Checklists, Instructions, Templates

Letter of Information/Consent Form Checklist

This form is available in MS Word and can be downloaded at: www.mcmaster.ca/ors/ethics/faculty_checklists.htm

All Letters of Information and Consent Forms should be written in lay terms (ordinary language), at an appropriate level taking into consideration who the participants will be, and they should be written in the prospective participant’s preferred language.

To assess readability using Microsoft Word, go to “Tools” --> "Spelling & Grammar” --> ”Options” --> ”Show Readability Statistics”. When Word finishes checking spelling and grammar, it displays information about the reading grade level.

Letters of Information and Consent Forms should also:

• Be on appropriate letterhead and a version date should be noted
  (final date will be the date of the REB approval of the protocol);
• Include the title of the study (shortened if appropriate) ;
• Provide the name of the Faculty Investigator(s)/Supervisor(s) and
  Student Investigator(s) where applicable
• Provide contact information for the researcher(s) and if applicable his
  or her supervisor to enable participants to contact the researchers with
  any questions about the research
• Provide a clear explanation that the letter / consent is in respect of a
  research study
• Indicate the purpose of the proposed research (Why is the research being
  conducted?)
• Describe in lay language (avoiding technical terms, acronyms and
  abbreviations) the nature of the research (i.e., what the research involves,
  including details of what will happen to the participant)
• Provide an explanation of how long the research and each stage of
  the process will take
• If the study involves questionnaires or interviews, include a statement
  indicating that the participants may decline to answer any or all questions
• If the study involves an interview indicate whether tape recordings or notes
  are going to be taken
• Describe all foreseeable risks, discomforts and inconveniences including
  physical, psychological, emotional, and financial. The description should
  delineate both the likelihood and the magnitude of the risk or inconvenience
• Describe any known or anticipated benefits that may arise from the
  research (their nature and their likelihood)
• Describe the procedures which will be taken to ensure security of the data,
  and the anonymity or confidentiality of the participants. If there are any limitations
  on confidentiality (e.g. if the research involves focus groups), these should
  be noted
• Include a statement indicating that participation is voluntary and that
  participants may withdraw their agreement to participate at any time
  without consequence, and describe what will be done with the
  data collected up to the time of withdrawal
• Indicate what compensation or reimbursement will be provided to the participants
• Include a statement indicating whether or not the research findings will be available
  to the participants, and if so, how the findings will be communicated to them
• Include a statement indicating that the project has been reviewed and received ethics
  clearance from the McMaster Research Ethics Board, and that participants with
  concerns or questions respecting their involvement in the study may contact:

The McMaster Research Ethics Board Secretariat
c/o the Office of Research Ethics
Telephone: 905-525-9140 ext. 23142
E-mail: ethicsoffice@mcmaster.ca

• Give a copy of the signed consent form to the participant