For researchers submitting proposals to the Internal Review Board (IRB) at Florida Hebrew University, several forms and templates are typically required. These forms ensure that researchers provide comprehensive information about their study, including details on methodology, participant consent, and data management.

 

Here are the forms and templates required for submission to IRB:

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1. Initial Application Form

   • This form collects basic information about the research project, including the title, investigator(s), purpose of the study, methodology, risks to participants, and measures to protect participant confidentiality.

   • It often includes sections on recruitment methods, inclusion/exclusion criteria, and data analysis plans.

   • Researchers need to complete this form thoroughly to provide a clear overview of the study to the IRB.

2. Protocol Template

   • The protocol template outlines the detailed plan for conducting the research.

   • It includes sections on study objectives, study design, participant selection, procedures, data collection methods, data analysis plan, and potential risks and benefits.

   • Researchers should use this template to structure their study plan according to IRB requirements.

3. Informed Consent Form

   • The informed consent form is crucial for ensuring that participants are fully informed about the study and voluntarily agree to participate.

   • It includes information on the study's purpose, procedures, risks, benefits, confidentiality, and the rights of participants.

   • Researchers must provide a copy of the informed consent form that participants will sign.

4. Assent Form (for studies involving minors)

   • If the study involves minors, an assent form is required in addition to the informed consent form.

   • The assent form is written in language appropriate for the age and understanding of the child, explaining the study in a way they can comprehend.

   • Both the parent/guardian and the child must sign the forms.

5. Recruitment Materials

   • If researchers plan to use flyers, advertisements, emails, or other materials to recruit participants, these need to be submitted for IRB review.

   • Materials should accurately represent the study, avoid coercion, and include contact information for the research team and IRB.

6. Data Collection Instruments

   • This includes surveys, questionnaires, interview scripts, or any tools used to collect data from participants.

   • Researchers need to submit these instruments to demonstrate how data will be gathered and what information will be collected.

7. Data Management Plan

   • The data management plan outlines how researchers will handle and protect data throughout the study.

   • It includes procedures for data storage, encryption, sharing, and retention.

   • Researchers need to describe how they will maintain participant confidentiality and data security.

8. Amendment Form

   • If there are changes to the approved study protocol during the course of the research, researchers must submit an amendment form.

   • This form outlines the proposed modifications and reasons for the changes.

   • The IRB must review and approve any amendments before they are implemented.

9. Continuing Review Form

   • For studies that require ongoing oversight, researchers must submit a continuing review form at specified intervals (e.g., annually).

   • This form updates the IRB on the progress of the study, any adverse events, changes to the protocol, and ensures that the study continues to meet ethical standards.

10. Closure Report

    • When the study is complete, researchers submit a closure report to the IRB.

    • This report summarizes the study's outcomes, any publications resulting from the research, and confirms that all data has been appropriately handled and stored.

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