How are procedures for reporting unanticipated problems determined?

The procedures for reporting unanticipated problems are primarily determined by the institution's written policies and procedures. Institutions that conduct research are required to develop and implement guidelines that outline how unanticipated problems should be reported, ensuring compliance with ethical standards and regulatory requirements.

This institutional approach helps to create a standardized process that reflects the specific context and environment of the research setting, providing clarity and consistency for researchers. Additionally, written policies ensure that all team members are informed about the necessary steps to follow in the event of an unanticipated issue, facilitating prompt and appropriate responses to protect participants and address any potential ethical concerns.

While federal laws and external guidelines, such as those from the Human Subjects Institutional Review Board (IRB), inform these institutional policies, it is ultimately the institution that tailors and enacts them. This leads to a structured and organized method for handling unanticipated problems, which is essential for maintaining ethical standards in research involving human subjects.