Office of Scientific Integrity
- OSI works with the Centers and the Office of Regulatory Affairs (ORA) to preserve and promote integrity in scientific decision-making, as well as consistency on such issues across the agency. OSI identifies the need for additional policies and procedures through the work of its Office of the Ombudsman and the Office of Appeals. The office also collaborates with representatives from the Office of Science and Technology Policy at the White House and other agencies to implement government-wide requirements and initiatives designed to ensure scientific integrity.
- Through its Office of Appeals (OA), OSI coordinates for the Office of the Commissioner all requests for hearings in matters for which the FD&C Act or FDA’s regulations require an opportunity for a hearing (see, e.g., 21 CFR parts 12 and 16). OA also works with the Chief Scientist (and sometimes other decision-makers) to resolve requests to review decisions made by the Centers or ORA, as submitted by interested persons outside the agency (see 21 CFR 10.75).
- Through its Office of the Ombudsman, OSI investigates and facilitates resolution of informal complaints and disagreements elevated from lower levels of the agency by working with the parties to the dispute, which may include both internal and external constituents. The Office of the Ombudsman further works, under tight deadlines, with various agency components to address complaints forwarded to the agency by the Small Business Administration.
- Through its RIHSC Program Management Staff (RPMS), OSI works with the Chief Scientist to oversee human subject research (whether intramural or extramural) and to ensure that it is conducted in accordance with the Common Rule. Of note, RPMS evaluates: (1) whether human subject research is exempt from oversight by an institutional review board (IRB) and (2) whether FDA should enter an IRB authorization agreement that defers to another institution’s oversight of human subject research. RPMS also administers the Research Involving Human Subjects Committee, the agency’s IRB, by handling record-keeping, reviewing incoming submissions, preparing meeting materials, coordinating pre-meeting reviews, and generally working with the RIHSC and its Chair in fulfilling their responsibilities under the Common Rule.
- The Agency Intramural Research Integrity Officer (AIRIO) is housed in OSI (see Staff Manual Guide (SMG) 9003.1 (“Policy for Responding to Allegations of Research Misconduct”). The AIRIO receives and assesses incoming allegations to determine whether they constitute research misconduct under the regulations (i.e., falsification, fabrication, or plagiarism), refers the allegations to a board of inquiry as appropriate, coordinates both the inquiry and investigative boards, and communicates the conclusions of the investigation to the Office of Research Integrity, as appropriate.
- OSI convenes the process review board (the Board) for all internal scientific disputes elevated to the Office of the Commissioner under SMG 9010.1 (“Scientific Dispute Resolution at FDA”) and works with the Chief Scientist (as Chair) and the Board to make a recommendation to the Commissioner as to how the dispute should be resolved.
- OSI Responsibilities SMG
- Scientific Integrity at FDA SMG
- Public Access to Results of FDA-Funded Scientific Research