Human subject research
Human Subject Research[edit | edit source]
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[edit | edit source]
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."
Categories of Human Subjects[edit | edit source]
Healthy Volunteers[edit | edit source]
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[edit | edit source]
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[edit | edit source]
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.
.jpg)
Regulations and Guidelines[edit | edit source]
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[edit | edit source]
References[edit | edit source]
- Title 21, Code of Federal Regulations, Part 50 – Protection of Human Subjects. U.S. Food and Drug Administration.
| Human subject research Resources | |
|---|---|
|
 |
Search WikiMD
Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro / Zepbound) available.
Advertise on WikiMD
|
WikiMD's Wellness Encyclopedia |
| Let Food Be Thy Medicine Medicine Thy Food - Hippocrates |
Translate this page: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
தமிழ்,
తెలుగు,
Urdu,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
বাংলা
European
español,
Deutsch,
français,
Greek,
português do Brasil,
polski,
română,
русский,
Nederlands,
norsk,
svenska,
suomi,
Italian
Middle Eastern & African
عربى,
Turkish,
Persian,
Hebrew,
Afrikaans,
isiZulu,
Kiswahili,
Other
Bulgarian,
Hungarian,
Czech,
Swedish,
മലയാളം,
मराठी,
ਪੰਜਾਬੀ,
ગુજરાતી,
Portuguese,
Ukrainian
Medical Disclaimer: WikiMD is not a substitute for professional medical advice. The information on WikiMD is provided as an information resource only, may be incorrect, outdated or misleading, and is not to be used or relied on for any diagnostic or treatment purposes. Please consult your health care provider before making any healthcare decisions or for guidance about a specific medical condition. WikiMD expressly disclaims responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site. By visiting this site you agree to the foregoing terms and conditions, which may from time to time be changed or supplemented by WikiMD. If you do not agree to the foregoing terms and conditions, you should not enter or use this site. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.
Contributors: Kondreddy Naveen
