RMP.6:5.5 - Two different merits answers, one authority boundary

A research protocol requires an additional independent check of a consequential record transformation. Its marginal protection is questioned.

In the first constructed case, supplied examination records show that the check catches an otherwise missed transformation error capable of changing a safety-relevant exposure classification. The baseline controls miss that error, and the check fits the available window without displacing more protective work. The evidence supports retaining that protection or an alternative that preserves its function.

In the second case, supplied records show that the proposed check repeats the same source and procedure, adds no demonstrated discrimination of the protected failure, and displaces a different examination that can expose a consequential error. The merits comparison supports revising or replacing the duplicate requirement under those premises.

These are different substantive recommendations. Neither case transfers amendment authority to the researcher. Retain the in-force condition while returning the evidence, uncertainty, burden and protected-function comparison to its competent owner. A favorable resource argument alone never grants a waiver.