Criteria for review

1.0 Introduction

Purpose

This statement of criteria used by NRC's REBs when they are reviewing applications for ethics approval of projects involving human participants is offered to help applicants complete the Parts 2 and 3 of the application in a manner that is more likely to result in a successful application. The headings used follow those in the template.

Ethics review is constantly evolving. Though considerable effort has been made to ensure completeness and fair representation of what the REB members will be seeking, this statement is not binding on NRC's REBs, especially since new issues arise, or interpretations of older issues evolve. This statement will be under continuing review. NRC's REBs welcome any suggestions as to how this statement can be improved.

General comments

Before approving a proposed project the REB must conclude that answers to questions such as those below are consistent with the ethics standards expected by Canadians.

Because these questions have been developed to allow for a very wide range of potential projects, the significance attached by the REB to each question will vary between projects according to factors such as its ethical sensitivity, including the harms identified, and the extent of protection perceived to be needed by the participants or the community from which they are drawn.

Not all questions will be relevant to all projects.

REBs generally consider applications in two stages, which correspond to Parts 2 and 3 of the application format:

  • In the first stage, the REB concentrates on the ethics aspects of the project that are addressed in Part 2 of the application template. The REB considers the importance of the knowledge sought and the suitability of involving human participants to develop this knowledge, how the project will be carried out, the risks and benefits to the participants, and the processes to be followed in seeking to involve the potential participants in the project.
  • In the second stage, the REB focuses on the information that will be provided to potential participants, usually the consent form and any advertising or other materials, which is addressed in Part 3 of the application template.

2.0 Criteria For REB Review – Part 2

Objective of the Research

Does the proposed project address an issue or question that is of sufficient importance to justify the involvement of human participants?

Involvement of Human Participants

Has needed / appropriate preliminary work, e.g., in non-human or other systems, shown that it is appropriate to involve human participants in this project at this time?

Does the question asked require involvement of the population from which the potential participants will be sought?

Can the project be carried out with participants who are less vulnerable or who need less protection?

Scientific Validity

Does the design of the project give confidence that it can provide an answer to the question(s) posed?

Are the approaches and methods to be used relevant and sufficient to the knowledge being sought?

  • Factors include e.g., identifying and recruiting potential participants, dividing them into the various groups proposed in the project, measuring their responses to the various experimental conditions, and analyzing the results,

Will an appropriate number of participants be enrolled to allow a meaningful result from the project? Will the means of separating the participants into the various experimental groups be scientifically and ethically acceptable?

Will the participants selected provide appropriate representation within the study population?

Are the expectations by the investigating team from the participants appropriate to the needs of the project, and are they ethically acceptable?

Once started, is the project likely to be completed?

  • Factors include likelihood of recruiting the needed participants, availability of funds and other resources.

Note: Though the signature of the NRC scientific manager on the application form signifies that NRC has found the proposed project to be scientifically valid, the REB may ask for clarification of scientific or technical aspects to address certain questions such as those relating to harms and benefits.

Harms and Benefits

Harms

Have the potential harms to participants or others (e.g., family members, other patients, the community from which the participants will be drawn, or society as a whole) been identified and described fairly and accurately?

Does the design of the project minimize potential harms?

Are appropriate procedures in place to identify harms as they arise and to take steps to modify the project in response to those harms?

Are the potential harms acceptable?

Benefits

Have the potential benefits to participants or others (e.g., family members, other patients, the community from which the participants will be drawn, or society as a whole) been identified and described fairly and accurately?

Does the design of the project maximize potential benefits?

Research in which consent is not to be sought

If written consent is not to be sought, are the alternative approaches or the reasons for this appropriate?

Free and Informed Consent

Note: The information to be provided to potential participants is assessed in Stage 2, below.

Identifying and approaching potential participants

Do means of informing potential participants about the possibility of participating in the project provide them with the needed information in a manner that does not inappropriately intrude into their privacy? e.g.,

  • Are patients approached by people who they do not know, or who have no right to know about the condition that makes them potential participants?
  • Does the proposed advertising provide appropriate information?

Is there likely to be inappropriate discrimination in selection of participants?

Seeking informed consent

Do the means proposed for informing potential participants meet the needs for free and informed consent?

Will the potential participants be given sufficient time and opportunity to ask questions of the investigators, to consult with others, such as family, friends, advisors, and to consider their decision?

  • If not, are the reasons for not providing this time and opportunity justifiable, and what procedures are in place to address the ethical concern?

Voluntariness

Are potential participants in a situation that places coercive pressures on their decision on whether to consent to participate in the project?

  • If so, are appropriate procedures in place to allow them to exercise a free and informed consent?

Is any reimbursement offered to potential participants at such a level as to inappropriately coerce them into consenting to participate?

Incompetence

If the potential participants required for the project are not competent to provide a free and informed consent (or not likely to be), are appropriate mechanisms in place to determine their competence and to seek appropriate proxy consent?

Will appropriate mechanisms be used to allow incompetent participants to express their assent or dissent to participate?

Continuing consent

Will appropriate mechanisms be in place for ensuring effective opportunities for continuing consent?

Research in which consent is not to be sought

If written consent is not to be sought, are the alternative approaches or the reasons for this appropriate?

Privacy and Confidentiality

Are appropriate mechanisms in place to protect the privacy and dignity of the participants and/or the community(ies) involved?

  • Will only appropriately designated personnel have access to information that could invade the privacy of the participants?
  • Will appropriate procedures be in place for e.g., safeguarding, coding, storing and destroying information?
  • Will the results obtained from the project be published in a manner that respects requirements for objectivity and also that respects the privacy of the participants?
  • If information that identifies the participant is to be disclosed, the investigator(s) must state the nature of the information to be disclosed, the purpose of disclosure, the persons or agencies (e.g., the research sponsor, governmental regulatory authorities, the REB) who will have access to this information, why (e.g., for study monitoring purposes), how and where (usually only at the study site). Unless specified in the consent information, personal identifiable study information should never leave the study site.

Continuing Review

Has an appropriate plan for continuing review of the project as it proceeds been described?

Is an appropriate process in place for review of the data accumulating, e.g., to identify harms as they become evident during the course of the project and take the appropriate actions, e.g., to modify the project (which requires REB approval) or to stop the project?

Are appropriate mechanisms in place to monitor the performance of the investigation team in carrying out the project?

Compensation And Liability

Have concerns about compensation in case of injury in the project been appropriately addressed?

Investigator Qualifications and Expertise

Is the investigation team capable of carrying out the proposed project to both scientific and ethical standards consistent with Canadian expectations?

Do the investigators have the professional qualifications required for some areas of project?

Conflict of Interest

Has actual or perceived conflict of interest with respect to investigators and institutions in carrying out the project been disclosed and addressed satisfactorily? Factors include:

  • Fees paid to investigators or the institution in carrying out the project;
  • Freedom of those performing or guiding the project to make decisions without influence of commercial or other interests.
  • Investments or potential gain if the project is successful.

Legislation and Regulations

Is the applicant aware of applicable legislation and regulation?

3.0 Criteria for REB Review – Part 3 Consent Information

Overall, the major questions asked by NRC's REBs are:

  • Is the information in any documents or other materials to be used in seeking consent understandable by the potential participants to whom it is addressed?
  • Do the consent materials contain the information that a potential participant might reasonably be expected to want or need before making a decision on whether to participate in the study?

To develop their assessment of these overall major questions, the REBs will be considering a range of questions such as the following:

Project Team and Sponsor(s)

Does the consent information appropriately:

  • State that the invitation is to participate in a project?
  • Identify the leader of the project and other members of the investigation team?
  • Identify the sponsor of the project?
  • Explain the purposes of the study, e.g., the question being asked, or the hypothesis that is being tested, and/or outcome being sought?
  • Explain the possibilities of commercialization if relevant?

Why is the Study Being Done?

Does the consent information appropriately describe:

  • What the project is designed to achieve? How the project will be done? and where?; e.g., single or many sites, approximate numbers of participants?

How is this Project Expected to Affect You?

Does the consent information appropriately:

  • Explain what the participant will be asked to do, and/or the experimental procedures to which the participant will be exposed? Factors include:
    • Processes for distributing participants into different groups (e.g., randomization);
    • The possibilities that participants who have consented might not be included in the study;
    • What will happen within each group, including e.g., treatment with placebo; and
    • What will happen with any samples, tissues or data that arise from the study, especially if they are identifiable.

Potential Harms and Benefits

Does the consent information appropriately:

  • Identify the foreseeable harms that might arise from participation in the study, including physical, emotional and/or psychological harms, their anticipated seriousness and probabilities.
  • State that no harms are foreseen, if appropriate?
  • Identify the foreseeable benefits or state that no benefits are foreseen to participants.

Commercialization

Does the consent information appropriately state:

  • The intent to produce commercial products as a result of this research? Whether any financial gain to participants is to be expected if a commercial product is developed?

Alternatives to Participating in this Study

Does the consent information appropriately:

  • Identify the alternatives that are open to participants other than participating in the study (particularly relevant in studies about treatment for a health condition?

Privacy and Confidentiality

Does the consent information appropriately:

  • Provide commitments to preservation of privacy and confidentiality, including how research data will be collected, guarded, accessed by authorized people, stored (and for how long), and/or destroyed?
  • Indicate whether the research participants will have access to their own data?

Compensation for Injury; Legal Rights

Does the consent information appropriately:

  • Describe access by the research participants to care or assistance in the event of harms arising from the research?
  • Identify the professional responsibilities of investigators to participants?
  • State that consenting does not mean waiving any of their legal rights?

Reimbursement of Costs; Payment

Does the consent information appropriately:

  • Explain any re-imbursement that will be provided for expenses or as payments for participation.

You Have the Right to Decide and to Change Your Mind

Does the consent information appropriately:

  • Explain the right of research participants to withdraw from the research at any time, without penalty, and how they can exercise this right?

New Information

Does the consent information appropriately:

  • Explain continuing opportunities for consent in research that is envisaged to involve the participants for a significant time period?

Who to Contact if You Have any Further Concerns or Questions

Does the consent information:

  • Identify the people who can be contacted by the research participants about any questions or concerns or suffering of adverse reactions, including the leader of the research team and the O-REB office that has given ethics approval for the research.

Ethics Review

Does the consent information appropriately identify NRC's REB review?

Signatures

Does the consent form:

  • Allow for the appropriate signatures on the form?

    • Usually the research participant (or proxy consent) and the research team member who interacted with the research participant to seek the consent.
  • Appropriately explain the significance of the signatures as commitments by the investigators to the participants but not as commitments by the participants to the investigators.
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