Which of the following are the three principles discussed in the Belmont Report?
A. IRB review, Federal regulations, Declaration of Helsinki.
B. Informed Consent, Institutional Assurance, Researcher responsibility.
C. Privacy, Confidentiality, Equitable selection of subjects.
D. Respect for Persons, Beneficence, Justice.
The Correct Answer and Explanation is :
The correct answer is D. Respect for Persons, Beneficence, Justice.
The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, established ethical principles and guidelines for research involving human subjects. These principles guide researchers in maintaining ethical conduct and ensuring the protection of participants in research studies. Here’s an explanation of each principle:
- Respect for Persons: This principle emphasizes the importance of recognizing the autonomy of individuals and protecting those with diminished autonomy. It includes two key elements:
- Informed Consent: Researchers must provide participants with all necessary information to make an informed decision about their involvement in a study. This includes explaining the purpose, procedures, risks, and benefits of the research, as well as ensuring that participation is voluntary.
- Protection of Vulnerable Populations: Those who are unable to make informed decisions, such as children, prisoners, or individuals with cognitive impairments, must be given additional safeguards to protect their rights and well-being.
- Beneficence: This principle requires researchers to maximize the potential benefits of research while minimizing potential harm to participants. Researchers must ensure that their studies are designed in a way that maximizes the positive impact on participants and society, while minimizing any risks or discomfort. The concept of do no harm is a central component of beneficence.
- Justice: The principle of justice involves ensuring that the benefits and burdens of research are distributed fairly among all groups in society. Researchers must ensure that no group is unfairly burdened by the risks of the research, and that vulnerable populations are not exploited. It also implies that the benefits of research should be equitably shared, so that no group disproportionately benefits at the expense of another.
These principles are the foundation of ethical conduct in human subjects research and are intended to guide the review and approval of research protocols.