Helsinki Declaration: Ethical Principles in Biomedical Research

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10 Questions

What was the primary motivation behind the birth of modern research ethics?

To protect human subjects involved in research projects

What is the primary purpose of Institutional Review Boards (IRBs) in research ethics?

To monitor and ensure compliance with research protocols

What is the fundamental principle of informed consent in research ethics?

The participant's right to withdraw from the study at any time

What is the primary concern of research ethics in regards to animal experimentation?

The reduction of animal suffering and distress

What is the primary role of Research Ethics in biomedical research?

To provide guidelines for the responsible conduct of research

What is the primary consequence of violating Ethical Principles in research?

Harm to human subjects or animal participants

What is the primary purpose of confidentiality and anonymity in research ethics?

To ensure the privacy of research participants

What is the primary difference between Ethics and Morality in the context of research ethics?

Ethics are governed by professional guidelines, while Morality is based on personal values

What is the primary responsibility of researchers in regards to research participant rights?

To ensure the safety and well-being of participants

What is the primary goal of Research Ethics in promoting the responsible conduct of research?

To protect human subjects and animal participants

Study Notes

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.

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