General introduction in rules and regulations for medical research (2.0) Flashcards
Sum up some historic events related to clinical research.
- 600 BC → the Bible describes an experiment where they researched the effects of a plant-based diet with a carnivore diet.
- 1061 in China → an experiment to test whether ginseng could help with shortness of breath
- 1537 in France → two treatments are compared (hot oil vs ointment)
- 1772 in UK → first use of placebo in medical context
- 1847 by James Lind → first controlled experiment with different diets and the effect of these diets on scurvies
- 1948 by Bradford Hill → the first RCT where a new treatment was compared to the standard treatment against tuberculosis.
Name two examples that occurred in history that lead to the formation of new rules and regulations for experimentation on e.g. human subjects.
- In the early 1900s in the USA, the doctors had the most to say and decide over their patients. For this, patients protested and demanded more autonomy over their own bodies. This led to the formation of the Nuremberg Code and the Universal Declaration of Human Rights (UDHR).
- Thalidomide (DES) was described as a medicine against nausau in pregnant women. This drug led to thousands of malformed babies.
What is the hippocratic oath (‘nil nocere’)?
An oath that is taken by physicians, it states that physicians must not harm (their patients) (‘nil nocere → do not harm).
What is the Universal Declaration of Human Rights (UDHR) and the Nuremberg Code?
- Nuremberg Code → a code that describes ethical research principles for human experimentation.
- Universal Declaration of Human Rights → a document where the fundamental human rights are described.
What is the World Medical Association (WMA) and the Declaration of Geneva?
- World Medical Association (WMA) → an international association representing doctors internationally.
- Declaration of Geneva → one of the oldest policies of the WMA originating from the Hippocratic Oath.
What is the declaration of Helsinki? And why does this declaration exist?
The declaration of Helsinki describes ethical principles for medical research involving human subjects. The declaration arose from human experiments that had gone wrong in the past (e.g. DES).
- Note: the declaration of Helsinki is not legally binding.
What is Good Clinical Practice (GCP)?
An international guideline where ethical and scientific quality standards for designing, recording, and reporting human trials are described.
What does Good Clinical Practise (GCP) protect?
The rights, safety and well-being of human subjects.
What is the Wet Medisch wetenschappelijk Onderzoek (WMO)?
A law that is to be followed when research is performed on human subjects, where people are being subjected to actions or where rules of behaviours are imposed on them.
What is the Centrale Commissie Mensgebonden Onderzoek (CCMO)?
The CCMO is a commission that executes the WMO. It oversees accredited medical research ethics committees (e.g. MREC).
What is the Medical Research Ethical Committee (MREC)?
An independent committee of experts that decides over the start and continuation of research. With this, MREC has legal jurisdiction.
What is the Dutch Medical Treatment Contract Act (or so-called behandelovereenkomst or WGBO)?
A law for medical research that is non-WMO. It states that participants of (medical) research must be adequately informed about the research and must give legally valid permission for their data to be accessed.
What is the General Data Protection Regulation (GDPR)?
The GDPR consists of a number of rules for the (automatic) processing and free movement of personal data.
What are (EU) Clinical Trial Regulations (CTR)?
These are European regulations regarding medicines and treatments.
What are Medical Device Regulations (MDR)?
These are European regulations regarding the use of medical devices.
