The proper identification of investigators includes the name, professional degree(s), and office phone numbers. Investigators should be indentified as principal or secondary investigators.
For research studies involving greater than minimal risk, the home/night phone number(s) of the investigator(s) must be provided. For parental consent forms in child research studies involving minimal risk or greater, the home/night phone number(s) of the investigators must be provided.
For research studies conducted by students, the name and phone number of the student’s advisor must be provided. The basis for the inclusion of home/night phone numbers in this section of the consent form is because all investigators must take extraordinary measures to protect the rights and welfare of their subjects. Consistent with this philosophy, investigators must be reasonably available to answer any and all questions a subject may have regardless of the time of day. A contact procedure, therefore, should exist that allows each subject to directly contact the investigator of his/her choice. A home phone number on the consent form also demonstrates an investigator’s commitment to the total well-being of his or her research subjects.
All research conducted by students must list the student’s advisor as a secondary investigator. Because it is the responsibility of the advisor to supervise the students’ research project, listing the advisor as an investigator provides a clear indication of that responsibility.
The date the consent form was approved by the IRB (date of the official letter of approval) should be placed below the “Identification of Investigators” section.