Radiation - Florida Department of Health Institutional Review Board

Transcription

1 Radiation Radiation - Florida Department of Health Institutional Review Board Protocol title: Researcher: Application contact: For questions, concerns, to provide input, or request a consultation, call HRPP staff at Use of Radiation in Research Describe any use of diagnostic or therapeutic ionizing radiation in the research, including: Procedures that are standard of care and that research participants would receive as part of treatment regardless of participating in the research (including but not limited to medical or dental X-rays, DEXA scans, or use of ionizing radiation for treatment) Procedures that are not part of treatment a patient would otherwise receive (including but not limited to medical or dental X-rays, DEXA scans, or use of ionizing radiation for treatment) Non-Ionizing Radiation Describe any other types of radiation emitting electronic products used in the research, including but not limited to MRI scans, lasers, ultraviolet lamps, or ultrasonic imaging equipment Incidental Findings Describe procedures for informing participants about incidental findings, if applicable.

2 Application to Modify Research Florida Department of Health Application to Modify Research - for review by the Institutional Review Board Protocol title Researcher: Application contact: For questions, concerns, to provide input, or request a consultation, call HRPP staff at 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) Describe the proposed modification 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 Changes to documents List all documents and indicate their status. Add rows as needed. Document name (add rows as needed) Version Modified? Changes to staff List all staff and indicate their status. Add rows as needed. Yes no Yes no Name Role Modified? Yes no Yes no

3 Application to Modify Research Conflict of Interest - No New Reportable Interests skip to the attestation section Conflict of Interest Submit New Reportable Interest Researchers and research staff are required to disclose reportable financial interests related to the research. Use the following tests to determine if the researcher and the researcher s immediate family, or any other members of the research team (sub-investigators and research staff) and their immediate families, have any of the following financial interests related to the research. "Immediate Family" means spouse, domestic partner, children, and dependents. "Financial Interest Related to the Research" means financial interest in the sponsor, product or service being tested, or competitor of the sponsor. If any new reportable events have occurred please upload a conflict of interest management plan. Ownership interest, stock options, or other financial interest of any value related to the research. Does not include mutual funds or companies publicly traded on a stock exchange. Compensation of any value related to the research in the preceding 12 month including, but not limited to honoraria, consultant fees, royalties, or other income. Proprietary interest related to the research of any value including, but not limited to, a patent, trademark, copyright or licensing agreement. Board or executive relationship in a company (such as a startup company but including publicly traded companies) related to the research, regardless of compensation. Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or medical center. Any arrangement where the value of the ownership interests will be affected by the outcome of the research. For example, an arrangement has been made where the value of stock options given to the researcher by a startup company will vary depending on the outcome of the research. Any other interest that could be affected by the outcome of the research. No reportable interests for any members of the research team. Failure to disclose reportable interests and provide an updated disclosure at least at the time of the continuation request or if the financial interests of the researcher and personnel on the grant change, may result in: Immediate termination of the research study Any other action required by state law Attestation I agree to follow Department policies and provide complete and accurate information concerning research involving human participants and data. Type your name here Date:

4 Application to Modify Research For questions, concerns, to provide input, or request a consultation, call HRPP staff at If a fee is required, complete the fee worksheet below, print out the worksheet and mail with payment.

5 Application to Modify Research 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 title Researcher: Application contact: Date: Data Studies: Confidential information (e.g., Cancer Registry) no intervention or interaction Amendments fee: Industry-sponsored research, or research sponsored by a for-profit organization Amendments fee: All other research Amendments fee: 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. Notification of study closure 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 How to send payment Send payments, with a copy of this completed invoice, to the following address. DOH accepts check payment ONLY. DOH accepts checks from following sources: Researcher s university or research institute researcher s funding organization cashier's checks personal checks Make checks payable to: Florida Department of Health Human Research Protection Program 4052 Bald Cypress Way, Bin A-24 Tallahassee, Florida

6 Application to Continue Research Florida Department of Health Application to Continue Research - for review by the Institutional Review Board Protocol title Researcher: Application contact: For questions, concerns, to provide input, or request a consultation, call HRPP staff at 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) 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) 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) 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? How many completed the study? How many withdrew/discontinued from the study Provide the reason for participant withdrawals Age range of participants Gender Male Female Other

7 Application to Continue Research Ethnic categories Hispanic or Latino Not Hispanic or Latino Unknown (Individuals not reporting ethnicity) Ethnic Category: Total All Subjects* Racial categories 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 Prisoners Children Adults unable to give consent Study progress Females Males Unknown or not reported Females Males Unknown or not reported Yes no Yes no Yes no Yes no 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 of changes since the study was last approved. If the study is closed to enrollment and participants are in follow-up, please detail your followup. Total Total 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

8 Application to Continue Research Empowerment Other 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: 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: 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: 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: 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. 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)

9 Application to Continue Research 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 / offsite) 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 Conflict of Interest Researchers and research staff are required to disclose reportable financial interests related to the research. Use the following tests to determine if the researcher and the researcher s immediate family, or any other members of the research team (sub-investigators and research staff) and their immediate families, have any of the following financial interests related to the research. "Immediate Family" means spouse, domestic partner, children, and dependents. "Financial Interest Related to the Research" means financial interest in the sponsor, product or service being tested, or competitor of the sponsor. If any new reportable events have occurred please upload a conflict of interest management plan. Ownership interest, stock options, or other financial interest of any value related to the research. Does not include mutual funds or companies publicly traded on a stock exchange. Compensation of any value related to the research in the preceding 12 month including, but not limited to honoraria, consultant fees, royalties, or other income. Proprietary interest related to the research of any value including, but not limited to, a patent, trademark, copyright or licensing agreement. Board or executive relationship in a company (such as a startup company but including publicly traded companies) related to the research, regardless of compensation. Reimbursed or sponsored travel by an entity other than a federal, state, or local government agency, higher education institution or affiliated research institute, academic teaching hospital, or

10 Application to Continue Research medical center. Any arrangement where the value of the ownership interests will be affected by the outcome of the research. For example, an arrangement has been made where the value of stock options given to the researcher by a startup company will vary depending on the outcome of the research. Any other interest that could be affected by the outcome of the research. No reportable interests for any members of the research team. Failure to disclose reportable interests and provide an updated disclosure at least at the time of the continuation request or if the financial interests of the researcher and personnel on the grant change, may result in: Immediate termination of the research study Any other action required by state law There are modifications 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) Describe the proposed modification 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 Changes to documents List all documents and indicate their status. Add rows as needed. Document name (add rows as needed) Version Modified? Changes to staff List all staff and indicate their status. Add rows as needed. Yes no Yes no

11 Application to Continue Research Name Role Modified? Yes no Yes no Attestation I agree to follow Department policies and provide complete and accurate information concerning research involving human participants and data. Type your name here Date: For questions, concerns, to provide input, or request a consultation, call HRPP staff at If a fee is required, complete the fee worksheet below, print out the worksheet and mail with payment.

12 Application to Continue Research 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 title Researcher: Application contact: Date: Data Studies: Confidential information (e.g., Cancer Registry) no intervention or interaction Continuing Reviews fee: Expiration of IRB approval additional fee: Total Industry-sponsored research, or research sponsored by a for-profit organization Continuing Reviews fee: Expiration of IRB approval additional fee: Total All other research Continuing Reviews fee: Expiration of IRB approval additional fee: 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 How to send payment Send payments, with a copy of this completed invoice, to the following address. DOH accepts check payment ONLY. DOH accepts checks from following sources: Researcher s university or research institute researcher s funding organization cashier's checks personal checks Make checks payable to: Florida Department of Health Human Research Protection Program

13 4052 Bald Cypress Way, Bin A-24 Tallahassee, Florida Application to Continue Research

14 Report Problems Florida Department of Health Report Problems For questions, concerns, to provide input, or request a consultation, call HRPP staff at Description of Problem Specify the problem(s): New or increased risk 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 Unresolved participant complaint 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 / offsite) 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 Revocation of hospital privileges for any research on the study Provide a narrative description of the problem. Include: Description of problem or what is known currently Date of occurrence or discovery Description of potential risks or impacts Corrective Actions Describe actions taken to eliminate immediate hazard to participants, or planned responses: Changes to the protocol Required Documentation 1

15 Report Problems Changes to the consent document Disclosure to participants and obtaining consent Changes to other documents Education for Research Staff Monitoring of research Status of other reporting required by the Department (e.g., management, Inspector General) Other activities to protect participants (describe below) Provide a narrative description of the actions taken or planned. Include: Date of action if immediate action was required to protect participants and description of what actions were taken Description of quality improvement plan, including responsible persons, dates, monitoring, and ways to measure actions were successful Attach reports of investigations regardless of source, copies of relevant correspondence (e.g., reports to other Department officials), corrective action plans, or quality improvement plans Required Documentation 2

16 Notification of Study Closure Florida Department of Health Notification of Study Closure For questions, concerns, to provide input, or request a consultation, call HRPP staff at Describe Status Specify the status: Interactions and interventions, if any, are complete at local site Analysis of identifiable information is complete Researcher no longer is in possession of identifiable information (if researcher continues to have identifiable information, study is considered ongoing) Describe process that was completed to close research, including: Transfer of study participants to standard of care Process to remove identifiers from data Plans to maintain research records for at least three years (six years for research involving medical data) Dissemination of Research Findings Describe any dissemination of research findings. Include: Information for participants or community members Presentations (list title, data, conference) Publications (provide citation) Optional: attach presentations or publications Required Documentation 1

17 Differentiating Research From Public Health Practice and Quality Improvement Florida Department of Health Human Subject Research Determination Worksheet Name of person requesting consultation: Title of project: KEY: Solid box: All items in the box must be true Dotted box: One item in the box must be true Determination DOH is not engaged in this research (See part 6) DHHS-regulated research Research not involving human subjects (DHHS) Non-research: Public health practice Non-research Quality improvement FDA-regulated research Completed by the Human Research Protection Administrator designated in the FWA within 5 business days of submission of a request for consultation; the person completing the form shall not have any involvement in the research Part I: DHHS research DHHS-regulated research involving human subjects as defined in DHHS regulations (both are true) Research as Defined by DHHS (45 CFR (d): A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Project involves: an investigation (inquiry, examination, or search for facts, usually involving the formulation or testing of a hypothesis); and is systematic (conducted according to a plan, organized method, or procedure for testing or formulating a question or hypothesis and interpreting results); and is designed (planned, purposed, or conducted to apply to phenomena outside the observed data) to contribute to generalizable knowledge (observations, findings, information, or results that have been demonstrated with enough confidence and significance to confirm or alter the consensus within the professional norms of a community or discipline) or develop such knowledge Human subject as defined by DHHS (45 CFR (f): the project involves one or more living individuals about whom an investigator (whether professional or student) conducting research obtains Both are true Investigator obtains data about living individuals through intervention or interaction or private and identifiable data data about living individuals through intervention (physical procedures or manipulations of individuals or their environment) or interaction (communication or interpersonal contact) with individuals OR data about living individuals that is private AND identifiable (the data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, or use of data provided for specific purposes in which the individuals can reasonably expect that it will NOT be made public (e.g., medical record) AND The investigator is able to readily ascertain the identities of individual participants in research with the data DHHS research (45 CFR (d)) does not involve human subjects (45 CFR (f)) Insufficient information to determine; return for additional information Part 2: FDA-regulated research Research as defined by FDA (21 CFR 102(c)) applies if any of the following are true: The activity will involve the use of a drug in one or more persons that is NOT the use of an approved drug in the course of medical practice (21 CFR 312.3(b)) The activity will evaluate the safety or effectiveness of a device in one or more persons (21 CFR 812.2(a)) Data regarding subjects or control subjects will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit (21 CFR 50.3(c), 21 CFR (c)) Data regarding the use of a device on human specimens will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit. Insufficient information to determine; return for additional information

18 Differentiating Research From Public Health Practice and Quality Improvement Part 3: Non-research: public health practice Public health practice: the project Is designed to improve the health of a population; it is not designed in whole or in part, to contribute to generalzable knowledge; Involves specific legal authorization for conducting the activity under state public health law; The Department is required in the project to: Identify, assess, and control the presence and spread of communicable diseases ( (2) F.S.) Detect and investigate food-borne disease, waterborne disease, and other diseases of environmental causation where the Department under statutory authority conducts epidemiological investigations and ongoing surveillance ( (2) and (10)) Investigate the sanitary condition of any city, town, or place in the state (386.02) Collect data and conduct analyses and studies related to health care needs of the community for purposes of advising county health departments and the state health department regarding local and state health planning ( F.S.) Conduct epidemiological investigations, surveillance, programmatic evaluations, and clinical care for the population.( ) Includes a corresponding governmental duty to perform the activity to protect the public s health; Involves direct performance or oversight by a governmental public health authority (or its authorized partner) and accountability to the public for its performance; May legitimately involve persons who did not specifically volunteer to participate (i.e., they did not provide informed consent); and Supported by principles of public health ethics that focus on populations while respecting the dignity and rights of individuals. Is not FDA-regulated Insufficient information to determine; return for additional information See Public Health Practice vs. Research: A Report for Public Health Practitioners Including Cases and Guidance for Making Distinctions. Hodge and Gostin, et al Part 4: Non-research: quality improvement

19 Differentiating Research From Public Health Practice and Quality Improvement Quality improvement: data-guided activities designed to bring about immediate, positive changes in the delivery of health care or organizational effectiveness in particular settings. The project: is designed for the purpose of continuously improving ongoing care and management of the system for delivering clinical care, including but not limited to activities that (at least one is true): implement and monitor a practice to improve the quality of patient care collects patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes measures and reports provider performance data for clinical, practical, or administrative uses See OHRP Quality Improvement Activities Frequently Asked Questions is an integral ongoing part of standard program operations (organization may require participation and the use of a specific quality framework, such as Kaizen, Six Sigma, PDCA, TQM, etc) helps the organization track activities in terms of existing quality improvement frameworks or national best practices or benchmarks (e.g., Tobacco program activities are required in Florida statute to implement national best practices, including quality improvement monitoring) is funded as integral part of ongoing operations (e.g., through established ongoing programmatic commitment to continuous quality improvement) is the responsibility of institutional leadership who supervise quality initiatives; may involve a quality improvement committee or other ongoing organizational structure is consistent with principles of biomedical and organizational ethics that supports organization efforts to provide high quality care aligned with ongoing systematic collection and measurement of quality data to improve individual patient care (e.g., transparency about the process, proportionality and use of the least intrusive monitoring, and fairness in the application of the results of monitoring) Is not FDA-regulated Insufficient information to determine; return for additional information Part 5: Other Determinations The project meets the Florida Department of Health s ethical standards (e.g., acceptable risk-benefit relationship, equitable selection, informed consent where appropriate, protections of privacy interests of participants and the confidentiality of their data (under state law) where appropriate, transparency about the process, proportionality, and where applicable community involvement in quality improvement efforts (e.g., through the PACE format, or other standard Department frameworks for incorporating community attitudes and information Part 6: Engagement in Research DOH is engaged in research (when any of the following are true): The research is sponsored (funded) in whole or in part from federal research appropriations to DOH, even where all activities involving human subjects research are carried out by agents or employees of another institution ("pass-through funding"); The research is conducted by or under the direction of any employee or agent of DOH in connection with his or her official responsibilities; The research is conducted using any property or facility of the DOH; The research involves DOH clients; The research involves the use of non-public information maintained by the DOH when released outside DOH, except as otherwise required by law. The research is conducted in accordance with an Assurance filed with the Office of Human Research Protections (OHRP) in which the DOH IRB is designated as the IRB of record through an established Memorandum of Understanding. Insufficient information to determine; return for additional information Comments Signed Dated

20 Differentiating Research From Public Health Practice and Quality Improvement Florida Department of Health Human subject protection worksheet for exemptions PROTOCOL NUMBER: PRINCIPAL INVESTIGATOR: TITLE OF STUDY: KEY: Solid box: All items in the box must be true Dotted box: One item in the box must be true Exemption prohibited; one or more of the following are true The research involves prisoners as participants For categories 1 through 5: The research is subject to FDA regulation The research involves deception (DOH policy) The research involves greater than minimal risk to participants The research is classified. The project involves significant physical invasions or intrusions upon the privacy of participants Exemption permitted; research meets one or more exempt categories The research falls into one or more of the following categories (check all that apply): 45 CFR (b) Category (1): Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as Research on regular and special education instructional strategies, OR Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 45 CFR (b) Category (2): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and Any disclosure of the human subjects' responses outside of the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation; and If the research involves children as participants, the research must be limited to educational tests (cognitive, diagnostic, aptitude, achievement), and observation of public behavior when the investigator(s) do not participate in the activities being observed. Research that uses survey procedures, interview procedures, or observation of public behavior when the investigator(s) participate in the activities being observed cannot be granted an exemption. 45 CFR (b) Category (3): Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures: or observation of public behavior that is not exempt under 45 CFR (b) Category (2) above if: The human subjects are elected or appointed public officials or candidates for public office; OR, Federal statutes require without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. 45 CFR (b) Category (4): Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or the information is recorded by the Investigator in such a manner that subjects cannot be identified, directly or

21 Differentiating Research From Public Health Practice and Quality Improvement through identifiers linked to the subjects. To qualify for this exemption, normally data, documents, records, or specimens must have been collected before the research project begins. However, OHRP Guidance (08/10/05) specifies limited conditions whereby an Investigator may de-identify data prior to the initiation of research that would qualify for exempt review. These sources are publicly available Information is recorded by the investigator in such a manner that: Participants cannot be directly identified AND Participants cannot be identified through identifiers linked to them AND The research does not involve significant physical invasions or intrusions upon the privacy of participants. 45 CFR (b) Category (5): Research and demonstration projects, which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: Public benefit or service programs; this exemption is for Federally supported projects and is most appropriately invoked with authorization or concurrence by the funding agency. The following criteria must be satisfied to invoke the exemption for research and demonstration projects examining public benefit or service programs: The project does not involve significant physical invasions or intrusions upon the privacy of participants, OR All of the following are true The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services under the Older Americans Act); The research or demonstration project must be conducted pursuant to specific Federal statutory authority; There must be no statutory requirements that the project be reviewed by an IRB Procedures for obtaining benefits or services under those programs; The research or demonstration project must be conducted pursuant to specific Federal statutory authority; Possible changes in or alternatives to those programs or procedures; or Possible changes in methods or levels of payment for benefits or services under those programs. This exemption is for projects conducted by or subject to approval of Federal agencies and requires authorization or concurrence by the funding agency. 45 CFR (b) Category (6) and 21 CFR (d): Taste and food quality evaluation and consumer acceptance studies, if The research involves one of the following: Wholesome foods without additives will be consumed, OR A food will be consumed that contains a food ingredient when the food ingredient is at or below the level to be safe OR the food ingredient is for a use found to be safe A food will be consumed that contains an agricultural chemical or environmental contaminant and one of the following is true: The agricultural chemical or environmental contaminant is at or below the level found to be safe by the Food and Drug Administration The agricultural chemical or environmental contaminant is at or below the level

22 Differentiating Research From Public Health Practice and Quality Improvement approved by the Environmental Protection Agency The agricultural chemical or environmental contaminant is at or below the level approved by the Food Safety and Inspection Service of the U.S. Department of Agriculture Other Determinations The project meets the Florida Department of Health s ethical standards governing the conduct of research (e.g., acceptable risk-benefit relationship, equitable selection, informed consent, protections of privacy, maintenance of confidentiality, and protections for vulnerable populations) Comments The research: This protocol DOES meet the criteria of Exemption This protocol DOES NOT meet the criteria of Exemption; return for review using expedited procedure or by the convened IRB Signed Dated PRINCIPAL INVESTIGATOR: TITLE OF STUDY: KEY: Solid box: All items in the box must be true Dotted box: One item in the box must be true The Florida Department of Health works with public, industry, and private Sponsors to apply the requirements of the Human Research Protection Program to all participants. Complete this worksheet to determine when human subject protections in funding agreements (including contracts, grants, and any other funding agreements) Arrangements for medical care for research-related injury are defined before the research starts and communicated to prospective participants. (AAHRPP Element I.8.A.) Element not applicable. All of the following are true: The proposed research: is not a clinical study does not involve medical tests such as blood draws does not present risk of research-related injury Element met: Standard language present or Element not met; return to researcher Element met: Acceptable alternative language present

23 Differentiating Research From Public Health Practice and Quality Improvement Funding agreements require the Sponsor (or federal agency) to promptly report to DOH any findings that could (1) Affect the safety of participants or (2) Influence the conduct of the study. (AAHRPP Element I.8.B.) (See 21 CFR ) Element not applicable. All of the following are true: the Sponsor is not responsible for monitoring the research the Sponsor has not subcontracted monitoring to a Contract Research Organization (CRO) or other organization Element met: Standard language present or Element not met; return to researcher Element met: Acceptable alternative language present Funding agreements require the Sponsor specify (1) that data and safety monitoring plans to the IRB prior to approval of the study, and (2) the time frame for providing routine and urgent data and safety monitoring reports to the IRB (AAHRPP Element I.8.C) Element not applicable. All of the following are true: the Sponsor is not responsible for monitoring the research the Sponsor has not subcontracted monitoring to a Contract Research Organization (CRO) or other organization Element met: Standard language present or Element not met Element met: Acceptable alternative language present Funding agreements require a written agreement with the Sponsor about plans for disseminating findings from research and the roles that Researchers and Sponsors will play in the publication or disclosure of results. (AAHRPP Element I.8.D) Element not applicable. DOH has no policy regarding the dissemination of findings from sponsored research Funding agreements describe the steps followed to communicate findings from a closed research study to the Researcher or DOH when those findings directly affect participant safety. Funding agreements specify a time frame after closure of the study during which the Sponsor will communicate findings (e.g., two years). (AAHRPP Element I.8.E) Element not applicable. All of the following are true: The proposed research: is not a clinical study will not produce results that will directly affect participant safety or medical care Element met: Standard language present or Element not met Element met: Acceptable alternative language present Human subject requirements for funding agreements are: NOT REQUIRED REQUIRED PRESENT REQUIRED - NOT PRESENT - return to researcher with a link to this web page about funding agreements: Florida Department of Health Ethics and Human Research Protection Program Investigational Articles Worksheet Name of the drug: Name of commercial sponsor: KEY: Solid box: All items in the box must be true Dotted box: One item in the box must be true Determining whether FDA regulations governing drug research apply The drug is FDA approved Drug is used in accordance with its approved indication FDA regulations involving device research apply when either of the following is true: The activity will evaluate the safety or effectiveness of a device in one or more persons (21 CFR 812.2(a)) Data regarding the use of a device on human specimens will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit. When FDA regulations apply, the IRB needs to verify the drug has an IND, or is exempt from requirements to have an IND Verifying the IND, or that the protocol is exempt from requirements to have an IND The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer

24 Differentiating Research From Public Health Practice and Quality Improvement Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device is exempt from the requirement to have an IDE (21 CFR 812.2(c)) Use of the investigational drug, agent or biologic is not intended to be reported to the FDA in support of a new indication for use nor support any significant change in labeling for the product; The use of the investigational drug, agent, or biologic is not intended to support a significant change in the advertising of the product; The use of the product does not involve a route of administration, dosage level, and/or use in a subpopulation, or other factors that significantly increase the risks, or decrease the acceptability of the risks associated with the use of the drug, agent, or biologic. The use will be conducted in compliance with the IRB approval and informed consent procedures; The use will be conducted in compliance with the requirements concerning the promotion and sale of the drug, agent, or biologic as described in FDA regulations 21 CFR Sec 312.7; The use does not intent to invoke exception from informed consent requirements for emergency use. Investigator and Sponsor Information The investigator is conducting research on behalf of a commercial sponsor (most research involving DOH) The investigator is investigator-initiated or the investigator is serving as the sponsor The investigator has provided documentation that responsibility for complying with all FDA regulatory requirements of sponsors has been assigned to a contract research organization (Initial review and verify at

25 Differentiating Research From Public Health Practice and Quality Improvement continuing review) Investigator has provided documentation of an audit by a contract research organization that all FDA regulatory requirements of sponsors are met. (Verify at continuing review) The IRB shall not approve research where the investigator is serving as the sponsor unless a contract research organization is responsible for compliance with FDA requirements. Comments Signed Dated Florida Department of Health Ethics and Human Research Protection Program Investigational Devices Worksheet Name of the device: Name of commercial sponsor: KEY: Solid box: All items in the box must be true Dotted box: One item in the box must be true Determining whether FDA regulations governing device research apply The device is FDA approved Device is used in accordance with its approved indication FDA regulations involving device research apply when either of the following is true: The activity will evaluate the safety or effectiveness of a device in one or more persons (21 CFR 812.2(a)) Data regarding the use of a device on human specimens will be submitted to or held for inspection by FDA as part of an application for a research or marketing permit. When FDA regulations apply, the IRB needs to verify the device has an IDE, or is exempt from requirements to have an IDE Verifying the IDE, or that the protocol is exempt from requirements to have an IDE The device has an IDE, which has been verified by:

26 Differentiating Research From Public Health Practice and Quality Improvement the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device has an IDE, which has been verified by: the IDE number is listed or stamped on the commercial sponsor protocol communication from the commercial sponsor communication from the FDA For additional devices list the name and manufacturer Name Manufacturer The device is exempt from the requirement to have an IDE (21 CFR 812.2(c)) Option 1: The Device Is not a transitional device. Has been in commercial distribution immediately before May 28, 1976 Is being used or investigated in accordance with the indications in labeling in effect at that time. Option 2: The Device Is not a transitional device. Was introduced into commercial distribution on or after May 28, The FDA has determined to it be substantially equivalent to a device in commercial distribution immediately before May 28, 1976 Is being used or investigated in accordance with the indications in the labeling FDA reviewed under subpart E of part 807 in determining substantial equivalence. Option 3: The Device Is a diagnostic device. The sponsor will comply with applicable requirements in 21 CFR (c).

27 Differentiating Research From Public Health Practice and Quality Improvement The testing: Is noninvasive, Is noninvasive, Does not require an invasive sampling procedure that presents significant risk, Does not by design or intention introduce energy into a subject, and Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. Option 4: The Device Is not a transitional device. Has been in commercial distribution immediately before May 28, 1976 Is being used or investigated in accordance with the indications in labeling in effect at that time. Option 5: The Device The device is a custom device as defined in 21 CFR 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution. Option 6: Option 6: The device meets the abbreviated requirements for an IDE: The device is not a banned device; The device is not a significant risk device; Investigator and Sponsor Information The investigator is conducting research on behalf of a commercial sponsor (most research involving DOH) The investigator is investigator-initiated or the investigator is serving as the sponsor The investigator has provided documentation that responsibility for complying with all FDA regulatory requirements of sponsors has been assigned to a contract research organization (Initial review and verify at continuing review) Investigator has provided documentation of an audit by a contract research organization that all FDA regulatory requirements of sponsors are met. (Verify at continuing review) The IRB shall not approve research where the investigator is serving as the sponsor unless a contract research organization is responsible for compliance with FDA requirements. Comments