Standard Operating Procedures for NRC's Research Ethics Boards
NRC's Research Ethics Boards (REBs), and their support staff, are central to NRC's human subject ethics functions. Reporting to the Senior Executive Committee through the Secretary General, NRC's REBs review applications for human subjects ethics approval, oversee and advise on the ethical aspects of all research involving human subjects in which NRC participates, and provide a resource for education, guidance and leadership in the application of ethical principles in the conduct of research involving human subjects.
Appointments
REB members are appointed by NRC's Secretary General.
Composition
NRC's REBs contain at least 5 members, including both men and women, of whom:
- At least two members have broad expertise in the methods or in the areas of the research that are generally covered by the REB;
- At least one member is knowledgeable in ethics;
- At least one member is knowledgeable in the relevant law;
- At least one member serves as a community representative and is not affiliated with the NRC;
- 50% or more of NRC's REB members are not otherwise affiliated with the NRC, and
- For the Ottawa REB, which is in a designated bilingual region for language of work, half of the O-REB members shall be capable of reviewing applications in both official languages.
Secretariat
Each of NRC's REBs is supported by a Secretariat who report to the Secretary General (through the Director General of IBD for W-REB).
Ad hoc advice
The REB may seek advice from others (NRC employees or not) for specific applications or issues, at the discretion of the Chair or at the request of members, subject to NRC's policies for confidentiality and conflict of interest. Such advisors will not vote on REB decisions.
REB Chairs
The Secretary General appoints the Chairs of the REBs. The Chair of an NRC REB is usually not an NRC employee, but may serve under contract with NRC. If appointed under contract, the Chair shall not be counted as a member who is not affiliated with the institution. In the temporary absence of the Chair, the Secretary General may delegate the responsibilities of the Chair to a member of the Committee.
List of members
NRC publishes the names and affiliations of the members of its REBs on its ethics web site.
Term of office
Members are usually appointed for a three year term, though this term may be varied to allow for such factors as turnover and continuity. Appointments may be renewed.
Quorum
A quorum shall be 50% + 1 of the members of the REB.
Resignation
An REB member may resign from the Committee by notifying the Chair, the REB secretariat or the Secretary General.
Vacancy
The REB Chair and/or secretariat will inform the Secretary General if the REB membership is, or is expected to be, inadequate to meet the requirements for membership or the anticipated workloads.
Language
NRC's REBs shall be able to review documents in either official language. Communications with the applicants should always be in the official language of their choice. Also, meetings should be conducted in a manner that encourages participants to express themselves in the official language of their choice. For the Ottawa REB, which is in a designated bilingual region for language of work, half of the O-REB members shall be capable of reviewing applications in both official languages.
Confidentiality
REB members and ad hoc advisors and staff perform their work under NRC's policies for confidentiality.
Conflict of interest
Consistent with NRC's policies, REB members, ad hoc advisors, and staff shall declare any conflict of interest in consideration of any application, and excuse themselves from considerations of applications in which a conflict of interest is identified, or seek the decision of the Chair as to whether they should excuse themselves.
Indemnification of REB members
Under NRC's Indemnification Policy, REB members are protected by NRC against third-party claims.
NRC's institutes or programs may appoint Human Subject Ethics Advisors as they deem appropriate. Human Subject Ethics Advisors (Human Ethics ITAs within the IRAP program) normally undertake this work in addition to other duties, to provide liaison between their NRC Programs or Institutes and the NRC's REBs. Their responsibilities include:
- Providing a resource for education and assistance to investigators (NRC investigators, collaborators or recipients of NRC funds, e.g., through IRAP) who are planning research involving human subjects to work with NRC's REBs to ensure compliance with NRC's policies and procedures;
- Working with the REBs to establish criteria for the various levels of consideration of human subject ethics proposals, and to continuously review and adapt these as needed.
All research involving human subjects in which NRC participates must make formal application for ethics approval from the appropriate NRC Research Ethics Board, following processes set out below. The project must not involve any human subjects before an NRC REB has given its ethics approval.
REB Addresses
For applications from IRAP or NRC Institutes other than the Institute for Biodiagnostics, all communications should be made with NRC's Ottawa REB through:
Secretary, NRC Ottawa Research Ethics Board
Secretary General's Office
Building M-58
Ottawa, ON K1A 0R6
Tel: (613) 991-9920
Fax: (613) 991-0398
Email: OREB-CERO@nrc-cnrc.gc.ca
For the Institute for Biodiagnostics, all communications should be made with NRC's Winnipeg REB through:
Secretary, NRC Winnipeg Research Ethics Board
NRC Institute for Biodiagnostics
435 Ellice Avenue
Winnipeg, MB R3B 1Y6
Tel: (204) 984-6976
Fax: (204) 984-4722
Email: WREB-CERW@nrc-cnrc.gc.ca
Enquiries about human subject research projects
The REBs, IRAP's Human Ethics ITAs and NRC's Human Subject Ethics Advisors welcome enquiries and questions about projects at any stage of their development. As appropriate, these officers consult with the Chair or REB members to offer as much help as possible. However, no advice given in response to such enquiries pre-empts the independence of the REB in its consideration of a formal submission.
Preliminary ethics approval
When, for example, a major program is being planned that will include a component of research involving human subjects in its later stages, the REBs are prepared to consider preliminary ethics approval. This preliminary ethics approval is intended only to allow approval for the non-human subject research to start. Full ethics review by an NRC REB as described below is required before the human subjects research is started.
Research involving human subjects that does not need REB review
Applicants should presume that any human subjects research requires REB approval unless their project has been specifically identified by the appropriate REB Chair as not needing REB review. Criteria for such decisions will be published and regularly reviewed.
An application for ethics approval must include:
Part 1.
The signature page specified by NRC's REBs for such applications;
Part 2
A description of the human subject study being proposed. This description must be in terms understandable by all the members of the REB, recognizing that most members may not be familiar with technical concepts or terminology. This description should be prepared using the appropriate NRC REB template, or an equivalent template that provides the same range of information;
Part 3
The patient information (consent) documentation that is proposed for purposes of informing potential human subjects about the activity and for seeking their consent to participate as subjects. This information should be prepared using the appropriate NRC REB template or an equivalent template.
Part 4
The detailed scientific or technical protocol, and technical documentation on products to be tested, including documents required by regulatory authorities (e.g. Health Canada requires detailed documentation on pharmaceuticals, biologics, medical devices, or foodstuffs.)
In accordance with NRC's Official Languages Policy, applications for ethics approval may be in either official language.
Materials for review may be submitted electronically, or in hard copy.
Signatures required
Applications for REB review must identify and be signed by:
For all research projects
- The Principal Investigator
This signature certifies that the submission accurately describes the proposed project, and also certifies acceptance of full responsibility for performing the proposed research in accord with NRC's policies, the requirements of the REB and the commitments made in the application as approved by the REB.
- The NRC Scientific Manager
Each NRC Institute, or IRAP, should identify the appropriate person(s) for this responsibility.
This signature certifies, on behalf of NRC, that:
- The proposed research has been assessed by NRC's scientific review processes and has been found to meet NRC's scientific standards;
- The safety of the proposed research has been evaluated and the risk to human subjects meets NRC's standards;
- The study team is competent to carry out the research in accord with high scientific and ethical standards; and
- Planning is in hand or completed for the needed funds and other resources to be available for the research.
For research not carried out by NRC employees
- The Chief Executive Officer or delegate of the organization that is performing the research.
This signature certifies that the organization accepts responsibility for performing the proposed research in accord with NRC's policies, the requirements of the REB and the commitments made in the application as approved by the REB.
- The NRC collaborating investigator
The NRC representative who will work directly with the Principal Investigator must sign to certify co-responsibility with the Principal Investigator. For IRAP, this person might be the lead ITA.
Correspondence with applicants
Correspondence from the REB concerning an application under consideration or research involving human subjects being carried out on the basis of an approved project are normally addressed to the Principal Investigator and NRC Scientific Manager and copied to all others identified in Part 1 of the application.
Record keeping
The REB secretariat maintains a file with a unique numerical identifier for all documentation for each project. To facilitate record keeping, all correspondence about the project should use this file identifier.
Access to Information and Privacy Acts
All REB records are subject to the provisions of the federal Access to Information Act and the Privacy Act.
Review of completeness of the application
The REB Secretariat normally reviews the application within 2 working days to check for completeness. If needed items are missing or inadequate, the REB Secretariat requests completion. The Secretariat has the discretion to require the full documentation before placing the application on the agenda of the next meeting, or to allow the incomplete application to be on the agenda, subject to having the full documentation in time for the meeting or, in the case of minor administrative matters, before an REB decision is rendered.
Determining the need for additional expertise for review
Working together, the Chair and the Secretariat review the application to determine whether additional advice will be needed for adequate review, and take steps to identify and invite appropriate ad hoc advisors.
Determining eligibility for sub-committee review
The Chair determines whether sub-committee review should be used for an application. If so, the secretariat, in consultation with the Chair, identifies a sub-committee to consider the application (see Section 6.2)
Notification of Receipt of Application
The REB Secretariat usually acknowledges receipt of an application within 3 working days of receipt and, subject to considerations of completeness (above).
Overview
All research involving human subjects must be approved by one of NRC's REBs. All such approvals must be gained through application to NRC's REB processes unless the appropriate REB chair has determined that REB application is not required.
Applications for ethics approval are considered by the REB at a formal meeting unless the application is to be considered by sub-committee (See Section 6.2)
6.1 Projects Requiring Full REB Review
REB meeting schedules
Applications requiring full REB review are usually considered at formally scheduled REB meetings. In exceptional circumstances, during months when no REB meetings are scheduled, or in response to unforeseeable urgent situations, the Chair may convene a special REB meeting, by electronic means if necessary, provided that requirements for factors such as a quorum and time for members to consider the application are satisfied.
Agenda for REB meetings
The Chair and REB secretariat determine the agenda approximately two weeks before the meeting.
Providing agenda materials to members
The Secretariat provides as much of the agenda materials as possible to REB members at least 7 working days before the meeting, usually in hard copy.
Attendance by Human Subjects Ethics Advisors and by applicants at REB meetings
The Principal Investigator and/or the relevant Human Subjects Ethics Advisor or Human Ethics ITA are encouraged to attend the part of the REB meeting that considers their application to clarify aspects of the application and respond to questions, in person or through telephone conferencing links.
Decision criteria
The criteria on which the Research Ethics Boards base decisions on whether to approve an application are published together with the application template.
Discussion of the application at the REB
The Chair leads a discussion of the application by the Board. The Principal Investigator or the Human Subjects Ethics Advisor (Human Ethics ITA), a Board member or ad hoc advisor outlines the application. Board members and ad hoc advisors discuss any issues that they think need to be raised with the Principal Investigator and the Human Subjects Ethics Advisor (Human Ethics ITA). When the Board members are satisfied that they have the information that they need, the Principal Investigator will leave the meeting. At the discretion of the Chair, the Human Subjects Ethics Advisor may be present for the entire meeting.
REB decisions
After excusing guests, the Board continues the discussion to arrive at a decision. The REB may make decisions such as to:
- Approve the project as submitted;
- Approve the application, but identify minor issues that need to be addressed before the research starts, with final approval by the Chair.
- State its intent to approve the application, but only after satisfactory modifications have been made. The REB invites the applicant to re-submit those aspects that need to be addressed; at the discretion of the REB, this re-submitted material may be reviewed and, if found acceptable, approved, by the full REB at a full meeting, or through mail review, or by an identified sub-committee of Board members, or by the Chair alone;
- Reject the application as submitted because major problems prevent approving the application. The REB invites the applicant(s) to re-apply with a full application which addresses the concerns identified, and which must be considered by the full Board;
The Chair summarizes the discussion in the form of a proposed decision. A motion to approve this decision is moved and seconded, amended as needed, and voted upon. In the absence of consensus, a decision for approval requires 2/3 of those present. Abstentions or absences from the decision for reasons of conflict of interest are recorded.
6.2 Review of Applications Eligible for REB Sub-Committee Review
Eligibility for REB sub-committee review
An application is considered to be minimal risk and hence eligible for REB sub-committee review outside a normal REB meeting if ALL the following conditions are met:
- The risks of participating in the research are no greater than those of day-to-day life;
- The potential research subjects are competent to make a free and informed consent, free from coercion, on their own behalf; and
- Potential conflicts of interest by the principal investigator and the study team are minimal and effectively managed.
The REB may use a full Board review even if all these criteria have been met.
The REB may also use a sub-committee to review the responses to REB concerns, requests for renewal of REB approval, reports of adverse events, proposed amendments, and project termination reports.
Selection of sub-committee members
The sub-committee will normally be selected by the Chair or the REB secretariat. The sub-committee for review of a new application or for the applicant's response to a review will normally consist of the Chair and two members. For review of requests for renewal of REB approval, reports of adverse events, proposed amendments, and project termination reports, the Chair may decide alone or may involve only one REB member.
Procedures for sub-committee review
The REB secretariat sends the complete application to the members of the sub-committee. The sub-committee members review the materials to determine first whether they agree that the application is eligible for sub-committee review. If so, each member determines whether the application meets the NRC REB decision criteria, and provides a written report of his/her conclusions.
The REB Chair reviews the responses from the sub-committee members, clarifies them if needed with the members, and reaches a decision on the application, consulting with sub-committee members as needed. The sub-committee may decide to:
- Approve the application as submitted;
- Approve the application, but identify minor issues that need to be demonstrably addressed before the research starts, with final approval by the Chair.
- State its intent to approve the application, but only after satisfactory modifications have been made. The Sub-committee will invite the applicant to re-submit those aspects that need to be addressed; at the discretion of the Chair, this re-submitted material may be reviewed and, if found acceptable, approved, by the sub-committee or by the Chair alone;
- Refer the application to the full REB at its next scheduled meeting.
6.3 Projects that have been Reviewed by Another REB
When NRC participates in research with another organization that has its own REB, NRC's REBs are prepared to consider an application that is submitted on the other organization's forms if they contain the information required by NRC's REB. If the other organization has already considered the application for ethics approval, review by NRC's REBs might be facilitated if any correspondence related to concerns raised by the other REB is made available to NRC's REB.
NRC-IRAP project which has been reviewed by another REB:
For research projects in which NRC's only involvement is through provision of research funds through IRAP; NRC's Human Ethics ITAs are authorized to determine whether an REB that is mandated by the organization where the research is carried out has an established REB process, that complies with the regulatory requirements of Health Canada for ethics review of activities under the Food and Drugs Act, or with the TCPS under the Tri-Council MOU Mechanism. If the HE ITA determines that this is the case, and that appropriate ethics review has been carried out, the HE ITA must notify the NRC's O-REB Secretariat that NRC's requirements for ethics review have been met. The HE ITA provides sufficient project identification information.
Procedures for NRC-IRAP Protocols that do not Require
O-REB Review:
- The HE ITA tests the project against criteria for eligibility under the policy. That is that: NRC's involvement is limited to providing funds; no NRC personnel or facilities are involved in the project; and the project falls under the control of an established ethics review function that meets Tri-Council Policy Statement (TCPS) or Health Canada requirements, or their equivalent - if the research is carried out abroad.
The HE ITA reports the project to the O-REB Secretariat and provides sufficient information including the protocol, consent form and the appropriate documents from the approving REB. At that time, the HE ITA attests that the project meets eligibility criteria.
6.4 Protocols that can be approved by the Chair
1. Projects with tasks fall within employee responsibility:
Criteria for eligibility
The project involves employees doing work that is clearly within their responsibilities as employees of the organization, or involves routine quality assessment of operations or products, performance evaluation, etc. that can reasonably be expected as normal operational procedures by employees;
Mechanisms for application
The person leading the project applies in writing to the Secretariat of the O-REB, describing the activity to be undertaken, identifying the group from which those who will participate in the activity will be drawn, and describing such factors as their responsibilities within the organization or the relevant normal operating procedures of the organization. In some cases it may be useful to append a typical job description relevant to those who will be asked to participate in the activity.
Decision-making authority
The Chair of the O-REB is authorized to make the decision on behalf of the REB, taking whatever advice she or he may feel is necessary from REB members or NRC officials. All decisions made will be reported to the O-REB at the next meeting, and the collected decisions will be reviewed by the O-REB at regular intervals. The decision is made project by project, and not as a generic exclusion.
2. Sensory food panel:
The O-REB Chair is authorized on a case-by-case basis to approve research projects that meet all of the following criteria:
The project is designed only to assess the sensory characteristics of a food, defined by the Food and Drugs Act (1953) as:
"... any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatsoever".
The foods to be considered will be either:
No health benefit claims are to be made for the food.
Sensory evaluation of foods for which health benefits will be claimed shall be reviewed by sub-committee or the full Board.
Projects seeking to test for or establish a health benefit shall be reviewed by the full Board.
3. Generic Protocols:
A research team or organization that employs an essentially constant research design for a number of different projects that involve minimal risk to the research subjects may seek O-REB approval of a generic application and consent form for their work.
Generic application and consent forms have been approved in areas such as software testing, research into various aspects of office work conditions, in flight testing of instrumentation for pilots, and development and testing of mobile IT equipment.
General Criteria for eligibility for generic application include:
- Risks of participating are no greater than those of everyday life;
- The project will test the product, not the subject;
- Potential subjects are representative of the target population for marketing the product;
- The subject's involvement in the project is complete within a few hours or one day, with no recalls or further contacts;
- The subject material of any software is innocuous;
- All research records, including videotapes will be kept confidential to designated personnel;
- No material that could identify any participant will be released beyond the designated research team;
- Payments are at most consistent with normal remuneration of the target population.
Once the generic application form has been approved by the O-REB, the Chair is authorized to approve the specific project, basing the decision on whether the project is consistent with the generic form approved. The decisions of the Chair are reported to the O-REB at its next meeting, and all the applications are reviewed at regular intervals.
Applications requiring modifications before approval
If modifications are required to any aspect of the application before it can be approved, or if the REB rejects the application as submitted, the REB, through the Chair, the REB secretariat and Human Subject Ethics Advisors will help the applicant(s) to address the issues raised and help to work towards an acceptable resolution.
Applicants are normally notified of the concerns raised by the REB within two working days of the decision of the REB or sub-committee.
The REB secretariat drafts the decision letter for the signature of the Chair. The Chair may authorize the secretariat to sign on his/her behalf, and also to inform the applicant(s) informally by phone or e-mail. Correspondence identifying concerns in NRC Institute research is addressed to the Principal Investigator, with copies to all others who signed the application. For IRAP projects, correspondence is addressed to the NRC scientific manager identified in Part 1 of the application, and copied to all others identified in Part 1 of the application.
The notification letter identifies the concerns raised and invites responses, in writing, to each of the issues raised. To facilitate further review, when the REB or sub-committee requires modifications before approval can be granted, the applicants should provide a copy of the revised document that indicates any changes made in the original documentation together with a "clean" copy of the new text.
When the REB has found an application to be unacceptable in its present state, an entirely new application without reference to the previous one should be submitted.
Consideration of applicant responses
Responses by the applicant to concerns, issues or questions raised in the review are considered according to the mechanisms decided upon by the REB (see above). When sub-committee review of revisions is appropriate, the sub-committee can approve revised applications, or request further modifications, or refer the revised application back to the REB. When full REB review of modifications is requested, the modifications are considered at the next REB meeting. If sub-committee review is used, the REB secretariat will normally inform the applicant by fax or email of the sub-committee decision within 5-7 working days after submission of the revised application.
For applications that are not eligible for sub-committee review, the REB asks the appropriate NRC Vice-President for permission to notify the applicant of ethics approval. The REBs are authorized to directly notify the researchers of ethics approval of applications that are eligible for sub-committee review.
An investigator who disagrees with the position taken by an NRC REB must first discuss the issue with the REB, and both REB and investigator will seek a mutually agreeable position. In the event of an impasse, the applicant may appeal to the Secretary General to refer the application to NRC's other REB. If the Secretary General gives permission for an appeal, the file is referred to the second NRC REB which takes over complete responsibility for the project, and considers the full application together with the concerns raised by the first REB and the responses of the applicant to those concerns. No further appeal is available.
All decisions on behalf of NRC's REB concerning the need for REB application, or sub-committee review, must be reported to the appropriate NRC REB at its next meeting, and the collected decisions must be reviewed at least annually by the REB.
Determining the needs for continuing ethics review
The applicant proposes in the application mechanisms and approaches for continuing ethics review of the human subjects activity as it is carried out. The REB considers these proposals, and requests modifications as necessary. The mechanisms decided upon for continuing ethics review of the project as it is carried out form a part of the conditions upon which ethics approval of the project is based.
Minimum requirements
At a minimum the applicant must commit to:
- Report immediately to the REB any information, from sources such as the literature or the accumulating data, that could be perceived by the REB as significantly changing the understandings on which the REB based its approval of the project;
- Report immediately to the REB any serious unanticipated adverse events arising from the project;
- Report immediately to the REB any sanctions imposed on the study by any regulatory offices or bodies, trial monitors or auditors.
- Propose appropriate amendments to the project or the consent information for consideration by the REB that are seen as necessary as a result of new information, including adverse events;
- Stop recruitment or continued involvement of human subjects that involves risks to them at the end of the time period authorized by the REB in its most recent notification of ethics approval. Treatment may be continued if stopping would act against the interests of the human subjects already in the research program;
- Submit an application for extension of the period of ethics approval if the project will continue beyond the period stated in the notification of ethics approval (maximum one year), in good time to allow its consideration by the REB before the current approval period expires;
- Submit a final report within a reasonable time after completion of the project.
Reconsideration
In the event of new information that could significantly affect the factors on which ethics approval was based, the REB reserves the right to reconsider any project. The REB may request the further documentation that it needs for this reconsideration.
Additional requirements
More extensive approaches to continuing review may be required for activities that are perceived to involve significant ethics concerns. Such mechanisms may include, for example: establishment of a data and safety monitoring board; establishment of stopping rules or other periodic reviews of the accumulating data; specific monitoring of aspects such as consent processes; or random audits of data.
Adverse events
Adverse events that arise in the course of human subjects research must be recorded by the principal investigator. All serious adverse events (e.g., deaths, serious illnesses) must be reported to the REB within 48 hours. Adverse events that are unexpected, or occur at a higher frequency than expected, and that cause significant discomfort or stress to human subjects, must be reported within 14 days. All adverse events must be reported at the next request for renewal of REB approval, or in the termination report, whichever comes first. All reports of adverse events must be accompanied by an assessment of the impact(s) of the adverse event on the ethics of the research, and amendments that are proposed to address either the project or the consent information.
Adverse events reports should be reported on the adverse event report form in Annex D, or equivalent.
The REB will consider reports of adverse events using a sub-committee or the full Board, as appropriate in the light of the severity of the adverse event reported.
Reports on new information that could affect the REB's ethics approval
Any new information from any source, e.g., the literature or the results, that could change the considerations on which the REB based its ethics approval, must be reported by the principal investigator to the REB, together with an assessment of the impact of the adverse event of the ethics of the research or risk to human subjects, and amendments that are proposed to address either the project or the consent information.
The Principal Investigator should use the New Information report form in Annex D, or equivalent.
The REB will consider a report of new information using a sub-committee or full board mechanism, as appropriate in the light of the severity of the adverse event reported.
Amendments to the research as approved by the REB
The applicant may propose amendments to the research or consent documents approved by the REB for any reason. These proposed amendments may not be implemented until they have been approved by the REB, unless they involve issues of immediate relevance to the safety of the subjects in the project. New subjects may not be recruited until the REB has approved the amendment if the proposed amendments deal with a matter of patient safety or the information that is provided to potential subjects.
The applicant proposes the amendments using the forms in Annex D, or equivalent.
The REB secretariat informs the Chair normally within 2 working days of receipt of a proposed amendment. The Chair determines the level of review needed for REB consideration (full REB review, review by a sub-committee or review by the Chair alone). The REB secretariat acknowledges receipt of the proposed amendment, whether the documents submitted are sufficient for consideration, the extent to which the research may proceed pending its consideration, and the anticipated dates for completion of the review.
Renewal of ethics approval
The REB's approval is for a maximum of one year. In some cases, the REB may give its approval for a shorter period. All research involving human subjects must normally cease if there is not a currently valid REB ethics approval, except for continuing treatment of subjects already started on medication, or other areas in which the safety of subjects would be compromised.
To continue the project for longer than the period approved by the REB, a request for renewal must be submitted. The principal investigator should use the Request for Renewal of Human Subject Ethics Approval form in Annex D, or equivalent. To facilitate continuity of the human subject research without stoppage, the application for renewal should be submitted in time for consideration by the REB at least two months before expiry of the REB's approval, using procedures set out in the templates and forms. The REB secretariat normally advises the applicant approximately two months ahead of the need for renewal of approval.
The Chair determines the process to be used for reviewing applications for renewal of ethics approval (full REB, sub-committee, or Chair only). The REB secretariat implements the review processes in a manner parallel to those described for review of applications.
Each project will continue on the REB's files until notice of completion of the project is received and acknowledged. The principal investigator is required to submit the notification of completion of the human subject research as soon as practical, using the form in Annex D, or equivalent.
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