Who protects my interests?

Protecting Your Interests in Clinical Studies: Ethical Guidelines

The way clinical research is conducted today is based on the Declaration of Helsinki. The Declaration, adopted by the World Medical Association in 1964 and updated over the years, provides ethical guidelines for research involving human subjects in the biomedical field.

It states that it is the physician's duty to constantly improve treatment methods and expand our knowledge of diseases, but that this must not come at the expense of individual integrity or safety. Trials must be designed so that the risk to the participant is no greater than the benefit, and they must be well-planned to genuinely answer the scientific question posed.

To ensure that all these requirements are met and that participants' interests are protected, several parties are involved:

• Participating physicians and any companies involved have a shared responsibility to clearly explain why a clinical trial should be conducted and why it should be done in a specific way. If a clinical trial is carried out without a company's involvement, it is the responsible physician's duty to provide the same justification.
• The physician has a duty to assess whether the trial is medically sound and feasible. Once the company (if involved) and the physician agree on the trial's design, it must be approved by both the Swedish Medical Products Agency and a regional ethical review board (for all trials), which includes both medical professionals and laypersons. 
• The Swedish Medical Products Agency reviews that the drug trial is correctly planned, that information about the drug is well-supported, and that all regulatory requirements for safety, etc., are met.
• The Swedish Medical Products Agency also conducts inspections, reviewing clinical drug trials to ensure that all parties carry them out correctly. 
• The regional ethical review board reviews all types of clinical trials and assesses whether the balance between potential risk and potential benefit for the individual is acceptable, and whether the information intended for participants is accurate and understandable.