Declaration of Helsinki (DOH) Ethical Guidelines

This set of vocabulary flashcards covers the history, core principles, and iterative revisions of the Declaration of Helsinki as detailed in the lecture notes.

Declaration of Helsinki

A set of ethical guidelines for doctors and researchers conducting research involving human participants, developed by the World Medical Association in $1964$.

World Medical Association (WMA)

The organization that created the Declaration of Helsinki in Helsinki, Finland, to protect the rights, safety, and well-being of medical research participants.

Respect for People

A main principle stating that participants must be treated with dignity and respect, ensuring their rights and privacy are protected.

Informed Consent

The requirement that participants receive complete information about a study and voluntarily agree to participate without any pressure.

Safety First

An ethical principle where the health and safety of participants are prioritized over research goals, and risks are minimized.

Scientific Value

The requirement that research must be based on scientific knowledge and serve a useful purpose.

Ethics Committee

An independent body that must review and approve a research study before it is allowed to begin.

Confidentiality

The ethical obligation to keep the personal information of research participants private.

Vulnerable Groups

Categories of participants requiring extra care, including children, elderly people, pregnant women, mentally disabled individuals, and the economically disadvantaged.

Nuremberg Trials

Legal proceedings after $WWII$ that exposed unethical medical experiments, leading to the creation of the Nuremberg Code in $1947$.

Tokyo Revision ($1975$)

A revision to the Declaration of Helsinki that added the requirement for ethical review by an independent committee.

Somerset West Revision ($1996$)

A revision that added specific guidance on the use of placebos in clinical trials (CT).

Edinburgh Revision ($2000$)

A major update of the Declaration that further increased protection for research participants.

Fortaleza Revision ($2013$)

The current major version of the Declaration of Helsinki ethical guidelines.

Patient Welfare

A principle asserting that the health, safety, and rights of the patient must always be more important than the interests of science or society.

Freedom to Withdraw

The right of participants to leave a study at any time without negative consequences for their regular medical treatment.

Risk-Benefit Assessment

The process by which researchers carefully compare possible risks and benefits before starting a study.

Best Proven Treatment

The standard indicating that new treatments should be compared with the current best treatment whenever possible.

Qualified Researchers

Trained and qualified health care professionals who must conduct and supervise research projects.

Compensation and Treatment for Harm

The provision of appropriate care and reimbursement if a participant suffers an injury due to the research.

Publication of Results

The ethical duty for researchers to honestly and accurately report both positive and negative results.

Continuous Monitoring of Safety

The ongoing observation of participants throughout a study, requiring the research to stop if serious risks are discovered.