Guidelines for Constructing Research Consent Forms
Follow the format in the sample consent form and use the following checklist to ensure that all elements of informed consent are included:
___ A statement that the study involves research.
___ For student research, a statement that the study is being undertaken by students under the supervision of a faculty member. The name of the department should be indicated as well as the name of the faculty member.
___ An explanation of the purposes of the research.
___ The duration of the subject's participation.
___ The number of subjects involved in the research.
___ A step by step description of the procedures to be used.
___ A description of the expected or foreseeable risks or discomforts to the subject.
___ A description of any benefits to the subject or to others which may reasonably be expected from the research.
___ A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
___ A description of the measures that the researcher will follow to assure confidentiality of records that identify each subject by name and/or identification number.
___ An explanation of how to contact the researcher and the sponsor for questions about the study.
___ If physical contact is involved, an explanation of whom to contact regarding the research, the subject's rights, and research-related injury.
___ A statement that the subject is free to choose to participate in the study, and that by refusing to participate, the subject will not be penalized or lose any benefits to which the subject may otherwise be entitled.
___ A statement that clearly indicates that the subject may discontinue participation at any time, even after the consent form is signed, without any loss of benefits.
___ A statement indicating that the subject will be offered a copy of the form to keep.
___ A line for the signature of the subject followed by the date(do not make an "x" to show where to sign)
___ A line for the signature of the investigator followed by the date of the signing