Helsinki Declaration: Ethical Principles in Biomedical Research

Helsinki Declaration

• Lays out basic ethical principles for conducting biomedical research and specifies guidelines for research conducted by a physician or within a clinical setting.
• Unique principles include:
  • Necessity of using an independent investigator to review potential research projects.
  • Employing a medically qualified person to supervise research and assume responsibility for human subjects' health and welfare.
  • Importance of preserving the accuracy of research results.
  • Guidelines for obtaining informed consent from research participants.
  • Rules for research with children and mentally incompetent persons.
  • Evaluating and using experimental treatments on patients.
  • Determining which medical situations and conditions are appropriate and safe for research.

Encouraging Participation Ethically

• Anonymity: promise and keep promises of anonymity, and reassure people that personal information will not be shared with the media.
• Confidentiality: guarantee that no individual will be identifiable in research reports, publications, and tables.
• Informed Consent: provide participants with information about the research purpose, procedures, potential risks, benefits, and confidentiality.

Institutional Review Board (IRB)

• A board consisting of professionals and lay people review research proposals to ensure ethical standards.
• Researcher must submit a research protocol to the IRB for review.
• Three main categories of review: exempt studies, expedited review, and full board review.
• Educational research often falls into the exempt category, but it is still essential to follow ethical guidelines.

Imperatives for Animal Use

• Nuremberg Code (1947): experiments on humans should be based on results of animal experimentation.
• Declaration of Helsinki (1964): medical research on humans should be based on adequately performed laboratory and animal experimentation.
• Animal rights: theorists equate animal lives with human lives, and believe humans do not have the right to use animals.
• Animal welfare: believe animals have a right not to suffer needlessly.
• Animal Welfare Act (1966): provides guidelines and regulations for research with animals.

Ethics and Morality

• Ethics: governed by professional and legal guidelines within a particular time and place.
• Morality: transcends cultural norms and may be guided by a higher covenant.
• Origin: ethics comes from the Greek word "ethos" meaning "character", and morality comes from the Latin word "mos" meaning "custom".

Research Ethics

• Provides guidelines for responsible conduct of biomedical research.
• Educates and monitors scientists to ensure high ethical standards.
• Originated from a desire to protect human subjects involved in research projects.
• The birth of modern research ethics began with the Doctors Trial of 1946-1947.

Learn about the Helsinki Declaration, a set of ethical principles guiding biomedical research, including the role of independent investigators and medically qualified supervisors. Understand the guidelines for physician-conducted research and clinical settings.