Policies Menu Introduction Federal Policies PHS Policies ORI Policies Statutes/Regulations

Misconduct Regs PHS Policies on Research Misconduct HTML | PDF Requirements for Institutional Policies and Procedures HTML | PDF Frequently Asked Questions HTML | PDF

Policies

UPDATED ORI SAMPLE POLICY AND PROCEDURES FOR RESPONDING TO ALLEGATIONS OF RESEARCH MISCONDUCT

In response to comments from affected parties, ORI has renamed and amended the Model Policy for Responding to Allegations of Research Misconduct that previously appeared on this website.  The comments primarily expressed the concern that the Model Policy was overly detailed.  The commentators recognized that much of the detail in the policy results from the detailed provisions of the research misconduct regulation at 42 CFR Part 93, and added the regulation to their criticism.  Both the Model Policy and this new Sample Policy and Procedures for Responding to Allegations of Research Misconduct reflect the detailed procedures for research misconduct proceedings in the research misconduct regulation.  There were both negative and positive public comments on the amount of detail in the proposed research misconduct regulation (see preamble to the final rule at 70 FR 28370-71).  No significant change in the level of detail was made in the final rule, as those details were determined to be necessary to ensure uniformity and fairness (see preamble to the final rule for a more complete explanation, 70 FR at 28379).  In some cases, changes to enhance fairness and clarity that were made in response to specific comments on the proposed rule increased the level of detail in the final rule.

The comments on the Model Policy indicate that there is some confusion about the expected content of, and the level of detail in, institutional policies vis-à-vis institutional procedures. We understand this confusion because:  (1) the research misconduct regulation refers to policies and procedures; (2) under the old scientific misconduct regulation ORI disseminated both model policies and model procedures for institutions to use; (3) institutions have typically adopted very general misconduct policies and much more detailed procedures; and (4) to update those previous documents to comply with 42 CFR Part 93, ORI disseminated only a new Model Policy on its website.  ORI’s dissemination of an updated, detailed Model Policy to comply with 42 CFR Part 93 was not intended to signal that institutional policies should contain the same level of detail as their procedures.  Rather, it was a recognition that the previous ORI model policy and model procedures were redundant and that given the level of detail in the model policy, it could also serve as the requisite procedures.  The research misconduct regulation requires institutions to have written policies and procedures for addressing research misconduct that meet the requirements of the regulation (42 CFR §§ 93.300, 93.302, 92.304).  It does not require that policies contain certain requirements or that procedures contain certain other requirements, or even that the policies and procedures be separate documents.    To clarify that the document is intended to meet all of the requirements of the regulation for both policies and procedures, we have expanded its title to include procedures.  This combining of the policy and procedures, however, is not intended to indicate that institutions should change their typical practice of having general misconduct policies and more detailed procedures.  

This Sample Policy and Procedures is intended to meet the regulatory requirements, but as explained in the preamble and in notes appearing in specific sections of the Policy, it is not intended to represent the best or only way of meeting those requirements.  We have sought to emphasize this by renaming it as a “sample” rather than a “model,” by further clarifying what parts of the sample are required by the regulation, and by explicitly stating that it does not create a standard or expectation for institutional research misconduct policies and procedures.  The template for institutional compliance is 42 CFR Part 93.  This Sample Policy and Procedures will assist institutions in meeting the requirements of the regulation, but ORI will make compliance determinations on the basis of the regulation, not on the basis of fealty to the Sample Policy and Procedures.