Sponsor ID Number (if known):
•
UT Proposal Number (if known):
•
II. PROJECT OBJECTIVES
III. DESCRIPTION AND SOURCE OF RESEARCH PARTICIPANTS
IV. METHODS AND PROCEDURES
V. SPECIFIC RISKS AND PROTECTION MEASURES
VI. BENEFITS
VII. METHODS FOR OBTAINING "INFORMED CONSENT" FROM
PARTICIPANTS
VIII. QUALIFICATIONS OF THE INVESTIGATOR(S) TO CONDUCT RESEARCH
IX. FACILITIES AND EQUIPMENT TO BE USED IN THE RESEARCH
X. RESPONSIBILITY OF THE PRINCIPAL/CO-PRINCIPAL INVESTIGATOR(S)
The following information must be entered verbatim into this section:
By compliance with the policies established by the Institutional Review
Board of The University of Tennessee the principal investigator(s) subscribe
to the principles stated in "The Belmont Report" and standards of
professional ethics in all research, development, and related activities
involving human subjects under the auspices of The University of
Tennessee. The principal investigator(s) further agree that:
1. Approval will be obtained from
the Institutional Review Board prior
to instituting any change in this research project.
2. Development of any unexpected
risks will be immediately reported to
Research Compliance Services.
3. An annual review and progress report (Form R) will be completed
and submitted when requested by the Institutional Review Board.
4. Signed informed consent documents will be kept for the duration of
the project and for at least three years thereafter at a location
approved by the Institutional Review Board.
XI. SIGNATURES
ALL SIGNATURES MUST BE ORIGINAL. The Principal Investigator should keep the
original copy of the Form B and submit a copy with original signatures for review.
Type the name of each individual above the appropriate signature line. Add signature