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Queen's University
 

 

Letter of Information and Consent Form - Instructions

Preamble

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 more appropriate, these a Combined Letter of Information and Consent Form. These may be combined into 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 characterizing 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, supervisors, parents, guardians, relatives or employers. It should also be written in lay language at a Grade 8 level.

Exceptions

The Tri-Council Policy Statement does grant times when exceptions can be obtained under Article 1.1a. The GREB has further defined these situations where researchers may apply for an exemption from obtaining signed consent.

Category 1 Exemptions: A study may qualify for an exemption if the following points are satisfied: data collection is via interviewing individuals in public life such as: ministers, deputy ministers or senior bureaucrats; the interviews focus on public policy issues; and individual results are to be held in confidence and used only on a not-for-attribution basis.

Category 2 Exemptions: A study may qualify for exemption from the need to obtain written consent for other reasons. Researchers applying for a Category 2 exemption should provide a justification under section E.1.c) of the GREB submission form. Note: if the research involves aboriginal peoples or is being conducted outside of Canada, this should be taken into account in considering the appropriateness of an exemption from obtaining written consent.

If oral consent is permitted, researchers should keep a written (or taped) record of the consent process.

Letters of Information

Letters of Information should be typed in simple direct style using language which the participant understands and must include the following:

1. Project title (as submitted to the Unit REB or the General Research Ethics Board);

2. The name of the participant (this can be place at the top or bottom of the letter )

3. Identity researcher(s) and sponsoring institution(s);

4. 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);

5. 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;

6. A clear description of any known risks (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 risks to participation in the study.

7. 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 if they are students, (b) any contractual or other relationships with the investigator if they are clients, or (c) their future involvement with that institution (care if patients; employment if workers, etc);

8. Participants should be informed that they are not obliged to answer any questions that they find objectionable or which make them feel uncomfortable;

9. A clear description of the recording devices used, if any, and notification that you will ask their permission for its use on the consent form;

10. A clear description of any identifying information to be collected and a list of who will have access to it (e.g., government agency, research sponsor, or Research Ethics Board);

11. 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;

12. 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; e.g., in other studies, data-bases, publications, etc., and who will have access to them;

13. 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;

14. Instructions about who the participants may contact, including at least the investigator or a representative as well as the General Research Ethics Board, if they have any questions, concerns or complaints about the research procedures. "Any questions about study participation may be directed to the at < contact info >. Any ethical concerns about the study may be directed to the Chair of the General Research Ethics Board at chair.GREB@queensu.ca or 613-533-6081."

15. Add the following statement: "This study has been granted clearance according to the recommended principles of Canadian ethics guidelines, and Queen's policies."

Consent Forms

Consent forms should be kept in equally direct and comprehensible language and must include the following:

1. The project title (as submitted to the Unit REB or the General Research Ethics Board);

2. The participant's name;

3. A statement that this participant has read the Letter of Information and has had any questions answered to their satisfaction;

4. 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];

5. A statement that the participant is aware that s/he can contact [researcher and the Unit REB or the General Research Ethics Board] with any question, concern or complaint that s/he has;

6. 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).

7. A statement that the participant has been assured that [insert provisions taken to maintain confidentiality].


Name: __________________________
Date: ___________________________
Signature: ________________________


NOTE: If permission is sought for quotes, use of a person's name or other exceptions to confidentiality or anonymity, the researcher should ask the participant to initial this request below their signature. For example:

By initialing this statement below,

____ I am granting permission for the researcher to use a tape recorder (and/or)

____ I am granting permission for the researcher to attribute my name to any quotes

Combined Information and Consent Form

There are occasions when it may be more efficient to have just one Letter of Information and Consent Form. This style is acceptable to the GREB and within the Tri-Council Policy Statement (TCPS) criteria. The text below defines the required components to meet the TCPS and Queen's criteria. The Letter of Information and Consent Form should be typed in simple direct style using language which the participant understands and must include the following:

1. Project title (as submitted to the Unit REB or the General Research Ethics Board);

2. Identity researcher(s) and sponsoring institution(s);

3. 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 statement that participant's signature below is meant to confirm that they understand the expectations and requirements of them.

4. 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;

5. A clear description of any known risks (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 risks to participation in the study.

6. 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 if they are students, (b) any contractual or other relationships with the investigator if they are clients, or (c) their future involvement with that institution (care if patients; employment if workers, etc). A statement that participant's signature below is meant to confirm that they understand that her/his participation is voluntary and that s/he is free to withdraw at any time.

7. Participants should be informed that they are not obliged to answer any questions that they find objectionable or which make them feel uncomfortable;

8. A clear description of the recording devices used, if any, and notification that you will ask their permission for its use on the consent form;

9. A clear description of any identifying information to be collected and a list of who will have access to it (e.g., government agency, research sponsor, or Research Ethics Board);

10. 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 that participant's signature below is meant to confirm that they understand the provisions around confidentiality and anonymity.

11. 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; e.g., in other studies, data-bases, publications, etc., and who will have access to them;

12. 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;

13. A statement that the participant is aware that s/he may contact the investigator, a departmental representative or the General Research Ethics Board, if they have any questions, concerns or complaints about the research procedures. "Any questions about study participation may be directed to the at < contact info >. Any ethical concerns about the study may be directed to the Chair of the General Research Ethics Board at chair.GREB@queensu.ca or 613-533-6081."

14. Add the following statement: "This study has been granted clearance according to the recommended principles of Canadian ethics guidelines, and Queen's policies."

15. A statement that the participant has read this Letter of Information and has had any questions answered to his/her satisfaction and will keep a copy of this letter for his/her records;

Name: __________________________
Date: ___________________________
Signature: ________________________


NOTE: If permission is sought for quotes, use of a person's name or other exceptions to confidentiality or anonymity, the researcher should ask the participant to initial this request below their initial signature. For example:

By initialing this statement below,

____ I am granting permission for the researcher to use a tape recorder (and/or)

____I am granting permission for the researcher to attribute my name to any quotes


 

Kingston, Ontario, Canada. K7L 3N6. 613.533.2000