- Patients need to be fully informed about the risks and benefits and have to sign an informed consent document.
- Patients must be given enough time to decide whether they want to participate and must be able to discuss it with their family, if they wish to.
- Patients must not be coerced into or paid for participating in a clinical trial. Reasonable expenses like traveling expenses may be covered by the sponsor.
- Patients may withdraw from the trial at any time without fear of their treatment being negatively influenced by their decision.
- Patients must have access to the investigator/ ethical committee/ study coordinator during the trial if needed.
Bets Breedt, MBChB, B Med Sci, M Fam Med
Manager Investigator Services: Quintiles
1. Code of Federal regulations.
2. International Conference on Harmonisation guidelines.
3. Ken Flieger. Testing drugs in people. FDA Consumer July-August 1994.
4. Joanne Kabak. Clinical Trials: How drugs get from the test tubes to us. Drkoop.com:Family:Features
5. T.A.M. Kramer. Drug Development. Medscape Psychiatry & Mental Health eJournal, 24 July 2002.