MONEY AND RESEARCH: 
DO WE NEED TO WORRY?

In October the Los Angeles Times reported an investigation of apparent conflict of interest in eight of 36 "Drug Therapy" review articles published in the New England Journal of Medicine since 1997. Authors of these eight articles were found to have undisclosed financial the manufacturers of the drugs reviewed. The journal's guidelines prohibit "editorialists and authors of review articles from having any financial connection with a company that benefits from a drug or device discussed in the editorial or review article." Under these guidelines such prohibited financial connections would include equity interest, consultancies and major research support. According to the LA Times: 

"Among the articles questioned in the "Drug Therapy" series was a 1997 review of multiple sclerosis treatments. The lead author, Dr. Richard A. Rudick of the Cleveland Clinic Foundation, received research funds, speaking fees and travel expenses from three drug companies whose treatments were discussed in the article, he said. 

"In another instance, the sole author of a 1998 review of breast cancer treatments, Dr. Gabriel N. Hortobagyi of the University of Texas M.D. Anderson Cancer Center, said he had received consulting fees, research funds and speaking fees from multiple companies that make drugs assessed in his article." 

Are these revelations something to worry about? There is an ongoing debate about the possible biasing effect that money may have in the scientific enterprise. As the LA Times points out, "because physicians rely on journals for unbiased information, arcane matters of financial conflict of interest may touch the lives of many patients". In other words, there are potential real-life consequences if someone's hidden financial interests lead to reviews of therapies that are more glowing than they might have been without personal monetary incentives. For this reason, most scientific journals now require disclosure of potential conflicts of interest so the reader may evaluate the objectivity of the author's claims in the light of his or her interest. The New England Journal of Medicine has gone a step further, by not the allowing authors of review articles to have any significant financial interest in the therapy being reviewed. In explanation of this policy, Marcia Angell, editor of the journal, is quoted in the LA Times article, "There is a lot of goodwill on the part of an author toward a company that he or she is working with closely, and that can unconsciously bias the work." 

This unconscious bias has been an area of concern for funding agencies for some time, not just as it may affect the writing of reviews, but also as it may affect the design, execution and reporting of original research. In 1995, a federal rule was enacted that requires institutions which receive research funding from the Department of Health and Human Services or the National Science Foundation to have in place policies and procedures for monitoring and managing potential conflicts of interest among investigators. 

As part of the recent reorganization of the Bureau's research policies, a new "Research Financial Disclosure Policy" was finalized in October which will apply to all investigators within the Bureau. This policy will replace the one enacted in 1995 at Cook County Hospital, but is very similar in its particulars. Specifically, all named investigators will be asked at the time they apply for approval from the Scientific Committee or the Animal Care and Use Committee if they have a significant financial interest in the research. If the answer is "yes" (see definition below), the investigator will be asked to provide a statement describing that interest. The committee reviewing the research will determine whether the interest is of a magnitude or type that it might bias the research, and will make a recommendation to the Office of Research Development as to how the potential conflict should be managed. The most likely recommendation will be for simple disclosure of the existence of the interest, in line with the requirements of most scientific journals. 
 

FINANCIAL DISCLOSURE POLICY: KEY POINTS 

All Investigators Must Disclose Significant Financial Interests

An "Investigator" means the principal investigator and any other person who is responsible for the design, conduct, or reporting of research. This means that all persons listed on a protocol as investigators will be expected to disclose their interests, not just the principal investigator. For purposes of determining financial interests, the Investigator's interests include those of his/her spouse and dependent children. 

What Constitutes a Significant Financial Interest?

Significant Financial Interest means anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents, copyrights and royalties from such rights). 

Financial interests which are subject to reporting for any given research proposal include those which would reasonably appear to be affected by the specific research proposed; and/or are interests in entities whose financial interests would reasonably appear to be affected by the research. 

The term "Significant Financial Interest" does NOT include: 
 

A. Salary, royalties, or other remuneration from the applicant institution; 

B. Any ownership interests in the institution, if the institution is an applicant under the Small 
Business Innovation Research Program; 

C. Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit 
entities; 

D. Income from service on advisory committees or review panels for public or nonprofit entities; 

E. An equity interest that when aggregated for the Investigator and the Investigator's spouse and dependent children, meets both of the following tests: 
 

1) Does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, 

AND 

2) Does not represent more than a five percent ownership interest in any single entity; 
 

F. Salary, royalties or other payments that when aggregated for the Investigator and the Investigator's spouse and dependent children over the next twelve months, are not expected 
to exceed $10,000. 

G. Contracts or grant awards made to the institution for which the Investigator is the principal investigator. 
 

Investigators are required to report any significant financial interests at the time of applying for institutional approval of a research proposal. Officials appointed by the institution will consider any reported interests, determine if there is a potential conflict of interest, and, if so, will determine how to manage, reduce or eliminate the conflict. 

Examples of conditions or restrictions that might be imposed to manage conflicts of interest include, but are not limited to: 
 

Public disclosure of significant financial interests; 
Monitoring of research by independent reviewers; 
Modification of the research plan; 
Disqualification from participation in all or a portion of the research funded; 
Divestiture of significant financial interests; or 
Severance of relationships that create actual or potential conflicts. 

NEW HRSA PREVIEW AVAILABLE

The Health Resources and Services Administration, a key federal agency for funding of training programs, service projects and research demonstrations, has issued its Fall edition of the "Preview". This compilation of upcoming opportunities for fiscal year 2000 give details of many HRSA grants, including the purpose, eligibility, deadlines, estimated number of awards to be made, and the phone numbers for obtaining application kits or additional information about the program. 

Unlike many funding agencies, HRSA gives potential applicants very generous lead times for preparing applications by way of this Preview. To obtain a copy, call 1-877-477-2123. 
To look at the Preview on line, go to http://www.hrsa.dhhs.gov/
 
 
 

CORRECTION

In last month's Newsletter, the Associate Research Integrity Officer for the Ambulatory & Community Health Network was listed as Mildred Williamson. The person who will in fact take on this role is Mary Driscoll, RN, who can be reached at 312-633-8236. 

NEW RULE ON DISCLOSING RESEARCH DATA

A new federal rule requires that some data produced as a result of federal funding will have to be made available to the public under the Freedom of Information Act. The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data that are: 

(1) first produced in a project that is supported in whole or in part with Federal funds, and 
(2) cited publicly and officially by a Federal agency in support of an action 
that has the force and effect of law. Agency actions that have the force and effect of law include both regulations and administrative orders.

This new rule, which has been the subject of intense debate in academic circles, became effective in November. In early 2000, NIH will issue a formal guidance about how the rule will affect recipients of NIH grants. Updates on this guidance and on implementation of the rule can be found on the web at: http://www.nih.gov/grants/news.htm

SEMINARS, CONFERENCES, WORKSHOPS, ETC 

[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] 
 

PRIVACY AND CONFIDENTIALITY IN CLINICAL AND SOCIAL SCIENCE RESEARCH: MYTH OR REALITY?  is a conference cosponsored by the University of Texas at Houston and the Office for Protection from Research Risks. It will take place February 10 and 11 in Houston. Call 713-500-5827 for more information. 
 
 

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.
 

          WORKSHOP SCHEDULE, 1999-2000
 

TITLE	Grant Writing	Grant Budgeting	All These Forms (interacting with the IRB)
LENGTH	3 hours	3 hours	2 hours
PLACE	Conference Room,  219 Hektoen	Research Development Office, 277 Hektoen	Conference Room,  219 Hektoen
ENROLLMENT	Limited to 15	Limited to 6	Limited to 15
DATE & TIME	January 11, 2000 12:30 PM May 4, 2000 9:30 AM	February 17, 2000 9:30 AM June 7, 2000 12:30 PM	April 13, 2000 10:00 AM

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All NIH announcements from the past several years, including full text versions of RFA's and PA's, can be reached on the web at: http://www.nih.gov/grants/guide/index.html

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

COGNITIVE APPROACHES TO ADDICTIVE PROCESSES (RFA-DA-01-001) National Institute on Drug Abuse 

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 

NEW THERAPIES FOR DIABETIC FOOT DISEASE (RFA-DK-00-009) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Nursing Research 

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 

HYPERACCELERATED AWARD/ MECHANISMS IN IMMUNOMODULATION TRIALS (RFA-AI-00-005) National Institute of Allergy and Infectious Diseases, National Institute on Aging, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Heart, Lung and Blood Institute, National Institute of Neurological Disorders and Stroke, Office of Research on Women's Health 

CENTERS FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH (RFA-AT-00-001) National Center for Complementary and Alternative Medicine, National Cancer Institute, National Heart, Lung, and Blood Institute 

FOODBORNE ILLNESSES, GASTROINTESTINAL AND RENAL COMPLICATIONS (RFA-DK-00-005) 
National Institute of Diabetes and Digestive and Kidney Diseases, American Digestive Health Foundation 

TYPE 2 DIABETES IN THE PEDIATRIC POPULATION (RFA-DK-00-008) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development 

OXYGEN SENSING DURING INTERMITTENT HYPOXIA (RFA-HL-00-004) National Heart, Lung, and Blood Institute 

PROGRAMS OF EXCELLENCE IN GENE THERAPY (RFA-HL-00-008) National Heart, Lung and Blood Institute 

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

MICROARRAY-BASED RESEARCH ON DRUG ABUSE (RFA-DA-00-003) National Institute on Drug Abuse 

BASIC BEHAVIORAL, COGNITIVE, AND NEUROLOGICAL RESEARCH: APPLICATIONS TO HIV/AIDS AND DRUG ABUSE (RFA-DA-00-005) National Institute on Drug Abuse 

HOST IMMUNE RESPONSE TO OROPHARYNGEAL CANDIDIASIS (RFA-DE-00-001) National Institute of Dental and Craniofacial Research 

HEMODIALYSIS VASCULAR ACCESS CLINICAL TRIALS CONSORTIUM  (RFA-DK-00-012) National Institute of Diabetes and Digestive and Kidney Diseases 

COMPARATIVE MOUSE GENOMICS CENTERS CONSORTIUM (RFA-ES-00-005) National Institute of Environmental Health Sciences 

A QUALITY ASSESSMENT CENTER FOR GENOMIC DNA SEQUENCE (RFA-HG-00-001) National Human Genome Research Institute 

SYSTEMS-RELATED BEST PRACTICES TO IMPROVE PATIENT SAFETY (RFA-HS-00-007) Agency for Healthcare Research and Quality (formerly AHCPR) 

TRANSLATING RESEARCH INTO PRACTICE II (RFA-HS-00-008) Agency for Healthcare Research and Quality (formerly AHCPR) 

INTERNET CONNECTION FOR HEALTH INSTITUTIONS (RFA-LM-00-001) National Library of Medicine 

IMPACT OF HAART ON HIV/CNS DISEASE  (RFA-MH-00-003) National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute on Deafness and Other Communication Disorders 

NATIONAL STEM CELL RESOURCE (RFA-RR-00-001) National Center for Research Resources 

EXTRAMURAL RESEARCH FACILITIES CONSTRUCTION PROJECTS (RFA-RR-00-002) National Center for Research Resources 

AIDS INTERNATIONAL TRAINING AND RESEARCH PROGRAM (RFA-TW-00-003) Fogarty International Center 

NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK (RFA-DA-00-002) National Institute on Drug Abuse 

THE NEXT GENERATION OF DRUG ABUSE PREVENTION RESEARCH (RFA-DA-00-004) National Institute on Drug Abuse 

RESEARCH ON VIRAL HEPATITIS AND HIV IN DRUG USERS (RFA-DA-00-006) National Institute on Drug Abuse 

HIV THERAPY FOR DRUG USERS: ACCESS, ADHERENCE, EFFECTIVENESS (RFA-DA-00-007) National Institute on Drug Abuse 

INTERNATIONAL TRAINING AND RESEARCH IN POPULATION AND HEALTH (RFA-TW-00-004) Fogarty International Center, National Institute of Child Health and Human Development, National Institute on Aging 
 

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(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.

COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) CLINICAL RESEARCH CURRICULUM AWARD (PAS-00-024) National Center for Complementary and Alternative Medicine 

CANCER PREVENTION RESEARCH SMALL GRANT PROGRAM (PAR-00-025) National Cancer Institute 

THE ROLE OF ENDOTHELIAL DYSFUNCTION IN DIABETIC COMPLICATIONS (PA-00-026) National Institute of Diabetes and Digestive and Kidney Diseases 

COMPLEMENTARY AND ALTERNATIVE MEDICINE (CAM) EDUCATION PROJECT GRANT (PAR-00-027) National Center for Complementary and Alternative Medicine,  National Cancer Institute 

RACE/ETHNIC DISPARITIES IN THE INCIDENCE OF DIABETES COMPLICATIONS (PAS-00-028) National Institute of Diabetes and Digestive and Kidney Diseases 

THE ROLE OF MICROGLIA IN NORMAL AND ABNORMAL IMMUNE RESPONSES OF THE NERVOUS SYSTEM (PA-00-029) National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, National Center for Research Resources, National Institute on Deafness and other Communicative Disorders, 
National Institute on Drug Abuse 

NCRR SHARED INSTRUMENTATION GRANT (PAR-00-031) National Center for Research Resources 

BIOENGINEERING RESEARCH PARTNERSHIPS (PAS-00-006) National Cancer Institute, National Center for Research Resources, National Eye Institute, National Human Genome Research Institute, National Heart, Lung, and Blood Institute, National Institute on Aging,National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences, National Institute of Mental Health, 
National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, 
National Library of Medicine 

TRANSLATION OF TECHNOLOGIES TO DETECT ALTERATIONS IN HUMAN TUMORS 
(PAR-00-013) National Cancer Institute 

DEEP INFECTIONS OF TOTAL JOINT REPLACEMENTS (PA-00-014) National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development 

DEVELOPMENT OF THE ENDOCRINE PANCREAS (PAS-00-015) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Child Health and Human Development 

RESEARCH ON ADHERENCE TO INTERVENTIONS FOR MENTAL DISORDERS (PA-00-016) National Institute of Mental Health 

RECEPTORS AND SIGNALING IN BONE IN HEALTH AND DISEASE (PA-00-017) National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Dental and Craniofacial Research, National Institute on Aging, National Institute of Child Health and Human Development 

BIOENGINEERING NANOTECHNOLOGY INITIATIVE (PA-00-018) National Cancer Institute, National Center for Research Resources, National Eye Institute, National Human Genome Research Institute, National Heart, Lung, and Blood Institute, National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute on Drug Abuse, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute of Environmental Health Sciences, National Institute of General Medical Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, ational Library of Medicine 

MENTORED RESEARCH SCIENTIST DEVELOPMENT AWARD (K01) (A-00-019) National Institute on Aging, ational Institute on Alcohol Abuse and Alcoholism, National Institute of Arthritis and Musculoskeletal and Skin Diseases, 
National Cancer Institute, National Institute of Child Health and Human Development, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health Sciences, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Institute of Nursing Research, National Human Genome Research Institute, National Center for Complementary and Alternative Medicine, National Center for Research Resources 

INDEPENDENT SCIENTIST AWARD (K02) (PA-00-020) National Institute on Aging, National Institute on Alcohol Abuse and Alcoholism, National Institute of Allergy and Infectious Diseases, National Institute of Arthritis and Musculoskeletal and Skin Diseases, National Institute of Child Health and Human Development, National Institute on Deafness and Other Communication Disorders, National Institute of Dental and Craniofacial Research, National Institute of Diabetes and Digestive and Kidney Diseases, National Institute on Drug Abuse, National Institute of Environmental Health Sciences, National Heart, Lung, and Blood Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, National Center for Complementary and Alternative Medicine 

SENIOR SCIENTIST AWARD (K05) (PA-00-021) National Institute on Alcohol Abuse and Alcoholism, National Cancer Institute, National Institute on Drug Abuse, National Institute of Mental Health, National Center for Complementary and Alternative Medicine 

MBRS INITIATIVE FOR MINORITY STUDENT DEVELOPMENT (IMSD) (PAR-00-022) National Institute of General Medical Sciences (NIGMS) 

PREDOCTORAL RESEARCH TRAINING IN COMPLEMENTARY AND ALTERNATIVE MEDICINE (PAR-00-023) National Center for Complementary and Alternative Medicine 

INTERNATIONAL COLLABORATIVE ORAL HEALTH RESEARCH PLANNING GRANT (PAR-00-012) National Institute of Dental and Craniofacial Research 
 
 
 

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