CITI Training Practice Exam

For consent forms, which guideline only requires the listing of treatment alternatives?

1. FDA

2. ICH GCP

3. EU Directive

4. HIPAA

The correct answer is: FDA

Consent forms are an important part of the informed consent process in clinical trials. Their purpose is to provide potential participants with all the necessary information about the trial so they can make an informed decision about participating. The FDA guidelines require that the consent form list all the available treatment alternatives, while the other options listed only provide general guidelines for clinical trials and do not specifically address the requirement of listing treatment alternatives. For example, ICH GCP (International Conference on Harmonization Good Clinical Practice) focuses on ethical and quality standards for designing, conducting, and reporting clinical trials, while EU Directive (European Union Directive on clinical trials) outlines the principles and procedures for conducting clinical trials in the European Union. HIPAA (Health Insurance Portability and Accountability Act) sets standards for the protection of patients' private health information. Therefore, the correct answer is A as the other options do not specifically address the requirement for listing treatment