Does the final rule prescribe a formal hearing process for reviewing ORI findings of research misconduct?
Yes. The hearing process is modeled upon the current regulation, at 42 CFR 1005, governing the Office of Inspector General hearing process for the exclusion of health care providers, with modifications to reflect current practice, knowledge, and experience in research misconduct proceedings. The hearing process has the following key features: • Administrative Law Judge. The hearing is conducted by a single ALJ appointed from the Departmental Appeals Board (DAB) Administrative Law Judges. This is a change from the current practice of using a panel of three members of the DAB. Section 93.502(a), (c)-(e). • Recommended Decision. The ALJ’s findings of fact and conclusions of law constitute a recommended decision to the Assistant Secretary for Health (ASH). Under the final rule, the ASH may let the ALJ’s recommended decision stand, or take final agency action, exercising authority to affirm, reverse, or modify the ALJ’s recommended decision, if it is found to be arbitrary and capricious, or
