Date: August 4, 2016
- What is the Office of Research Integrity (ORI)?
- How was ORI’s authority established?
- Is ORI part of the National Institutes of Health (NIH)?
- What is ORI’s mission?
- What is “research misconduct”?
- What is the difference between a “complainant” and a “respondent?
- How does ORI oversee research misconduct?
- What is the relationship between HHS and ORI when it comes to research misconduct findings and administrative actions imposed upon researchers found to have committed research misconduct?
- How does HHS determine what administrative actions may be made against respondents found to have committed research misconduct?
- When ORI makes findings of research misconduct, what kind of administrative actions can HHS impose on a respondent?
- Can HHS also take action against an institution?
- What actions cannot be taken by ORI?
- What are the potential outcomes from a finding of research misconduct by ORI?
- What is a voluntary agreement?
- What can happen to a researcher who is found to have committed misconduct by ORI?
- Can ORI make the researcher/institution return the money spent on a project in which misconduct was committed?
- Can ORI send a researcher to prison?
- Can ORI tell the public whether it is currently investigating someone or offer more details about the case, if ORI has published findings on a researcher?
- Can a respondent appeal HHS’s proposed administrative actions?
- What is the Office of Research Integrity (ORI)?
The Office of Research Integrity (ORI) oversees and directs U.S. Public Health Service (PHS) research integrity activities on behalf of the Secretary of Health and Human Services. This includes oversight of research misconduct inquiries and investigations, as well as of institutional compliance. Organizationally, ORI is located within the Office of the Assistant Secretary for Health (OASH) within the U.S. Department of Health and Human Services (HHS).
- How was ORI’s authority established?
ORI was established by Congress in 1993 as an independent entity within HHS. The statute authorizing ORI’s responsibilities also directs entities (intramural or extramural research facilities) that perform U.S. Public Health Service (PHS)-sponsored biomedical or behavioral research to share responsibility for the integrity of the research process and to protect PHS funds from misuse. Subsequently, regulations were passed that implemented the requirements of this statute for ORI and PHS-funded institutions. Additional information on the history of ORI is available here.
- Is ORI part of the National Institutes of Health (NIH)?
No. NIH is an agency within HHS and is a component of the U.S. Public Health Service (PHS), as are the Centers for Disease Control and Prevention, the Food and Drug Administration, and a number of other entities. Although ORI is also part of HHS, it is not part of NIH. ORI’s predecessor office was part of NIH, but the NIH Revitalization Act of 1993 established ORI as an independent entity within HHS and removed from funding agencies the authority to oversee misconduct allegations for research that they fund. Please go here to read about the history of ORI.
- What is ORI’s mission?
ORI’s mission is to protect the health and safety of the public, promote the integrity of U.S. Public Health Service (PHS)-supported research and conserve public funds by ensuring the integrity of all PHS-supported work. ORI:
- oversees and directs PHS research integrity activities on behalf of the HHS Secretary, including the oversight of research misconduct inquiries and investigations, education and training in the responsible conduct of research, activities designed to promote research integrity and prevent misconduct, and research and evaluation programs
- makes findings of research misconduct and proposes administrative actions in connection with research conducted or supported by PHS
- reviews institutional policies to ensure compliance with misconduct regulations.
- oversees and directs PHS research integrity activities on behalf of the HHS Secretary, including the oversight of research misconduct inquiries and investigations, education and training in the responsible conduct of research, activities designed to promote research integrity and prevent misconduct, and research and evaluation programs
- What is “research misconduct”?
Research misconduct (formerly called scientific misconduct) is a narrowly defined set of actions that call into question the scientific integrity of a body of work. Under the regulations that articulate ORI’s statutory authority, research misconduct is defined as "fabrication, falsification or plagiarism in proposing, performing or reviewing research, or in reporting research results....Research misconduct does not include honest error or differences of opinion" (42 C.F.R. Part 93). ORI’s regulatory authority is limited to the oversight of research misconduct involving PHS-funded research. Fraud, which is regulated by civil or criminal fraud statutes, is outside of the jurisdiction of ORI.
- What is the difference between a “complainant” and a “respondent”?
A “complainant” is a person who in good faith makes an allegation of research misconduct. A “respondent” is a person against whom an allegation of research misconduct is directed or who is the subject of a research misconduct proceeding.
- How does ORI oversee research misconduct?
Promoting research integrity is a responsibility shared between an institution that receives U.S. Public Health Service funding and ORI. In many situations, allegations are first brought to the attention of the research integrity officer at the institution where the alleged misconduct occurred. The institution must notify ORI if it determines that an investigation is warranted. Allegations of research misconduct also may come directly to ORI. In this scenario, ORI will assess the allegation to determine whether it falls within its jurisdiction. If it does, ORI then forwards the case to the institution where the alleged research misconduct took place for its subsequent inquiry and investigation (as warranted). ORI always is available to assist the institution with its inquiry and investigation to ensure that it follows the regulatory requirements. ORI has no direct involvement in the decision-making by an institution. When an institution completes its investigation, ORI reviews the institution’s findings and process and then make its own independent findings. If ORI determines that misconduct has occurred, HHS imposes administrative actions (see #8) that protect the public against any further misuse of public funds by the researcher. If ORI does not issue findings against a respondent, this does not negate the institution’s findings. ORI’s findings are independent of the institution’s findings.
- What is the relationship between HHS and ORI when it comes to research misconduct findings and administrative actions imposed upon researchers found to have committed research misconduct?
Under the statute and implementing regulations governing research misconduct processes, ORI and the Secretary of HHS (or his/her delegate) have unique roles and responsibilities to ensure a fair and impartial process. Whereas ORI makes a finding about misconduct, HHS is the entity that takes final administrative actions against a respondent as well as the entity that oversees the appeal process through the HHS Departmental Appeals Board. In performing its oversight functions, specifically, ORI can conduct allegation assessments, determine jurisdiction, forward allegations to the appropriate institution or HHS component for inquiry and/or investigation, recommend that HHS perform an inquiry and/or investigation, notify U.S. Public Health Service (PHS) funding components or other Federal agencies of a finding so that they may recover PHS funds, review an institution’s findings and process, make a finding of misconduct, and propose administrative actions to HHS. HHS, in turn, imposes the final administrative actions. If the proposed action is suspension or debarment, HHS follows both the government-wide and HHS-specific debarment regulations (see #10).
- How does HHS determine what administrative actions may be made against respondents found to have committed research misconduct?
HHS imposes administrative actions (see #10) based on the circumstances and severity of the misconduct. HHS also must consider whether there were any aggravating or mitigating factors in assessing the severity of administrative actions. HHS considers various factors, such as whether the misconduct was an isolated event or represented a pattern of behavior, the impact of the misconduct on the research record and on public health, the extent to which the respondent accepted responsibility for his/her action, the extent to which a respondent retaliated against persons involved in assessing misconduct and whether or not HHS found the respondent “presently responsible” to conduct U.S. Public Health Service-funded research. To protect the public interest, the Federal Government ensures the integrity of Federal programs by conducting business only with responsible persons.
- When ORI makes findings of research misconduct, what kind of administrative actions can HHS impose on a respondent?
The administrative actions that HHS may impose include:
- correction of the research record
- letters of reprimand
- inclusion of certifications or assurances to ensure compliance with PHS grants, contracts, or cooperative agreements (these are written attestations that the respondent’s future U.S. Public Health Service (PHS) grant submissions have been reviewed by the institution and do not contain falsification, fabrication, or plagiarism)
- suspension or termination of PHS grants, contracts, or cooperative agreements
- restrictions on specific activities or expenditures under an active PHS grant, contract, or cooperative agreement
- special review of all PHS funding requests
- supervision requirements on PHS funding
- exclusion from participation in advisory roles to PHS
- adverse personnel action of the respondent if s/he is a federal employee
- suspension or debarment under two sets of regulations, which prohibit a person from participating in certain federal programs or transactions, such as federal grants and contracts
- recovery of PHS funds sent to support activities that involved research misconduct (see below)
- other HHS administrative actions, including actions taken by the Office of Inspector General (could be civil or criminal proceedings), the PHS funding component, and the debarring official.
Under the regulations, ORI publishes notices of final agency findings of research misconduct, settlements, and HHS administrative actions. ORI does not have the statutory authority to issue subpoenas or to prosecute respondents, either civilly or criminally. However, if ORI believes that a criminal or civil fraud violation may have occurred, ORI is required to refer the matter to the appropriate office (the Department of Justice or the HHS Office of the Inspector General, for example) for further consideration. ORI has jurisdiction over a narrowly defined subset of activities that can occur in a research setting, limited to plagiarism, fabrication and falsification. Fraud regulated by civil or criminal fraud statutes is outside ORI’s jurisdiction.
- correction of the research record
- Can HHS also take action against an institution?
Yes. An institution is eligible for U.S. Public Health Service (PHS) funding only when it has an “assurance” on file with ORI stating that it has developed and will comply with an administrative process for responding to allegations of research misconduct. If an institution shows a disregard for, or inability or unwillingness to implement and follow ORI’s regulatory requirements and its own assurance, HHS may also take further compliance actions against the institution. These may include:
- issuing a letter of reprimand
- directing HHS to handle research misconduct proceedings for PHS-funded research
- placing the institution on special review status
- publishing information about the institution’s noncompliance on ORI’s website
- requiring the institution to take corrective actions
- requiring the institution to adopt and implement an institutional integrity agreement
- recommending that HHS debar the institution
- other actions appropriate to the circumstances
If an institution’s actions related to its research misconduct review process constitute a substantial or recurrent failure to comply, ORI may also revoke the institution’s assurance, thereby suspending PHS awards to that institution. ORI may make public any finding of institutional noncompliance and HHS compliance actions.
- issuing a letter of reprimand
- What actions cannot be taken by ORI?
ORI proposes administrative actions to HHS, as outlined above, but does not have the statutory authority to undertake any civil or criminal justice proceedings. Under its regulations, if ORI believes that a criminal or civil fraud violation may have occurred, it must promptly refer the matter to the Department of Justice (DOJ), the HHS Office of Inspector General (OIG), or other appropriate investigative bodies. ORI may provide assistance to the DOJ, OIG, U.S. Public Health Service offices, or other federal offices as well as state and local offices involved in investigating or otherwise pursuing research misconduct allegations or related matters.
- What are the potential outcomes from a finding of research misconduct by ORI?
A finding of research misconduct may result in a voluntary agreement between HHS and the respondent, if settlement is in the best interests of the federal government and the public health or welfare. In this scenario, ORI makes misconduct findings and HHS imposes final administrative actions, through an agreement with the respondent, who, in turn, agrees not to contest the findings and administrative actions. If there is no settlement, HHS may issue a charge letter, notifying the respondent of the research misconduct findings and proposed administrative actions. Once issued, a respondent then may contest either the research misconduct findings or the proposed administrative actions in accordance with Subpart E of the regulations.
- What is a voluntary agreement?
ORI may make a finding of research misconduct and seek to settle the matter with the respondent if it concludes that it is in the best interests of the federal government and public health or welfare. HHS administrative actions often include exclusion from participation in advisory roles to U.S. Public Health Service (PHS) (e.g., the respondent may not sit on a PHS agency study section during the exclusion period) with either debarment or a supervision requirement. A supervision requirement means that the respondent must be supervised for a specified period for any PHS-supported research he or she conducts.
- What can happen to a researcher who is found to have committed misconduct by ORI?
The most egregious cases of research misconduct could result in government-wide debarment for a period of time from certain federal programs or transactions, such as federal grants and contracts [including U.S. Public Health Service (PHS) and non-PHS funding] and Medicare and Medicaid reimbursement. In cases in which the misconduct investigations uncover potential civil or criminal fraud or other illegal activities, additional legal proceedings and remedies may be pursued by other federal agencies, which can result in more severe outcomes, including permanent debarment, fines, and/or imprisonment.
- Can ORI make the researcher/institution return the money spent on a project in which misconduct was committed?
HHS (not ORI) can require an institution to return U.S. Public Health Service (PHS) funds that were spent on activities that involved research misconduct, as specified in the regulations. In this case, the funding agency (not ORI) usually works directly with the institution that received the funding to return PHS funds to that agency. There are policies and procedures in place both at the agencies and at the research institutions to perform such actions.
- Can ORI send a researcher to prison?
No. ORI does not have statutory authority to undertake any criminal actions and cannot send a respondent to prison. However, when a research misconduct investigation uncovers other misdeeds or allegations of criminal activity, ORI refers those through the appropriate channels to other agencies for further action. ORI may provide expertise and assistance to such other agencies to the extent allowed by law.
- Can ORI tell the public whether it is currently investigating someone or offer more details about the case, if ORI has published findings on a researcher?
In accordance with the Privacy Act of 1974, ORI is prohibited from disclosing information about individuals without the individual’s advance written consent. One exception to the Act is the “routine use” exception, which allows agencies to make certain third party disclosures in accordance with the agency’s system of records notice. HHS has a routine use in its system of records notice for ORI’s research misconduct records that provides that after a final HHS finding of research misconduct, disclosure of the findings may be made to professional journals, other publications, news media, and others. This generally is done by publishing the findings in the Federal Register, the NIH Guide to Grants and Contracts, and the ORI website. Disclosure of the findings also is warranted when there is a need to correct or retract research results or published reports that have been affected by research misconduct. No information is released that would reveal a confidential source. ORI’s regulations limit the disclosure of the identity of respondents and complainants in research misconduct proceedings, to the extent possible, to those who need to know, consistent with a thorough, competent, objective and fair proceeding, and as allowed by law. ORI also is directed to protect a complainant, witness or committee member from retaliation (an adverse action) for good faith cooperation with a research misconduct proceeding. All media queries should be made through our Public Affairs Office at ASHMedia@hhs.gov.
- Can a respondent appeal HHS’s proposed administrative actions?
Yes. A respondent found to have committed research misconduct and for whom administrative actions are recommended has the opportunity to contest ORI findings and HHS proposed administrative actions by requesting an administrative hearing before an Administrative Law Judge (ALJ), as specified in Subpart E of the regulations. The subsequent ruling by the ALJ constitutes a recommended decision to the Assistant Secretary for Health, who has the option to review the ALJ’s recommended decision and then to affirm, reverse, or modify that decision, unless a debarment or suspension is recommended, in which case, the HHS Debarring Official would be the official who would make the final decision on the recommended debarment or suspension.
