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 participants 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 participants with a written statement that they can keep, and that can serve as a basis for discussion between the potential participant 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 participant to specific actions. Its purpose is to inform the participant, not to cause him or her to enter into a contract.

The consent form must be readily legible and understandable by the potential participants. The language and terminology used must be adapted to the group from which potential participants 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 participants 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 participant 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 participants 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 participants 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 participants, 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 participants 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 participants 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 participants 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 participants 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 participants 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 participants should be informed of such possibilities. More generally and where appropriate, participants should be informed that the researcher(s) can end their participation in the research project.

Potential harms and benefits

Potential participants 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 participants 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 participants 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 participants (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 participants 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 participant.

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 participants suffering from a particular illness, disease or condition. Especially in such cases, it is important that the prospective participants 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 participants 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 participants that they will not benefit from this research from a medical point of view.

Commercialization

Especially if a project is sponsored by a company, participants 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 participants, or information (e.g., pictures) that identifies the participant, will be collected. Improper use of personal or identifiable information risks invading the participant's privacy. Such risks, and the measures to be taken to maintain the participant's privacy and maintain the confidentiality of the data collected in the study should be described to potential participants.

The participants 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 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.

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 participants 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 participant 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 participants (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 participants to undertake more risks than they would voluntarily consider.

You have the right to decide to change your mind

Prospective participants 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 participants 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, participants should also be informed of the possibility that the investigator(s) may remove the participant 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 participants should also be informed that they will be given continuing opportunities to decide whether or not to continue to participate. In this regard, the participants 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 participants 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 participants 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 Email and phone number of the appropriate NRC REB Secretariat.)

Signatures

Subject

The prospective research participant 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 participant does not mean that the participant 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 participant should be stated, and the above wording should be modified appropriately.

Investigation team member who interacted with the participant

The person who interacted with the participant 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 participant receives a copy of this consent form.

Principal investigator

If the person interacting with the participant 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.