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This document is an application for conducting research involving human subjects, requiring review by the Institutional Review Board (IRB) at Arizona State University.
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How to fill out APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS

01
Begin by downloading the APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS from the relevant institution's website.
02
Fill out the research project title and principal investigator's information at the top of the application.
03
Provide a brief description of the research project, including objectives and the significance of the study.
04
Describe the methodology, including participants, data collection methods, and any interventions.
05
Clearly outline the consent process for participants, including how informed consent will be obtained.
06
Include potential risks and benefits to participants, along with measures to mitigate risks.
07
Detail how participant confidentiality will be maintained throughout the research process.
08
Attach any relevant supplementary materials, such as consent forms or surveys, to the application.
09
Review the completed application for accuracy and completeness.
10
Submit the application to the appropriate review board or ethics committee for approval.

Who needs APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS?

01
Researchers conducting studies involving human subjects.
02
Academic institutions requiring ethical compliance for research.
03
Organizations funding or reviewing research proposals.
04
Individuals seeking institutional approval for their research projects.
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People Also Ask about

To be considered not human subject research, the data or specimen must meet one of the following standards: Exists without ANY personal identifiers (see list of HIPAA identifiers) or links to identifiers. Provided by a research repository (Biospecimen bank, data bank, medical record system, etc.)
The NIH further defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Human science aims to expand the understanding of the human world through a broad interdisciplinary approach. It encompasses a wide range of fields - including history, philosophy, sociology, psychology, justice studies, evolutionary biology, biochemistry, neurosciences, folkloristics, and anthropology.
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.
Asking participants questions about their attitudes, opinions, preferences, behavior, experiences, background/history, and characteristics, or analyzing demographic, academic or medical records, are just some examples of human subjects data.
Human subject research is systematic, scientific investigation that can be either interventional (a "trial") or observational (no "test article") and involves human beings as research subjects, commonly known as test subjects.
ing to 45 CFR 46, a human subject is "a living individual about whom an investigator (whether professional or student) conducting research: Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or.
Three basic ethical principles are outlined in The Belmont Report to serve as a guide for research involving human subjects. These are respect for persons, beneficence and justice.

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APPLICATION FOR THE CONDUCT OF RESEARCH INVOLVING HUMAN SUBJECTS is a formal request that researchers must submit to an ethics review board or institutional review board (IRB) to obtain approval for studies involving human participants. It ensures that the rights and welfare of participants are protected.
Any researcher or institution planning to conduct research involving human subjects is required to file this application. This includes faculty members, graduate students, and independent researchers.
To fill out the application, researchers should provide detailed information about the study design, objectives, participant recruitment processes, potential risks and benefits, informed consent procedures, and data management plans. Each section must be addressed clearly and comprehensively.
The purpose of this application is to ensure that research involving human participants is ethical and compliant with regulatory requirements. It evaluates the potential impact on participants and helps in safeguarding their rights, safety, and well-being.
The application must report information such as the research objectives, methodology, participant demographics, consent procedures, potential risks, benefits, funding sources, and any conflicts of interest. Detailed information about data protection and management is also required.
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