What must be discussed with subjects regarding risks in the consent process?

The rationale for discussing unforeseeable risks during the consent process is rooted in the ethical obligation to ensure that participants are fully informed about potential hazards they may encounter while participating in a clinical trial. Informed consent is a foundational principle in Good Clinical Practice (GCP) and emphasizes the importance of transparency between researchers and study participants.

When obtaining consent, it is essential to address both known and potential risks, including those that are unforeseen or may not have been anticipated at the study's inception. This allows participants to weigh the risks against the possible benefits, fostering trust and respect for their autonomy.

Discussing only foreseeable risks or limiting the conversation to financial implications would not adequately inform participants about the full spectrum of risks associated with their involvement in the study. Additionally, focusing on risks only during preliminary stages does not reflect the ongoing nature of research, where new risks can emerge as the study progresses. Comprehensive informed consent supports ethical research practices and participant safety, making it critical to include unforeseeable risks in the discussion.