What should I put in a cover letter or document to ensure informed consent when a signed, consent form is not used?
Investigators who are requesting exempt status normally will not need to use a signed informed consent form when the identities of subjects will be completely anonymous if the consent form is not signed and there is minimal risk involved in the study. Investigators in these instances, however, should be conscious of the ethical principles guiding the process of informed consent and ensure that they have provided sufficient information to satisfy the basic elements of informed consent. At a minimum, they should either provide a cover letter or introductory remarks (e.g., at the beginning of a survey) that provide: a reference to UTC and the title of the research project; the identity of the principal investigator(s) and their contact information; an introduction to the study; the aims of the study; a brief summary of the background or reason for the project; a summary of why the individual has been asked to participate in the study; a description of the type of participation requested a
Related Questions
- What can the member of the study team obtaining informed consent do to ensure the signed consent form is a complete and accurate consent document?
- What should I put in a cover letter or document to ensure informed consent when a signed, consent form is not used?
- Is a faxed copy of the signed consent or parental permission form acceptable to document informed consent?
