Declaration of Helsinki
The
Declaration of Helsinki is a set of ethical guidelines and principles for
conducting human clinical trials and biomedical research involving human
subjects. It is considered one of the foundational documents in medical ethics
and was first adopted by the World Medical Association (WMA) in 1964 in
Helsinki, Finland. The Declaration has been revised multiple times to address
emerging ethical issues and align with evolving standards in research ethics.
Key
Principles of the Declaration of Helsinki:
Informed
Consent:
Participants
must give informed, voluntary, and explicit consent before participating in
research.
The
information provided to participants should be comprehensive, written in
understandable language, and cover all aspects of the study.
Beneficence
and Non-Maleficence:
The
well-being of participants must take precedence, and research should be
designed to maximize benefits while minimizing risks and harm.
The
potential benefits of the research should justify any risks involved.
Scientific
and Social Value:
Research
protocols should be scientifically rigorous and designed to contribute valuable
knowledge to society.
The
research should address important health issues and have the potential to
improve the well-being of individuals or society.
Scientific
and Ethical Review:
Independent
ethical review committees, such as Institutional Review Boards (IRBs), should
review and approve research protocols.
The
ethical review should ensure that the study complies with ethical standards and
regulations.
Equitable
Distribution of Benefits and Burdens:
The
benefits and burdens of research should be distributed fairly among different
groups in society.
Vulnerable
populations should not be exploited, and special protections are required for
those who may be unable to give informed consent.
Privacy
and Confidentiality:
Participants'
privacy must be respected, and confidentiality of their personal information
must be maintained.
Researchers
should ensure that the collection, storage, and dissemination of data are done
securely.
Post-Trial
Access to Benefits:
Participants
who have contributed to research should have access to any benefits that result
from the research.
The
principle of post-trial access emphasizes the importance of providing continued
access to interventions that have proven to be beneficial.
Placebo
Controls and Standard of Care:
The
use of placebo controls is acceptable only when there is no proven effective
intervention, or the use of a placebo is ethically justified.
Participants
in control groups should receive the best available treatment or care.
The
Declaration of Helsinki continues to evolve, addressing contemporary ethical
challenges in medical research. Researchers, sponsors, and regulatory
authorities globally recognize its significance in guiding ethical conduct and
safeguarding the rights and well-being of research participants. Adherence to
the principles outlined in the Declaration is crucial for maintaining public
trust in scientific research and promoting ethical standards in the global
research community.
Name: Ashwini P S
Qualification: Pharm D
Student ID:
CLS_225/112023
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