Human subject research

Human Subject Research

Human subject research is an integral part of various scientific and medical investigations. It involves the study of human beings, either as primary data sources or as beneficiaries of experimental interventions. Human subjects can be either healthy individuals or patients, and their participation can vary from filling out questionnaires to undergoing new treatments. The ethics and methodologies associated with human subject research have evolved over time, and the practice is subject to stringent regulations.

Definition

According to the Title 21 of the Code of Federal Regulations (21CFR50.3), a human subject, in the context of research, refers to:

"An individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient."

A research participant undergoing a test.

Categories of Human Subjects

Healthy Volunteers

Healthy volunteers, as the name suggests, are individuals without any known significant health issues. They often participate in research to provide baseline information, which can be compared with data derived from individuals with specific health conditions.

Patients

Patients are individuals diagnosed with a certain medical condition. In research, they are typically involved in clinical trials or studies that aim to evaluate the effectiveness and safety of new treatments, therapies, or interventions.

Ethical Considerations

Human subject research is subject to various ethical guidelines to ensure the safety, dignity, and rights of participants. Researchers must obtain informed consent from participants before involving them in a study. Moreover, research projects often require approval from an Institutional Review Board (IRB) or equivalent ethics committee to ensure that the study's potential benefits outweigh its risks.

Informed consent is crucial in human subject research for COVID vaccines.

Regulations and Guidelines

In addition to the guidelines outlined in 21CFR50.3, human subject research is regulated by several international and national guidelines, such as:

• The Declaration of Helsinki
• The Belmont Report
• Good Clinical Practice (GCP)

These documents, among others, guide researchers on ethical considerations, design methodologies, and the rights of human participants.

See Also

• Clinical trials
• Research ethics
• Institutional Review Board (IRB)
• Patient rights

References

1. Title 21, Code of Federal Regulations, Part 50 – Protection of Human Subjects. U.S. Food and Drug Administration.

Human subject research Resources
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