Towards better quality and transparency of ethical review with particular reference to GCP-compliant clinical trials
✍ Scribed by Jan H. Bergsma
- Publisher
- John Wiley and Sons
- Year
- 1997
- Tongue
- English
- Weight
- 103 KB
- Volume
- 2
- Category
- Article
- ISSN
- 1087-8378
No coin nor oath required. For personal study only.
✦ Synopsis
Towards Better Quality and
Transparency of Ethical Review with particular reference to GCP-compliant clinical trials
The quality and transparency of the ethical review of research plans/protocols involving human subjects is a result of effective communication between the Review Board and the investigator. Although the IRB and the investigator start from different points of view, their efforts may and should result in a common goal: high quality trial protocols including the correct and transparent recruitment of subjects before the start of the trial and the assurance of their safety and well-being during the trial. This article deals with some of the quality and transparency issues specifically relating to the ethical review of clinical trials. Some specific items are discussed: the educating role of Review Boards, the impact of international (ICH) guidelines for GCP and of national legislation in the Netherlands, informed consent and direct access to medical records, and ( finally) the speed of the review process.