PHS Regulation 42 C.F.R. Part 50, Subpart A

The Office of Research Integrity (ORI) has received numerous requests for assistance in the development of policies and procedures for institutions that conduct inquiries and investigations. To respond to this need, ORI has developed the enclosed model policy and model procedures for responding to allegations of scientific misconduct. These models are for guidance only.

ORI developed the model policy primarily to provide guidance to institutions that are developing or refining their policies and procedures for handling allegations of misconduct in science in cases where ORI has jurisdiction. The model procedures are targeted primarily toward those institutions that recognize a need for detailed guidance on how to conduct inquiries and investigations in cases where ORI may review and follow-up on actions that the institution decides to take.

ORI has prepared these models to assist extramural institutions in complying with Public Health Service (PHS) regulations at 42 CFR Part 50, Subpart A, and to encourage institutions to adopt "good investigative practices" in responding to allegations of scientific misconduct that involve PHS research grants or applications for funds. In other words, the intent of this guidance was precisely to help institutions where ORI has jurisdiction. For this reason, the models have been written in a manner tightly related to PHS requirements and needs, although ORI has attempted to provide more general advice where possible. Recognizing that institutions often receive funding from many sources, institutions are welcome to adapt the policies and procedures to broaden their coverage and applicability to agencies other than PHS.

These models have been written from the institution's perspective with the intention of simplifying the process of institutional adoption. Portions of the models that specifically address regulatory requirements are indicated by reference to the section number from the PHS regulation. Options are included in several places in both documents.

There is an appendix included with the models that summarizes the responsibilities assigned by the models to an institution's Deciding Official and Research Integrity Officer. Many institutions have found that designating the Research Integrity Officer to coordinate all activities related to scientific misconduct is helpful in creating and implementing the administrative processes necessary to handle allegations of scientific misconduct and to ensure that inquiries and investigations are conducted consistently and properly. The appendix is provided to help institutions quickly review the duties assigned to the Deciding Official and the Research Integrity Officer in these models so that an individual institution can determine if these assignments are appropriate and desirable.

In reviewing both models, institutions should note that ORI has attempted to incorporate each significant step necessary to comply with the current PHS regulation. Thus, adoption and adherence to the models should allow an institution to comply with the regulatory requirements. However, there are recommended ORI practices included in the models that are not explicitly tied to regulatory provisions, such as section IV of the procedures on preinquiry assessment of allegations and section V.B on sequestration of research records. These sections and others like them are intended to aid institutions by providing a rational and comprehensive approach to conducting investigations into allegations of scientific misconduct. While ORI believes they represent good investigative practice used by ORI in its own cases, they may be modified or deleted according to institutional needs. However, institutions must adopt procedures to ensure that investigations are timely, objective, thorough, and competent as required by 42CFR*50.104(a)(6).

One area in which the models have exceeded the regulatory requirements is the inclusion of contracts in the definition of "PHS Support" (section II). Although institutional responsibility for conducting investigations of alleged misconduct under PHS contracts is not covered by the current PHS regulation, ORI recommends that institutional policies cover misconduct under PHS contracts and that institutions investigate and report allegations involving contracts to ORI in the same manner as they do for PHS grants, fellowships, and cooperative agreements.

In a similar vein, ORI recommends that institutional procedures on protecting good faith whistleblowers from retaliation be expanded to provide protection for those who cooperate with institutional investigations and those who make allegations that the institution has inadequately responded to an allegation of misconduct. (See definitions of "complainant," and "retaliation" in section II). This would be consistent with the new whistleblower protection statute that was enacted in 1993 as part of the NIH Revitalization Act, 42 USC 289b(e). While this new statute will be implemented in future PHS whistleblower protection regulations, ORI encourages institutions voluntarily to extend whistleblower protection to these additional individuals in the meantime.

Institutional representatives may call ORI with questions concerning the model policy or model procedures as follows:

• For questions on the model policy, call the Division of Policy and Education at (301) 443-5300.
• For questions on the model procedures, call the Division of Research Investigations at (301) 443-5330.
• For legal questions, call the Research Integrity Branch, Office of the General Counsel at (301) 443-3466.