Guidance on completing applications and forms

Table of contents

• Part 1: Project identification and signatures
• Part 2: Guidance on completing the application for ethics approval
• Part 3: Guidance on completing the consent form template
• Part 4: Documentation for experts
• Request for renewal of ethics approval form
• Project/consent amendments form
• Adverse event report form
• Final report form

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.

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.

Forms: Contact REB-CER@nrc-cnrc.gc.ca to obtain a Word version of the forms.

Part 1: Project identification and signatures

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 participants 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.

Part 2: Guidance on completing the application for ethics approval

1.0 Introduction

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.

2.0 Purpose of the application form

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.

3.0 Guidance for completion

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.

Project identification

Project title
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

Research team
Sponsor
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.

Objective of the research

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?

Involvement of human participants

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).

Scientific validity

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.

Harms and benefits

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.

Free and informed consent

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.

Voluntariness

• "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.

Incompetence

• 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

• 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.

Datasets

Ensure Discrete and Authentic Consent

• Involve human participants and/or data that is personally identifiable with them only through free and informed consent (consent may be waived if all the conditions in TCPS 2 Article 5.5A are met);
• Secure participant consent or consent for the use of use personal information in a way that is clearly given and separate from the acceptance of any form of inducement, deprivation, or the exercise of control, or authority as cited in terms and conditions for the purchase of a product or service;
• Research that relies exclusively on the secondary use of non-identifiable information does not require participant consent but does require approval from the NRC-REB.

For research that relies on the secondary prospective or retrospective use of non-identifiable human participant data, a waiver of any limitation of liability and/or indemnity clauses contained in End-User License Agreements and/or Terms of Use Agreements is required. This should be stated in the wording of these agreements and/or should be posted on the website or application through which this data was collected until the data is destroyed. Standard wording is provided below:

"If your non-identifiable data are used for research purposes, then the limitation of liability and indemnity clauses contained within the End User License Agreement/Terms of Service Agreement are waived with respect to any harms suffered or liabilities incurred as a result of any research activities".

Privacy and confidentiality

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.

Continuing review

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.

Compensation and liability

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.

Investigator qualifications and expertise

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

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

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.

Part 3: Guidance on completing the consent form template

1.0 Introduction

The purpose of this guidance document is to help applicants prepare the consent form required as Part 3 for almost all applications for human research ethics approval from NRC's REBs. This guidance document is in addition to the Statement of Criteria for REB Review for such applications.

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 as to how it can be improved are welcomed.

The headings used below are consistent with those used in the template consent form that is offered under Part 3 of the application documentation.

2.0 Purpose of the consent form

The consent form is part of the approaches used to provide potential subjects with the information that they want and/or need to allow them to make a free and informed choice as to whether they will consent to participate in the research project. Its purpose is to provide subjects with a written statement that they can keep, and that can serve as a basis for discussion between the potential subject and the research team as the consent is being sought.

The consent form is binding on those who conduct the research, but does not in any way bind a research subject to specific actions. Its purpose is to inform the subject, not to cause him or her to enter into a contract.

The consent form must be readily legible and understandable by the potential subjects. The language and terminology used must be adapted to the group from which potential subjects will be drawn, and the typeface and layout of the materials must be such that they can be easily read and understood. Arial font, 12 point, is recommended, with clear headings and good spacing between paragraphs.

The detail to be provided in the consent form is a matter of judgement. Excessive length and detail can inhibit comprehension, just as much as omission of essential information. Balancing comprehensibility with completeness requires careful thought.

3.0 Guidance for preparation

Letterhead

The consent form must be under the letterhead of the organization taking responsibility for the study. An organization that applies for human participant ethics approval from one of NRC's REBs is expected to assume this responsibility. The responsibility for work in which NRC scientists collaborate with those of another organization should be agreed upon before the research ethics submission is made.

Consent form identifier

The version of the consent form that has been approved by the REB should be identified on each page. A version number with the date of its REB approval is appropriate

Why you are being given this form

Potential subjects must understand from the start facts such as: they are being invited to participate in a study; that the decision is entirely up to them; and that they should any questions and consult with whoever they want and take the time that they need to make the decision.

Wording such as the following is suggested:

You are being asked to be a subject on a study designed to .(For example: Learn about x or test a new device/software.) The information in this form is intended to help you understand exactly what we are asking of you so that your can decide whether or not you want to participate in this study. Please read this consent form carefully and ask all the questions you might have before deciding whether or not to participate or not in this study. Please take whatever time you want before reaching a decision, and consult with others as you wish. Your participation in this study is entirely voluntary, and a decision not to participate will not in any way be used against you.

Project team and sponsors

Project title
Lead Investigator
Team members
Sponsoring or collaborating organization(s)

Potential subjects should know who they are being asked by, and why.

The consent form should identify the leader of the project and other members of the research team with whom the subjects will be dealing, including their names, affiliations, and roles in the project. In addition, any sponsoring or collaborating organizations should be identified; when such identification would jeopardize the scientific validity of the project, the applicant should explain and fully justify this viewpoint.

Why is this study being done?

The consent information should explain, in terms that are understandable to the prospective subjects, information such as: the purpose of the study; the topic that is being explored or the hypothesis that is being tested; the anticipated outcome; and the total duration of the project. Also, particularly for projects of a medical nature, it may be relevant to indicate the approximate number of research subjects involved, and whether the study is being done at a single site or is part of a multi-centre project.

What will you be asked to do?

Potential subjects should be informed about what will be expected of them if they decide to participate in the study, the potential harms and benefits that may arise, and the alternatives that may be open to them instead of participating in the study (particularly important for studies of methods of treating disease). They should also have information about how their personal information will be protected, what provisions are available should they sustain injury in the study, any payments that might be made for participating, and their rights to withdraw from the study at any time. These issues are addressed below under separate headings.

Potential subjects should be informed, in terms that are understandable to them, what they will be asked to do at each stage of the study, including, as appropriate, for example: how long each stage will take; where the activities will be carried out; whether and how subjects will be further tested for meeting inclusion/exclusion criteria; processes for assignment to sub-groups; how each sub-group will be treated; tests that will be carried out during the study; the duration of their participation in the study; and procedures for ending the study.

In some studies, not all subjects who consent can be included in a project because, for example, they are found not to meet the requirements for inclusion in the study. Prospective subjects should be informed of such possibilities. More generally and where appropriate, subjects should be informed that the researcher(s) can end their participation in the research project.

Potential harms and benefits

Potential subjects must understand the risks of harm that they might incur through participation in the study.

The consent information should describe all foreseeable harms, including physical, emotional, and psychological harms and inconveniences (e.g., adverse reaction to a substance, loss of self-confidence after poor performance on a memory test, regret over the revelation of personal information to an interviewer, disruption of family routine, long waits, boredom, revelation of personal information). Anticipated harms or inconveniences to the research participant should be described as accurately as possible in easily comprehensible language.

This description should include relevant information about the nature of the potential harm(s) (how serious is the potential harm?), and the probability of occurrence (How likely is it that the potential harm will occur?). As well, information concerning the possibility of reversibility should be included along with a description of any precautions that will be taken to minimize the probability of harms.

If no harms are anticipated for subjects in the proposed study, this should be stated explicitly. Where appropriate, there should be a statement acknowledging the possibility of unforeseen harms.

The following wording might be used:

"There are no known harms associated with your participation in this research. If potential harms are discovered, you will be informed as soon as possible."

Potential benefits

The consent information should outline potential benefits to subjects in the study, including relevant information about the nature of the potential benefit(s), their importance, and the probability that the potential benefits will occur. Note that payments to subjects (generally as reimbursement for expenses) should not be regarded as potential benefits from the study in view of the ethical consideration that payments may cause subjects to undertake more risks than they would voluntarily consider. Payments and re-imbursement are addressed below.

In research projects where benefits are anticipated to society or to a specific group within society (e.g., persons with a particular disorder, consumers interested in a particular product, children learning to read), these potential benefits should be explained in a separate paragraph so as not to confuse potential benefits to others with potential benefits to the research subject.

Because of the uncertainties inherent in predicting outcomes of studies, especially at the forefront of knowledge, care should be taken not to over-state the potentials for benefits.

If no benefits are foreseen, possible wording might be:You will not benefit directly from your participation in this study. "You will not benefit directly from your participation in this study."

Alternatives to participating in this study

Projects may involve treatment of subjects suffering from a particular illness, disease or condition. Especially in such cases, it is important that the prospective subjects know whether there are any "treatment" alternatives. If there are no such alternatives (i.e., no available therapy), this should be stated. If there are treatment alternatives, the alternatives should be described and this description should include a summary of the nature of the alternative intervention(s), as well as the potential harms and benefits. As well, the potential subjects should be informed of what care to expect if they decide not to participate in the study. If such projects do not involve medical treatment of any nature, it must then be clear to the subjects that they will not benefit from this research from a medical point of view.

Commercialization

Especially if a project is sponsored by a company, subjects should be informed of any intention to produce a commercial product as a result of the project, and of whether they can expect any financial benefit in the event of commercial success.

Privacy and confidentiality

Most human participant studies raise the possibility that personal information about subjects, or information (e.g., pictures) that identifies the subject, will be collected. Improper use of personal or identifiable information risks invading the subject's privacy. Such risks, and the measures to be taken to maintain the subject's privacy and maintain the confidentiality of the data collected in the study should be described to potential subjects.

The subjects must be informed that the investigator(s) will keep confidential all information that identifies them, within the limits of the law. Suggested wording when the study raises no particular issues might be:

"Confidentiality will be respected. Unless required by law, no information that might directly or indirectly reveal your identity will be released or published without your specific consent to the disclosure."

Subjects should be informed of the way in which data relating to them will be stored, (especially if it is identifiable), including where, by whom, for how long and how it will be disposed of after that time. Subjects should also be informed about how their data will be kept confidential.

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.

Subjects should know whether they will have access to the results of the research and, if so, in what manner (information given by the investigator or available through publications, etc).

Compensation for injury; legal rights

The consent information must state that, by accepting to participate in the study, research subjects do not waive any of their legal rights. The consent form must not contain any clause or language that excuses, or appears to excuse, investigators, sponsors or other persons or institutions involved from liability for their negligence or other fault.

In addition, where appropriate, the prospective subject should be informed about the possibilities for compensation for injuries that might be sustained as a result of participating in the study.

NRC recommends the use of the following statement:

"By signing this consent form, you are not waiving your legal rights."

Reimbursement of costs/payments for participation

The consent information should describe any reimbursements for expenses (e.g., transportation costs, meals, baby-sitters, etc.) or other costs (e.g., lost wages), or payments for time in the study. It should also be clear that a decision to withdraw from the research will not affect any reimbursement of costs that may have been incurred prior to withdrawal.

Note that payments to subjects (generally as reimbursement for expenses) should not be regarded as potential benefits from the study in view of the ethical consideration that payments may cause subjects to undertake more risks than they would voluntarily consider.

You have the right to decide to change your mind

Prospective subjects must be informed that they have the right to refuse to participate in the proposed research and, moreover, that a decision to participate in the research is not binding. It is important to make it clear to the subjects that they can withdraw at any time, even with only verbal notice, without negative consequences.

Possible wording might be:

"Your participation is entirely voluntary. You can to refuse to take part in this project at this point or withdraw from it at any time during the study, without incurring any penalty."

Where appropriate, subjects should also be informed of the possibility that the investigator(s) may remove the subject from the study, e.g., for any reason, or for stated reasons, and also that the study might finish earlier than anticipated.

New information

When participation is expected to take place over an extended period of time, the subjects should also be informed that they will be given continuing opportunities to decide whether or not to continue to participate. In this regard, the subjects should also be told that they will be informed that any new element that, during the course of the study, could affect their decision to continue or not to participate.

In genetic research, there might be cases where some subjects would want to have their samples removed from the study. For example, such a case might arise when DNA research reveals evidence of linkage with a particular disease. If that possibility exists, the subjects should be informed.

Who to contact about any further concerns or questions

The consent form should contain information about whom to contact for further information, especially the principal researcher and the appropriate Research Ethics Board (REB) coordinator at NRC. The approval by an NRC Research Ethics Board, and its continuing responsibilities in the project should also be indicated.

Ethics review

Suggested wording. Since the National Research Council of Canada is supporting this study, which has been reviewed and approved by an NRC Research Ethics Board, any questions or concerns about the ethics of this study may be directed to (Insert E-mail and phone number of the appropriate NRC REB Secretariat.)

Signatures

Subject

The prospective research subject or, where applicable, that person's parent(s) or legal guardian(s), must sign the form. The signed form confirms that the person (or the person consenting on his/her behalf) has agreed to participation in this study on the basis of the information that (s)he has understood. The signature of the subject does not mean that the subject has entered into a contract to participate, nor a full understanding of all the information that has been provided.

Suggested wording:

"I, ____________________________, have read, or have been read, and understand the information given in this informed consent and all my questions have been answered to my satisfaction. I have had sufficient time to consider whether to participate in this study. I understand that my participation in this study is entirely voluntary and that I may withdraw from the study at any time without penalty."

"I voluntarily consent to participate in this study."

If consent is being given by a representative on behalf of a person who is temporarily or permanently incompetent to consent on his/her own behalf, the relationship of the person consenting to the subject should be stated, and the above wording should be modified appropriately.

Investigation team member who interacted with the subject

The person who interacted with the subject in seeking the consent should sign the consent form, under words such as:

To the best of my knowledge, the information in this consent form, and the information that I have provided in the response to any questions, fairly represents the project. I am committed to conducting this study in compliance with all the ethical standards that apply to projects that involve human participants. I will ensure that the subject receives a copy of this consent form.

Principal investigator

If the person interacting with the subject is not the Principal Investigator, consideration should also be given to having him/her also sign under wording such as:

I am committed to conducting this study in compliance with all the ethical standards that apply to projects that involve human participants.

Part 4: Documentation for experts

Detailed scientific/technical protocol

Part 4 of the human participants ethics approval application should include:

• A formal protocol, if available, that has been prepared for reasons such as project planning or implementation, or to meet the requirements of regulatory agencies overseeing the project.
• Documents such as questionnaires to be administered to subjects, statistical justifications of numbers of subjects to be enrolled, or other detailed scientific or technical documents relative to the proposed project.
• Technical details of products to be tested in the research, such as those that are required by regulatory authorities (e.g., Health Canada), or other documents relative to safety concerns.

Request for renewal of ethics approval form

Find below relevant information to renewal of the REB approval for any project involving human participants. A renewal is usually performed annually.

Project/consent amendments form

Find below relevant information to inform the REB about any project or consent amendment relevant to your research involving human participants.

Adverse event report form

• All serious adverse events must be reported to the Secretary, O-REB within 2 days
• All other adverse events must be reported to the Secretary, O-REB within 7 days.

Final report form

Find below some information to communicate to the NRC REB that the work on the project has finished.

Related links

• Research involving human participants