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Get the free HUMAN SUBJECTS REVIEW FORM FOR NEW/CONTINUOUS PROJECTS - famu

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This form is for researchers at Florida A&M University to submit proposals for approval by the Institutional Review Board, ensuring compliance with ethical standards in research involving human subjects.
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How to fill out human subjects review form

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How to fill out HUMAN SUBJECTS REVIEW FORM FOR NEW/CONTINUOUS PROJECTS

01
Title the form with the project name and date.
02
Provide your name and contact information.
03
Describe the purpose of the research project.
04
Outline the research objectives and methodology.
05
Detail the population involved, including inclusion/exclusion criteria.
06
Explain how you will recruit participants.
07
Describe any potential risks and how you will minimize them.
08
Explain how informed consent will be obtained from participants.
09
Include a plan for data confidentiality and security.
10
Submit the form to the designated review board for evaluation.

Who needs HUMAN SUBJECTS REVIEW FORM FOR NEW/CONTINUOUS PROJECTS?

01
Researchers conducting studies involving human subjects.
02
University faculty and students undertaking research projects.
03
Any individual or organization seeking ethical approval for human research.
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Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.
Examples of research that does not require IRB approval include: Internal management projects, such as program evaluation, quality assurance, quality improvement, or marketing studies. Projects that only document or report on events, situations, policies, institutions or systems without the intent to form hypotheses.
If a study intends to collect identifiable or information about a living individual, you would need IRB review and approval.
Research projects involving human participants that are conducted by students for the purpose of independent research papers, culminating graduate research papers, master's theses, and dissertations are all considered research and must be reviewed by the IRB.
Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.
Determine If Your Project Requires IRB Review Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

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The HUMAN SUBJECTS REVIEW FORM FOR NEW/CONTINUOUS PROJECTS is a document used to evaluate and ensure that research involving human subjects complies with ethical standards and regulations.
Researchers and institutions conducting studies involving human subjects must file the HUMAN SUBJECTS REVIEW FORM for new or ongoing projects.
To fill out the form, provide the required information about the study, including objectives, methodology, consent processes, and measures to protect participants' rights and welfare.
The purpose of the form is to assess potential risks to participants, ensure ethical conduct of research, and protect the rights and well-being of human subjects.
The form must report details such as study title, purpose, research methods, participant demographics, consent process, and any potential risks and benefits.
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