How often have you wondered “what do I need to do” when you’ve been faced with the prospect of running a non-interventional study?  Especially, if you are more familiar and comfortable with running clinical trials.

This is where I think we are missing a trick when we train team members in the requirements of ICH GCP.  Most GCP training skims over the foundational aspects…the ‘why’ we need to do the training (= prevent a reoccurrence of the Nazi doctor experiments)….why the Nuremberg Code and the Declaration of Helsinki were needed (= before they were created no international law or informal statement existed that differentiated between legal and illegal human experimentation).

The Declaration of Helsinki [ref 1] defines the “ethical principles for medical research involving human subjects”. This Declaration is the ethical foundation for:

1. Clinical trials of drugs
2. Non-interventional studies of drugs
3. Observational studies (no drugs)
4. Clinical trials and observational studies of medical devices

The Declaration of Helsinki forms the basis for ICH GCP (drugs) and ISO 14155 (GCP for medical devices)…and is the framework for non-interventional study regulations…globally.

Once you understand this, you will see the global similarities in the requirements for running non-interventional studies, which include:

1. Study participation must be voluntary
2. Voluntary informed consent is essential
3. Every precaution must be taken to protect the privacy of research subjects and the confidentiality of their personal information.
4. Researchers must have appropriate education, training, and qualifications
5. Design and performance must be clearly described and justified in a protocol
6. Protocol should contain a statement of the ethical considerations involved and should indicate how the principles in this Declaration have been addressed
7. Protocol must be submitted for approval to a research ethics committee before the study begins
8. The research study must be registered in a publicly accessible database before recruitment of the first subject.
9. No amendment to the protocol may be made without approval by the research ethics committee.
10. At the end of the study, researchers must submit a final report to the research ethics committee containing a summary of the study’s findings and conclusions.
11. Researchers have a duty to make publicly available the results of their research are accountable for the completeness and accuracy of their reports.

References:

1. World Medical Association (WMA) – Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects (October 2013): https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/