There are a variety of offices within the Department of Health and Human Services (HHS) that are responsible for handling abuses of the research process. The abuses include research misconduct, misuse of human research subjects, misuse of animals in research, financial mismanagement, and conflicts of interest. Each of these areas is the subject of Federal policies and regulations.
Research Misconduct Involving PHS Research
ORI handles allegations of misconduct that involve research supported by the PHS and that fit within the following definition:
"Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
(a) Fabrication is making up data or results and recording or reporting research.
(b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
(c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit.
(d) Research msconduct does not include honest error or differences of opinion."
For more information about handling allegations or ORI oversight of institutional findings, contact the ORI Division of Investigative Oversight (DIO) at 240-453-8800.
Research Misconduct Involving FDA Regulated Research
Allegations of misconduct in regulated research monitored by the Food and Drug Administration (FDA) are generally investigated by the Office of Regulatory Affairs, Bioresearch Monitoring Program Coordination, FDA, at 240-632-6834 or see the FDA web site at:
http://www.fda.gov/ora/compliance_ref/bimo/default.ht
This research focuses on testing and evaluating human and animal drugs, food and feed additives, and human biological products and medical devices. ORI may also take actions related to FDA regulated research if the research is also supported by PHS grants, cooperative agreements, or contracts.
Research Involving Human Subjects
The Office for Human Research Protections (OHRP) is responsible for responding to allegations of misuse of humans in research supported by PHS. Allegations in this area may involve the failure to obtain informed consent from human subjects, mistreatment of human subjects in research, and the failure to get approval from an institutional review board. Contact OHRP at 240-453-6900 or see the OHRP web site located at http://www.hhs.gov/ohrp.
Research Using Animal Subjects
The Office of Laboratory Animal Welfare (OLAW) is responsible for responding to allegations of misuse of animal subjects in PHS research. OLAW is responsible for all of the animal-related functions, including implementing and interpreting the PHS Policy on Humane Care and Use of Laboratory Animals, administering an educational program for PHS-supported institutions and investigators, negotiating Animal Welfare Assurances, and evaluating compliance with PHS policy. Contact OLAW at 301-402-2803 or see the OLAW web site http://grants.nih.gov/grants/olaw/olaw.htm.
Mismanagement of NIH Research Funds
The Office of Management Assessment (OMA) handles allegations of financial mismanagement of NIH research funding. Allegations in this area involve using research funds for unauthorized purposes and the submission of false expenditure claims. Contact OMA at 301-435-1901 or see the NIH web site located at http://oma.od.nih.gov/pi/allegations.html.
Conflicts of Interest
The Office of Extramural Research (OER) is responsible for dealing with conflicts of interest involved in NIH research funding. Contact OER at 301-435-2699 or see the OER web site at http://grants2.nih.gov/grants/policy/coi/index.htm
Other Federal Agencies
The ORI, OHRP, OLAW and OMA only deal with applications or awards for research supported by HHS agencies. Other Federal agencies such as the National Science Foundation, the Department of Veterans Affairs, and the Department of Agriculture also have offices to handle these abuses of the research process.
These abuses do not cover all the problem areas associated with the research process. Other areas - authorship responsibilities, collaboration agreements, data sharing, duplicate publication, laboratory management, and quality control - fall largely within the responsibility of institutions and scientific and professional associations.
