What does the Common Rule state about documenting reliance agreements?

The Common Rule offers flexibility in how reliance agreements are documented, allowing institutions and investigators to choose methods that best fit their needs and capabilities. This adaptability acknowledges the diversity of research settings and the varying capacities of organizations involved in human subjects research. As a result, while there may be recommended guidelines or best practices, the Common Rule does not impose rigid or strict documentation formats, enabling a more practical approach to creating and managing reliance agreements. This flexibility ensures that organizations can establish collaborations without being hindered by overly prescriptive requirements.