Humankind was always curious to its anatomy, health and overall wellbeing. Even ancient Egypt and China were already using all kinds of herbs and potions to treat illness. As time progressed, people got more experimental. Not only herbs and spices were used anymore, but now also significant interventions: surgically altering patients and making pharmaceutical drugs. The potential was endless, but evidently comes with responsibilities. What can or can we not do in experimental research? 

The Nuremberg code (1947) 

Some gruesome experiments were performed on humans before legislation came into being. Think of the Middle Ages, where lobotomies were commonly performed to battle mental illness. This is just one of many examples. The final straw was human research during WWII in Nuremberg. Doctors were performing experiments on captives for Nazi human experimentation. Eventually involved doctors were prosecuted and processed in US military court, in the later called subsequent Nuremberg trials. The result of these trials was the Nuremberg code (1947). The code provided ethical principles regarding human-related research and experiments. Main points were voluntary consent, ethical experimental design and a beneficial/harm-ratio. For the full list of principles in the Nuremberg code, click here.  

The Declaration of Helsinki (1964) 

The code was eventually elaborated upon in the Declaration of Helsinki (1964). Important additions were informed consent, publication of results, qualification of researchers, and an independent review by ethical committee. The articles of the Declaration can be found here.  

Informed consent 

Before applicants can participate in human-related research, they must sign an informed consent form first. This form is guarantee for the rights of the participant, so that people cannot be pressured into doing actions out of their will. The participant should be informed on the research objective, method, procedure, pro’s, con’s, and possible risks.

Essential criteria of informed consent are: understanding of the research; consent given uninfluenced; mentioning of right of the option to pull back out the research. The rules for children are slightly different. Children below the age of 12 are under the responsibility of the parents, and thus the parents decide. Between the age of 12-16, children can decide for their own as long as they have permission from parents/caretakers. Above the age of 16, children can decide without parents’ permission. 

Informed consent: procedure 

The procedure must be approved by the METC beforehand. The participant should have all the relevant information about the research. If the participant chooses to agree, they must sign and date the document in person (exceptions to this rule exist). Only then the researcher may sign the document, in order to not pressure the participant into signing the document. The researcher preferably signs immediately after the signature of the participant. The participant receives a copy of the informed consent form and is now registered for the research. However, the participant is free to leave at any time without having to give an explanation. 

In the Netherlands, the Medisch-Ethische Toetsingcommissie (METC) examine if the study design checks all requirements from the Declaration of Helsinki and the Wet Medisch-Wetenschappelijk Onderzoek met Mensen (WMO).