March 2002, Vol. 20 No. 3
CONFLICTS OF INTEREST IN CLINICAL RESEARCH
By Connie Bridges, Director of Administration for Research and Graduate Studies
This is the second in a series of short articles about issues related to management of potential conflicts of interest in research-related activities. To see the first article, go to http://www.med.umich.edu/medschool/orgs/biomednews/Vol20/February2002.html.
Although it is important to disclose all potential conflicts of interest, an area where particular care must be taken is in conflicts related to clinical projects with human research participants. The Medical School Conflict of Interest (COI) Board carefully reviews these potential conflicts and provides information to the IRBMED for their consideration when reviewing the protocol. The disclosure mechanisms and management strategies employed at the Medical School ensure the integrity of our research results, provide assurance of our ongoing commitment to the welfare of the human research participants entrusted to our care, and are consistent with recent national guidance on financial interests in clinical research.
Some of the typical financial interests reviewed for conflict management by the COI Board are found in the Table below. If you are the principal investigator or co-investigator on sponsored research projects where the potential for conflict exists, you must disclose your issue to the University.
Completing either the Medical School's Outside Employment Disclosure (http://www.med.umich.edu/medschool/orgs/coi.outside.html) or the University’s Significant Financial Interest Disclosure (http://www.research.umich.edu/research/policies/um/conflict_procedures.html#form) provides the initial information needed to ensure the systematic review of potential conflict situations.
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COMMON CONFLICTS REVIEWED AND HOW TO DISCLOSE
Provide consulting services for the sponsor of the research. Serve on any scientific, advisory or oversight boards for the sponsor. Receive income from the company through honoraria, speaker’s bureaus, etc., in excess of $10,000 in one year. Own stock, stock options or other equity interest in the sponsor in excess of $10,000 in one year. Receive outside remuneration from the sponsor, which, in aggregate, will exceed $10,000 in one year. Licensed technologies and/or equity in a start-up company related to the sponsor in any way. |
There are standard management strategies for financial conflicts, including disclosure of the interest to trainees, employees and faculty who work with you, disclosure of the interest in publications and presentations about the research, and possible outside monitoring oversight of the research by individuals without conflicts. In clinical research, additional management may include limitations on who may consent research subjects and/or disclosure of the financial interest in consent documents, as well as disclosure of the management plan to the IRBMED.
Do I have a conflict situation? The very best way to answer this question is to complete the appropriate disclosure form or call the number below and ask for advice.
Next month: Roles and responsibilities for monitoring conflict management plans
*COI on the web at: http://www.med.umich.edu/medschool/orgs/ResearchPolicies/index.html.
For questions or comments, contact Connie Bridges, cbridges@umich.edu or 763-4086.
GENERAL CLINICAL RESEARCH CENTER (GCRC) UPDATED APPLICATION FORMS
The GCRC has updated its application as of January 30, 2002 to be consistent with the recent NIH policies and changes. Investigators requesting GCRC resources and space for clinical research should use the application form online at http://www.med.umich.edu/gcrc/. Click on the "application" button for updated application forms and information. The GCRC continuously updates its application, therefore bookmark this website and check it often. For questions, email gcrc@med.umich.edu.
INTERNAL FUNDING OPPORTUNITIES
UM CANCER CENTER FUNDS AVAILABLE—Deadlines May 1 and November 1, 2002
http://www.cancer.med.umich.edu/i/researchfunding.htm
The U-M Cancer Center announces the following Cancer Research Committee funding opportunities: The John and Suzanne Munn Endowment—$25,000 available to senior investigators, IDEA Grants—$15,000 available to any level of investigator, and Innovation Cancer Research Grants-—up to $50,000 for one year. The Committee welcomes any proposal that will strengthen the position of the University in cancer research, particularly if it represents an interdisciplinary approach to the cancer problem. Complete details on the awards and application forms are available on the U-M Comprehensive Cancer Center web site or email Ginny Schneider at ginnysch@umich.edu.
INNOVATIVE RESEARCH APPLICATIONS IN THYROID CANCER—Deadline April 4, 2002
http://www.cancer.med.umich.edu/i/researchfunding.htm
The U-M Comprehensive Cancer Center announces the availability of funds to support innovative research projects that will advance understanding of the pathogenesis of thyroid cancer and/or improve its diagnosis and treatment. One applicant allowed at this time. Awards are for one year of support, with a budget of up to $50,000 that can be used for personnel, supplies, small equipment purchase, or other reasonable costs (e.g., animal purchase and maintenance or core laboratory usage). For complete details and application instructions see the Cancer Center web site or contact Ginny Schneider (6-9603) or ginnysch@umich.edu.
FUNDING OPPORTUNITIES
THE NATIONAL CANCER INSTITUTE AWARDS—http://www.cancer.gov/
The National Cancer Institute (NCI) has a series of career development awards available for faculty members, postdoctoral, junior and young investigators. These awards cover the basic and clinical sciences, patient oriented research, and prevention control behavioral and population sciences. Complete details on this series of "K" training grants can be found on the NCI website at http://cancertraining.nci.nih.gov/.
ASSOCIATION OF AMERICAN MEDICAL COLLEGES—Deadline March 22, 2002
The Association of American Medical Colleges is accepting letters of intent for 52 Potential Extramural Research Topics (PERT’s), as part of the Cooperative Agreement between the Centers for Disease Control and Prevention (CDC) and the AAMC. For detailed information, visit http://www.aamc.org/members/cdc/perts/.
ELLISON MEDICAL FOUNDATION—Deadline March 13, 2002—http://www.ellison-med-fn.org/emf_gid_ssa_over.jsp
The Ellison Medical Foundation requests letters of intent for their Senior Scholar Award in Global Infectious Disease. Awards will be made for up to $150,000 per year for up to four years. The Program funds basic research on molecular and cellular mechanisms of parasitology and infectious diseases that result from microbial, protozoan, or viral pathogenesis. See the Foundation website for complete details on the Program.
ROBERT WOOD JOHNSON FOUNDATION—Deadline April 5, 2002—http://www.rwjf.org
The Robert Wood Johnson Foundation requests letters of intent for their Investigator Awards in Health Policy Research. The Foundation will provide grants of up to $275,000 for a 24–36 month period to 10 highly qualified individuals, from investigators early in their careers to distinguished senior scholars. The program seeks to explore underlying values of health policy in the United States and to apply new perspectives from a variety of disciplines to analyze the functions of health care and public health systems. The program will analyze social, political, and economic factors that influence the population's health and develop innovative ideas for improving health and health care delivery. See the Foundation website for complete details, eligibility and application procedures.
INSITUTE FOR RESEARCH ON UNLIMITED LOVE—Deadline March 29, 2002—http://www.unlimitedloveinstitute.org
The Institute for Research on Unlimited Love request letters of intent from all scientific disciplines. The goals of the Institute are: To better understand the human potential for loving through the study of emotion and behavior from human development, epidemiology, health care, neurobiology, neuroscience, positive psychology, sociology, and evolutionary biology. To better understand how the expression of unlimited love in society might be fostered, and to promote widespread dialogue on the empirical, theoretical, practical and socially beneficial dimensions of exemplary lives of service and love. Funding is expected to range from $30,000 to $100,000 for each individual research project. Thirty projects may be funded. See the Institute website for complete details, eligibility and application procedures.
WILDERNESS MEDICAL SOCIETY AWARDS—Deadline May 1, 2002—http://www.wms.org
The Wilderness Medical Society, an organization that promotes quality research activities relating to environmental, outdoor and wilderness medicine announces award opportunities. The Charles S. Houston Award is $5,000 for medical student research. The Research Training Award of up to $5,000 is for investigators at the resident, graduate student or Fellow level and the Herbert N. Hultgren Research Award of up to $5,000 is available to post-graduate or other WMS members involved in research. See the Society website for complete details and application procedures.
KEIO UNIVERSITY MEDICAL SCIENCE PRIZE—Deadline April 1, 2002—http://www.ms-fund.keio.ac.jp/
The Keio University Medical Science Fund is accepting nominations for their prize, which is awarded in recognition for outstanding achievements in the field of medical or life sciences. The Prize consists of a certificate of merit, a medal, and a monetary award of 20 million yen ($149,52 US Dollars). See the Fund website for complete details and application procedures.
CONVENTIONS AND EXCHANGE PROGRAMS
NATIONAL MEDICAL ASSOCIATION ANNUAL CONVENTION—Deadline April 1, 2002
The National Institutes of Health and the National Medical Association announce the Annual Convention and Scientific Assembly to be held in Honolulu, Hawaii on August 3-8, 2002. The workshop for the Clinical Fellows Scholars Program will focus on "Opportunities and Sponsored Programs in Biomedical Research." The purpose of the award is to enhance the potential research careers of residents and fellows and to encourage research in disease areas that disproportionately affect the health of under served communities. The award will cover transportation, hotel and meals for 3 days. Contact Denise Swayze at dswayze@umich.edu or 763-4086 for a faxed copy of the eligibility and application requirements.
NATIONAL RESEARCH COUNCIL RUSSIAN EXCHANGE PROGRAM—Deadline April 30, 2002
The National Research Council (NRC) is sponsoring a program of international exchange for American scientists interested in the prophylaxis, diagnosis, epidemiology, and therapy of pathogens, including related basic research investigations. The program will provide the successful applicants with an opportunity to spend two weeks during the fall of 2002 becoming familiar with research and related work on pathogens being carried out at research institutes in Russia. This program is supported by the Department of Defense, which is interested in encouraging the redirection of former Soviet defense scientists to civilian pursuits. The NCR will cover all travel expenses related to participation in the program, including international airfare, food, lodging, and transportation within the foreign country. For complete details, application and eligibility requirements on this program contact Sara Gray at 202-334-2923 or at sgray@nas.edu.
SEMINARS
MEDICAL TECHNOLOGY COMMERCIALIZATION SEMINAR SERIES
http://www.techtransfer.umich.edu/news/articles/medtechcomm.html
Presented by the University of Michigan Office of Technology Transfer (OTT) and the Medical School Office of Technology Transfer and Corporate Research (OTTCR)
March 28
12:00-1:30 PM, North Lecture Hall of Med. Sci. II
Lunch will be provided
Topic: Comparing Cultures: Academic vs. Commercial - The importance of teamwork; relying on data; the importance of execution. Presented by Abhijit Banerjee (Pfizer, Inc.)
April 25
12:00-1:30 PM, North Lecture Hall of Med. Sci. II
Lunch will be provided
Topic: Intro to Intellectual Property: What are patents/copyrights, what do they do, why do you want one and how do you get one; why keep lab notebooks? Presented by Robin Rasor (OTT) & Rick Brandon (OTT).
May 23
12:00-1:30 PM, North Lecture Hall of Med. Sci. II
Lunch will be provided
Topic: Licensing: Key Terms - Licensing terms and related issues; what do they mean to inventors, licensees and taxpayers? Presented by Susan Kornfield (Bodman, Longley and Dahling, LLP) & Elaine Brock (OTTCR).
GRADUATE PROGRAM IN IMMUNOLOGY SEMINAR SERIES
Wednesday, March 6, 2002
12:00 - 1:00 p.m., Room 5623 Med Sci II
The Graduate Program in Immunology and the UM-Comprehensive Cancer Center Tumor Immunology Program will sponsor a seminar. The speaker will be Polly Matzinger, Ph.D., Ghost Lab, National Institutes of Allergy and Infectious Disease, National Institutes of Health. The topic will be "T cell conversations via dendritic cells."
INSTITUTE OF GERONTOLOGY SEMINAR SERIES
Thursday, March 7, 2002
3:30 p.m., 300 NIB, Room 904
"Informal Caregiving for Diabetes and Diabetic Complications among Older Americans", presented by Kenneth Langa, M.D., Ph.D., Assistant Professor of Internal Medicine and Faculty Associate at the Survey Research Center, Institute for Social Research.
Thursday, March 14, 2002
3:30 p.m., 300 NIB Room 904
"The Aging Mind: Behavioral, Cultural and Neuroscience Perspectives", presented by Denise Park, Ph.D., Professor of Psychology and Senior Research Scientist at the Research Center for Group Dynamics, Institute for Social Research.
CELLULAR & MOLECULAR THERAPEUTICS SEMINAR SERIES
Monday, March 4, 2002
1:00 PM, 2901 LRC (located on Floor 2 of the Taubman Library)
"SNPing Away at Disease", presented by Dr. Stephen Chanock, Immunocompromised Host Section, Pediatric Oncology, NCI/NIH.
GIL OMENN, EXECUTIVE VP FOR MEDICAL AFFAIRS: LIFE SCIENCES INITIATIVES
Wednesday, March 13, 2002
4:00 p.m., Room 1400 Chemistry Building
Gil Omenn, University of Michigan Executive Vice President for Medical Affairs, will deliver an address entitled "Life Sciences Initiatives at the U of M--From Basic Research to Clinical Translation to Tech Transfer."
COMPLEMENTARY AND ALTERNATIVE MEDICINE RESEARCH CENTER (CAMRC) WORKSHOP
Thursday, May 16 (evening)
Friday, May 17, 2002 (all day)
UM Brighton Medical Center
80001 Challis, Brighton, MI
Dan Dwyer, Ph.D, and Rita Benn, Ph.D., "Reclaiming the Passion for Medicine: A Physician Retreat." The program fee is $175. It is limited to 15 participants and approved for 8 AMA PRA Category 1 Credit Hour. The program will provide physicians with opportunity to take time and space to reflect and replenish inner resources, and to reaffirm the practices that enhance the ability and capacity to serve others while maintaining balance in life.
FUNCTIONAL NEUROIMAGING SPERAKER SERIES
March 7, 2002
3:30-5:00 p.m.
East Hall Room 4448, 4th Floor (Colloquium Room)
Juergen Lorenz, Ph.D, Associate Professor of Physiology, Institute of Physiology, University of Hamburg/Germany will speak on, "Keeping Pain Out of Mind-Neuroimaging Findings into the Role of the Dorsolateral Prefrontal Cortex in Human Pain Processing."
Light refreshments will be served.
March 12, 2002
3:30-5:00 p.m.
East Hall Room 4448, 4th Floor (Colloquium Room)
Paul J. Whalen, Ph.D,
Assistant Professor of Psychiatry and Psychology, University of Wisconsin - Madison, W.M. Keck Laboratory for Brain Imaging and Behavior, will speak on "Amygdala, Ambiguity, and Anxiety."
Light refreshments will be served.
ALTERNATIVE MEDICINE SPEAKER SERIES
Come learn about the most talked-about techniques in Alternative Medicine! The UMHS Women's Health Program and Complementary and Alternative Medicine Research Center sponsor this free event. Sessions will be held in Room D of the Michigan League from 7:00 -8:30 p.m. For more information, call
the Women's Health Resource Center at (734) 936-8886.
Tuesday, March 12: Neuromuscular Integrative Action Technique
Join us for an interactive session about this expressive fitness and
movement program! Wear comfortable clothes.
Tuesday, March 19: Understanding Homeopathic Medicine
Learn about the empowerment and peace of mind that homeopathy can bring to you!
Tuesday, March 26: Introduction to Acupuncture and Acupressure Come find out about this ancient healing method and how to make it a part of your everyday health routine!