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This document provides guidelines and standard operating procedures for conducting computer- and internet-based research involving human subjects in compliance with ethical standards and regulations.
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How to fill out Guidance on Conducting Computer – and Internet-Based Research Involving Human Subjects

01
Read the introductory section to understand the purpose of the guidance.
02
Familiarize yourself with the ethical considerations specific to online research.
03
Identify your research objectives and how they relate to human subjects.
04
Determine if your research meets the criteria for human subjects research.
05
Complete the risk assessment checklist to evaluate potential risks to participants.
06
Develop informed consent procedures that are appropriate for online formats.
07
Outline data collection methods and ensure they comply with privacy regulations.
08
Consider the analysis and reporting of data, ensuring confidentiality and anonymity.
09
Consult with an Institutional Review Board (IRB) if necessary.
10
Document all procedures and obtain approvals before conducting the research.

Who needs Guidance on Conducting Computer – and Internet-Based Research Involving Human Subjects?

01
Researchers conducting studies involving human subjects through computer and internet-based methods.
02
Academic institutions and organizations that oversee research activities.
03
Ethics committees and Institutional Review Boards (IRBs) that review research proposals.
04
Students and scholars aiming to adhere to ethical standards in their research.
05
Professionals in fields related to psychology, sociology, and behavioral studies.
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People Also Ask about

Research projects involving human subjects require review and approval by an Institutional Review Board. The IRB is responsible for assuring that the rights and welfare of human subjects in research are adequately protected.
IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.
Access to Information and Resources: The internet and digital libraries provide researchers with access to vast repositories of scholarly literature, datasets, and research tools. Computers enable researchers to search, retrieve, and analyze information quickly, enhancing the breadth and depth of research endeavors.
IRB approval is required when research involving human subjects: Receives federal funds either directly or indirectly. Takes place at a university or hospital. Tests therapies that will require U.S. Food and Drug Administration (FDA) marketing approval.
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.
Ensuring ethical standards and procedures for research with human beings. Research ethics govern the standards of conduct for scientific researchers. It is important to adhere to ethical principles in order to protect the dignity, rights and welfare of research participants.
IRB – Principles Respect for Persons. Acknowledgement of the autonomy of the individual and the responsibility to provide special protection for individuals with reduced autonomy. Beneficence. A responsibility to do no harm, to maximize possible benefits, and to minimize possible harm. Justice.

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Guidance on Conducting Computer – and Internet-Based Research Involving Human Subjects provides a framework and set of principles for researchers to ethically and effectively conduct studies involving human participants through digital platforms.
Researchers who intend to conduct studies involving human subjects using computer or internet-based methods are required to file this guidance, ensuring compliance with ethical standards and legal requirements.
To fill out the guidance, researchers must provide detailed information on their study design, participant recruitment strategies, informed consent processes, data handling procedures, and how they will ensure participant confidentiality.
The purpose of the guidance is to support researchers in adhering to ethical standards when conducting research involving human subjects online, ensuring participant protection and the integrity of the research process.
Researchers must report information including the purpose of the research, methodologies used, risks and benefits to participants, data collection and storage methods, and how informed consent will be obtained.
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