April 2002, Vol. 20 No. 4
CONFLICTS OF INTEREST IN RESEARCH - MANAGEMENT STRATEGIES
By Connie Bridges, Director of Administration for Research and Graduate Studies
This is the last in a series of short articles about issues related to management of potential conflicts of interest in research-related activities. To see the previous articles, view the January and February Biomedical Newsletters at:
http://www.med.umich.edu/medschool/orgs/biomednews/index.html
The Medical School Conflict of Interest Board recognizes the need to manage rather prohibit potential conflicts of interest when it is expected to serve the interests of the University of Michigan. With that in mind, the Conflict of Interest Board works with individuals to fashion plans that permit the activities to occur. Some of the typical elements are noted here.
Objectivity, reliability and management of research directions must be protected.
- It is important to protect the integrity of the research results when one or more of the investigators has an outside relationship to the sponsor of the project (consulting, technology license, etc.). The Board seeks to clearly separate the individual's roles as UM employee performing research and any role in advising the sponsor. If the investigator cannot clearly define separation between the topic of the research and the area of consulting, the Board may require that the investigator withdraw from consulting during the term of the research project. In unavoidable conflicts that serve the University's interests, the Board may require special oversight of the research project by an unconflicted individual.
Transparency is an important tool that protects both the investigator and the University from allegations of conflict of interest.
- The Board requires that the outside interest in the research be disclosed to all trainees, staff and faculty who participate in the research. It is recommended that documentation of the disclosures be retained.
- The Board also requires investigators to disclose the conflict of interest situation in presentations and publications resulting from the research.
- Disclosure of the relationship to the sponsor to human research participants is also an important management aspect in clinical research studies and will be managed through agreements on process with the IRBMED.
- If the conflict involves a financial interest (such as ownership of stock in the sponsor in excess of $10,000) the Board may require the investigator to disclose the management plan to the sponsor.
Reporting to Departments and Regular Progress Reports
- Management plans approved by the Conflict of Interest Board must be signed by the Department Chair. This ensures disclosure to the unit of the potential conflict issues.
- Management plans are also copied to individuals or groups who may have responsibility for overseeing parts of the plan.
- Management plans are not static documents and therefore, the Board requires regular progress reports to review changes in activities relative to the conflict and to provide an opportunity to request additional documentation, such as submission of research publications. Typically the progress reports are requested every six months.
*COI on the web at http://www.med.umich.edu/medschool/orgs/ResearchPolicies/index.html.
For questions or comments, contact Connie Bridges at cbridges@umich.edu or 763-4086.
NEW MEDICAL SCHOOL RESEARCH POLICIES EFFECTIVE MARCH 1, 2002
http://www.med.umich.edu/medschool/orgs/ResearchPolicies/index.html
In September 2001 the Research Policies Review Committee* was charged with the revision of certain Medical School research policies, some of which had not been reviewed in over a decade. The proposed policies were approved by the Medical School Executive Committee on March 1, 2002. The full policies can be found on the web at the URL noted above.
- Sub-Accounts – This new policy provides guidance to Medical School departments/units on establishing sub-accounts for inter-unit research projects. The policy formalizes current practice between units and is consistent with the usual expectations for projects between Schools and Colleges. If a secondary unit on a project has 5% or more faculty effort on the project, the primary unit must establish a sub-account when requested. For proposals with significant non-faculty expenses on a grant in a secondary unit, but with less than 5% faculty effort, a sub-account is a reasonable expectation if the project will use the secondary unit's facilities or administrative resources.
- Indirect Cost Waivers – This revision emphasizes the financial cost for indirect cost waivers shared by departments and the Dean's Office. Waivers continue to be a rare occurrence and final approval remains the responsibility of the Associate Dean for Research. In addition to a revised policy, the Committee developed a worksheet to assist researchers and departments in determining the cost of proposed waivers.
- Institutional Cost Sharing – This revised policy takes into account the distribution of F&A recoveries and distributes commitments for institutional cost-sharing between the Dean’s Office and the departments/units participating in a project based upon the expected F&A recoveries expected. The categories considered for institutional cost-sharing remain largely unchanged.
Questions about these policies can be directed to Connie Bridges, Director of Administration for Research and Graduate Studies (cbridges@umich.edu, 763-4086).
*RPRC Committee members: Connie Bridges (Chair), Maria Ceo, Harry Granito, Dennis Martin, Heather Offhaus, Jim Randolph, Jim Shayman and Mike Welsh
POSTDOCTORAL FELLOW APPOINTMENT TIME LIMIT, NEW POLICY EFFECTIVE MARCH 1, 2002
In keeping with NIH guidance, postdoctoral researchers at the University of Michigan Medical School can henceforth be considered Postdoctoral Fellows or Research Fellows for a maximum of five years in the U.S. beyond awarding of a doctoral degree, not counting time taken off from research training or employment.
The official title of "Research Fellow" can be used for any postdoctoral researcher before the five-year limit, regardless of source of payment for the Fellow. The Principal Investigator (PI) is responsible for making sure the Research Fellow has health insurance. If the Fellow is paid directly by an outside agency, it is possible to arrange a University appointment that will allow the PI to provide University staff health insurance. To continue a University appointment beyond the five year training limit (or sooner), the Fellow must be converted to an employee with full staff benefits, including health insurance.
For a copy of the complete policy contact Denise Swayze in the Office of Research and Graduate Studies (dswayze@umich.edu, 3-4086). For questions about the policy, please contact David Engelke, Assistant Dean for Graduate and Postdoctoral Studies (engelke@umich.edu).
GET YOUR IRBMED SUBMISSION ON THE FAST TRACK!
Want to speed your protocol’s progress through the review process? The U-M Medical School’s Institutional Review Board (IRBMED) has identified 12 common mistakes and oversights that many investigators make. Avoid these, and your review may go much faster!
- Use current forms and templates. IRBMED forms and templates are continuously evolving to keep pace with a fast-changing regulatory climate. Download the latest versions from the IRBMED web site http://www.med.umich.edu/irbmed/ each time you submit an application.
- Answer each question clearly and completely. Consult the application instructions. Do not answer a question with "See Attached." Instead, clearly and concisely summarize the important points from the attached document.
- Provide current and revised copies when amending documents. Clearly indicate what each document is, and highlight the revisions being made.
- Include the currently approved consent document with each submission. There are only two exceptions: (1) if consent is waived for the project; or (2) if subject recruitment is closed. Clearly indicate any exception, and state the reason again in the section of the application form where the list of supporting documents is requested.
- Be sure that the project title is the same on all documents, and reflects the title approved by the IRBMED.
- Save electronic copies of all documents in Rich Text Format (.rtf) on a PC-formatted disk. Avoid Mac-formatted disks.
- Use simple file names. Examples are application.rtf, current consent.rtf, revised consent.rtf, protocol.rtf, advertisement.rtf, brochure.rtf, etc. Skip the snazzy study references like "RLXXZ 40 extension study on Iowa natives.rtf."
- Include only one application submission per disk. Multiple submissions on one disk can cause confusion and delay. Label the disk clearly.
- Be sure that your submission is complete. Use the checklist provided with the application to double-check that your submission packet includes all required items.
- Sign your name. Only applications with original signatures of investigators will be accepted. Principal investigators must sign every submission; co-investigators need to sign only when added to the project.
- Submit well in advance of deadlines. Giving special priority to tardy submissions because expiration is looming bogs down the entire system and causes delay for all.
- Tell us where to fax the approval notice. Enter one or more fax numbers in section 1.8 of the application for each submission. Double-check for typos or obsolete numbers.
AWARD RECIPIENT
The Office of Research and Graduate Studies is pleased to announce that Sarah Ross, Graduate Student in Physiology, is a winner of the Horace H. Rackham School of Graduate Studies Distinguished Dissertation Award. Congratulations Sarah!
FUNDING OPPORTUNITIES
Blue Cross Blue Shield of Michigan Foundation Grants to Reduce Disparities in Health Care
Deadline: April 15, 2002
http://www.bcbsm.com/foundation/
Blue Cross Blue Shield of Michigan Foundation is seeking letters of interest from academic institutions, community nonprofit and health care organizations to develop and evaluate projects to understand the causes of and to reduce healthcare disparities driven by race and ethnicity. BCBSM is dedicating $500,000 to this initiative over a two year period to fund several projects at approximately $75,000 per year which will cover salary support, supplies, office operation, limited travel expenses and consultation fees. See the Foundation website for complete details on the initiative.
Blue Cross Blue Shield of Michigan Foundation Grants for Patient Safety in Hospitals
Deadline: April 15, 2002
http://www.bcbsm.com/foundation/
Blue Cross Blue Shield of Michigan Foundation is seeking letters of interest from Michigan-based clinicians and researchers interested in developing ways to improve patient safety by reducing errors and accidental injuries in hospitals. BCBSM is dedicating $500,000 to this initiative. Several multi-year grants are to be awarded which will cover salary support, supplies, office operation, limited travel expenses and consultation fees. See the Foundation website for complete details on the initiative.
Bristol-Myers Squibb Award for Distinguished Achievement in Infectious Diseases Research
Deadline: April 22, 2002
http://www.bms.com/foundation/awards.html
Bristol Myers Squibb is currently accepting nominations for their annual award of $50,000 to a scientist who has made an outstanding contribution to progress in infectious diseases research in laboratory or clinical studies. Complete details and nomination forms can be found on their website.
Institute of Medicine Gustav O. Lienhard Award
Deadline: May 17, 2002
The Institute of Medicine is accepting nominations for the Gustav O. Lienhard Award. The award is a medal and $25,000 and recognizes individuals for outstanding achievement in improving health care services in the U.S. The Award focuses on creative or pioneering efforts that have improved personal health services rather than on contributions to the science base of health care. There are no eligibility limits on the education and profession of individuals who may be nominated. Award recipients are selected on the basis of two principal criteria: achievement in the area of personal health services, and achievement of national scope. Contact Denise Swayze at dswayze@umich.edu or 3-4086 for a faxed copy of the Award announcement with complete details.
Centers for Disease Control and Prevention Price Fellowships for HIV Prevention Leadership
Deadline: May 1, 2002
http://www.cdcfoundation.org/fellowships/price/index.html
The Centers for Disease Control and Prevention (CDC) is accepting applications for the Price Fellowship for HIV Prevention Leadership. The fellowship enables representatives from three non-governmental, community-based organizations to spend a month at the CDC in Atlanta, Georgia. They can explore the latest, most effective ways to stop the spread of HIV and learn how the agency's research, funding, and communication systems work. The fellows are given the opportunity to complete a project or pursue a special interest. The fellowship period is August 5-30, 2002. The CDC will reimburse each fellow's salary up to $4,000 for the month of the fellowship. Check the CDC website for complete details.
Ethel Louise Armstrong Foundation Offers Scholarships for Female Graduate Students with Disabilities
Deadline: June 25, 2002
http://www.ela.org/
The Ethel Louise Armstrong Foundation, Inc. (ELA) promotes health in communities through arts, education, and advocacy for the inclusion of people with disabilities. ELA seeks to expand opportunities for female graduate students with disabilities and develop future leadership in the disability community. The foundation will award one or two scholarships of up to $2,000 each per academic year to supplement financial assistance received by a female graduate student. Visit the ELA website for complete details.
United Auto Workers-General Motors RFP
Deadline: May 16, 2002
The United Auto Workers-General Motors and United Auto Workers-Delphi National Joint Committee on Health and Safety requests proposals (letters of intent) to address several concerns related to the incidence, prevalence and/or management of fatigue, discomfort and/or musculoskeletal disorders related to standing and walking among UAW-GM and UAW-Delphi employees. For complete information, contact Suzette.Jewell@uawgm-chr.org or 313-324-5000.
SYMPOSIUM, WORKSHOP & SEMINARS
Michigan Life Sciences Corridor Core Technology Alliance Symposium
May 14, 2002, Holiday Inn—West Lansing Conference Center, Lansing, Michigan
http://www.CTAalliance.org
The Michigan Life Sciences Corridor Core Technology Alliance Symposium is titled "Exploring Opportunities for Research Advancement and Product Development in Genomics, Proteomics, Structural Biology, Animal Models and Biological Information." This scientific event will announce the development of the Core Technology Alliance (CTA), a collaborative network of advanced technology facilities available for use by Michigan researchers affiliated with universities, private research institutes, and biotechnology or pharmaceutical firms. See the CTA website for more information and to register.
The IRBMED Announces Spring Workshop
Wednesday, April 10, 2002
10 a.m. - 12:15 p.m., Dow Auditorium, Towsley Center
"Navigating IRBMED Processes Research & IRBMED Review"
No registration required. For more information, email insco@umich.edu
Graduate Program in Immunology/UM Comprehensive Cancer Center Tumor Immunology Program Seminar
Wednesday, April 10, 2002
12:00 - 1:00 p.m., Room 2901 LRC (James V. Neel Lecture Hall)
The speaker will be Joseph E. Craft, M.D., Professor of Medicine and Immunobiology, Chief, Section of Rheumatology, Yale School of Medicine. The topic will be "T Cell Activation in Systemic Autoimmunity."
The Center for Organogenesis Seminar Series
Friday, April 12, 2002
11:00 a.m., 2901 LRC (Learning Resource Center)
Jonas Frisen, M.D., Ph.D., Professor in Stem Cell Research at the Laboratory of Genetics in the Department of Cell and Molecular Biology, Medical Nobel Institute, Karolinska Institute in Stockholm, Sweden will speak on "Generations of Neurons from Stem Cells in the Adult Brain."
Friday, April 26, 2002
3:30 p.m., 5915 Buhl Building
Monte Westerfield, Ph.D., Professor at the Institute of Neuroscience in the Department of Biology at the University of Oregon will speak on "Induction of Muscle Cell Fates by Hedgehog Signaling."
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)
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).
Cellular & Molecular Therapeutics Seminar Series
Monday, April 8, 2002
1:00 p.m., 2903 LRC (located on Floor 2 of the Taubman Library)
"Stem Cell Therapy for Acute and Chronic Disease" presented by H. David Humes, M.D., Professor of Internal Medicine.