Tips for informed consent
Checklist for Preparing an Informed Consent Document
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 should be written on MSU letterhead. If not and/or 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 mentor 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 the student’s 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. If there are no anticipated risks, say so.
- 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 individual benefits to the individual, say so. You must still identify general benefits that may accrue from the study (e.g., addition to the knowledge base, etc.).
- 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 MURRAY STATE UNIVERSITY INSTITUTIONAL REVIEW BOARD (IRB) FOR THE PROTECTION OF HUMAN SUBJECTS.
- ANY QUESTIONS PERTAINING TO YOUR RIGHTS AS A PARTICIPANT SHOULD BE BROUGHT TO THE ATTENTION OF THE IRB COORDINATOR AT (270) 809-2916 OR email@example.com.
- 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 ,address, and email or if PI is a student, the faculty advisor’s telephone number, address, and email).