Questionnaire Cover Letter
If the study requires that subjects complete a questionnaire, ordinarily a consent form is not required. Instead, begin the questionnaire with a cover letter which includes the following information:
- Purpose of the research
- Rationale, why the research is important, and how information will be used
- Contact person for questions and affiliation of that person
- IRB Statement
- Confidentiality
- Return of the survey serves as consent
- Time it will take to complete survey
- In the case of sensitive questions, add a statement saying the respondent can omit any question they prefer not to answer
- Appreciation for participation
A copy of the questionnaire, including these explanatory statements, must be submitted to the IRB office for approval.
If the study involves interviewing subjects, each subject must be given a brief written explanation of the study and its purpose which shall include a statement that participation in the study is voluntary. If the subject agrees to participate, the explanation must be signed. A copy of the statement must be given to the subject, and the investigator must keep a signed copy.



