Certified Clinical Research Associate (CCRA) Practice Exam

The Declaration of Helsinki provides ethical guidelines for medical research involving human subjects, particularly concerning the use of unproven interventions. It stipulates that while there is a general preference for proven interventions, the use of unproven treatments can be permissible under specific circumstances.

These conditions typically include scenarios where no alternative treatment is available and the expected benefits outweigh the risks involved. Furthermore, researchers must ensure that their use of unproven interventions is based on well-formulated hypotheses and that a thorough explanation of potential risks and benefits is provided to participants. The conditions also highlight the importance of ethical oversight and review by an independent committee to ensure participant safety and informed consent.

This response highlights the nuanced approach of the Declaration of Helsinki towards the use of unproven interventions, recognizing that in some situations, clinical judgment may allow for their application provided that ethical standards are adhered to.