Writing Subject Information Letters and Informed Consent Forms
For the consent procedures researchers must comply with all applicable regulatory requirements, GCP guidelines and the ethical principles defined in the Declaration of Helsinki. A key regulatory requirement stipulates that all relevant trial information should be presented to subjects both orally and in writing.
Penthecilia can develop all necessary consent documentation in compliance with these rules and regulations. We review patient information letters from the sponsors before the approval by the IRB. Additionally we will advise you on standard consent clauses such as the insurance clause and the clause involving the privacy of subjects and independent doctors. If the subject information letters meets all the requirements, this will considerably speed up the IRB/IEC approval process.
Penthecilia also provides training in this area. One of our teaching instruments is role-playing. Using research protocols and checklists participants will learn to compile appropriate information letters and informed consent interviews.
Our services include:
- Compiling information letters and informed consent forms
- Reviewing, editing and rewriting existing documentation
- Advice on standard clauses in informed consent documentation
- Issuing standard or customized checklists
- Training on regulatory requirements and GCP guidelines for informed consent procedures
- Training on informed consent documentation procedures and obtaining the subject’s informed consent to participate in the research project