Describe the relevant experience and gaps in current knowledge. Describe any relevant preliminary data. Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge. Describe the resources available to accomplish this research. Specifically include a summary of the qualifications (e.g., training, experience, oversight) of you and your as required to perform their role. When applicable describe your knowledge of the local study sites, culture, language, and society. Subject Population Describe the eligibility criteria that define who will be included and/or excluded in your study sample. If you will include or exclude any of the following special populations, this should be clearly stated: adults unable to consent; children (< 18 years of age); pregnant women; and/or prisoners or individuals likely to become prisoners during the research. Clearly state the total number of subjects to be accrued in this study. If this study is part of a larger multi-site project, clarify the total number of subjects to be accrued locally. Procedures Involved Describe and explain the study design. Provide a description of all research procedures being performed and how, when, and where they are performed. Use bullet points or simple step-by-step language to describe procedures in the order in which they will occur. Include, when applicable: A list and description of all study instruments and/or data that will be collected (e.g., surveys, questionnaires, demographic questions, interview questions, data collection forms, observations, recordings, etc.). Study instruments should be referenced here and uploaded into IRBNet as separate documents. If data will be collected via video-taping, or photography, this should be specified. Expected time commitment for participants (per specific procedure or task and in total). A description of any source records that will be used to collect data about subjects (e.g., student educational records, medical records, online resources, etc.). For record reviews, specify the date range for the collection of data. A description of the setting, sites, and/or locations where your research team will conduct the research. Any provisions to protect the privacy interests of subjects. “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information. (Example of a privacy protection: Conducting interviews in a quiet setting where others cannot overhear the conversation.)
Describe the relevant experience and gaps in current knowledge. Describe any relevant preliminary data. Provide the scientific or scholarly background for, rationale for, and significance of the research based on the existing literature and how it will add to existing knowledge. Describe the resources available to accomplish this research. Specifically include a summary of the qualifications (e.g., training, experience, oversight) of you and your as required to perform their role. When applicable describe your knowledge of the local study sites, culture, language, and society. Subject Population Describe the eligibility criteria that define who will be included and/or excluded in your study sample. If you will include or exclude any of the following special populations, this should be clearly stated: adults unable to consent; children (< 18 years of age); pregnant women; and/or prisoners or individuals likely to become prisoners during the research. Clearly state the total number of subjects to be accrued in this study. If this study is part of a larger multi-site project, clarify the total number of subjects to be accrued locally. Procedures Involved Describe and explain the study design. Provide a description of all research procedures being performed and how, when, and where they are performed. Use bullet points or simple step-by-step language to describe procedures in the order in which they will occur. Include, when applicable: A list and description of all study instruments and/or data that will be collected (e.g., surveys, questionnaires, demographic questions, interview questions, data collection forms, observations, recordings, etc.). Study instruments should be referenced here and uploaded into IRBNet as separate documents. If data will be collected via video-taping, or photography, this should be specified. Expected time commitment for participants (per specific procedure or task and in total). A description of any source records that will be used to collect data about subjects (e.g., student educational records, medical records, online resources, etc.). For record reviews, specify the date range for the collection of data. A description of the setting, sites, and/or locations where your research team will conduct the research. Any provisions to protect the privacy interests of subjects. “Privacy interest” refers to a person’s desire to place limits on whom they interact or whom they provide personal information. (Example of a privacy protection: Conducting interviews in a quiet setting where others cannot overhear the conversation.)
HRP-503a%20-%20TEMPLATE%20PROTOCOL%20-%20Social-Behavioral.docx