McMaster University





Instructions for the Preparation of Information Letter/Consent Form

Information letters/consent forms should be typed in a simple direct style using terms and language which the participant understands and should incorporate the following criteria and information:

  1. Name of Faculty Investigator(s)/Supervisor(s) and Student Investigator(s), where applicable.
  2. Department affiliation and contact phone number for Faculty Investigator(s)/Supervisor(s) and Student Investigator(s), as applicable, to enable participants to contact researchers if necessary.
  3. Indication that this is a research study and the purpose for conducting the study.  This should include several sentences outlining the rationale for the study.
  4. Identification of sponsoring agency(ies)/organization(s).
  5. Description in lay language of all procedures, including purposes, duration, frequency, if applicable.  For studies involving questionnaires or interviews, prospective participants should be offered examples of the types of questions to be asked.  Identify whether or not interviews or focus groups will be tape recorded.
  6. For studies involving questionnaires or interviews, a statement should be included indicating that participants may decline answering any question(s).
  7. Description of all known and/or anticipated benefits arising from participation in the study.  Make clear that participants may not benefit from their participation in the study.
  8. Description of all known and/or reasonably anticipated risks, discomforts and/or inconveniences including for example, physical, psychological, emotional, financial and social.
  9. Details of time commitment required for participation in the study.
  10. Details about any plan to contact participants for follow-up sessions or subsequent related study.
  11. Procedures to ensure confidentiality of data and anonymity of participants.  Any limitations on confidentiality should be noted.
  12. Details concerning financial or other remuneration of participants.
  13. Information on length of retention and security of data.
  14. A statement indicating that participants may withdraw their agreement to participate at any time during the study and have data withdrawn without reprisal.  A statement should be included that explains how this should be communicated to the participants.
  15. A statement of whether or not research findings will be available to the participants and how/where they will be made available to the participants.
  16. A statement indicating that the project has been reviewed and received ethics clearance through the McMaster Research Ethics Board (MREB) and that participants with concerns or questions about their involvement in the study may contact:
        McMaster Research Ethics Board Secretariat
        Telephone:  905-525-9140, ext. 23142
        c/o Office of Research Services
        McMaster University


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