Difference between revisions of "Theme:D44fd22a-ed5d-4120-a78b-8881747131fd"
| Line 9: | Line 9: | ||
'''Protecting research subjects''' | '''Protecting research subjects''' | ||
| − | The Belmont report lays down three basic ethical principles for human research which are aimed at protecting research subjects. The three ethical principles are: | + | The Belmont report lays down three basic ethical principles for human research which are aimed at protecting research subjects. <ref>The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report: ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington DC.</ref>The three ethical principles are: |
| − | #'''Respect for | + | #'''Respect for persons''' includes acknowledging the autonomy of individuals and protecting those with diminished autonomy. The principle respect for persons is protected in the form of informed consent. |
| − | #'''Beneficence''' is understood as minimizing harm and maximizing possible benefits. Systematically assessing the risks and benefits of a research project is needed to ensure the harms are minimized and the benefits of the study are maximized. | + | #'''Beneficence''' is understood as minimizing harm and maximizing possible benefits. Systematically assessing the risks and benefits of a research project is needed to ensure the harms are minimized and the benefits of the study are maximized. |
| − | #'''Justice''' | + | #'''Justice''' concerns who receives the benefits of a research study and who carries the cost. Fair procedures to select subjects is one important way to ensure justice in a study. |
|Important For=Researchers; Bachelor students; Master students | |Important For=Researchers; Bachelor students; Master students | ||
|Has Best Practice=Throughout history, multiple violations of ethical principles in human research have happened. Most known and most widely publicized are experiments done by Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, they did not eradicate research misconduct. In the United States, a huge study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. | |Has Best Practice=Throughout history, multiple violations of ethical principles in human research have happened. Most known and most widely publicized are experiments done by Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, they did not eradicate research misconduct. In the United States, a huge study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978. | ||
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*[https://history.nih.gov/research/downloads/nuremberg.pdf Nuremberg code] | *[https://history.nih.gov/research/downloads/nuremberg.pdf Nuremberg code] | ||
| + | *[https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/ Declaration of Helsinki] | ||
*[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Belmont report] | *[https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/read-the-belmont-report/index.html Belmont report] | ||
| − | |||
Revision as of 11:08, 20 October 2020
ThemesResearch with humans
What is this about?
In research with humans, human beings are not only researchers, but also the main subjects of research. Such research can be observational or interventional, and can be medical (including biology, physiology, and clinical trials) or non-medical (social science, political science). Because of ethical issues arising from human research, this area is heavily regulated, to protect the rights and dignity of research participants. [1]
- ↑ World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. World Medical Association Declaration of Helsinki Special Communication. JAMA. 2013;310(20):2191-4.
Why is this important?
New drugs. procedures and treatments require detailed testing to ensure they are safe, effective and do not harm those undergoing the treatment or taking the drug. While a lot can be answered using in vitro experiments and animal testing, testing on humans is necessary in order to verify the safety and efficacy of novel treatments.
Protecting research subjects
The Belmont report lays down three basic ethical principles for human research which are aimed at protecting research subjects. [1]The three ethical principles are:
- Respect for persons includes acknowledging the autonomy of individuals and protecting those with diminished autonomy. The principle respect for persons is protected in the form of informed consent.
- Beneficence is understood as minimizing harm and maximizing possible benefits. Systematically assessing the risks and benefits of a research project is needed to ensure the harms are minimized and the benefits of the study are maximized.
- Justice concerns who receives the benefits of a research study and who carries the cost. Fair procedures to select subjects is one important way to ensure justice in a study.
For whom is this important?
What are the best practices?
Throughout history, multiple violations of ethical principles in human research have happened. Most known and most widely publicized are experiments done by Nazis and Japanese during the WW2. In the aftermath of the WW2, the Nuremberg Code was published to provide basic guidelines in human research. To further improve ethics of human research, the World Medical Association developed the Declaration of Helsinki in 1964. While providing some guidance, they did not eradicate research misconduct. In the United States, a huge study was conducted to assess the impact of syphilis, and hundreds of participants were barred from seeking treatment in what was known as Tuskegee experiment. Following the public outcry, the Belmont report was published in 1978.
These documents set important standards in human research and provide the foundations of medical ethics. Some of the important points are respect for the person, personal autonomy (and informed consent), justice, and beneficence. Nowadays, different countries have different laws regarding clinical research, and these are closely related with ethical committees.
Related guidelines
Related cases
The Embassy Editorial team, Iris Lechner, Natalie Evans, Philipp Hoevel, Tom Lindemann, Ružica Tokalić contributed to this theme. Latest contribution was Mar 25, 2021
Other information
Virtues & Values
Good Practices & Misconduct
- ↑ The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1978). The Belmont Report: ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington DC.
