ORI Releases New Guidance to Support Compliance with Updated Research Misconduct Regulations

Introduction

The Office of Research Integrity (ORI) has released a new set of topic-specific guidance documents to help institutions prepare for the updated Public Health Service (PHS) Policies on Research Misconduct (42 CFR Part 93). The revised regulation, finalized by the U.S. Department of Health and Human Services in September 2024, will take effect for all institutions on January 1, 2026.

As institutions approach the effective date, ORI has emphasized its commitment to supporting compliance through clear guidance that promotes fairness, transparency, and strong research integrity practices. The newly released documents focus on three areas central to effective research misconduct proceedings: the institutional record, research records and sequestration, and misconduct proceedings involving multiple institutions.

Helping Institutions Comply With the Updated Research Misconduct Rule

ORI’s guidance is designed to help institutions understand how the updated regulation should be implemented in practice. While the Final Rule provides greater regulatory clarity, it also places increased responsibility on institutions to document, manage, and retain records that support oversight and accountability.

Across all three guidance documents, ORI reinforces a consistent objective: ensuring that research misconduct proceedings are conducted in a timely, objective, and well-documented manner, while protecting respondent rights and maintaining public trust in federally funded research.

Understanding the Institutional Record Under 42 CFR Part 93

One of the most significant updates in the revised regulation is the expanded definition of the institutional record, which is central to ORI’s oversight review process.

ORI Guidance on the Institutional Record

The institutional record includes the materials an institution compiles or generates during a research misconduct proceeding and relies upon in reaching its determinations. ORI uses this record to assess compliance with 42 CFR Part 93 and to determine whether to close a case or proceed with further federal action.

Under the regulations, the institutional record consists of three core components:

• Records compiled or generated during the proceeding and relied upon by the institution.
• A single index listing all research records and evidence considered.
• A general description of records that were sequestered but not relied upon.

ORI’s guidance emphasizes that the institutional record should be logically organized and complete. During its oversight review, ORI evaluates whether proceedings were conducted with sufficient thoroughness, objectivity, competence, and fairness to support the institution’s conclusions.

Identifying and Sequestering Research Records in Misconduct Proceedings

A second guidance document, ORI Guidance on Research Records, outlines what constitutes research records and how institutions should manage them when an allegation advances to inquiry.

The updated regulation defines research records broadly as data or results that embody the facts resulting from scientific inquiry, regardless of format. Institutions must be prepared to secure a wide range of materials, including raw and processed data, laboratory notebooks, clinical research records, manuscripts, presentations, and digital files.

ORI emphasizes that institutions must promptly take reasonable and practical steps to:

• Obtain and inventory all relevant research records and other evidence.
• Sequester those materials in a secure manner.
• Maintain the chain of custody and integrity of the records throughout the proceeding.

Raw data is of particular evidentiary importance. ORI notes that copies of data stored on shared instruments or systems are acceptable when they are substantially equivalent in evidentiary value, including preservation of metadata and file structure. This enables independent reviewers to trace questioned results back to their source data.

When allegations involve clinical research, additional legal and privacy considerations may apply. ORI recommends consulting legal counsel before sequestering clinical research records to ensure compliance with applicable laws.

Managing Research Misconduct Cases Involving Multiple Institutions

The third guidance document focuses on the challenges of research misconduct proceedings involving multiple institutions, an area addressed more explicitly in the updated regulation.

ORI Guidance on Research Misconduct Proceedings Involving Multiple Institutions

When institutions elect to conduct a joint research misconduct proceeding, 42 CFR Part 93 requires the designation of a lead institution. ORI encourages participating institutions to establish a written agreement, such as a Memorandum of Understanding, that clearly defines roles, responsibilities, and procedures.

These agreements often address:

• Responsibility for obtaining and securing research records and evidence.
• Coordination and communication among institutions and with ORI.
• Committee composition, interviews, and meeting schedules.
• How determinations and institutional actions will be made.

Institutions that conduct proceedings independently should limit their review and determinations to allegations involving PHS-funded research at their own institution, unless a formal joint proceeding is established.

ORI Oversight, Notifications, and Record Retention Requirements

ORI’s guidance reiterates that institutions must notify ORI immediately if special circumstances arise during a misconduct proceeding, such as threats to public health or safety, potential legal violations, or risks to federal interests.

Institutions are also required to maintain the institutional record and all sequestered evidence securely for seven years after the completion of the institutional or HHS proceeding, whichever is later, unless custody is transferred to HHS or ORI advises otherwise.

Preparing Institutions for the January 1, 2026 Effective Date

With the updated research misconduct regulation taking effect on January 1, 2026, ORI encourages institutions to begin reviewing and updating their research misconduct policies and procedures now. Research Integrity Officers and other institutional officials are invited to seek technical assistance from ORI and participate in ORI-sponsored training opportunities, including RIO Boot Camps.

Through these guidance documents, ORI aims to promote consistent implementation of the Final Rule and support institutional environments that prioritize research integrity, accountability, and trust.