Research Ethics Board.

The advertisements should also include the contact person and telephone number. When naming the contact person, use statements like "contact the study coordinator" or "contact the research assistant" etc as this allows for staff turnover.

The Principal Investigator’s name should not be included in the ad. The College of Physicians & Surgeons of Ontario prohibits the use of the physician’s name in any communication offering a product or service to the public. Please refer to their website for additional information. http://www.cpso.on.ca/policies/legislation/default.aspx?id=1768

Bilingualism in Clinical Research

All potential research participants at The Ottawa Hospital, University of Ottawa Heart Institute and University of Ottawa should have the opportunity to receive informed consent and study documentation in the official language of their choice, English or French.

Please refer to the Informed Consent Form Requirements and Documentation Standard Operating Procedure (SOP 701.001) and French Translation Requirements Addendum (SOP 701 Addendum) for more detailed information. It is important to note that this is the basic OHSN-REB standard. Please check with your institution and adhere to their specific policies.

If you have any questions about this policy, contact the Manager of the OHSN-REB Office at 613-798-5555, ext. 15072.