Topic 6: Understanding the Nuremberg Code

The main point of the Nuremberg Code is that medical experiments must not be done on humans without their informed consent, but what is informed consent? It also covers transparency about the procedures and purpose of the research.

The UK’s General Medical Council sets the standards medical practice and medical ethics in the UK regarding medical research and participation in research by members of the general public.

This is taken from their guidance to doctors.

We advise doctors who are involved in research that:

Decision making and Consent sets out the principles of good practice in making decisions in partnership with patients. That guidance focuses on decision-making in the context of investigations and treatment, but the principles apply more widely, including to decisions on taking part in research. It gives advice on sharing information, discussing side effects, complications and other risks, and making and recording decisions. When relevant, you must follow the principles it sets out when seeking people’s consent to take part in research.

This supplementary guidance is intended to explain how good practice principles in making decisions and seeking consent apply to research. It also provides advice on involving research children or young people, vulnerable people, and people who lack the capacity to consent.

Good practice in research, which sets out the principles on which good practice in research is founded; confidentiality: good practice in handling patient information, which gives guidance on research and other secondary uses of data; and confidentiality: good practice in handling patient information, which gives guidance on research and other secondary uses of data, and 0–18 years: guidance for all doctors, which gives additional advice on research involving children or young people.

Together, these guidance documents set out the GMC’s advice to doctors involved in research. You must use your judgement in applying the principles in the guidance to the types of research you undertake and to the situations you face in practice as a doctor, whether or not you hold a licence to practise.  Only serious or persistent failure to follow our guidance that poses a risk to patient safety or public trust in doctors will put your registration at risk.

Seeking valid consent

1. Seeking consent is fundamental in research involving people. Participants’ consent is legally valid and professionally acceptable only if they have the capacity to decide whether to take part in the research, have been properly informed, and have agreed to participate without pressure or coercion.
2. When conducting research involving people who cannot consent for themselves, you must follow the guidance that applies, such as the advice on research involving children or young people in paragraphs 14 – 20 and on adults who lack capacity in paragraphs 23 – 25.
3. You must make sure that people are informed of, and that you respect, their right to decline to take part in research and to withdraw from the research project at any time, with an assurance that this will not adversely affect their relationship with those providing care or the care they receive. You should tell people if the treatment options available to them might be affected by a decision to withdraw from a research project.

Sharing information

• You must give people the information they want or need in order to decide whether to take part in research. How much information you share with them will depend on their individual circumstances. You must not make assumptions about the information a person might want or need, or their knowledge and understanding of the proposed research project.
• In most cases, the information people will need to decide whether to take part in research will be included in the participant information sheet. The National Research Ethics Service gives advice on the design of information sheets and consent forms, and the key points they should cover. You should follow that advice if you are developing information sheets or consent forms.
• You should give people any further information they ask for. This might include a copy of the protocol approved by a research ethics committee (subject to considerations of confidentiality, commercial privilege or the possible undermining of the purpose of the study). You should make sure people have the details of an individual or organisation they can contact to discuss the research project and get further information.

Giving information in a way that people can understand

• You must make sure that people are given information in a way that they can understand. You should check that people understand the terms that you use and any explanation given about the proposed research method. If necessary, you should support your discussions with simple and accurate written material or visual or other aids.
• You must make sure, whenever practical, that arrangements are made to meet people’s language, communication and other support needs. It is important to make sure that people who require additional assistance are not excluded from research and from the benefits that research can offer them and the wider groups to which they belong.

Responsibility for seeking consent

• If you are responsible for seeking consent, you must understand the research project, including what the project will involve and any anticipated benefits and foreseeable risks.
• If you delegate the responsibility to someone else, you must make sure they have sufficient understanding of the research project, and the appropriate skills and competence to seek consent.

Recording consent

1. You should record the key elements of your discussion with people about their decision to take part in research. If practical, you should ask them, or someone with valid authority, to give written consent. It is a legal requirement to get written consent from participants in clinical trials of investigational medicinal products.6

Sharing information with others involved in care

1. With the participant’s consent, you should usually inform their GP and other clinicians responsible for their care about their involvement in a research project, and you should provide the doctors with any other information necessary for the participant’s continuing care. You should follow this advice regardless of whether the participant is a patient or a healthy volunteer.
2. If a participant objects to information being shared in this way, you should explain to them the potential consequences of not sharing information. If the participant continues to object, you must respect their wishes unless sharing the information is justified in the public interest.