Conflicts of Interest and Outside Employment Activities
By Connie Bridges, Director of Administration for Research and Graduate Studies
This is the first in a series of short articles about issues related to management of potential conflicts of interest in research-related activities.
Since 1993, the Medical School has had an active Conflict of Interest Board reviewing potential conflicts related to research activities. * The Board has ten voting members, including nine from the faculty, and is chaired by Associate Dean Steven Goldstein. The Board’s authority to review and approve conflict management plans is derived from the Dean and the Executive Committee of the Medical School, who approve Board appointments and operating procedures. The Office of the Vice President for Research (OVPR) is responsible for institutional compliance with Federal, State and University regulations, laws and policies and is represented at Board meetings. A second campus board within OVPR reviews conflicts for individuals in units outside the Medical School.
The typical ways that the Medical School COI Board is notified of a potential conflict situation are:
- Investigator disclosure of significant financial interest when submitting proposals for externally sponsored funds. The University threshold is $10,000 or 5% equity. These thresholds are established by Federal regulation.
- Review of the disclosure of an outside employment activity determines that the individual also has sponsored research from the same external organization. There is no dollar threshold for Medical School researchers; any outside activity with a sponsor requires review of the COI Board.
- Activities related to disclosure of inventions, the licensing of technologies, or the establishment of "start-up" companies in which a UM-investigator has a role requires disclosure and management prior to obtaining Regental approval.
The Board recognizes the need to manage rather than prohibit potential conflicts of interest when it is expected to serve the interests of the community and the University of Michigan. Disclosure of activities in these categories does not mean an investigator will be prohibited from the activity. Often there are management strategies that will permit the relationship to continue. With adequate disclosure and management, along with regular follow-up to update the COI Board on the activity, important collaborations and relationships are likely to be permitted.
What happens when the Board is notified of a potential conflict?
Staff supporting the Conflict of Interest Board will contact the investigator to evaluate the specific situation. They will obtain needed information for a full disclosure, and then work with the investigator to develop a draft management plan for review and approval of the Board. There are standard management strategies that meet most common conflict situations. More complex interactions may require additional review to develop appropriate oversight that protects both the investigator and the University.
Next month: conflicts involving research with human subjects.
*Medical School COI on the web:
http://www.med.umich.edu/medschool/orgs/ResearchPolicies/index.html.
For questions or comments, contact Connie Bridges at cbridges@umich.edu or 763-4086.
Behind Closed Doors of a Study Section: How to get your NIH Grant Funded
Saturday, March 16, 2002
9:00 a.m. - 12:00 noon, Dow Auditorium, Towsley Center, University Hospital
http://www.med.umich.edu/medschool/bmrc/bmrcstudysection.html
The Biomedical Research Council (BMRC) invites you to become a member of a University of Michigan Special Study Section. We have organized this Study Section to review a grant from a U-M faculty member which was reviewed, revised, and then funded after its first revision. The Study Section will be comprised of approximately ten BMRC members who have all served on NIH committees, and you. As a new Study Section member, the Chairman will review for you the process of an evaluation and critique and will introduce you to the particularities of our Study Section (because each Study section has its own chemistry). The applications will be sent to you as your registration for this program is confirmed. Comments of the reviewers will also be sent as they become available so that you can read the grant prior to March 16 to better follow the critique by the study section and participate in the discussion.
The morning will begin with a general review of grant writing skills by Christine Black of the School of Nursing (former DRDA grant writing specialist). The second section of the program will be a brief exposition by James Ferrara of the Medical School regarding the normal, tortuous journey of a grant application from the PI to the Study Section reviewer. He will also describe the criteria by which R01 applications are evaluated and how study section members use these criteria. Following these presentations, the majority of the morning will be occupied with the review of the initial application followed by a review of the revised application. The morning will conclude with an open question period between the audience and the BMRC Study Section reviewers.
One of the most important survival skills for academic researchers is the ability to write successful grant applications. This workshop will provide valuable information and insight into the NIH review process. We believe this exercise will be of considerable value to young investigators who are striving to achieve independence. Postdoctoral fellows and junior faculty are strongly encouraged to attend.
There is no registration fee for this session, however, we ask for your preregistration so that we can send you the proposals materials and recommendations being reviewed. You may register by e-mailing bmrcstudysection@umich.edu. Please direct your questions to Camille Mrozowski at cmrozow@umich.edu or 5-8802. A continental breakfast will be available starting at 8:45 a.m. in the Dow Lobby.
Internal Award Opportunities
Biomedical Research Council New Initiative for Basic Science
Internal Deadline February 15, 2002
The New Initiative Funding program supports high-quality scientific projects of a primarily basic science nature, specifically aimed at obtaining preliminary results to facilitate the investigators’ applications for extramural support. One-year awards of up to $40,000 are available for projects identified through competitive peer review as being catalysts for exciting new research initiatives. In some cases, funding for a second year may be considered. All projects must involve a PI with a primary instructional or research track appointment at the Medical School. It is expected that proposals will provide a clear statement detailing plans for submission of an application for external support submitted by the end of the first year of funding. The application and guidelines are available on the web at: http://www.med.umich.edu/medschool/bmrc/bmrcnewinit.html or by contacting Camille Mrozowski, cmrozow@umich.edu, 615-8802. 25 copies of the proposal should be submitted to the Office of Research and Graduate Studies, 4107 Medical Science I / 0624 by Friday, February 15, 2002.
Biomedical Research Council Equipment Competition
Internal Deadline March 1, 2002
The annual Equipment Competition supports the purchase of research equipment by Medical School Faculty. The equipment use must be broad in scope and enhance the externally funded research efforts of multiple users representing a variety of disciplines. Priority is extended to applications involving users from more than one unit or department, to equipment requests involving funding needs which could otherwise not be accommodated through external grants, and to those requests which include cost-sharing contributions from the units of the participating users. Well-justified applications from Biomedical Core Facilities are also acceptable. Applications may request between $20,000 and $100,000 for items which do not duplicate existing equipment currently available for use on campus and which do not duplicate services provided by any of the Biomedical Shared Core Facilities. The application and guidelines are available on the web at: http://www.med.umich.edu/medschool/bmrc/bmrcequip.html or by contacting Camille Mrozowski, cmrozow@umich.edu, 615-8802. 25 copies of the proposal should be submitted to the Office of Research and Graduate Studies, 4107 Medical Science I / 0624 by Friday, March 1, 2002.
Bioinformatics Pilot Grant Award
Internal Deadline March 1, 2002
http://www.bioinformatics.med.umich.edu
The U-M Program in Bioinformatics announces the availability of funds to support collaborative research in bioinformatics. For purposes of this program, we view bioinformatics as a field whose goal is to elucidate and quantify the complex web of interactions that link the numerous hierarchical levels of organization from DNA sequence to integrated behavior of the intact organism in its environment. The following interrelated thematic areas are included: measurement of molecular components (especially using high throughput technologies), automated feature extraction, systemic modeling and prediction, and management of evolving databases.
Proposals that deal with the development of widely applicable methods and global approaches are particularly encouraged. Collaboration is essential and preferably will involve investigators in different disciplines or
sub-disciplines. Eligible investigators include members of the university’s regular instructional and research track faculty and Pfizer employees who are collaborating with a University investigator. Collaborations between different units are encouraged. Awards of up to $75,000 will be made for a period of one year.
Application materials and detailed instructions may be obtained from our web page. Contact: Michelle Overholser at moverhosler@umich.edu or 615-5510. Applications must be submitted no later than March 1, 2002.
U-M Research Partnership Program (Distinguished Faculty and Graduate Student Seminars)
Internal Deadline March 1, 2002
http://www.research.umich.edu/research/funding/um_sources/rpp2002.html
The purpose of these awards is to enhance the intellectual climate for faculty and graduate student scholarship by sponsoring a limited number of special seminars, colloquia, and distinguished visitor events. The opportunity for faculty and graduate students to spend time exploring topics of mutual interest, often with the benefit of interaction with renowned scholars from other institutions, has proven to be an excellent means for fostering collaboration and stimulating new research. Any department, interdisciplinary program or school that has an approved doctoral program under the Horace H. Rackham School of Graduate Studies may participate.
A maximum of ten awards will be made for 2002. Awards will range from $5,000 to $10,000 and may be used to complement funds from department, college or external sponsors. See the OVPR web site (listed above) for complete information and application guidelines. Contact: Stacy Wilkin at swilkin@umich.edu or 3-6048. Deadline for applications is March 1, 2002.
U-M Research Partnership Program (Spring/Summer Research Grants)
Internal Deadline March 1, 2002
http://www.research.umich.edu/research/funding/um_sources/rpp2002.html
This program provides faculty with research assistance during the Spring/Summer terms and provides financial support and tasks of intellectual and professional benefit to doctoral students. The proposed work need not be central to the student's area of interest or part of a larger collaboration. Any department, interdisciplinary program or school that has an approved doctoral program under the Horace H. Rackham School of Graduate Studies may participate. Up to thirty grants will be awarded. In addition, there will be two Sokol Grants for Faculty and Graduate Student Research Projects in the Sciences. No additional application is required for consideration for the Sokol Grants. Grants of up to $4,000 are available to faculty with the expectation that they will hire a doctoral student admitted to or currently enrolled at the U-M committed to work 200 hours for the Spring/Summer term. The salary does not include tuition or health benefits.
See the OVPR web site (listed above) for complete details and application guidelines or contact Rackham Graduate School Dean's office, 764-4400.
Funding Opportunities
Damon Runyon Clinical Investigator Award
Internal Deadline February 11, 2002
http://www.drcrf.org
The Clinical Investigator Award program is specifically intended to provide outstanding young physicians with the resources and training structure essential to becoming independent clinical investigators in the area of cancer research. Applicants must have a M.D. or M.D./Ph.D. degree from an accredited institution and be board-eligible in a cancer or cancer related specialty (e.g., oncology, pathology, radiation therapy, surgery, and hematology). Applicants may apply during the final year of their sub-specialty training or within the first two-years of their junior faculty appointment. Their mentor and institution must nominate applicants. The award will provide financial support for the investigator ($100,000 per year for 5 years), a senior mentor (15,000-30,000 per year) and the costs of research (75,000 per year). The University of Michigan may nominate one individual. Deadline for submission of application to Damon Runyon is March 1, 2002. For consideration as the institutional nominee, submit the following by February 11, 2002: a 1-2 page research summary, a CV, and a nominating letter from the department chair.
Submit all internal applications to the Office of Research and Graduate Studies, 4107 Med Sci I, Box 0624 by February 11, 2002. Contact: Denise Swayze, 763-4086 or dswayze@umich.edu. Complete details on this award can be found on the Damon Runyon web site.
The Camille and Henry Dreyfus Foundation New Faculty Awards Program
Internal Deadline April 1, 2002
http://www.dreyfus.org/
The Dreyfus Foundation New Faculty Awards Program grant is for new faculty members in the chemical sciences who are beginning research and teaching activities at institutions that grant doctorates in chemistry, chemical engineering, or biochemistry. This prestigious award includes an unrestricted research grant of $40,000. Only faculty members who start their first full-time tenure-track appointments between January 1, 2002 and December 31, 2002 are eligible for awards in 2002. Nominees are normally expected to have no more than three years of postdoctoral experience. The U-M is allowed to nominate one faculty member for this award. Please see the DRDA limited submissions web site for guidelines on the internal nomination process at:
http://www.research.umich.edu/research/funding/limited_submissions/limited_submissions.html
The Foundation deadline is May 15, 2002.
Pfizer ARA Program: A Focus on the Science
Deadline March 15, 2002
Pfizer Inc. announces the 2002 ARA Program. The mission of the ARA program is to support outstanding investigators at the early stages of their careers in academic research. The ARA will support research into basic mechanisms of disease that may broadly involve Lipid metabolism and/or vascular biology and HMG-CoA reductase pathways or novel effects of statins. Research may be in any of the following areas: Neuroscience, Cardiovascular medicine, Diabetes, Endocrinology, Immunology and Oncology. Awards are $50,000 per year with the potential for funding for 2 years. For more information about the ARA Program, contact: Grant Coordinator at ARAwards@mindspring.com.
Invitrogen Research Tools Grant Program
Deadline March 1, 2002
http://www.invitrogen.com/content.cfm?pageid=3945&cfid=153234&cf
Invitrogen announces the Research Tools Development Grants Program. This Program allows investigators to develop innovative tools for use in life science research, including discovery, development, and commercialization. The Grants are provided on a quarterly basis. Each quarter Invitrogen requests grant proposals for a specific field of interest. For the first quarter of 2002, Invitrogen seeks applications in the area of Enzymes for Molecular and Cell Biology, including topics such as labeling technologies, gene reporter systems, gene cloning, gene expression and gene amplification. Funding ranges from $25,000 to $100,000 for one year. Applicants must submit a preproposal. Applicants that are accepted will be asked to submit a full proposal. Invitrogen indicates that grant proposals will only be accepted through execution of a Confidential Disclosure Agreement (CDA) between Invitrgen and the University. If so, the CDA must be processed through DRDA. See the Invitrogen web site for complete details and forms.
The Louis and Artur Lucian Award for Research in Circulatory Diseases
Deadline March 1, 2002
McGill University is securing nominations for the twenty-fourth annual Louis and Artur Lucian Award for Research in Circulatory Diseases. The Award provides for financial support of the investigators and their families during their visit to McGill University. The goal of this Award is to produce collaborative research in the field of circulatory diseases between McGill and research centers in Canada, the United States and other countries. The deadline for applications is March 1, 2002. Contact Denise Swayze at dswayze@umich.edu or 763-4086 for a faxed copy of the nomination form and guidelines.
The Alton Ochsner Award
Deadline March 29, 2002
Nominations are now being accepted for the Seventeenth Annual Alton Ochsner Award Relating Smoking and Health. An annual award of $15, 000 will be presented to one or more clinical and/or basic science investigators, for outstanding and exemplary original scientific investigations that relate tobacco consumption and health. This scientific work may be clinical, fundamental, epidemiological or preventive in scope. The prime criterion for award selection is its scientific impact on this major health threat. Deadline for nominations is March 29, 2000. Contact Denise Swayze at dswayze@umich.edu or 763-4086 for a faxed copy of the guidelines.
Blue Cross Blue Shield of Michigan Foundation Student Award Program
Deadline April 30, 2002
http://www.bcbsm.com/foundation
The Blue Cross and Blue Shield of Michigan Foundation invites medical and doctoral students at Michigan universities to submit proposals for the 2002 Student Award Program. The Program provides a stipend to students conducting research designed to improve health care in Michigan and encourages students to conduct research, thus enhancing their academic experience. The Program offers a one-year stipend of $3,000 for research activities. Students are eligible for one award. Grant monies are not intended to support field placements, practica or internships. See the Foundation web site for application guidelines.
Blue Cross Blue Shield of Michigan Foundation Excellence in Research Award Program
Deadline March 15, 2002
http://www.bcbsm.com/foundation
The Blue Cross and Blue Shield of Michigan Foundation is pleased to announce its seventh annual Excellence in Research Award: Recognizing Excellence in Health and Medical Research. The Foundation will award $10,000 for unrestricted research in two categories: (1) Health Policy including public health or health service research and (2) Clinical Research. The BCBSM Foundation seeks nominations of Michigan-based researchers with terminal research degrees (e.g., Ph.D., Dr.P.H.). Nomination guidelines can be found on their web site.
Blue Cross Blue Shield of Michigan Foundation Excellence in Research Award Program for Physicians
Deadline March 15, 2002
http://www.bcbsm.com/foundation
The Blue Cross and Blue Shield of Michigan Foundation is pleased to announce its seventh annual Excellence in Research Award for Physicians. This award recognizes research that contributes to improving health and medical care for Michigan residents. The BCBSM Foundation will award $10,000 for unrestricted research in two categories: (1) Health Policy including public health and/or health service research and (2) Clinical Research. The Foundation seeks nominations of Michigan-based physicians (M.D. or D.O.). Complete details can be found on their web site.
Seminars
Graduate Program in Immunology Seminar
Wednesday, February 13, 2002
12:00-1:00 p.m. Room 5623 Med Sci II
The Graduate Program in Immunology and the U-M Comprehensive Cancer Center Tumor Immunology Program will host this seminar. The speaker will be Dr. Craig L. Slingluff, Jr., M.D., Professor of Surgery, Chief, Division of Surgical Oncology, and Director, Human Immune Therapy Center at the University of Virginia. The topic will be "Multi-Epitope Peptide Vaccines for Melanoma."
Complementary & Alternative Medicine Research Center Workshop
Thursday & Friday, February 7 & 8, 2002
Brighton Medical Center, University of Michigan Health System
Dan Dwyer, Ph.D. and Rita Benn, Ph.D. "Reclaiming the Passion for Medicine: A Physician Retreat." Program will provide physicians with opportunity to reflect and replenish inner resources, and reaffirm practices that enhance the ability and capacity to serve others while maintaining balance in life. Register on-line: http://www.med.umihc.edu/camrc.
Complementary & Alternative Medicine Research Center Distinguished Lecture
Friday, February 8, 2002
11:30-12:30 p.m. MCHC Auditorium, Mott Children's Hospital
Charles Figley, P.h.D. "Compassion Fatigue." Dr. Figley is a Professor in the School of Social Work at Florida State University, Director of theTraumatology Institute and Green Cross Projects, and a highly recognized marriage and family therapist. His research and clinical interests have focused on stress, trauma and burnout. He is the author of over 160 scholarly works, including 16 books and the editor of the American Psychological Association Book Series on Stress and Trauma.
Complementary & Alternative Medicine Research Center Lecture Series
Thursday, February 14, 2002
12:00 noon, MCHC Auditorium, Mott Children's Hospital
Diane Culik, M.D. "Magnetics for Prevention and Treatment in Medicine." Dr. Diane Culik is a family physician in private practice, who has extensive experience in utilizing magnetic technologies for health promotion and treatment.
Cellular & Molecular Therapeutics Seminar Series
Monday, February 11, 2002
1:00 p.m., Room 2901 LRC (located on Floor 2 of the Taubman Library)
"Angiogenic Gene Therapy for Vascular Disease-Separating Fact from Fantasy." Sanjay Rajagopalan, M.D., Assistant Professor of Internal Medicine
Center for Organogenesis 2002 Seminar Series
Friday, February 8, 2002
3:30 PM, 5915 Buhl Building
Eric R. Fearon, M.D., Ph.D. and Emanual N. Maisel, Professor of Oncology, Assoc. Professor of Patholgoy and Human Genetics will speak on: "Role of APC and Catenin Defects in Cancer."
Center for Organogensis 2002 Seminar Series
Friday, February 22, 2002
3:30 PM, 5915 Buhl Building
Jack M. Parent, M.D., Assistant Professor of Neurology will speak on: "Adult CND Neurogenesis: Can We Rebuild a Broken Brain?"
Functional Neuroimaging Speaker Series
Tuesday, February 12, 2002
3:30-5:00 p.m., East Hall, 4448 Colloquium Room
Sponsored by the Functional MRI Laboratory (fMRI). David McGonigle, Biomagnetic Imaging Lab, Department of Radiology, University of California, San Francisco, UCSF. "Never Mind the BOLD, Here's the Session Effects: Generalisability in fMRI." Light refreshments will be served.
