Review Council for Human Subjects

FloridaA&MUniversity

Instititional Review Board

APPLICATION FOR CONTINUATION REVIEW

Please submit this application and attached materials to the FAMU IRB administrative office one month before the renewal date for your study. COMPLETE THE FORM IN MICROSOFT WORD©

Note: Please double-click on the boxes and select "checked" to put an X into a box.

Study Information

1. FAMU Project Number:
2. Project Title:
3. Principal Investigator:
Address:
Phone:
Fax:
Email:

Summary of Enrollment, Withdrawals and Subject Recruitment

1.Number of subjects proposedin the original application.
2.Number of subjects enrolled since this project was initially approved.
3.Number of subjects enrolled since the last FAMU IRB review.
4.How many subjects voluntarily withdrew from the study at their own request?
5.How many subjects were withdrawn by the investigator or lost to follow-up?
6.Is the study permanently closed to enrollment of subjects?
7.If no to question six above, how many more subjects do you plan to enroll?
8.Have all research-related interventions involving subjects been completed?
9.Is your study monitored? If so, please provide the company name below and the frequency of visits.
10.If applicable, please provide a brief summary of any difficulty in obtaining/retaining subjects or obtaining informed consent during the approval period. (please record in the Remarks section on the last page)
The Risk : Benefit Ratio (significant new findings)

Do not answer this Section if the study involves only chart review and/or collection of specimens/data or the study is permanently closed to accrual and all treatments/procedures have been completed and follow-up is for survival only

1.Have there been any significant new findings (either good or bad) that should be disclosed to participants of the study?
Yes No
If yes, please describe below, or attach a description.

Risk Level

1. Please check the risk level associated with this study.

Note: According to HHS/FDA regulations minimal risk means, “The probability and magnitude of harm
or discomfort anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or psychological
examinations or tests.” When the risks that are associated with a new procedure or product are
unknown, they cannot be classified as minimal.

minimal risk greater than minimal risk level of risk is unknown

Adverse Events

1. Have there been any adverse or unanticipated events during the course of this study?
Yes No
If yes, please describe below and attach copies of all adverse event reporting forms for events that have occurred since the most recent RCHS approval period.
2. If you answered “yes” above, please discuss whether adequate safeguards are in place to
protect human subjects and if the benefits of the study still outweigh the risks.
3. If you answered “yes” above, please indicate whether the informed consent document
requires modifications to appropriately describe the potential risks associated with the study.
If applicable, please describe the required modifications.
4. Please describe any relevant information, including recent literature, or other findings that
may affect the risks associated with this research. If applicable, please describe the required
modifications to the consent document.
Consent Document and Study Protocol
1. Please attach a copy of the current informed consent document and if applicable, one with
highlighted modifications addressing any changes in procedures or information provided to
potential subjects.
2. Please attach a copy of the current study protocol and if applicable, any proposed
modifications.

Remarks

Certification of the Principal Investigator: I understand the requirements of applicable laws and regulations, and FloridaA&MUniversity’s policies governing the use of human subjects for research purposes. I further certify that all personnel associated with this project will continue to conduct the project in full compliance with the aforementioned requirements. I will not implement changes in the previously approved research without prior approval of the Florida A&M University IRB, except where changes are necessary to eliminate apparent immediate hazards.

Principal Investigator’s Signature Date

Via US Mail:

FloridaA&MUniversity

Institutional Review Board

Dyson Pharmacy Building Room 130

Tallahassee, Florida32307

(850) 599-5246 telephone

(850) 599-8830 fax

updated 7/5/05 Application for Continuing Review

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