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This document serves as an application for conducting research involving human subjects at Ball State University, outlining the protocol, principal investigator details, funding, and ethical considerations
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How to fill out human subjects research application

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How to fill out Human Subjects Research Application

01
Gather required documentation including research proposal and consent forms.
02
Identify all personnel involved in the research.
03
Specify the research objectives and methodologies.
04
Describe the participant recruitment process.
05
Assess potential risks to participants and outline mitigation strategies.
06
Detail the measures for ensuring confidentiality and data security.
07
Provide information on obtaining informed consent.
08
Include any relevant previous Institutional Review Board (IRB) approvals.
09
Review the application for completeness before submission.

Who needs Human Subjects Research Application?

01
Researchers conducting studies involving human participants.
02
Institutions or organizations that require ethical review of research.
03
Students and faculty in academic settings planning human subjects research.
04
Any entity seeking funding for research that involves human subjects.
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People Also Ask about

As required by federal regulations (45 CFR 46) and NIH policy, applications that propose to involve human subjects must address the following four points: 1. the risk to subjects 2. the adequacy of protections against risk 3. potential benefits of the research to subjects and others 4.
The regulations do outline the criteria for IRB approval of research. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits.
Information must be individually identifiable to constitute human subjects research. Research using human specimens or data. Human subjects research involving individually identifiable human specimens or data and subject to federal and state regulatory requirements.
Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are identifiable is considered “research involving human subjects.” Some research may qualify for an exemption from federal regulatory requirements but is still considered to be human subjects research.
Researchers submitting studies involving human participants must meet the following requirements: Obtain prior approval for human subjects research by an institutional review board (IRB) or equivalent ethics committee(s) Submit documentation from the review board or ethics committee confirming approval of the research.
No you do not need to have IRB approval prior when you submit a research proposal. The fact that you plan to use human subject data must be included on both the internal routing form and the sponsor's form pages.

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A Human Subjects Research Application is a formal request submitted to an institutional review board (IRB) to review research proposals involving human participants, ensuring ethical standards and participant rights are protected.
Researchers who intend to conduct studies involving human subjects are required to file a Human Subjects Research Application, including faculty, staff, and students in academic or research institutions.
To fill out a Human Subjects Research Application, you must provide detailed information about the research project, including the study design, participant recruitment, informed consent process, potential risks, benefits, and data handling procedures.
The purpose of the Human Subjects Research Application is to protect the rights and welfare of human participants by ensuring that research is conducted ethically and that appropriate safeguards are in place.
The application must report information such as the research objectives, methodology, participant demographics, consent process, risk assessment, confidentiality measures, and any funding sources associated with the research.
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