For questions, concerns, to provide input, or request a consultation, call HRPP staff at

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1 Florida Department of Health Request for Determination of Whether IRB Review is Required Determination of Whether IRB Review is Required For questions, concerns, to provide input, or request a consultation, call HRPP staff at Project Title Abstract Provide a summary of the project (approximately 250 words) Purpose of the Project Describe the purpose, specific aims, or objectives. Background and Rationale Provide the background and rationale for the project: Describe the background, relevant prior experience, and gaps in current knowledge Describe and explain the project design If the project is limited to secondary analysis of existing data, describe the source of the data, methods of analysis, and plans for data storage. List the data fields to be used If the project involves interactions or interventions with people, describe all procedures from the beginning of the proposed research through the conclusion of the project, including surveys, interviews, focus groups, screening, study visits, drug treatments, randomization, and any long-term participant follow-up Describe the number, qualifications, and expertise of staff, their experience in conducting similar projects, and their knowledge of the population being studied (or the data being analyzed) If applicable, provide a brief list of references to support the information provided Attestation I agree to follow Department policies and provide complete and accurate information concerning projects involving human participants and data. Type your name here Date: For questions, concerns, to provide input, or request a consultation, call HRPP staff at Research Outline 1

2 IRB Application Overview IRB Application Overview Application for review by the Institutional Review Board Protocol title Researcher: Application contact: Select one: Initial review of a new research study Request to modify or amend an existing study Request to continue an existing study (continuing review) Notification of study closure For questions, concerns, to provide input, or request a consultation, call HRPP staff at Type of Research Select all that apply: Surveys (in-person, by mail, through or the internet), interviews, focus groups, internet research (websites, social media such as Facebook or Twitter), program evaluation, or quality improvement methods. Secondary analysis of existing data, including Florida registry data (e.g., Cancer Registry, Vital Statistics) or biological samples where the researcher will not contact participants Use of existing data, including Florida registry data (e.g., Cancer Registry, Vital Statistics) for recruitment or follow up Medical records from patients seen at Local Health Department clinics (or other patients or facilities, such as tuberculosis patient referrals) Protected Health Information Drugs or dietary supplements Medical devices FDA-regulated research involving biological samples, including anonymous tissues from Department labs or other tissue samples Emergency Use Of A Test Article DHHS-regulated or FDA-regulated planned emergency research Ionizing radiation (such as x-ray or other medical imaging technologies) Other Funding information Is the research funded? Yes no If funded, please select the source of funding: Pharmaceutical company enter company name US state government enter state US federal government enter agency

3 IRB Application Overview State of Florida Funding Programs enter program Private foundation grant enter organization name Other Participant information Select the populations to be enrolled in the research. No vulnerable populations Children Pregnant women Wards of the state (foster children) Prisoners Adult participants who are unable to consent for themselves Undocumented workers Employees of research site or sponsor Limited to non-readers Institutionalized persons Students or trainees or employees of the PI or sub-investigator Students to be recruited in an educational setting (in class or at school) Department of Defense-funded research, or research involving military personnel recruited by military personnel Individuals under isolation or civil confinement orders (for examples, individuals with an infectious disease who are restricted by court order to protect public health) Consent Select the consent process and plans to document consent, or select a waiver option: Consent discussion and long form consent document (Signed consent document) Consent discussion and short form consent document (Signed consent document) Consent discussion but waiver of documentation of consent Waiver or alteration of consent, including not obtaining consent (for example, when it is impracticable when conducting research involving records) FDA-regulated research involving anonymous tissue samples 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

4 Research Outline Research Outline Research Outline - Application for Initial Review by the Institutional Review Board For questions, concerns, to provide input, or request a consultation, call HRPP staff at Study Title Abstract Provide a summary of the study (approximately 250 words) Purpose of the Research Describe the purpose, specific aims, or objectives. State the hypotheses to be tested Scientific or Scholarly Rationale Provide the scientific or scholarly background and rationale for the study, including prior research, past experimental or clinical findings Describe the background, relevant prior experience, and gaps in current knowledge Describe any relevant preliminary data Describe and explain the study design If applicable, also describe the primary and secondary study endpoints. (For example, studies may be conducted until a certain time point, until a re-occurrence of disease, or certain clinical condition is met.) If applicable, also describe any primary or secondary safety endpoints. (Examples may include evidence of liver toxicity, an inability to tolerate further chemotherapy, or other side effects related to a drug or device.) This may not be applicable to studies that are not greater than minimal risk Provide a brief list of references to support the information provided Explain the significance of the research, including why this research is important and how will it add to existing knowledge. Describe the importance of the knowledge expected to result. Describe the potential for the research to result in improved health outcomes for individuals or communities, or improved measurement or surveillance of health outcomes. Research Outline 1

5 Research Outline If applicable, describe plans to involve community members in the design and conduct of the research; otherwise indicate not applicable If applicable, describe plans for informing community members about the results of the research and involving community members in the dissemination of results; otherwise indicate not applicable Resources Describe the number, qualifications, and expertise of staff, their experience in conducting research, and their knowledge of the population being studied (or the data being analyzed) Describe/estimate the time that researchers will devote to the research (for example, a certain percent effort for a defined period of time) Describe the process to ensure all persons assisting with the research are adequately informed about the protocol, research-related duties and functions, and any drugs and devices in the research, and any requirements for storage and use of confidential data For studies involving interactions or interventions, describe the researcher s ability to recruit the required number of participants (For studies limited to secondary analysis of existing data, indicate not applicable ) For studies involving interactions or interventions, describe psychological, social, or medical services, including counseling or social support services that may be required because of research participation, including referral to licensed counselor, referral to telephone crisis hotlines, support from the researcher, or peer support groups psychological, social, or medical monitoring ancillary care equipment needed to protect participants resources for participant communication, such as language translation services (For studies limited to secondary analysis of existing data, indicate not applicable ) Describe the setting, facilities, and location in which research will be conducted. Include documentation of permission from the site to conduct research with your application (For studies limited to secondary analysis of existing data, indicate not applicable ) Personnel Knowledge and experience: Describe the knowledge and experience of the research team that qualifies the researchers and staff to conduct the research. Include: Research Outline 2

6 Research Outline Number of studies the researcher is currently conducting Number of people supervised by the researcher Number of research settings overseen by the researcher Approximate number of participants in all studies Compliance and disciplinary actions whether any member of the research team has had research suspended or terminated by any IRB; been convicted of a crime; been disciplined by a public or private medical organization or is currently subject to such a proceeding; been disciplined by a licensing authority or is currently subject to such a proceeding; has received a warning letter from the FDA or action from the FDA Whether the researcher or any member of the research team receive recruitment bonuses (additional payments or incentives in exchange for referrals of prospective participants payments or incentives that are designed to accelerate recruitment, or the timing or rate of enrollment, such as payments for enrolling a certain number of participants in a certain period time, or payments based on the speed of enrollment "Payments or incentives" includes any item of value, including direct payments, gift certificates, travel vouchers or trips, or physical items such as watches.) Conflict of interest Researchers must provide a management plan when there is a financial conflict of interest. This requirement applies to all researchers, research staff, and their immediate family members, as defined below. Use the following criteria to determine if any researchers, staff, or immediate family members have a reportable financial interest related to the research: 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. The principal investigator is responsible for disclosing interests of the principal investigator, immediate family, and all members of the research team and their immediate families. 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. Research Outline 3

7 Research Outline "Financial Interest Related to the Research" means financial interest in the sponsor, product or service being tested, or competitor of the sponsor. 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 Complete the Biosketch Worksheet and provide with your application Procedures Select all that apply: Secondary analysis of existing data with no participant interaction or intervention, and no attempt to contact participants. Complete the Section, Procedures Secondary Analysis of Existing Data* Interactions or interventions with living individuals. Complete the Section, Procedures Interactions or Interventions* *Complete both sections if your research involves both interactions or interventions, and secondary analysis of data Procedures Secondary Analysis of Existing Data The research does not involve secondary analysis of existing Department data; skip this section Indicate the source(s) of private identifiable data involved in the research: Medical records Florida Cancer Registry Data System Vital Statistics WIC data Emergency Medical Services registry data Immunization registry data EMSTARS Emergency Medical Services Tracking and Review System data Trauma system data Behavioral Risk Factor Surveillance System (BRFSS) Pregnancy Risk Assessment Monitoring System Youth Risk Behavior Surveys MQA Registry Data (Physicians' Workforce Survey) Other: How will the data be analyzed? What statistical procedures will be used to test hypotheses; if qualitative, how will data be coded, etc. List all the data fields requested from the data program Research Outline 4

8 Research Outline Does the researcher have access to any of the data as part of their regular non-research-related professional responsibilities? Yes No If yes, provide a rationale for utilizing the data in the research, and describe how the use of data for research is different from the use of the data in standard practice / the non-research related job (otherwise indicate not applicable ) Procedures Interaction or Intervention The research does not involve interactions or interventions with participants; skip this section Describe all procedures from the beginning of the proposed research through the conclusion of the project, including surveys, interviews, focus groups, screening, study visits, drug treatments, randomization, and any long-term participant follow-up Describe any procedures being performed for diagnostic or treatment purposes that are being conducted anyway for other reasons Describe alternative procedures or courses of treatment, if any that might be advantageous to the participant. Describe the potential risks and benefits of the alternate procedures. Do the treatments or procedures in the research differ from standard of care? Yes No If yes, describe how study procedures differ from standard of care and whether participants may be at increased risk due to participation in the research (otherwise indicate not applicable ) Describe what data will be collected including long-term follow-up. If student records are used, include a list of specific data to be collected from schools Describe plans to audio or video tape participants Anticipated Risks and Potential Benefits Describe the magnitude and probability of physical, social, economic, psychological and legal harm that may result from participation in the research. Indicate which procedures, if any, may have risks to participants that are currently unforeseeable. If applicable, describe risks to others (third parties) who are not participants Describe the plans to minimize risks. Explain how the procedures in the research are the least risky that can be performed consistent with sound research design Research Outline 5

9 Research Outline Indicate whether there are any direct benefits to participants from participation in the research No anticipated direct benefit Therapy Education Information Resources Empowerment Other: Participant Selection and Recruitment The research does not involve interactions or interventions with participants; skip this section Describe the number, age range, and demographics of participants needed to complete the research Describe the selection (inclusion and exclusion) criteria Describe how participants will be identified for recruitment Advertisements Chart review Department of Health registry (Cancer registry, Vital Statistics, other registry) From a database for which participants have given prior permission to be contacted for research studies Existing researcher contacts (patients, students) Referral from the individual's treating physician Other: Identify the site(s) where recruitment will occur Local Health Department clinic Community location (street, park, beach) Clinic other than DOH County Health Department clinic Hospital School Other: Indicate the overall duration of subject participation and provide a timeline of procedures Indicate any research-related costs that will be charged to the participant or participant's insurance Research Outline 6

10 Research Outline Specify the amount and schedule of all payments to participants Describe the provisions for medical care and available compensation in the event of research related injury. (If research is not greater than minimal risk, indicate not applicable ) For clinical studies: Describe how you will know of other research studies in which the participants might be enrolled. Indicate if participants will be enrolled in more than one study Estimate the number of participants who are expected to be healthy volunteers. Explain why healthy volunteers are included. (For non-clinical studies, indicate not applicable ) Indicate the mode of communication of advertising or recruitment materials Web page Social media (Facebook, Instagram, Path, Pinterest, Twitter, Youtube) Video Radio Letter Telephone Other Consent Refer to the appendix on required and optional consent disclosures including Department-specific required disclosures -attached at the end of this form. Research is limited to secondary analysis of existing data only Describe: Why the research cannot be practicably carried out without the waiver or alteration Why the waiver or alteration will not adversely affect the rights or welfare of participants Whether participants will be provided additional pertinent information about the research If research is limited to secondary analysis of existing data, skip the next questions and go to the next section on privacy and confidentiality. Consent Process - research involves interactions or interventions Who will conduct the consent interview with the participant? Principal investigator Research Outline 7

11 Research Outline Sub-investigator Research coordinator Other (specify and describe qualifications and expertise): Who will provide consent or permission? Participant Participant's legally authorized representative Where will consent be obtained? Indicate the location or setting for providing information to participants and obtaining consent In a private exam room In a waiting room In an open clinic In a group setting In a group setting with follow-up in a private room In emergency situations Other: When will consent be obtained? Describe how much time will be devoted to the consent discussion? Indicate whether these periods provide sufficient opportunity for the participant to consider whether or not to participate and sign the consent document? Indicate the language(s) understood by the participant or participant's legally authorized representative English Spanish Haitian The protocol prohibits enrollment of non-english speaking participants Other: Indicate the language(s) used by those conducting the consent discussion with the participant English Spanish Haitian Other: If non-english speaking participants are being enrolled, there must be plans for conducting the consent discussion in a language the participant understands, and ongoing communication with the participant throughout the research and in event of an emergency. At least one member of the research team is fluent in the language that will be used for communication, and the staff member(s) will be available during emergencies Research Outline 8

12 Research Outline The research team has 24-hour access to translation services with sufficient medical expertise to discuss the research Other: Describe steps taken to minimize the possibility of coercion or undue influence in the consent process: Describe the process to ensure participants have sufficient opportunity to decide whether to participate and give consent Participants will be allowed to take home the unsigned form for consideration before signing it Participants will be allowed a waiting period to consider it Other: Describe any information to be communicated to the participant or participant's legally authorized representative that is not included in the consent document, if applicable Provisions to Protect the Privacy Interests of Participants and the Confidentiality of Data Privacy refers to persons and their interest in controlling the access of others to themselves. It includes being seen without clothing, being observed while conducting personal behavior, being asked personal questions in public settings, or being photographed or videotaped. Study does not involve interactions or interventions with living individuals skip to Confidentiality Section. Select protections for the privacy interests of participants: Use of private exam rooms Use of drapes or other barriers when participants have to disrobe Collection of sensitive information is limited to the minimum amount necessary to achieve the aims of the research Obtaining permission prior to phoning a participant or leaving messages in voic Not asking personal information in public settings Asking permission before allowing persons not involved in the patient's care to participate in rounds (e.g., medical students, interns, or residents) Other: Indicate plans to protect the confidentiality of participant data Confidentiality refers to how the participant s private information will be handled, managed, and disseminated. Indicate protections for confidentiality of the participant's identifiable data: Limitations on the number of persons who can access records Logs on who has accessed or viewed records Use of mandatory passwords to limit access to data Research Outline 9

13 Research Outline Use of encryption to store data Storing records in locked facilities, including locked cabinets, locked rooms Only storing identifiable confidential information for the minimum amount of time required to achieve the aims of the research, or requirements in statute Removing, masking, or collapsing variables after obtaining records, or using codes to reduce the amount of readily identifiable information Providing staff education and having all staff sign statements agreeing to protect the confidentiality of data Transcribing audio and video recordings and then destroying the tapes to eliminate identification of participants via voice or images Having a signed data use agreement that sets out formal responsibilities for confidentiality and data protection Obtaining a Certificate of Confidentiality Other: Indicate whether results (study results or individual participant results) will be shared with participants or others (e.g., the participant s teacher, advisory, or primary care physician) and procedures for sharing data Indicate where electronic research records and data will be stored at the local research site Data stored on a stand-alone computer, tablet or other device with no network or internet connection Data stored on an external hard drive in encrypted format Data stored on a computer, tablet or other device connected to a private network Data stored on a computer, tablet, or other device connected to a network or the internet Consumer cloud-storage (Dropbox, OneDrive) Other: List the names of the people who will have access to the data and who has permission to access the data at the local research site What is the secure storage location (building, room number, and type of storage unit) at the local research site Safety Monitoring If the research is not greater than minimal risk, indicate not applicable ; otherwise describe: What safety information will be collected, including serious adverse events How the safety information will be collected (e.g., with case report forms, at study visits, by telephone calls with participants) The frequency of data collection, including when safety data collection starts Research Outline 10

14 Research Outline When safety data will be reviewed Who will review safety information Whether the plan includes establishing a data monitoring committee and a plan for reporting data monitoring committee findings to the IRB and the Sponsor If a safety monitoring board is used, the qualifications of members Conditions that trigger an immediate suspension of the research, if applicable 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 Complete the Fees Worksheet and review the Consent Checklist, below. Research Outline 11

15 Research Outline Fees required No fees required Invoice for Initial 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: Phone: Application contact: Phone: Date: Data Studies: Confidential information (e.g., Cancer Registry) no intervention or interaction Initial review fee: Industry-sponsored research, or research sponsored by a for-profit organization Initial review 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 Research Outline 12

16 Research Outline Required and Optional Consent Disclosure Checklist Required (*Can be omitted if there are none) A statement that the study involves research An explanation of the purposes of the research An explanation of the expected duration of the subject's participation A description of the procedures to be followed Identification of any procedures which are experimental* A description of any reasonably foreseeable risks or discomforts to the subject* A description of any benefits to the subject or to others which may reasonably be expected from the research* A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject* A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained* How to contact the research team for questions, concerns, or complaints about the research. How to contact someone independent of the research team for questions, concerns, or complaints about the research; questions about the subjects rights; to obtain information; or to offer input. Required Department language: If you want to talk with someone independent of the research team for questions, concerns, or complaints about the research; questions about your rights; to obtain information; or to offer input, you can contact the Florida Department of Health Institutional Review Board. An Institutional Review Board is a group of people who review research to ensure participants are protected and the research is conducted in an ethical way. You can contact the IRB at: An explanation of whom to contact in the event of a research-related injury to the subject A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled Required for more than minimal risk research An explanation as to whether any compensation is available if injury occurs and, if so, what it consists of, or where it may be obtained Required for clinical trials A statement that the study is approved by an IRB The probability of random assignment to each treatment The participant s responsibilities When applicable, a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, or nursing infant) which are currently unforeseeable The important potential benefits and risks of the alternative procedures or courses of treatment that may be available to the subject. When there is no intended clinical benefit to the subject, a statement to this effect. The monitors, auditors, IRB, and regulatory authorities will be granted direct access to the subject's original medical records for verification of clinical trial procedures and data, without violating the confidentiality of the subject, to the extent permitted by applicable laws and regulations and that, by signing the consent document, the subject or legally authorized representative is authorizing such access. If the results of the trial are published, the subject s identity will remain confidential. Required disclosures for FDA-regulated research The possibility that the Food and Drug Administration may inspect the records. The data collected on the subject to the point of withdrawal remains part of the study database and may not be removed. The investigator will ask a subject who is withdrawing whether the subject wishes to provide data collection from routine medical care. For controlled drug/device trials (except Phase I drug trials) and pediatric device surveillance trials the consent document must contain the following statement (verbatim): A description of this clinical trial will be available on as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time. Other additional disclosures (include when appropriate) The particular treatment or procedure may involve risks to the subject, which are currently unforeseeable. If the subject is or becomes pregnant, the particular treatment or procedure may involve risks to the embryo or fetus, which are currently unforeseeable. Anticipated circumstances under which the subject s participation may be terminated by the investigator without regard to the subject s consent. Any additional costs to the subject that may result from participation in the research. Consequences of a subject s decision to withdraw from the research. Procedures for orderly termination of participation by the subject. Significant new findings developed during the course of the research, which may relate to the subject s willingness to continue participation will be provided to the subject. Approximate number of subjects involved in the study. Amount and schedule of all payments. Research Outline 13

17 Research Outline An explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained Research Outline 14

18 Biographical Sketch BIOGRAPHICAL SKETCH Provide the following information for 1) researchers and 2) key study personnel with substantial interaction with research participants, 3) any personnel who have access to identifiable data NAME POSITION TITLE EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) INSTITUTION AND LOCATION DEGREE (if applicable) YEAR(s) FIELD OF STUDY A. Positions and Honors. List in chronological order previous positions, concluding with your present position. List any honors. Include present membership on any Federal Government public advisory committee. Professional Positions Awards and Other Professional Activities B. Selected peer-reviewed publications (in chronological order). Do not include publications submitted or in preparation. For publicly available citations, URLs or PMC submission identification numbers may accompany the full reference. Note copies of these publications are no longer accepted as appendix material. C. Research Support. List selected ongoing or completed (during the last three years) research projects (federal and non-federal support). Begin with the projects that are most relevant to the research proposed in this application. Briefly indicate the overall goals of the projects and your role (e.g. PI, Co-Investigator, Consultant) in the research project. Do not list award amounts or percent effort in projects. Ongoing Completed Page Biographical Sketch Format Page

19 Checklist for Required Documentation Florida Department of Health Checklist for Required Documentation For questions, concerns, to provide input, or request a consultation, call HRPP staff at For Initial Review Full protocol, including instruments Data collection supporting materials: Surveys, evaluation instruments (spreadsheets, logs, worksheets, forms) Recruitment materials, advertisements (printed, audio, and video, copies of proposed web pages, copies of proposed information for social media) Any pictures, audio, or video used; a script may be submitted for review prior to production of audio or video, but the final audio and video files must be submitted prior to research starting) Proposed consent, assent, and parental permission document(s); consent script(s) if consent or parental permission or assent is not documented in writing HIPAA authorization, if not included in the consent document Funding agreements Any relevant grant applications Industry sponsor contracts, if applicable Any other written materials to be provided to, or meant to be seen or heard by, participants Documentation of researcher qualifications, including Biosketch Record of research ethics education (completion of the Collaborative IRB Training Initiative course; if members of the research team completed CITI training through the researcher s university or research institution, documentation of CITI training through the research team s institution may be submitted) Volunteer form, when non-department staff conduct research at Department facilities License or certification for translators, if materials are translated to or from other languages Scientific evaluations, if the research has received scientific review (for example, results of Department review or peer review results), if applicable Conflict of interest management plans, if a conflict of interest is disclosed Additional Department permissions Data use agreements with Department programs (e.g., Cancer Registry, Vital Statistics) Local health department director approval, when research occurs in a local health department If another IRB has not approved the research, copies of correspondence with the other IRB concerning the reasons the study was declined. Additional materials for DHHS-sponsored research DHHS-approved sample consent document (when one exists). Required Documentation 1

20 Checklist for Required Documentation Complete DHHS-approved protocol (when one exists). Additional materials for FDA-regulated research Investigator brochure for each investigational drug Package insert for each marketed drug Product information for each investigational device If IND number is not listed on the protocol, correspondence from the sponsor or FDA confirming the protocol has an IND Any additional materials required for research falling under regulation of other federal agencies Any additional materials requested by HRPP staff For Requests to Modify Research All modified documents Any additional documents required by a change in study design For Requests to Continue Research All modified documents Any additional documents required by a change in study design Data and safety monitoring board reports Any sponsor monitor reports If there are significant new findings or publications in the literature, a copy of publications or reports For Reportable Events and Problems Any reports, correspondence or other documents associated with investigations or reports (for example, correspondence with regulatory agencies, notification of proposed action by state medical board) Documentation of suspension or termination of research by another IRB. For Notification of Study Closure Any manuscripts or publications based on the research, if any List of conference presentations based on the research, if any List of grants based on results of the research, if any Required Documentation 2

21 Program and Local Site Support Florida Department of Health Program and Local Site Support For questions, concerns, to provide input, or request a consultation, call HRPP staff at Description of Problem Contact the appropriate central office program or local health department and have a Department official complete and sign the form. Form does not need to be completed for secondary analysis of existing data if there is a data use agreement. Attach a scanned signed copy with application. Authorizing official Local health department director or administrator, or nursing director or medical director, or other person with delegated authority able to authorize the research study Bureau of Laboratories, for research involving labs or human biological materials Bureau chief or division director for research involving central office programs Other: Attestation by Department Official The authorizing official attests that: The researcher has appropriate qualifications and expertise to conduct the research When appropriate, the proposed research will be conducted within scope of practice and license There are adequate county health department resources to conduct the research (for example, CHD employees have time to complete research ethics training, time to recruit patients, obtain informed consent, distribute recruitment materials or engage in other research-related procedures) There will be proper storage, handling and dispensing of test articles and unapproved medical devices using the facility s pharmacy or other approved location The research uses procedures consistent with sound research design The scientific design is sound enough to yield the expected knowledge When appropriate, the researcher has attempted to engage the community in the design and conduct of the research, and has planned how to communicate results to the community Signature Printed name: Signature: Date: Required Documentation 1

22 Research Involving Children Research Involving Children Protocol title: Researcher: Application contact: Definition of child in Florida Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research. In Florida, children are minors under 18 years of age, except as provided elsewhere in Florida law: A person under the age of 18 years of age who has had the disability of nonage removed by a circuit court is no longer a child and may consent to treatments and procedures in research; F.S. A person under the age of 18 years of age who is married or has been married, including one whose marriage is dissolved, or who is widowed or widowered is no longer a child and may consent to treatments and procedures in research; F.S. An unwed pregnant person under the age of 18 years of age may consent to the performance of medical or surgical care or services relating to her pregnancy, or relation to her child, including not greater than minimal risk research relating to her pregnancy or her child, and such consent is valid and binding as if she had achieved her majority; F.S. A person under the age of 18 years of age seeking medical care or services related to sexually transmitted disease may consent to such treatments and procedures, including not greater than minimal risk research related to sexually transmitted diseases, and the consent of the parents or guardians of a minor is not a prerequisite; F.S. If your research involves persons under 18 who are no longer minors, do not complete this form Involvement in Children in Research Describe how children will be involved in research, or for studies involving secondary analysis of existing data, describe the type of data about children. Categories of Research Involving Children Select one category that best describes your research* Category #1 ( / 50.51): The research poses no greater than minimal risk to children.* * Minimal risk means that 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. Complete questions below for only Category 1 Category #2 ( / 21.52): The research poses greater than minimal risk to children and includes an intervention or procedure that does hold out the prospective of a direct benefit for the

23 Research Involving Children individual child or involves a monitoring procedure that is likely to contribute to the child s well-being. Complete questions below for only Category 2 Category #3 ( / 21.53): The research poses greater than minimal risk to children and includes an intervention or procedure that does not hold out the prospective of a direct benefit for the individual child or involves a monitoring procedure that is likely to contribute to the child s wellbeing. Complete questions below for only Category 3 Category #4 ( / 21.54): This proposed research does not meet the requirements of Categories 1-3. Complete questions below for only Category 407 Category #1 ( / 50.51): Explain why the research presents no greater than minimal risk to the children: Category #2 ( / 21.52) Explain why the research involves more than minimal risk to the children: Explain why the risk is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual child, or the risk is presented by a monitoring procedure that is likely to contribute to the child s well-being Explain why the research presents the prospect of direct benefits to the children: Explain why the risk is justified by the anticipated benefit to the child: Explain why the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches: Category #3 ( / 21.53) Explain why the research involves greater than minimal risk to children presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject. Explain why the risk represents a minor increase over minimal risk ( Minor increase over minimal risk means no greater than the risk in the daily lives of children with the condition or disorder being studied, but still socially acceptable)

24 Research Involving Children Explain why the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition, which is of vital importance for the understanding or amelioration of the subjects' disorder or condition. When research is covered by Category 3, consent must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Describe the process for parental permission and assent below. Category #4 ( / 21.54) Explain why the research does not meet the conditions of categories 1-3 above Explain why the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children Explain why the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children Explain why the research will be conducted in accordance with sound ethical principles When research falls under Category 4, consent must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Describe the process for parental permission and assent below. When research in Category 4 is funded by DHHS or otherwise covered by federal regulations, it must also receive approval from the Secretary of DHHS and/or FDA. When research in Category 4 is not funded by DHHS or otherwise fall under federal regulations, the research may be approved if the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children and the research will be conducted in accordance with sound ethical principles. Research Involving Wards of the State or Any Other Agency or Entity Explain why the research meets one of the following: The research is related to their status as wards. Describe how the research is related to their status as wards:

25 Research Involving Children * If the research is not funded by DHHS, and does not involve interactions or interventions, skip to Parental Permission and Child Assent. If the research enrolls wards and includes interactions or interventions with wards or is funded by DHHS or regulated by the FDA answer the following: The research is related to their status as wards. The research is conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. Explain why the research meets the condition selected: An advocate is appointed for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. Describe the process to appoint an advocate The advocate has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research Describe the qualifications of the advocate The advocate is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization. Explain why the advocate is not associated with the study, researcher or organization Parental Permission and Child Assent Please review the following options for waiver of parental permission, waiver of documentation of parental permission, or requirements for parental permission, and select the option that best fits your research. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. Parent means a child's biological or adoptive parent. Guardian means an individual who is authorized under applicable Florida or local law to consent on behalf of a child to general medical care. In Florida, a guardian is a natural or adoptive parent, or a guardian appointed by a court, provided the court has granted specific authority to the guardian to enroll the child in research. When permission of a guardian is proposed, the researcher should provide the court order authorizing the guardian to enroll children in specific research studies.

26 Research Involving Children Adequate provisions for soliciting the permission of parents or guardians. (Requires that all boxes are checked) Permission is to be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. Permission of one parent is sufficient even if the other parent is alive, known, competent, reasonably available, and shares legal responsibility for the care and custody of the child. (Cannot be selected for Section 4 or 5 criteria) Parental permission is waived. Skip to the waiver of parental permission section below. Describe the process for obtaining parental permission and child assent: Who will provide permission Circumstances, timing, location of discussion Whether permission will be obtained from individuals other than parents, and if so, who will be allowed to provide permission? Describe the process used to determine these individuals authority to consent to each child s general medical care. Whether assent will be obtained from all, some, or none of the children, and if some children, which children will be required to assent. If requesting a waiver of child assent, complete the section below. When assent of children is obtained, describe whether and how it will be documented. Waiver of Parental Permission Permission is not a Reasonable Requirement 45 CFR (c) The research is designed for conditions or for a participant population for which parental or guardian permission is not a reasonable requirement to protect the participants. An appropriate mechanism for protecting the children who will participate as participants in the research is substituted. The waiver is not inconsistent with Federal, State, or Local law The research is not FDA-regulated. Describe why the research meets these conditions Waiver of Parental Permission Research Cannot Practicably be Carried Out Without the Waiver - 45 CFR (c)/45 CFR (d). Applies only to Category 1 research The research involves no more than minimal risk to the participants. The waiver or alteration will not adversely affect the rights and welfare of the participants. The research cannot practicably be carried out without the waiver or alteration. When appropriate, the participants will be provided with additional pertinent information after participation. The research is not FDA-regulated. Describe why the research meets these conditions