World Medical Association [WMA]

Research Ethics Committees (RECs) evaluate the ethical acceptability of research before participants can be enrolled in a study. RECs are highly regulated, neutral bodies which operate according to standard operating procedures in order to protect the health and safety of human participants of clinical trials, among other things.

Data from non-clinical trials is important as a predictor and decision-making tool in the medicines development process. Adequate and satisfactory non-clinical results are required before a medicine may be administered to healthy human volunteers, and non-clinical data is closely reviewed before a medicine is allowed to enter the market.

Human medical research is conducted according to strict principles of ethics. These principles have been developed over time, in reaction to various events in human history, and continue to require evaluation and assessment as the scope of scientific and medical research changes and expands

The European Patients’ Academy (EUPATI) guidance document on patient involvement in industry-led medicines R&D aims to support the integration of patient involvement across the entire process.

The European Patients’ Academy (EUPATI) guidance document on patient involvement in regulatory processes aims to support the integration of patient involvement across the entire process.