Name of Unaffiliated Investigator:
Name of Institution Providing IRB Oversight:  University of Florida
OHRP Federalwide Assurance Number:   FWA 00000335
Research Covered Under This Agreement:  [IRB Project # / Title]

1. The above-named Unaffiliated Investigator has reviewed:
a. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm)
b. The U.S. Department of Health and Human Services (DHHS) regulations for the protection of human subjects at 45 CFR 46 (http://ohrp.osophs.dhhs.gov/ humansubjects/guidance/45cfr46.htm)
c. The Assurance referenced above (FWA 00000335) (rgp.ufl.edu/irb)
d. The institutional policies and procedures for the protection of human subjects.  (rgp.ufl.edu/irb)

2. The Investigator understands and hereby accepts the responsibility to comply with the standards and requirements stipulated in the above documents and to protect the rights and welfare of human subjects involved in research conducted under this Agreement.

3. The Investigator will comply with all other National, State, or local laws or regulations that may provide additional protection for human subjects.

4. The Investigator will abide by all determinations of the IRB designated under the above Assurance and will accept the final authority and decisions of the IRB, including but not limited to directives to terminate participation in designated research activities.

5. The Investigator will complete any training required by the IRB prior to initiating research covered under this Agreement.

6. The Investigator will report promptly to the IRB proposed changes in the research conducted under this Agreement.  The investigator will not initiate changes in the research without prior IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.

7. The Investigator will report immediately to the IRB any unanticipated problems in research covered under this Agreement that involve risks to subjects or others.

8. The Investigator will seek, document, and maintain records of informed consent from each subject or the subject’s legally authorized representative as required under DHHS regulations and stipulated by the IRB.

9. The Investigator acknowledges and agrees to cooperate in the IRB’s responsibility for initial and continuing review, record keeping, reporting, and certification.  The Investigator will provide all information requested by the IRB in a timely fashion.

10. In conducting research involving products regulated by the Food and Drug Administration (FDA), the investigator will comply with all applicable FDA regulations and fulfill all investigator responsibilities (or investigator-sponsor responsibilities, where appropriate), including those described at:
a. 21 CFR 312:  Investigational New Drugs (www.access.gpo.gov/nara/cfr/ waisidx_00/21cfr312_00.html)
b. 21 CFR 812:  Investigational Device Exemptions (www.access.gpo.gov/nara/cfr/ waisidx_00/21cfr812_00.html)

11. The investigator will not enroll subjects in research under this Agreement prior to its review and approval by the IRB.

12. Emergency medical care may be delivered without IRB review and approval to the extent permitted under applicable Federal regulations and State law.  However, such medical care may not be included as part of Federally-supported research.

13. This Agreement does not preclude the investigator from taking part in research not covered under the Agreement

14. The investigator acknowledges that her/his primary responsibility is to safeguard the rights and welfare of each research subject, and that the subject’s rights and welfare must take precedence over the goals and requirements of the research.