Part 2: Guidance on completing the application for ethics approval
The purpose of this guidance document is to help applicants prepare their applications for approval by one of NRC's REBs of the ethics aspects of their proposed project. This guidance document complements both the Template Application Form and the Statement of Criteria for REB Review for applications for ethics approval.
Ethics review is constantly evolving; new issues arise, and interpretations of older issues evolve. Though we have made every effort to be accurate and up-to-date, this guidance document does not bind NRC's REBs to taking specific positions. This statement will be under continuing review, and any suggestions for improvement are welcome.
The headings used below parallel those in the template Application Form that is offered under Part 2 of the application documentation.
The completed application should provide each REB member with the scientific, technical, procedural and ethics information that it needs both to evaluate the ethics of the proposed project, and also to evaluate whether subject information and consent materials in Part 3 accurately represent the project to potential subjects. The information provided must therefore accurately present the proposed research, and is, in effect, a binding statement by the research team to the REB.
The application form must be readily understandable by each REB member. Since different members bring different expertises to the REB, most will not be familiar with scientific or technical terminology of a specific project. Care is therefore needed to ensure that the application provides the information that the REB needs to assess the ethical acceptability of the proposed research, but that does not provide unnecessary scientific or technical detail; such details can be provided in Part 4 of the application for ethics approval.
The Application Template Form consists of a series of headings. If applicants decide that some headings or REB questions are not significant in their project, a response such as 'Not applicable' might be appropriate, especially if reasons are given. However, no headings in the template application form should be deleted.
The information provided in response to Part 2 must be complete in itself, without reference to another document or another part of the application. Literature references may be provided as the sources of scientific or technical descriptions provided in Part 2. When essentially the same text is used in the consent form (in Part 3), it may be copied to Part 2 without editing (e.g., "You will be... " in the consent form need not be changed to "Subjects will be... " in Part 2).
To facilitate legibility, NRC asks applicants to use Arial 12 point font.
REB identification number (if already assigned by the REB secretariat).
This repeats information on Part 1, the documentation for administration, to help ensure that the documentation is correct
Where the research will be carried out
The REB will want to know from the start who are involved with the research, their qualifications, how the research will be funded, and where it will be carried out.
The application should address questions such as:
- Why is the proposed research to be undertaken?
- What questions (primary and secondary) is the research project intended to answer, or what hypotheses is it intended to test
- What is the rationale for these objectives and why are they important?
- What outcomes are expected from the research?
The application should justify the use of human participants in the proposed research. Relevant questions include:
- Why are human participants needed?
- Why is the group of potential subjects with the specific characteristics identified needed for the research (particularly important if the competence of the potential subjects to consent for themselves is compromised)?
- Why can the work not be done with non-human subjects, or in other systems?
- Has the needed preliminary research been done, for example with non-human subjects or with human participants who have a higher capacity to consent for themselves?
What will be expected of the subjects in the project?
- The REB needs to understand what the subjects will be asked to do so that they can address later questions of, for example, balancing harms and benefits, and privacy and confidentiality. The REB needs to know what the subjects will be asked to do or how they will be involved in the project. This description should include what analyses will be done on samples or other information that will be obtained in the project. It should also state how long each subject will be involved in the project, as well as the overall time that completion of the project is expected to take.
- Many research projects involve collecting personal information about the subjects. The needs for collecting such information must be justified in the context of the objectives of the research, and the means of collecting this information (e.g., questionnaires) provided as part of the application (as an appendix to Part 2, or in Part 4).
A research project can only be justified ethically if it has the potential to achieve its objectives. The REB therefore must be satisfied that the project has the potential to achieve the desired objectives. Issues that will need to be addressed in many projects include:
The overall design of the research project:
- This description in the application form should provide sufficient information to allow the project design to be understood, but not in the detail that would be required for full technical performance.(which, if available, should be provided in Part 4 of the application). The description could include, for example:
- The major steps that will be followed in the project,
- An adequate description of the research design is needed to allow the REB to understand the proposed research. This outline should include the data that will be collected and how it will address the research objective. The means of analysing the data should also be outlined.
- The criteria for identifying and including or excluding potential subjects
- Inappropriate exclusion of potential subjects from research can raise issues of justice and fairness, for example because it excludes individuals or groups from the benefits of research, and minimizes the significance of the research results. No group should be excluded without good reason. On the other hand, inclusion criteria that are too broad could expose individuals or groups who are unlikely to benefit from the research to the risks of the research, and significantly increase the costs of the research.
- The numbers of subjects to be recruited for the project, and how they will be assigned to the various experimental groups.
- The numbers of subjects to be recruited for the project must be identified and justified. Many projects will be driven by statistical requirements. For example, the numbers of subjects to be recruited may depend on the objectives sought, and the extent to which the proposed intervention is expected to change the outcome(s) to be measured in the project. Too few subjects will decrease the ability to detect a difference between experimental groups, and hence risk invalidating the overall research design. Too many will expose more subjects to the risks of the research. The appropriate number of subjects may also take into account expected refusals to consent, or the possibility of subjects dropping out of the project. In addition, the means of assigning subjects to the various arms of a project (e.g., randomization) can affect the significance of the results.
- In some projects, design issues and numbers of subjects may be selected for reasons other than statistics; such reasons should be stated and justified.
Most research subjects expose themselves to the harms of the research project in order that others might achieve benefit. The REB must decide whether the harms anticipated, to research subjects and their families and communities, can be justified ethically in terms of the potential benefits to them, to others and to society as a whole. The description should address the following questions:
What harms are anticipated for research subjects and their families or communities from participation in the research?
- The anticipated harms from participation in the research must be described for the REB with estimates as to their potential seriousness and frequency. Where appropriate, the evidence on which the estimates of harms are made should be described. Potential harms include those that are physical or psychological. Physical harms may be serious (e.g., severe toxicity or danger) or not very serious (e.g., fainting or bruising as a result of having a blood sample taken).
- Psychological harms may also be serious or minor, for example, an increased risk of suicide in depression or mental illness, or feelings of frustration or loss of self-esteem resulting from inability to succeed in a task, or embarrassment about providing personal data. The objective of this description is to provide the REB with a basis for assessing the information that should be included in the consent information (Part 3 of the application).
- Some research projects, for example, those that require the collection of family histories or genetic materials, or that are carried out in selected families or communities, have the potential to cause harms such as invasion of privacy or stigmatization to families or communities, including people who are not the direct subjects of the research. The potential for such harms must be described in the application.
- In some research projects, it may be true to say that no potential harms can be identified. If applicable, this should be stated and justified.
What approaches have been taken to minimize the potential harms?
- Especially for serious potential harms, the application should identify the steps that will be in place to identify rapidly whether each subject, family or the community is suffering from the harm, and to minimize its effect.
What benefits are anticipated for research subjects, for their families or communities, for others e.g., who suffer from the same condition, or for society as a whole, can be anticipated from the research?
- The potential benefits from the proposed project should be outlined and assessed, and approaches planned to maximize benefits outlined.
- If no potential benefits can be identified, this should be stated in the application.
NB. The consent form and other materials are in Part 3 of this application. This section of the application form is intended to describe for the REB the processes to be used by the research team to identify potential subjects and seek their consent.
In almost all research, potential research subjects can be involved in research only if they have given free and informed consent. In some research that requires people who, because of mental incompetence, are unable to exercise their right to give free and informed consent, a proxy consent may be given on the subject's behalf by another person. In a few specific situations research may be permissible without consent. Examples may include projects involving naturalistic observation, secondary use of information in databases, or emergency medical interventions.
The application for ethics approval of a research project must provide a full description of the approaches that will be used to identify potential subjects and to seek their consent. A key concept throughout the consent process is that of inappropriateness. It is always possible to raise concerns with the completeness of information, opportunities for discussion and reflection, possibilities of a coercive environment etc. Judgment is required to determine whether such possible perceived inadequacies make the proposed consent process sufficiently questionable ethically that they are not acceptable in the conditions under which the research will be carried out.
Recruitment: identifying and approaching potential subjects
- Potential research subjects might be identified by a number of means, including referral by a health care professional, an employer, or a person who knows the potential subject, or by advertising for potential subjects in the media or bulletin boards, or approaching people at random in a defined environment (as long as that does not invade their privacy), on the street or through the telephone.
- It is ethically unacceptable for potential subjects to be approached by a stranger who has access to private personal information. For example, in a research project that requires people suffering from a certain disease, it might be thought convenient for the researchers to directly approach patients whose names they have been given by a clinic. This would probably be ethically unacceptable. A possible route for identifying potential subjects would be for the patient's physician to inform the patient about the proposed research and either seek their permission to inform the research team of their willingness to be approached for the research, or ask the potential research subject to contact the research team.
- Potential research subjects might be notified of the proposed research by, for example, a public announcement, or a letter from an employer or physician, with the invitation for those interested to contact the research team. Any means used to advertise the possibility for being a research subject must be described accurately and completely in the application, which must include copies of any advertisement or letter etc.
Seeking informed consent
- The application should describe how potential subjects will be asked for their consent to participate in the research. In addition to the validity, completeness and comprehensibility of the information presented in the consent form (discussed under Part 3), and the considerations outlined below of voluntariness and competence, the critical considerations include how the information will be presented to potential subjects, the opportunities for potential subjects to ask questions of the research team, to seek advice from others (e.g., family and friends), and to have the time to think about their decision.
- "Free" indicates that the consent must be given without pressures or coercion. Coercion can be perceived to arise in many ways, for example, because a potential subject's employer, teacher, military superior, prison environment, or health care professional is involved in the research, or because of rewards (financial, marks in a course, opportunity for promotion) associated with participation.
- If potential subjects for a research project may have limited competence to consent for themselves to participate in the research, consent must be sought on their behalf by another person, for example a caregiver, family member or guardian. The status of the law in such situations is very uncertain. In such cases, the application should identify the approaches that will be taken to determine competence, and, if potential subjects are not competent, how appropriate proxies will be identified and approached to consent on behalf of the subjects. In addition, in situations of partial competence, the application should describe approaches to allowing the potential subject to express assent to, or dissent from, the research, and how the researchers will respond to such expressions.
- Continuing consent recognizes the right of a subject to withdraw his or her consent to participate in a research project at any time, and hence to stop the research. Especially in projects in which the subject will be involved for an extended period of time, the application should outline procedures that will be in place to ensure that the subject is fully informed of any new information that might affect his or her consent, and remains willing to continue in the research. The subject should also have the right to withdraw his or her data from a research project. However, if the data have been made anonymous by removing any possibility of linking them to a particular subject, or the data have been melded with those from all research subjects, it may become impossible to honour this right. The application should indicate how such issues will be resolved.
Research without consent
- In specific very restricted situations, (e.g., some naturalistic observations under specific conditions, emergency room research, and secondary use of information in data banks) research might be justifiable without consent. If relevant to the proposed project, the rationale for not seeking consent must be described in the application.
Since much research collects information about individuals, the means that will be used to ensure that personal information is not revealed, and that its confidentiality is assured through security measures to protect data, should be described in the application. Such mechanisms might include such aspects as the handling of videotapes made during the research, how data will be combined for purposes of analysis and publication, how samples are stored, identified and disposed of, and controls over who will have access to materials in which individuals can be identified, etc.
The REB's decision to approve the ethical aspects of a research project depends on the information that it had when the decision was made. Any new knowledge that significantly changes the information on which the REB's ethics approval was based may therefore invalidate that approval. Processes for continuing review must therefore be in place to inform the REB about any changes and to amend the project as necessary.
New information can arise from many sources, including the literature, data accumulating during the research (e.g., observation of unexpected harms), problems in recruitment etc. Some research projects may include plans for interim analyses of the data as they accumulate, to determine whether the research is on track to yield the hoped for outcome, and to end the research early for reasons such that the desired outcome has already been achieved, or it is evident that it will not be achieved. Some projects include plans for a data and safety monitoring function to review accumulating safety information. In some projects, mechanisms might be put in place to monitor the data as they accumulate to ensure completeness and accuracy.
The application for ethics approval should describe plans for continuing review.
The possibility that a research subject might suffer injury as a result of the research is always present. The application should address this possibility in an appropriate manner. At a minimum, the research team must be aware that the giving of consent does not in any way mean that the subject has waived any of his or her legal rights. In the consent form guidance, NRC has developed wording that covers this point.
The REB must be satisfied that the research team is able to carry out the research from both the scientific and ethical aspects. The application should therefore indicate the relevant training and experience of the investigative team.
Conflict of interest that could, or could be perceived to, introduce biases into the research as it is performed, including the recruitment of subjects, has implications of ethics. The REB therefore needs to be made aware of the potential that conflict of interest will affect how the research is done, and the steps that will be taken to minimize such possibilities.
Legislation and regulations at federal, provincial or local levels can influence the performance of the proposed research. The REB should be informed in the application of legislation or regulation that could affect the research as it is carried out, and of the steps being taken to ensure that the research is in compliance.
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