Process for Appeal to a BSC Review

An informal discussion with the Principal Investigator's (PI) Scientific Director (SD) and/or Institute Director should always be the first step. If this informal discussion is not successful in resolving the issues, the PI may request initiation of the formal process detailed below. Step 1 of the formal process involves the Institute IRP, which will attempt to resolve the problem to the satisfaction of the involved parties. Step 2 of the formal process will be handled by the Office of the Deputy Director for Intramural Research, NIH. There will be no appeal beyond this step.

Formal Process

Note: This appeal process is to determine whether there were any flaws in the process of the BSC review, not in the content or outcome. If any such process problems are found, corrections usually involve instituting a process judged by the DDIR/OIR and the IC to be appropriate and consistent with other NIH IRP and IC policies.

Step 1: The PI presents their concerns in writing to the Scientific Director (SD). The PI is responsible for providing all documentation to support the claims made in writing, and for including in the request the specific relief sought. The SD may seek additional documentation or information from any party with pertinent information. All parties must agree to maintain absolute confidentiality with regard to any information or documents obtained as a result of this process. The SD's review of the dispute must be completed, and a written decision issued, with concurrence of the IC director, within sixty (60) calendar days of receiving a complaint from an employee.

Step 2: The NIH Deputy Director for Intramural Research (DDIR) will consider an appeal of an initial decision by the IC when the PI can document: (a) that the IC decision is based on demonstrable errors in fact; (b) if new information not available before is received; (c) a conflict of interest existed in Step 1; or (d) the decision contradicts an established NIH or government policy. A request for appeal of the SD decision must be received in writing by the DDIR within thirty (30) calendar days of the SD's decision. The PI seeking further appeal through Step 2 is responsible for submitting a complete record of the initial decision, plus a written statement and other documentation demonstrating why the original decision should be overturned. The DDIR will have thirty (30) calendar days to decide whether the original decision should be upheld, or the decision in Step 1 should be reconsidered. If the DDIR agrees with the original decision of the SD, that decision will become final and binding.

If the DDIR decides to reconsider the SD’s decision, the DDIR may seek information or documentation from any party to the dispute, and may utilize other procedures, such as peer panel review, to provide advice and input to the decision process. Parties involved in a reconsideration process are not entitled to a formal hearing or to examine witnesses (parties) to the dispute. The DDIR will issue a formal decision on the reconsideration within sixty (60) days after agreeing to the reconsideration. This decision is final and not subject to appeal.

[Extracted and updated from the document “Processes for Resolution of Conflicts in the NIH IRP”, implemented 1997-2020]