Criteria for Review
Purpose
This statement of criteria used by NRC's REBs when they are reviewing applications for ethics approval of projects involving human subjects 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 subjects 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 beings as subjects to develop this knowledge, how the project will be carried out, the risks and benefits to the subjects, and the processes to be followed in seeking to involve the potential subjects in the project.
- In the second stage, the REB focuses on the information that will be provided to potential subjects, usually the consent form and any advertising or other materials, which is addressed in Part 3 of the application template.
Objective of the Research
Does the proposed project address an issue or question that is of sufficient importance to justify the involvement of human beings as subjects?
Involvement of Human Subjects
Has needed / appropriate preliminary work, e.g., in non-human or other systems, shown that it is appropriate to involve humans as subjects in this project at this time?
Does the question asked require involvement of the population from which the potential subjects will be sought?
Can the project be carried out with subjects 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 subjects, 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 subjects be enrolled to allow a meaningful result from the project? Will the means of separating the subjects into the various experimental groups be scientifically and ethically acceptable?
Will the subjects selected provide appropriate representation within the study population?
Are the expectations by the investigating team from the subjects 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 subjects, 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 subjects or others (e.g., family members, other patients, the community from which the subjects 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 subjects or others (e.g., family members, other patients, the community from which the subjects 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 subjects is assessed in Stage 2, below.
Identifying and approaching potential subjects
Do means of informing potential subjects 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 subjects?
- Does the proposed advertising provide appropriate information?
Is there likely to be inappropriate discrimination in selection of subjects?
Seeking informed consent
Do the means proposed for informing potential subjects meet the needs for free and informed consent?
Will the potential subjects 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 subjects 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 subjects at such a level as to inappropriately coerce them into consenting to participate?
Incompetence
If the potential subjects 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 subjects 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 subjects and/or the community(ies) involved?
- Will only appropriately designated personnel have access to information that could invade the privacy of the subjects?
- 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 subjects?
- If information that identifies the subject 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?
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 subjects to whom it is addressed?
- Do the consent materials contain the information that a potential subject 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 subjects?
How is this Project Expected to Affect You?
Does the consent information appropriately:
- Explain what the subject will be asked to do, and/or the experimental procedures to which the subject will be exposed? Factors include:
- Processes for distributing subjects into different groups (e.g., randomization);
- The possibilities that subjects 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 subjects.
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 subjects 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 subjects will have access to their own data?
Compensation for Injury; Legal Rights
Does the consent information appropriately:
- Describe access by the research subjects to care or assistance in the event of harms arising from the research?
- Identify the professional responsibilities of investigators to subjects?
- 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 subjects 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 subjects 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 subjects 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 subject (or proxy consent) and the research team member who interacted with the research subject to seek the consent.
- Appropriately explain the significance of the signatures as commitments by the investigators to the subjects but not as commitments by the subjects to the investigators.
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