500-40 Application to Continue Research
Florida Department of Health500-40 Application to Continue Research - for review by the Institutional Review Board
Protocol titleClick here to enter text.
Researcher:Click here to enter text.
Application contact:Click here to enter text.
For questions, concerns, to provide input, or request a consultation, call HRPP staff at
850-245-4444 ext. 3591
1. Participant Accrual
Number accrued –Means the number of subjects who signed a consent form; or who gave verbal consent on a study conducted under a waiver of documentation of consent; OR the number of records obtained for secondary analysis of existing data
Number approved by the IRB - What number of participants did the IRB approve for you to enroll (for secondary analysis of existing data, how many records did you plan to obtain or did you request) / Click here to enter text.
Number accrued during the previous year (at DOH sites or in the DOH part of a larger study; for secondary analysis indicate the number of records received) / Click here to enter text.
Number accrued during life of study to date / cumulative(at DOH sites or in the DOH part of a larger study; for secondary analysis indicate the total number of records received) / Click here to enter text.
Of the number of participants accrued (signed consent and passed screening - do not include screen failures):*
*For secondary analysis of existing data only, skip this section and go to Age Range of Participants
How many remain in the study? / Click here to enter text.
How many completed the study? / Click here to enter text.
How many withdrew/discontinued from the study / Click here to enter text.
Provide the reason for participant withdrawals
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Age range of participants
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Gender
Male / Click here to enter text.
Female / Click here to enter text.
Other / Click here to enter text.
Ethnic categories
Females / Males / Unknown or not reported / Total
Hispanic or Latino
Not Hispanic or Latino
Unknown (Individuals not reporting ethnicity)
Ethnic Category: Total All Subjects*
Racial categories
Females / Males / Unknown or not reported / Total
Asian
Black or African American
Native American
Native Hawaiian or Other Pacific Islander
White
More than one race
Unknown or not reported
Racial categories: total of all participants
Vulnerable populations
Pregnant women / ☐ Yes ☐ no
Prisoners / ☐ Yes ☐ no
Children / ☐ Yes ☐ no
Adults unable to give consent / ☐ Yes ☐ no
2. Study progress
Please provide summarize the progress of the study, including:
- A narrative summary of the study progress to date
- Any delays or other issues with the progress of the study
- A summary ofapproved changes since the last time the study underwent continuing reviewi.e approved modifications.
- If the study is closed to enrollment and participants are in follow-up, please detail your follow-up.
Describe any direct benefits to participants from participation in the research since the last time the IRB reviewed the research:
☐Therapy or screening for disease risks
☐Education
☐Information
☐Counseling
☐Empowerment
☐ Other Click here to enter text.
☐No direct benefits
Is there any new risk or benefit information related to this study, not previously reported to the IRB, or has your assessment of the risks and benefits changed?
☐ Yes ☐ no
If yes, describe new risks or benefits:Click here to enter text.
Are you aware of any scientific publications, safety monitoring reports, interim findings, multi-center trial reports, changes in standard of care, or any similar reports relevant to the risks or potential benefits of this study or that suggest the risks or potential benefits of the study may have changed?
☐ Yes ☐ no
If yes, describe new information that changes risks or benefits:Click here to enter text.
Have you published any articles related to this study? Have others published based on results from the study?
☐ Yes ☐ no
If yes, enter bibliographic citation:Click here to enter text.
Since the last time the IRB reviewed, have there been any significant changes to what is generally accepted as standard clinical care for people from whom the participant population will be drawn?
☐ Yes ☐ no
If yes, describe change in general standard of care:Click here to enter text.
Summarize all modifications, amendments and changes to the research since the last time the IRB reviewed the research, if any, and include an overview of the documents changed.
Click here to enter text.
3. Problems
Since the last time the IRB reviewed the study, have any of the following events occurred?
☐ Participant complaint
☐ Protocol deviation or error due to the action or inaction of the investigator or research staff
☐ Protocol deviation or error that harmed a subject or placed subject at risk of harm
☐ Protocol deviation made without prior IRB approval to eliminate an immediate hazard or harm to a participant
☐ Audit, inspection, or inquiry by a federal agency, the researcher’s organization, or the Department of Health or other state agency
☐ Written reports of state or federal agencies (e.g., FDA Form 483)
☐ Written reports of study monitors
☐ Allegation of Noncompliance or Finding of Noncompliance
☐ Unauthorized disclosure of confidential information
☐ Suspension or premature termination by the sponsor, investigator, or institution
☐ Incarceration of a subject in a research study not approved to involve prisoners
☐Adverse events or IND safety reports that require a change to the protocol or consent (events that are unexpected and related, regardless of whether the event was internal / on-site or external / off-site)
☐ Unanticipated adverse device effect
☐ Any change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol
☐ State medical board actions, such as loss of license for any researcher and study staff
☐ Revocation of hospital privileges for any researcher or staff on the study
☐ No reportable events have occurred in this review period
Describe problems, if any
Click here to enter text.
4. Modifications
☐There are proposed modifications i.e. not currently approved. If there are modifications to the currently approved protocol, consent, assent, parental permission, survey, investigator’s brochure, or package insert documents please submit a track changed and clean version.Also, be sure to version all documents listed in the previous sentence with either a version (e.g. version 2) or a date.
☐There are no modifications – research continues without change – skip to the fees section
Current status
Check all that are true:
☐ Participants are enrolled or recruitment continues
☐ Secondary analysis of private identifiable data, records, or specimens continues
☐ The study is permanently closed to enrollment at this site
☐ All participants at this site have completed all protocol mandated interventions and interactions and collection of private identifiable data, including those related to long-term follow-up
☐ No additional identifiable private information about the subjects is being obtained by this site
☐ Analysis of private identifiable information at this site is completed (This can be checked if the industry sponsor or another organization will conduct the analysis)
☐Modification revises selection and recruitment to include children, pregnant women, prisoners, or adults who are unable to consent, or includes data about such persons. Complete additional forms for vulnerable participants.
Describe the proposed modification, include description of how changes impact the following, when applicable:
- Research design and research procedures
- Potential risks and anticipated benefits of the research
- Subject selection and recruitment
- Process or documentation of consent
- Safety monitoring
- Protections for privacy interests of participants and confidentiality of data
Participant notification
Indicate if you are planning on notifying participants:
☐ Current subjects will be notified of these changes
☐ Former subjects will be notified of these changes
☐ Current or former participants will not be notified of the changes
Describe how participants will be notified, or reasons for not notifying participants
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Changes to documents
List all documents and indicate their status. Add rows as needed.
Document name (add rows as needed) / Version / Modified?
☐ Yes ☐ no
☐ Yes ☐ no
Changes to staff
List all staff and indicate their status. Add rows as needed.
Name / Role / Modified?
☐ Yes ☐ no
☐ Yes ☐ no
5. Attestation
I agree to follow Department policies and provide complete and accurate information concerning research involving human participants and data.
Type your name here Click here to enter text.
Date: Click here to enter text.
For questions, concerns, to provide input, or request a consultation, call HRPP staff at 850-245-4585
If a fee is required, complete the fee worksheet below, print out the worksheet and mail with payment.
Florida Department of Health500-03 Researcher Reportable Interest Form
For questions, concerns, to provide input, or request a consultation, call HRPP staff at 850-245-4034
Instructions
Investigators and all research personnel whose institutional responsibilities include the design, conduct, or reporting of research, or service on research-related Department committees such as the Institutional Review Board, must report financial interests related to the research, including interests of their immediate family, as defined in this policy.
Related to the research means a financial interest in the sponsor, product or service being tested, or in a product or service that competes with the product or service being tested.
Immediate family means spouse, domestic partner, and dependent children
Researchers and others covered by this policy must complete financial conflicts of interest training initial, at least every four years, and immediately then joining the Department, or when the Department’s financial conflicts of interest policies are revised in a way that changes researcher requirements, or when there is non-compliance with financial conflicts of interest policies and procedures. Education is available through required IRB researcher training.
Researchers must disclose the following financial interests when requesting initial review by the IRB, when requesting to continue research (continuing review by the IRB), and must report within 30 days of discovering (e.g., through inheritance or marriage) any new financial interest related to the research during the research. Researchers should contact the Human Research Protection Administrator if there are questions about whether a financial interest must be reported.
Reportable interests:
☐Compensation or payments for services (e.g., consulting fees, lecture payments, bonus, royalties, paid authorship, honoraria, gifts, or in-kind products or services) related to the research of any value, except as otherwise excluded by this policy.
☐Compensation or payments for services where an arrangement has been entered into such that the amount of compensation will be affected by the outcome of the research.
☐Equity interests (stocks, stock options, security, or other ownership interests) related to the research of any value
☐Equity interest related to the research in a non-publicly traded corporation of any value by the individual or a member of the individual’s immediate family
☐Equity interest related to the research of any amount to the researcher or any member of the researcher’s immediate family where an arrangement has been entered into such that the amount of compensation will be affected by the outcome of the research.
☐Intellectual property rights and interests (patents, copyrights, royalties, licensing agreements, and any other proprietary interest related to the research).
☐Board or executive relationship related to the research, regardless of compensation.
☐Any other interest that could be affected by the outcome of the research
☐Travel related to the research, including the purpose of the trip, the identity of the sponsor or organizer, the destination, and the duration.
Do not report the following interests:
☐Publicly-traded mutual funds, including the Florida Retirement System
☐Salary from the Department or a University
☐Income from seminars, lectures, or teaching engagements sponsored by Federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education
☐Income from service on advisory committees or review panels for federal, state, or local government agency, an institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education (e.g., Centers for Disease Control and Prevention)
☐Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Individual does not directly control the investment decisions made in these vehicles
Attestation
☐I have no conflicts to report
I agree to follow Department policies and provide complete and accurate information concerning research involving human participants and data.
Type your name here Click here to enter text.
Date: Click here to enter text.
For questions, concerns, to provide input, or request a consultation, call HRPP staff at 850-245-4585
☐Fees required
☐No fees required – skip to the attestation section
Invoice for Review by the Institutional Review Board
If you are required to pay a fee, complete this form. This form must accompany payment.Print out a copy of the completed form and send it along with your payment to the address below.
Protocol titleClick here to enter text.
Researcher:Click here to enter text.
Application contact:Click here to enter text.
Date: Click here to enter text.
☐Data Studies: Confidential information (e.g., Cancer Registry) no intervention or interaction
Continuing Reviews fee: 250.00 / Click here to enter text.
Expiration of IRB approval additional fee: 250.00 / Click here to enter text.
Total / Click here to enter text.
☐Industry-sponsored research, or research sponsored by a for-profit organization
Continuing Reviews fee: 1000.00 / Click here to enter text.
Expiration of IRB approval additional fee: 2000.00 / Click here to enter text.
Total / Click here to enter text.
☐All other research
Continuing Reviews fee: 500.00 / Click here to enter text.
Expiration of IRB approval additional fee: 500.00 / Click here to enter text.
A fee is not required for the following:
- The research is conducted by a student who is a candidate for a degree at a university in Florida.
- Research conducted by a DOH employee, contracted employees, or researcher conducting research at the request of the Department, UNLESS the study is industry sponsored, or sponsored by a for-profit organization.
- Applications submitted to close a study
- Continuing Review applications submitted during the no-cost extension period or afterward when the study remains open with no funding
- Amendments submitted as part of continuing review
- Amendments related to personnel changes only
Send payments, with a copy of this completed invoice, to the following address.
DOH accepts check paymentONLY. DOH accepts checks from following sources:
- Researcher’s university or research institute
- researcher’s funding organization
- cashier's checks
- personal checks
Florida Department of Health
Human Research Protection Program
4052 Bald Cypress Way, Bin A-24
Tallahassee, Florida 32399-1749