The purpose of informed consent is to obtain assurance that participants in research projects clearly understand what they are agreeing to do, that they are free to decline involvement or withdraw from the study at any time, and that steps are being taken to protect them. Normally investigators should prepare a Letter of Information describing the research project and the demands it will place on participants (items 1-8 below), accompanied by a brief Consent Form which the participants can sign. If this process is not to be followed, the investigator should provide justification. See submission form.
In presenting this information, it is important to avoid characterising the research project to unduly influence the person into participating, either by making offers, coercing or manipulating. The language of the Letter of Information as well as the mode of recruitment of participants should ensure that participants have a genuine choice about their involvement. It is inappropriate, for example, to overstress the importance of the project by appealing to its potential benefits ("This research will cure AIDS."); the virtues of participation ("Those who choose to help us will be helping humanity."); or the authority of its sponsorship ("This research is being done at the request of the Ministry of ....). Language limiting or qualifying the participant's legal rights, or releasing the researcher from liability for negligence may not be included. Free and informed consent should be obtained from the individuals who will actually participate in the research. For individuals who are not competent to consent, their assent must be obtained and provisions must be made for proxy or substitute consent to be given by someone with legal authority to do so. The person giving substitute consent must be given all relevant information about the research and cannot be induced or coerced into consenting for the participant. No study participant should be pressured by anyone who might have authority or other control over them, such as teachers, professors, supervisors, parents, guardians, relatives or employers.
Letters of Information
Letters of Information should be typed in simple direct style using language which the participant understands and must include the following:
- the identities of the researchers and sponsoring institutions;
- a brief but clear statement of the aims and procedures of the research project, specifying what will be required of the participant, and the purpose of the procedures, in language that will be comprehensible to them (i.e., avoid technical jargon; describe tests or instruments rather than referring to them by name);
- a realistic estimate of the length of time that will be taken by individual procedures, their frequency and overall duration, including the time associated with any follow-up studies;
- a clear description of any physical risks, discomforts or inconvenience as well as any psychological or social discomforts that may be associated with participation in the research, or a statement that there are no known physical, psychological, economic or social risks;
- an instruction that participation is voluntary and that participants are free to withdraw at any time. If appropriate, a specification should be added, that the participants are free to withdraw with no effect on (a) their standing in school or class if they are students, (b) any contractual or other relationships with the investigator if they are clients, or (c) their future care if they are patients;
- participants should be informed that they are not obliged to answer any questions that they find objectionable or which make them feel uncomfortable;
- a clear description of the recording devices used, if any;
- a clear description of any identifying information to be collected and a list of who will have access to it (e.g., a government agency, the research sponsor, or the Research Ethics Board);
- a statement indicating how confidentiality will be protected including both provisions for protection of confidentiality in publication and the disposition of any raw data pertaining to individuals' involvement in the study; and/or a description of any condition in which confidentiality or anonymity cannot be guaranteed or must be breached;
- a statement indicating a) the ways in which the research results will be published and who will have access to them, and b) any foreseeable secondary uses of the data; i.e., in other studies, data-bases, publications, etc., and who will have access to them;
- details of remuneration, if any, and in the case of long-term projects, the manner in which compensation is to be given if the participant withdraws from the study prior to its completion but after partial participation;
- instructions about who the participants may contact, including at least the investigator or a representative as well as the RMC Research Ethics Board, if they have any questions, concerns or complaints about the research procedures.
Consent forms should be kept in equally direct and comprehensible language and must include
- the project title (as submitted to the Unit REB or the RMC Research Ethics Board);
- the participant's name;
- a statement that this participant has read the Letter of Information and has had any questions answered to their satisfaction;
- a statement that the participant understands that s/he will be participating in [title of study], that they have been informed that her/his involvement consists of [procedures] which will be recorded by [recording device], that s/he understand that the purpose of the [study] is to [insert purpose];
- a statement that the participant is aware that s/he can contact [researcher and the Unit REB or the RMC Resarch Ethics Board] with any question, concern or complaint that s/he has;
- a statement that the participant understands that her/his participation is voluntary and that s/he is free to withdraw at any time (if relevant add further specifics from point 5 above).
- a statement that the participant has been assured that [insert provisions taken to maintain confidentiality].