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Protecting Human Research Participants NIH Office of Extramural ResearchOverview ................................................................................. iIntroduction ..............................................................
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01
Familiarize yourself with the guidelines provided by your institution's Institutional Review Board (IRB) or equivalent.
02
Determine if your research involves human participants and identify the types of data you will be collecting.
03
Obtain informed consent from participants, clearly explaining the purpose of the research, procedures, risks, and benefits.
04
Ensure confidentiality and anonymity by implementing appropriate data management protocols.
05
Collect and store data securely, limiting access to only authorized personnel.
06
Prepare and submit the filled-out protecting human research participants form to your IRB for review.
07
Address any feedback or requests for revisions from the IRB before proceeding with your research.

Who needs protecting human research participants?

01
Researchers conducting studies involving human participants.
02
Institutions that are responsible for overseeing research ethics.
03
Participants involved in research, who require protection from harm and unethical practices.
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Protecting human research participants refers to the ethical guidelines and regulations designed to ensure the safety, rights, and welfare of individuals participating in research studies.
Researchers and institutions conducting studies involving human participants are required to file and comply with protecting human research participants regulations.
To fill out protecting human research participants documentation, researchers must provide detailed information about their study, including the purpose, methodology, potential risks, and consent processes.
The purpose is to safeguard the dignity, rights, and welfare of research participants, ensuring that they are informed, voluntary, and protected from harm.
Researchers must report information such as study protocols, participant selection criteria, informed consent processes, risks involved, and measures taken to protect participants.
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