Standard Operating Procedures for NRC's Research Ethics Boards

1.0 General

These Standard Operating Procedures (SOP) implement the National Research Council Policy for Research Involving Human Subjects, as adopted by NRC Senior Executive Committee on 4 June 2008. The Policy provides definitions of "research", "human subjects", and "NRC involvement in research" as well as setting out considerations in respect to accountability, independence and Canadian Standards. The NRC-Research Ethics Board (NRC-REB) plays a central role in NRC's human subject ethics function.

Reporting to the Senior Executive Committee through the Secretary General, the NRC-REB:

• Ensures the appropriate review of applications for ethics approval of NRC research projects involving human subjects;
• Oversees and advises on the ethical aspects of all research involving human subjects in which NRC participates; and
• Provides a resource for education, guidance and leadership in the application of ethical principles to the conduct of research involving human subjects at NRC.

2.0 NRC Research Ethics Board membership

Composition

The NRC-REB comprises:

• a minimum of five (5) members
• both men and women
• at least two members with scientific expertise in broad areas addressed by the NRC;
• at least one member knowledgeable in ethics;
• at least one member knowledgeable in the relevant law;
• at least half of its members are not otherwise affiliated with NRC to help ensure independent evaluation and public accountability; and
• at least half of members are capable of reviewing applications in both official languages.

More than one of the above areas of expertise may be embodied in one individual.

Appointments

NRC-REB members and Chair are appointed by the NRC Secretary General. The Chair may or may not be an NRC employee, and if not, can serve under contract with NRC. If appointed under contract, the Chair shall not be counted as a member with no NRC affiliation. The Secretary General may appoint a Vice Chair to be ready to assume the responsibilities of the Chair in his/her temporary absence, or may appoint an NRC-REB member to assume these responsibilities.

Secretariat

The NRC-REB is supported by a Secretariat reporting to the Secretary General.

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.

Resignation

An NRC-REB member may resign from the Board by notifying the Chair, Secretariat or Secretary General, preferably in writing.

Vacancy

The NRC-REB Chair and/or Secretariat inform the Secretary General if the NRC-REB membership is, or is expected to be, inadequate to meet the requirements for membership or the anticipated workloads.

Confidentiality

NRC-REB members perform their work under NRC's agreement for confidentiality.

Conflict of interest

NRC-REB members, and staff shall declare any conflict of interest in relation to the consideration of any application, and excuse themselves from consideration 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 NRC-REB members

NRC-REB members are indemnified by NRC against third-party claims under NRC's Indemnification Policy.

Language

The NRC-REB shall be able to review documents in either official language. Communication with applicants should always be in the official language of their choice. Meetings shall be conducted in a manner that encourages participants to express themselves in the official language of their choice.

List of members

NRC publishes the names and affiliations of the members of the NRC-REB on the web site.

List of acronyms used in this document:

• HE IA – Human Ethics Institute Advisor (NRC Institutes)
• HE ITA – Human Ethics Industrial Technology Advisor (NRC-IRAP)
• NRC – NRC Industrial Research Assistance Program – National Research Council of Canada
• PI – Principal Investigator
• NRC-REB – NRC Research Ethics Board
• TCPS – Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

3.0 HE ITA or HE IA

Any NRC institute may appoint HE IAs and NRC-IRAP may appoint HE ITAs to meet operational requirements. These persons normally undertake this role in addition to other duties, to provide a liaison between their NRC Programs or Institutes and the NRC-REB.

Their responsibilities include:

• Providing a resource for education and assistance to investigators (NRC investigators, collaborators or recipients of NRC funds, e.g., through NRC-IRAP) who are planning research involving human subjects;
• Working with the NRC-REB to ensure compliance with NRC's policies and procedures;
• Working with the NRC-REB to establish criteria for the various levels of consideration of human subject ethics proposals, and to continuously review and adapt these as needed.

HE ITAs and HE IAs work closely with the NRC-REB Chair and Secretariat, receive copies of the minutes and are welcome to observe any NRC-REB meeting if they are not members of the NRC-REB.

4.0 Applications for ethics approval

All researchers proposing research involving human subjects in which NRC participates must make formal application for ethics approval from the NRC-REB, following the procedures set out below. A project must not involve any human subjects before the NRC-REB has given its ethics approval. Annex 1 provides a list of activities that do not require NRC-REB review.

NRC-REB address

All communications with the REB are made through:

Secretariat of NRC-REB
1200 Montreal Road
Building M-58
Ottawa, ON K1A 0R6

Telephone: (613) 991-9920
Fax: (613) 991-0398
Email: REB-CER@nrc-cnrc.gc.ca

Documents may be submitted electronically or in hard copy.

Enquiries about human subject research projects

The Chair, Secretariat and HE ITAs or HE IAs welcome enquiries and questions about projects at any stage of their development. However, no advice given in response to such enquiries pre-empts the independence of the REB in its consideration of a formal submission.

5.0 Documentation for ethics applications

Applications for ethics review shall normally use the templates provided by the NRC-REB (available on NRC's web-site). The NRC-REB is ready to accept applications using the forms of another organization that has or will review the project, though Part 1 of the NRC-REB's application form must also be completed. If the other REB has already rendered its decision, a copy of the correspondence should be included with the application.

Part 1: Signature page

Applications for all NRC research projects must identify and be signed by:

1. The Principal Investigator (PI)
   This signature certifies that:
   • The submission accurately describes the proposed project;
   • Acceptance of full responsibility for performing the proposed research in accord with NRC's policies, the requirements of the NRC-REB and the commitments made in the application as approved by the NRC-REB.
2. The NRC Scientific Manager: Each NRC institute or program should identify the appropriate person(s) for this responsibility.
   This signature certifies, on behalf of the institute or program, 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 the institute or program'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.

Applications for projects not carried out by NRC employees must identify and be signed by:

1. 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 accordance with NRC's policies, the requirements of the NRC-REB and the commitments made in the application as approved by the NRC-REB.
2. The NRC collaborating investigator: The NRC representative who works directly with the PI must sign to certify co-responsibility with the Principal Investigator. For NRC-IRAP projects, this person should be the HE ITA.

Part 2: Project description

The human subject study being proposed must be described in terms that are understandable by individuals with varied backgrounds as per the prescribed membership of the NRC-REB, recognizing that most members may not be familiar with technical concepts or terminology.

This description should be prepared using the NRC-REB template, or an equivalent template that provides the same range of information.
(See the section "Projects that are also submitted to another REB").

Part 3: Consent documentation

The information and consent documentation that is proposed for purposes of informing potential human subjects about the activity and seeking their consent to participate as subjects should be prepared using the appropriate NRC-REB template or an equivalent template.

Part 4: Scientific information

Any already prepared and relevant documents should also be included with the application. Examples of such documents include: scientific or technical protocols; applications for research grants together with referee comments and decisions on funding if available; technical documentation on products to be tested; documents required by regulatory authorities (e.g. Health Canada requirements for detailed documentation on pharmaceuticals, biologics, medical devices).

6.0 Processing of applications

Correspondence with applicants

Correspondence from the NRC-REB is normally addressed to the PI and NRC Scientific Manager and copied (electronically only) to all others identified in Part 1 of the application.

Review of completeness of the application

The NRC-REB Secretariat normally reviews the application within two (2) working days to check for completeness. If needed items are missing or inadequate, the Secretariat requests completion. The incomplete application may, at the Secretariat's discretion, be sent for review on the condition that the full documentation is received in time for the meeting or teleconference or, in the case of minor administrative matters, before a decision is rendered.

Notification of Receipt of Application

The NRC-REB Secretariat usually acknowledges receipt of an application within three (3) working days of receipt and informs the PI of the level of review that is planned.

Record keeping

The NRC-REB Secretariat maintains a file with a unique numerical identifier for all documentation for each project that is brought to NRC-REB's attention. All correspondence about the project should use this file identifier.

Access to Information and Privacy Acts

All NRC-REB records are subject to the provisions of the federal Access to Information Act and the Privacy Act.

7.0 Review of applications

There are four modalities of review of an application

• Review by the Full Board
• Delegated review by a Sub-Committee
• Delegated review by the Chair
• Delegated review by the HE ITA (NRC-IRAP only)

All applications are reviewed by the Full Board unless they are eligible for delegated Sub-Committee, delegated Chair review or delegated review by the HE ITA as described in this document.

Research involving human tissues/images/data may be reviewed by the Full Board, by a Sub-Committee or the Chair. Review the level or review according to the characteristics of the project. The NRC-REB has developed a shortened application form for some of those projects.

Levels of review for projects involving the use of human tissues, images of the body and health data

Level of review

Full Board Review as the default option (Sub-committee review may be considered in minimal risk situations)

Characteristics of research project

• Prospective collection of human tissues, images or health data; or
• Samples, images or health data obtained from identifiable or traceable banks or collections that are under the custody of the researcher or collaborator; or
• Samples, images or health data that CAN be linked to individual donors and that have been obtained from banks or collections: or
• Samples, images or health data from hospitals or other local collections; or
• Applications involving embryonic stem cells, in conjunction with referral to Canadian Institutes of Health Research (CIHR) Stem Cell Oversight Committee; or
• Projects that do not satisfy the criteria for NRC-REB Chair

Level of review

NRC-REB Chair may approve the projects that satisfy all these criteria

Characteristics of research project

Samples/images/data that CANNOT be linked by the researchers to individual donors and that have been obtained from banks or collections that satisfy criteria of:

• Independence of the collection from the research team; and
• Consent under which the samples/images/data were obtained from the donors is compatible with the research project; and
• Samples/images/data anonymized before they are provided to the research team.

Level of review

No NRC-REB review required

Characteristics of research project

Anonymous or anonymized established cell lines obtained from a collection or another researcher.

• that are broadly available to researchers; and
• CANNOT be linked to the individual from whom the tissue was originally obtained

NRC-REB Review of decisions made on behalf of the board

All decisions taken by a sub-committee, the Chair or an HE ITA on behalf of the NRC-REB shall be reported to the NRC-REB Secretariat which shall provide these reports to the NRC-REB at its next meeting. The collected decisions shall be examined by the NRC-REB on a regular basis, but no decisions made on behalf of the NRC-REB, pursuant to the NRC RIHS Policy and these procedures shall be overturned provided those decisions were made and reported in accordance with these procedures.

7.1 Review by the full board

REB meeting schedules

The NRC-REB normally schedules monthly meetings on a fixed day of the month (presently the last Wednesday) except December and July, though meetings are occasionally cancelled in the absence of projects to review.

Applications requiring full NRC-REB review are usually considered at formally scheduled NRC-REB meetings. In exceptional circumstances (during months when no NRC-REB meetings are scheduled or in response to unforeseeable urgent situations), the Chair may convene a special NRC-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 NRC-REB meetings

The Chair and Secretariat determine the agenda approximately two (2) weeks before the meeting.

Providing agenda materials to members

The Secretariat provides as much of the agenda materials as possible to NRC-REB members at least seven (7) working days before the meeting, usually in hard copy.

Quorum for full board meeting

The quorum shall be 50% + 1 members of the NRC-REB and shall be reflected in the minutes. Since NRC activities are across Canada, some NRC-REB members may participate in meetings through electronic communication mechanisms. If no member knowledgeable in relevant law or in ethics can attend the meeting, members with this expertise are consulted before the formal decision is taken.

Attendance by applicants, HE ITA or HE IA at NRC-REB meetings

The PI and/or the relevant HE ITA or HE IA are encouraged to attend the part of the NRC-REB meeting that considers their application to clarify aspects thereof and respond to questions, in person or through electronic conferencing links.

Ad hoc advice

The NRC-REB may seek advice from others (NRC employees or others) on specific applications or issues, with the authorization of the applicant. Such advisors are to be subject to NRC's policies for confidentiality and conflict of interest, and do not vote on NRC-REB decisions.

Discussion of the application at the NRC-REB

The Chair leads discussion of the application by the Board. Board members and ad hoc advisors discuss any issues that need to be raised with the PI and the HE ITA or HE IA. When the Board members are satisfied that they have the information that they need, the PI leaves the meeting. At the discretion of the Chair, the HE ITA as well as the HE IA may be present for an entire meeting.

NRC-REB decisions

After excusing guests, the Board continues the discussion to arrive at a decision. NRC- REB decisions may include:

• Approval of the application as submitted;
• Approval of the application, with the need to address minor issues before the research starts. The Chair normally gives the final approval;
• A statement of intent to approve the application, but only after the applicant has satisfactorily responded to requests for modifications. At the discretion of the NRC-REB, this re-submitted material may be reviewed and approved, by the full NRC-REB, or by a sub-committee, or by the Chair alone; and
• In the case of a rejection of the application as submitted in the light of major problems, the NRC-REB usually invites a full re-application that addresses the concerns identified.

The Chair summarizes the discussion and seeks agreement at the meeting. When deemed helpful to NRC-REB functions, the Chair may propose to draft a letter to the applicant after the meeting, email it to members and seek comments and approval. In all cases, the substance of the letter to the applicant is included in the minutes as the record of decision.

The criteria on which the NRC-REB bases decisions on whether to approve an application are published together on the NRC web site with the application template.

7.2 Projects eligible for review by sub-committee

Eligibility for NRC-REB sub-committee review

An application is considered to be minimal risk and hence eligible for NRC-REB sub-committee review outside a normal NRC-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 of participants; and
• 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 NRC-REB may use the Full Board even if all the eligibility criteria have been met, when:

• An application is received when a Full Board meeting is in preparation
• Any member of the Board or a Sub-committee requests review by the Full Board.

Selection of sub-committee members

The sub-committee is selected by the Chair and normally consists of the Chair and two members. The NRC-REB Secretariat checks with selected members for their ability to participate in a teleconference within one (1) week after receipt of the documents by the reviewers.

Procedures for sub-committee review

In order to be inclusive of NRC-REB members, the NRC-REB Secretariat sends the complete application electronically to all members of the NRC-REB, and identifies the selected subcommittee members. Any other member may request to be on the sub-committee or may request that the application be reviewed by the Full Board.

Sub-committee members first review the materials to determine whether they agree that the application is eligible for sub-committee review. If they accept review by sub-committee, a teleconference is scheduled within one (1) week. The subsequent process is similar to the full board review.

Other situations eligible for sub-committee review

The NRC-REB may also use a sub-committee to review the responses to NRC-REB concerns, requests for renewal of NRC-REB approvals, reports of adverse events, proposed amendments, and project termination reports.

7.3 Projects eligible for review by the chair

The Chair is authorized to review and approve projects in the categories described below, or to refer the application to the Full Board or sub-committee.

7.3.1 Specific projects under a generic protocol

A research team that employs an essentially constant research design for a series of projects that involve minimal risk and non-vulnerable subjects may seek NRC-REB approval of a generic application and consent form for their work.

Once the generic forms have been approved by the NRC-REB, the Chair is authorized to approve the specific projects, basing the decision on whether the project is consistent with the approved generic forms.

7.3.2 Human samples/images/data

The Chair can review projects using human samples/images/data that CANNOT be linked to individual donors and that have been obtained from banks or collections with specific criteria: See Table 1.

7.3.3 Projects that have been reviewed by another institutional REB (apart from IRAP)

The Chair may approve research projects that fall within one of the following categories:

• Collaborations by NRC employees in projects involving human subjects that are carried out in the collaborator's organization;
• Research to be carried out by students working in NRC facilities, taking into account factors such as ongoing research in the host laboratory

The NRC researchers must provide sufficient project identification information, including the protocol, consent form and the appropriate documents from the approving REB.

7.4 Projects eligible for review by the HE ITA

Research projects in which NRC's only involvement is through provision of research funds that have been reviewed by another institutional REB may be approved by HE ITA when or if:

• 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 TCPS or Health Canada requirements, or their equivalent - if the research is carried out abroad.

When a project is reviewed and approved by a TCPS compliant external REB and the relevant documentation is submitted to the HE ITAs, the client will be informed the project is approved and may proceed. However, in order to ensure that NRC-REB is appropriately informed of all ethics review decisions, HE ITAs must at the same time send appropriate documentation including, the protocol, consent form, HE ITA attestations and approval letter from the approving REB to the NRC-REB Secretariat for record keeping and reporting.

8.0 Addressing concerns raised by the review

Notification of NRC-REB decisions

The Chair may authorize the Secretariat to sign letters or memos on his/her behalf, and also to inform the applicant(s) informally by phone or email of NRC-REB decisions.

Correspondence identifying concerns about an application submitted for ethics approval of research within an NRC institute is addressed to the Principal Investigator, with copies to all others who signed the application. For NRC-IRAP projects, correspondence is addressed to the NRC scientific manager identified in Part 1 of the application, and copied electronically to all others identified in Part 1 of the application.

Applicants are normally notified of the concerns raised by the NRC-REB within two (2) working days of the decision of the NRC-REB or sub-committee. The notification letter identifies the concerns raised and invites responses, in writing, to each of the issues raised.

If modifications are required to any aspect of the application before it can be approved, the Chair, the Secretariat and HE ITA or HE IA may help the applicant(s) to address the issues raised and help to work towards an acceptable resolution.

Applicants shall submit the revised documents indicating any changes made to the original documentation together with a "clean" copy of the new text.

When the NRC-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 NRC-REB and indicated in the notification letter. When sub-committee review of revisions is appropriate, the process is similar to sub-committee review. The sub-committee can approve revised applications, request further modifications, or refer the revised application back to the NRC-REB. When full NRC-REB review of modifications is requested, the modifications may be considered by electronic means or at the next NRC-REB meeting.

9.0 Notification of ethics approval

For projects above minimal risk, the NRC-REB is required to ask the appropriate NRC Vice-President for permission to notify the applicant of ethics approval. The NRC-REB is authorized to directly notify the researchers of ethics approval of applications that are eligible for sub-committee or Chair review, even if it was reviewed by the Full Board.

The notification normally states that ethics approval is given for only one (1) year and that all research must cease unless application for renewal of ethics approval has been given in response to an application (see Section 11, Continuing Review). The Notification also sets out any other conditions of approval, 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;
• Limitation of subject enrolment to allow re-evaluation on the basis of initial results;
• Approval for less than one year.

10.0 Appeals of NRC-REB decisions

An investigator who disagrees with the position taken by the NRC-REB should first discuss the issue with the NRC-REB, and both the NRC-REB and the investigator should seek a mutually agreeable position. In the event of an impasse, the applicant may appeal to the Secretary General who mandates an appeal committee. An appeal committee is composed of three persons: one member is knowledgeable in law or procedural issues; one member is knowledgeable in ethics of research involving human subjects, the last member may be an administrator, a scientific or a community member. At least one of the committee members should be external to NRC.

The scope of any appeal is limited to procedural and jurisdictional issues. That is, the Appeal Committee determines whether the NRC-REB acted outside its mandate and/or committed a breach of the process for ethics review as set out in the most recent version of these SOPs or the TCPS.

The Appeal Committee has no jurisdiction to make a decision regarding the ethical acceptability of the research study involved in the process under appeal. It should be stressed that the appeals process is not a substitute for the NRC-REB and the researcher working closely together to ensure high quality research, nor is it a forum to merely seek a second opinion. It is expected that an appeal should be an exceptionally rare occurrence.

The Appeal Committee shall:

1. dismiss the Appeal;
2. declare the original NRC-REB decision void and direct the responsible NRC-REB to reconsider the application while ensuring the NRC-REB is compliant with all procedural and jurisdictional requirements; or
3. in the case of protocols reviewed by delegated review, direct the investigator to submit the protocol, as a new submission, for review by the full NRC-REB. ^{Footnote 1}

11.0 Continuing ethics review

11.1 Minimum requirements

All research projects that are given ethics approval by NRC-REB must comply with minimal requirements for continuing ethics review:

• Any new information that could change the basis for the NRC-REB's ethics approval;
• Any proposed amendments to the project as approved by the NRC-REB;
• Any adverse events or unexpected outcomes;
• A final report at the conclusion of the project.

11.1.1 Annual renewal

The NRC-REB gives ethics approval for a maximum of one (1) year. In some cases, the NRC-REB may give its approval for a shorter period. In the absence of a current valid NRC-REB ethics approval, all research involving human subjects must cease, except for continuing treatment of subjects already started on medication, or in other situations in which the safety of subjects would be compromised.

To continue the project beyond the period approved by the NRC-REB, a request for renewal must be submitted using the Request for Renewal of Human Subject Ethics Approval form, or equivalent. The application for renewal should be submitted in time for consideration by the NRC-REB before expiry of the current approval. The NRC-REB Secretariat normally advises the applicant approximately one (1) month before the need for renewal of approval.

In accordance with the appropriate level of review, the Chair may review the request of renewal, or may refer it to sub-committee or to the full Board.

11.1.2 New information that could change the basis for the NRC-REB's ethics approval

The PI must immediately report to the NRC-REB any new information from the literature or from observations made during the research that could change the considerations on which the NRC-REB based its ethics approval. The PI must also immediately report to the NRC-REB any sanctions imposed on the study by, for example, any regulatory agencies or bodies, trial monitors or auditors.

The NRC-REB may request further documentation that it needs for this reconsideration. The Chair considers a report of new information using the appropriate level of ethics review.

11.1.3 Amendments to the project

The PI must propose appropriate amendments to the research or consent documents approved by the NRC-REB that are needed as a result of new information. These proposed amendments may not be implemented before they have been approved by the NRC-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 NRC-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 Secretariat normally informs the Chair within two (2) working days of receipt of a proposed amendment. The Chair determines the timeline of review needed for NRC-REB consideration. The Secretariat acknowledges receipt of the proposed amendment, and indicates 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.

11.1.4 Adverse events All adverse events must be recorded by the PI.

All serious adverse events (deaths, serious illnesses) must be reported to the NRC-REB within forty-eight (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 fourteen (14) days. Reports of serious and/or unexpected adverse events should be reported together with an assessment of the impact(s) on the ethics of the research, and amendments that are proposed to address either the project or the consent information.

All adverse events must also be reported at the next request for renewal of NRC-REB approval, or in the termination report, whichever comes first.

The NRC-REB considers 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.

11.2 Determining additional needs for continuing ethics review

In projects in which the PI foresees the possibility of the need for continuing ethics review in addition to those described as minimal requirements, the application should propose appropriate mechanisms and approaches for continuing ethics review of the research project as it is carried out. The NRC-REB considers these proposals, and request modifications as necessary, or may impose additional requirements. 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.

11.3 Termination report

The PI must notify the NRC-REB when the project has been finished, using the Termination report form on the NRC-REB website. Each project continues on the NRC-REB's files until notice of completion of the project is received and acknowledged.

Annex 1 Activities that do not need an NRC-REB review

Sensory food panels

• 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 are basic foods for which no health benefits are to be claimed, and contain permitted additives not exceeding recommended daily allowance guidelines (RDI) normally associated with those foods;

Sensory evaluation of foods for which health benefits will be claimed or tested shall be reviewed by the Full Board or sub-committee (or an external REB for IRAP Projects).

Anonymous or anonymized established cell lines

Anonymous established cell lines obtained from a collection or another researcher that meet the following conditions are exempted from NRC-REB Review:

• Cannot be linked to the individual from whom the tissue was originally obtained;
• Are broadly available to researchers

Quality assessment, performance evaluation, and projects with tasks that fall within normal employee responsibility and do not contain an element of research

As specified in the TCPS, those studies "are not subject to REB review. However, performance reviews or studies that contain an element of research in addition to assessment may need ethics review."

When in doubt, the person leading the project applies in writing to the Secretariat of the NRC-REB, describing:

• The activity to be undertaken;
• The group from which those who will participate in the activity will be drawn;
• His or her responsibilities within the organization or the relevant normal operating procedures.

Anonymous market surveys

Market surveys of specific products or services are exempted from NRC-REB review when:

• Potential participants are competent adults;
• Only the final cumulated data, without identifiers, are released to the sponsoring organization.