All activities that meet the federal definitions of “research” and “human subject” should complete a new protocol application.
Under 45 CHR 46.116(d) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:
- the research involves no more than minimal risk to the subjects;
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and,
- whenever appropriate, the subjects will be provided with additional pertinent information after participation.
ALL STUDENT investigators must have a supervisory faculty member for their research project. Supervisory faculty members need to review, approve, and sign the student's application before it is submitted to IRB.
IT IS IMPORTANT to note that a new protocol application should not be made until all research instruments, including recruitment scripts, informed consent forms, surveys, interview questions, etc. are in their complete and final form. Submitting incomplete or draft versions of any material will cause the protocol to be immediately rejected without further review.
Incomplete or incorrectly completed protocol applications will be immediately rejected without review.
New Protocol Application (docx)