The Informed Consent
document or presentation is written at the reading level of the target audience
(generally 6th grade when dealing with the general population).
You have used spell-check and grammar-check to edit your document
before you send it to the IRB for review.
The informed consent documents and cover letters are written on MSU
letterhead. If not and you are
conducting the research at a site other than the MSU campus, the name of the
university and its address must be
included in the body of the form.
The name of the project is on the consent form.
The name, department and telephone number of the faculty investigator
or faculty sponsor is on the consent form.
If this project is submitted by a student investigator, the student’s
name may appear on the consent form, not their contact information.
You have identified the faculty sponsor as “faculty sponsor” and the
student investigator as “student investigator.”
You have invited the subject to participate in your research project
and explained the (1)purpose,
(2)duration, and (3)procedures of your project.
You have clearly stated that this study involves “research.”
A list of foreseeable risks is given to the subject. These risks can be social, financial,
emotional, etc.
A list of possible benefits is given to the subject. (Remuneration is NOT a benefit! This must be explained in the procedures for
the study.) If there are no benefits to
the individual, say so.
You have stated that a copy of the form will be given to the
participant to keep.
If you are applying for an exempt or expedited review, you have stated
that participants must be 18
years of age
or older.
You have explained how you will keep any replies and/or identifying
information confidential.
You have explained that any identifying information will be kept in a
secure location, on the university campus for a period of at least 3 years
before being destroyed. If you are
dealing with subjects under the age of 18, you must keep all identifying
information for at least 3 years or until the child reaches 1 year past the age
of 18, whichever is longer. You have a statement about this on your form.
You have stated that participation is completely voluntary and that
subjects can withdraw AT ANY
TIME without fear of
reprisal (or words to that effect).
The following information is contained on the
consent form:
·
THE DATED APPROVAL STAMP ON THIS CONSENT FORM INDICATES THAT THIS
PROJECT HAS BEEN REVIEWED AND APPROVED BY THE
·
ANY QUESTIONS PERTAINING TO YOUR RIGHTS AS A PARTICIPANT OR ANY
ACTIVITY-RELATED INJURY SHOULD BE BROUGHT TO THE ATTENTION OF THE IRB
ADMINISTRATOR AT (270)762-3537.
·
ANY QUESTIONS ABOUT THE CONDUCT OF THIS RESEARCH PROJECT SHOULD BE
BROUGHT TO THE ATTENTION OF (Insert principal investigator’s name or if PI
is a student, the faculty advisor’s name) AT (insert principal
investigator’s telephone number and address or if PI is a student, the faculty
advisor’s telephone number and address).