Unaffiliated Investigator Agreement

Jacksonville – IRB-03
/ Unaffiliated Investigator Agreement

Unaffiliated Investigator Agreement Page 1 of 3

IRB version date: 11/24/2009

PI version date:

Please provide contact information for a representative who can answer any questions that the IRB might have concerning this submission:
Name:
Position:
E-mail:
Phone #:
Pager #:
2nd Contact: / name + e-mail or phone #
Group:
Form Instructions:
·  ATTACH A COPY OF THE UNAFFILIATED INVESTIGATOR’S CV.
·  All submissions must be typed.

Submit ONE ELECTRONIC AND ONE PAPER COPY of the entire submission to the IRB-03 office. Electronic submission must include protocol, consent, IQ, grants, surveys, data collection tools, articles, etc Paper submission must include the signed original IQ and protocol, consent, grants, surveys, data collection tools, articles, etc. You should make another copy for your files. You may need to make additional copies to submit to other committees/offices.

1. / Date:
2. / Name of Unaffiliated Investigator:
UF ID#: Contact our office to obtain a number.
3. / Name of Institution Providing IRB Oversight: University of Florida
4. / OHRP Federalwide Assurance Number: FWA 00005790
5. / Research Covered Under This Agreement:
a. / Principal Investigator:
b. / IRB Project Number:
c. / Project Title:

6.  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 00005970):
http://irb.ufl.edu/mpa.htm

d. The institutional policies and procedures for the protection of human subjects.
http://irb.ufl.edu/irb/irb01/

7.  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.

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

9.  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.

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

11. 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.

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

13. 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.

14. 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.

15. 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

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

17. 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.

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

19. 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.

Signatures
Investigator: / Date:
IRB Chairperson: / Date:
Alan Halperin, MD
IRB Institutional Official: / Date:
Winfred Phillips, DSc
Vice-President for Research

Unaffiliated Investigator Agreement Page 1 of 3

IRB version date: 11/24/2009

PI version date: