NEW BUREAU POLICY: INVESTIGATING POSSIBLE SCIENTIFIC MISCONDUCT

Three new policies have been adopted in recent months to insure that all research in the Cook County Bureau of Health Services qualifies for federal funding. The first of these, dealing with protection of human subjects, was discussed in the August issue of this Newsletter. The second of these new policies, dealing with scientific misconduct, is the focus of this issue. 

As discussed below, adoption of this new Bureau policy coincides with changes in policies recently adopted by the Department of Health and Human Services (DHHS), and with a proposed new rule to apply across the whole federal government. Since most research funding in the Bureau originates with DHHS, these changes in policy apply immediately to most of our research. 

What is Scientific Misconduct?

Investigators are sometimes puzzled about what is covered by the term "scientific misconduct". Science is a system that depends on every participant maintaining high standards of conduct in a number of arenas. For instance, when living beings - whether human or animal are the subjects of research, there are expectations about how they will be protected. When public funds support research, there are expectations about how they will be expended. When hazardous materials are used in research, there are expectations about how they will be handled to reduce any associated risks. In the arena of the scientific method itself, adherence to standards of truthfulness is necessary if the method is to produce valid knowledge. If scientific reports were filled with false data or misleading accounts of methods and procedures, the accumulated body of knowledge on which science is built would be shaky indeed. Not only would an investigator have no way to confidently move a research program forward, but real-life applications of scientific findings, especially clinical applications, would be unreliable, invalid, or even dangerous. "Scientific misconduct" refers specifically to violations of the expectation of honesty in reporting scientific findings. Violations of other expectations, such as those for protecting subjects mentioned earlier, are addressed by other policies and procedures. 

Scientific misconduct has been defined as " fabrication, falsification, plagiarism, or other practices that significantly deviate from the commonly accepted practices of the scientific community with respect to the proposal, performance or reporting of research". As discussed later in this article, this definition has recently been revised to be more specific, but it is still based primarily on three ways in which one can be dishonest about carrying out and reporting research. 

Is Scientific Misconduct a Problem?

All persons who have been trained to carry out research understand that the scientific enterprise depends on a social compact of honesty in reporting. Many have questioned whether instances of fabrication, falsification or plagiarism are frequent enough to require a raft of bureaucratic rules and procedures. For the past three years, the number of new allegations of misconduct reported to federal regulators has been between 50 and 70 per year, with the numbers declining. Of these allegations, around 10-15% result in full investigations. Of the cases in which the federal Office of Research Integrity carries out an investigation, about 1/3 result in findings of misconduct. This translates to perhaps 9 or 10 cases of confirmed misconduct per year. In the vast world of scientific research, these are very small numbers. 

However, it is impossible to know how many cases of misconduct go undiscovered. One thing both critics and supporters of the current system agree on: Ferreting out misconduct after it has happened is probably less effective and efficient than adequate training of researchers to avoid misconduct in the first place. For this reason, the ORI has decided to shift its focus to education, and the DHHS has adopted a rule requiring recipients of federal research funding to provide training in the responsible conduct of research to all staff engaged in research with PHS funds. This new requirement will apply to the entities of the Bureau. 
 

Department of Health and Human Services: Changes in Policy

The Department of Health and Human Services operates a collaborative system for promoting integrity in biomedical and behavioral research supported or conducted by agencies of the U.S. Public Health Service (PHS). The system for preventing, detecting, and investigating scientific misconduct involves cooperative efforts among individual scientists, research institutions, and PHS agencies, especially the National Institutes of Health. The HHS Office of Research Integrity (ORI) monitors the system. 

Institutions which carry out research funded by DHHS must make assurances that they have adopted appropriate policies and procedures for handling allegations of scientific misconduct. These assurances are made with each application for research funding, and are also supported by yearly reports made by the Research Integrity Officer. 

In 1996, the HHS Secretary convened the Review Group on Research Misconduct and Research Integrity to examine the system under which the Department handles allegations of research misconduct, which included a review of the issues addressed by the Commission. In October 1999, the review group issued its recommendations, which were accepted by the Secretary. Under the proposals agreed to: 
 

1. The Department will adopt through rulemaking a new definition of research misconduct that focuses on improper behaviors related specifically to the conduct of research. The definition, proposed by the National Science and Technology Council, will also be adopted by other federal agencies engaged in research [see box next section] 

2. Institutions that administer PHS-supported grants will maintain responsibility for conducting initial inquiries and investigations when allegations of misconduct are made. However, when further fact finding is required by the federal government, it will be carried out by the Office of the Inspector General rather than the ORI, as previously was the case. 

3. Inquiries and investigations into potential research misconduct will be separated from the decision making process of determining if misconduct occurred. The ORI will recommend findings and sanctions to the Assistant Secretary for Health, who will make the final decisions regarding misconduct, subject to appeal. 

4. The Departmental Appeals Board (DAB) will continue to hear appeals from individuals who contest findings of misconduct. Each DAB appeals panel will include 2 scientists, and the appeals process will be streamlined with clarified procedures and rules for conducting hearings. 

5. The Department will require research institutions to provide training in the responsible conduct of research to all staff engaged in research or research training with PHS funds. This expands an existing NIH requirement that applied only to research trainees. 

New Federal-Wide Rule Proposed 

The Federal Office of Science and Technology Policy has issued a proposed "Federal Policy on Research Misconduct To Protect the Integrity of the Research Record" with a request for public comment which will be open until December 13. This new rule will apply across all federal agencies. It adopts a definition of scientific misconduct that is consonant with the one recently adopted by HHS (see box) and also incorporates most of the procedural changes included in the new HHS policy. 
 
 

New Definition of Scientific Misconduct

From the proposed "Federal Policy on Research Misconduct To Protect the Integrity of the Research Record" 
 
 

Research misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.      1. Fabrication is making up results and recording or reporting them  2. 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.  The research record is defined as the record of data or results that embody the facts resulting from scientific inquiry, and includes, for example, laboratory records, both physical and electronic, research proposals, progress reports, abstracts, theses, oral presentations, internal reports, and journal articles.  3. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit, including those obtained through confidential review of others' research proposals and manuscripts.  [Ed. Note: see the following article for a discussion of what is and is not plagiarism] Research misconduct does not include honest error or honest differences of opinion.    A finding of research misconduct requires that:    There be a significant departure from accepted practices of the scientific community for maintaining the integrity of the research record;  The misconduct be committed intentionally, or knowingly, or in reckless disregard of accepted practices; and  The allegation be proven by a preponderance of evidence.

Other major points covered by the proposed policy are: 
 

• Initial responsibility for investigation lies with the research institution;
• Multiple phases of the investigation are required, including inquiry, investigation and adjudication phases, with provisions for appeals;
• Separation of the phases, with adjudication decisions separated from the inquiry and investigation processes;
• Institutional notification of the agency, which specifies the circumstances in which the institution must notify the federal funding agency of a scientific misconduct investigation;
• Safeguards for informants;
• Safeguards for the subject of the allegation;
• Objectivity and expertise of individuals to review allegations and conduct investigations;
• Timeliness of the inquiry, investigation, adjudication, and appeal phases;
• Confidentiality during inquiry and investigation.
• Possible administrative actions for those found to have committed scientific misconduct 

Under the new Bureau policy, responsibility for dealing with allegations of scientific misconduct is assigned to a Bureau Research Integrity Officer (RIO), assisted by an Associate Research Integrity Officer at each Bureau affiliate. Persons who have concerns about possible scientific misconduct may speak to one of these officers confidentially. When an allegation of misconduct is brought, the Associate RIO and the RIO will confer as to whether the alleged conduct falls within the definition of scientific misconduct and whether there is reasonably sufficient evidence to warrant further inquiry. If both conditions are met, a fact-finding inquiry will be carried out, by a small committee appointed by the RIO. The inquiry provides a preliminary review to separate serious allegations from frivolous, unjustified, or clearly mistaken conclusions which are drawn from observations. 

If the inquiry committee finds that a full investigation is warranted, the Chief Operating Officer of the entity where the misconduct is alleged to have taken place will appoint a committee to investigate and report on the allegations. This report will be delivered to the Chief Operating Officer, who will decide if sanctions are called for. 

The policy includes safeguards from retaliation for persons who bring complaints in good faith, and safeguards for persons accused of misconduct. The policy also delineates when the Bureau is obliged to report to ORI allegations that lead to inquiries or investigations. 

The new policy will be distributed to researchers at all Bureau affiliates in a research guidebook now being printed. 

Who Are the Bureau Research Integrity Officers? 
 

The Bureau Research Integrity Officer is Dr. Robert Weinstein. He can be contacted at 312-633-3237 

For Cook County Hospital, the Associate Research Integrity Officer is Keith Dookeran, MD, at 312-633-8207 

For Provident Hospital, the Associate Research Integrity Officer is Clyniece Watson, MD, at 312-572-2684. 

For Oak Forest Hospital, the Associate Research Integrity Officer is Henry Andoh, MD at 708-633-4193 

For the Ambulatory & Community Health Network, the Associate Research Integrity Officer is Mildred Williamson at 312-747-7700. 

For Cermak Health Services, the Associate Research Integrity Officer is Jean Kiriazes at 773-869-6575. 

For the Cook County Department of Public Health, the Associate Research Integrity Officer is Steven M. Seweryn, at 708-492-2021.

ORI PROVIDES WORKING DEFINITION OF PLAGIARISM

The following was prepared by the Office of Research Integrity to help researchers distinguish between plagiarism and other issues of contention, such as authorship disputes. 

Although there is widespread agreement in the scientific community on including plagiarism as a major element of the PHS definition of scientific misconduct, there is some uncertainty about how the definition of plagiarism itself is applied in ORI cases. 

As a general working definition, ORI considers plagiarism to include both the theft or misappropriation of intellectual property and the substantial unattributed textual copying of another's work. It does not include authorship or credit disputes. 

The theft or misappropriation of intellectual property includes the unauthorized use of ideas or unique methods obtained by a privileged 
communication, such as a grant or manuscript review. 

Substantial unattributed textual copying of another's work means the unattributed verbatim or nearly verbatim copying of sentences and 
paragraphs which materially mislead the ordinary reader regarding the contributions of the author. ORI generally does not pursue the limited use of identical or nearly-identical phrases which describe a commonly-used methodology or previous research because ORI does not consider such use as substantially misleading to the reader or of great significance. 

Many allegations of plagiarism involve disputes among former collaborators who participated jointly in the development or conduct of a research project, but who subsequently went their separate ways and made independent 
use of the jointly developed concepts, methods, descriptive language, or other product of the joint effort. The ownership of the intellectual 
property in many such situations is seldom clear, and the collaborative history among the scientists often supports a presumption of implied consent to use the products of the collaboration by any of the former 
collaborators. 

For this reason, ORI considers many such disputes to be authorship or credit disputes rather than plagiarism. Such disputes are referred to PHS agencies and extramural institutions for resolution. 
 

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[A long-term calendar showing most of the major academic medical society meetings can be found on the web at: http://www.aamc.org/meetings/mjmtgcal.htm] 

Office of Research Integrity Conferences: 
March 24,Teleconference on Making the Right Moves in Handling Misconduct Allegations, 
National Council of University Research Administrators (NCURA). Call 
618-650-3018; or email: shansen@siue.edu

April 10-11, The Role and Activities of Scientific Societies in Promoting Research Integrity, American Association for the Advancement of Science (AAAS), Washington, D.C. For information: Fax (202) 289-4950; or email: societies@aaas.org. 

June 4-5,Practicum on Responding to Allegations of Research Misconduct, American Association for the Advancement of Science (AAAS), St. Charles, IL. For more information call 202-326-7016, or email: rgray@aaas.org
 

Donor's Forum of Chicago Workshops:

ABC's of Proposal Preparation & Writing: December 6-7, January 13-14 

Major Gift and Capital Campaign Fund Raising: December 15 

Securing Support from Individuals: January 20 

Call 312-578-0175 for more information

Illinois Department of Public Health Conferences: 
Governor's Conference on Aging & Human Services, Chicago, December 1-3. Call 217-785-3387 

2000 Illinois Chronic Disease Prevention Conference; Springfield, February 23-24. Call 217-782-3300 
 

Office of Research Development Workshops 

These workshops are open to any County-affiliated investigator or grant-seeker. Enrollment for some sessions is limited, so please register only for those you will be able to attend. 

Grant Writing Seminar:

Gives an overview of the entire process of developing a project and applying for funding. Includes information on approaching both governmental and private funders, describes an approach to developing grant budgets, discusses stylistic and content issues that are frequent stumbling blocks in writing grant applications.

Constructing a Grant Budget:

Covers many of the technical aspects of developing an accurate time line and budget for a grant proposal.

What Are All These Forms? Interacting With the Scientific Committee: 

Gives an orientation to procedures -- and the associated forms -- used by the Scientific Committee to 
ensure that patients are protected from undue risks in research. The Bureau forms will be discussed, and new policies and changes in federal regulations will be covered.

To register for any of these, call Bennetta Anderson at 312-633-4941. If you would like to schedule one or more of these workshops in your Department or at another site, please call Karen Smith at 633-4940. 
 

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To have the NIH Guide sent automatically to your e-mail address every week, click on the LISTSERV link on this page and follow the instructions.

To ask specific questions about NIH grant programs, send e-mail to: grantsinfo@nih.gov 
 

These are one time only opportunities. Call 312-633-4940 to check for due dates or to get copies of full announcements

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MULTIDISCIPLINARY CLINICAL RESEARCH CENTERS FOR ARTHRITIS, MUSCULOSKELETAL, AND SKIN DISEASES (RFA-AR-00-001) National Institute of Arthritis and Musculoskeletal and Skin Diseases 

HEALTH DISPARITIES: LINKING BIOLOGICAL AND BEHAVIORAL MECHANISMS WITH SOCIAL AND PHYSICAL ENVIRONMENTS (RFA-ES-00-004) National Institute of Environmental Health Sciences, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute of Mental Health, National Institute for Occupational Safety and Health, Office of Behavioral and Social Sciences Research 

SCOR: MOLECULAR GENETICS OF HYPERTENSION (RFA-HL-00-002) 
National Heart, Lung, and Blood Institute 

ELECTRICAL REMODELING: NOVEL OPPORTUNITIES FOR ARRHYTHMIA CONTROL (RFA-HL-00-003) National Heart, Lung, and Blood Institute 

INFLAMMATION IN THE PATHOGENESIS OF COPD (RFA-HL-00-006) National Heart, Lung, and Blood Institute 

INTERDISCIPLINARY RESEARCH TEAMS FOR MOLECULAR TARGET ASSESSMENT (RFA-CA-00-001) National Cancer Institute 

SPECIALIZED CENTERS OF RESEARCH (SCORs) IN OSTEOPOROSIS, RHEUMATOID ARTHRITIS AND SCLERODERMA (RFA-AR-00-002) National Institute of Arthritis and Musculoskeletal and Skin Diseases 

CLINICAL RESEARCH CURRICULUM AWARD (RFA-OD-00-002) National Institutes of Health 

SMALL GRANTS FOR UNDERREPRESENTED MINORITY SCIENTISTS IN DIABETES AND DIGESTIVE AND KIDNEY DISEASES 
(RFA-DK-00-007) National Institute of Diabetes and Digestive and Kidney Diseases 

GENE EXPRESSION PROFILING IN THE NERVOUS SYSTEM (RFA-MH-00-002) 
National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, 
National Eye Institute, National Institute of Child Health and Human Development, National Institute on Aging, National Institute on Deafness and Other Communication Disorders, National Institute on Drug Abuse 

NEW TREATMENT FOR COMPLICATIONS FROM VACCINIA IMMUNIZATION 
(RFA-AI-00-001) National Institute of Allergy and Infectious Diseases 

ANTI-ORTHOPOXVIRUS DRUG DISCOVERY AND DEVELOPMENT (RFA-AI-00-002) National Institute of Allergy and Infectious Diseases 

ORTHOPOXVIRUS GENOMICS AND BIOINFORMATICS RESOURCE CENTER 
(RFA-AI-00-003) National Institute of Allergy and Infectious Diseases 

UNDERSTANDING AND ELIMINATING MINORITY HEALTH DISPARITIES 
(RFA-HS-00-003) Agency for Health Care Policy and Research 

MINORITY INTERNATIONAL RESEARCH TRAINING GRANTS (RFA-TW-00-001) 
Fogarty International Center, Office of Research on Minority Health 

ECOLOGY OF INFECTIOUS DISEASES 
(RFA-TW-00-002) Fogarty International Center, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences, National Institute of Allergy and Infectious Diseases, National Science Foundation, Agricultural Research Service, National Aeronautics and Space Administration, United States Geological Survey 
 

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NIH PROGRAM ANNOUNCEMENTS 
(PA'S): These are ongoing funding priorities, with due dates usually October 1, February 1 and June 1 of each year. Note that HIV-related applications are due January 2, May 1 and September. Past PA's, many of which are still open, can be searched at the NIH Guide web site.
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NIDCD CLINICAL TRIAL PLANNING GRANT (PAR-00-007) National Institute on Deafness and Other Communication Disorders 

COOPERATIVE PROGRAM ON RETINAL DEGENERATIVE DISEASE RESEARCH 
(PA-00-009) National Eye Institute 

MENTORED CLINICAL SCIENTIST DEVELOPMENT AWARD (PA-00-010) 
Agency for Health Care Policy and Research 

PLANNING GRANTS FOR NCI CANCER RESEARCH CENTERS (PAR-00-011) 
National Cancer Institute 

SOCIAL WORK RESEARCH DEVELOPMENT PROGRAM (PAR-00-008) National Institute on Drug Abuse 
 
 

March 1 
MATERNAL AND CHILD HEALTH RESEARCH, Health Resources and Services Administration (301-443-2190 or http://www.hrsa.dhhs.gov) 

December 15 
MATERNAL/CHILD HEALTH RAINING AT PEDIATRIC PULMONARY CENTERS, Health Resources and Services Administration (301-443-2190 or http://www.hrsa.dhhs.gov) 

February 9 
BIOMARKERS FOR CHILDREN, Environmental Protection Agency (202-564-6909 or http://es.epa.gov/ncerqa/rfa/kids2000.html) 

January 12 (preapplication) 
EXPERIMENTAL AND COMPUTATIONAL BIOLOGY, Department of Energy (301-903-9009 or http://www.sc.doe.gov/production/grants/grants.html) 

Open 
ENERGY SCIENCES, Department of Energy (301-903-5212 or http://www.sc.doe.gov/production/grants/grants.html) 

February 4 
DISABILITY AND REHABILITATION RESEARCH PROJECTS, Department of Education (877-433-7827 or http://ocfo.ed.gov/fedreg.htm) 

February 11 
CARE FOR PREGNANT WOMEN EXPERIENCING DOMESTIC VIOLENCE, Health Resources and Services Administration (301-443-9991 or http://www.hrsa.dhhs.gov) 

December 12 (letter of intent) 
MATERNAL AND CHILD HEALTH CONTINUING EDUCATION Health Resources and Services Administration (301-443-2190 or http://www.hrsa.dhhs.gov) 

February 2 (letter of intent) 
HEALTHY START INFRASTRUCTURE/ CAPACITY BUILDING Health Resources and Services Administration (301-443-0543 or http://www.hrsa.dhhs.gov) 

February 1 
ETHICS AND VALUES STUDIES, National Science Foundation (703-306-1743 or http://www.nsf.gov/pubs/1999/nsf9982/nsf9982.htm) 
 
 
 

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