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RESEARCH AND GRADUATE STUDIES

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Biomedical News
April 2003, Vol. 21 • No. 4

Table of Content

Dean's Awards Association for the Cure of Cancer of the Prostate Funding
Burroughs Wellcome Fund Awardees Sontag Distinguished Scientist Awards
Weintraub Graduate Student Award Recipient Department of Defense Breast Cancer Research Program
New! Clinical Research Grand Round Series Local Initiative Funding Partners Program
CACR Study Coordinator Workshop Center for Organogenesis Seminar Series
Conflicts of Interest Management Strategies Third Annual James V. Neel Lectureship
UM Ford Nuclear Reactor Decommissioned James Neubacher Award
Tylenol Scholarships Research Responsibility Program, final "Wrap-Up"

Dean's Awards
Basic Science Research Award
Internal Deadline: May 15, 2003
The Medical School Dean’s Office is soliciting nominations for the Basic Science Research Award. This award is to recognize a scientist or group of scientists identified as having made outstanding contributions to the Medical School in basic biomedical science research. This award carries a $5,000 discretionary academic support prize, which will be given to the faculty member or group.

Nominations submitted to the Biomedical Research Council will be reviewed and a list of potential awardees given to the Dean of the Medical School, who will make the final selection. Nominees must be faculty in the rank of Assistant or Associate Professor, or Assistant or Associate Research Scientist of the University of Michigan Medical School.

Nominations must include the following: a letter of support from the department chair or unit director; two or more letters of support from UM faculty; a three page maximum summation of the nominee’s research work; one or more manuscripts reflecting the substance of research achievement; and a current CV.

Send complete nomination to Steven A. Goldstein, Ph.D., Associate Dean for Research and Graduate Studies, 4107 Medical Science I/Box 0624.


Clinical Research Award
Internal Deadline: May 15, 2003
The Medical School Dean’s Office is soliciting nominations for the Clinical Research Award. This award is to recognize a faculty member or group of faculty members who are identified as having made outstanding contributions to the Medical School in clinical research. This award is open to all ranks of clinical research faculty in the Medical School. This award carries a $5,000 discretionary academic support prize, which will be given to the faculty member or group.

Nominations submitted to the Advisory Council on Clinical Research will be reviewed and a list of potential awardees given to the Dean of the Medical School, who will make the final selection.

Nominations must include the following: a letter of support from the Department Chair; two or more letters of support from UM faculty; a three page maximum summation of the nominee’s research work; one or more manuscripts reflecting the substance of research achievement; and a current CV.

Send complete nomination packets to Steven A. Goldstein, Ph.D. Associate Dean for Research and Graduate Studies, 4107 Medical Science I/Box 0624.

Merajver and Markovitz Receive Burroughs Wellcome Fund Awards
The Office of Research and Graduate Studies is pleased to congratulate David Markovitz, M.D. and Sofia Merajver, M.D., Ph.D. Each have been awarded the Burroughs Wellcome Fund Clinical Scientist Award in Translational Research. Dr. Markovitz, Professor, Internal Medicine, Division of Infectious Diseases will receive funding for his research titled "New Approaches to Inhibiting HIV Replication." Dr. Merajver’s, Associate Professor, Internal Medicine, Division of Hematology/Oncology research focuses on "Genetic Determinants of Aggressive Breast Cancer Phenotypes: Translation to the Clinic."

The Burroughs Wellcome Fund Clinical Scientist Awards in Translational Research are designed to help advance the productivity of independent physician-scientists at the mid-career level who will enhance translational research in academic health centers through their own studies and through mentoring of the next generation of physician scientists trainees. Only 6 awards were made for this prestigious national program, and we are the only institution with two awards this year.

Feng Shao Receives Harold M. Weintraub Graduate Student Award
Congratulations to Feng Shao, a Ph.D. candidate in Biological Chemistry for his receipt of this special award. Mr. Shao is mentored by Jack Dixon, Ph.D.

The Weintraub Award is sponsored by the Basic Sciences Division of the Fred Hutchinson Cancer Research Center. The award honors the late Harold M. Weintraub, Ph.D., a founding member of Fred Hutchinson's Basic Sciences Division, who in 1995 died from brain cancer at age 49. The Fred Hutchinson Cancer Research Center, home of two Nobel Prize laureates, is an independent, nonprofit research institution dedicated to the development and advancement of biomedical technology to eliminate cancer and other potentially fatal diseases. Only 6 students received this award internationally.

New! Clinical Research Grand Round Series
Monday, April 14
12–1 PM
MCHC Auditorium
The Center for the Advancement of Clinical Research (CACR) is launching a new Clinical Grand Round Series, highlighting topics of general interest to the clinical research community. CACR is co-sponsoring this series along with the General Clinical Research Center (GCRC) and the K-30 Training Program in Clinical Research.

The first speaker in the series will be Eugene Orringer, M.D., Executive Associate Dean for Faculty Affairs at the University of North Carolina Medical School. Dr. Orringer has been instrumental in the clinical research infrastructure, programs, and training at UNC. He will present "New Career Opportunities for Clinician/Scientists: Mentored Research & Professional Development".

CACR is arranging for CME/CEU credits for this session. For more information email CACR: umcacr@umich.edu or check the CACR website.

CACR Study Coordinator Training Workshop
The Education and Certification Core (ECC) from the Center for the Advancement of Clinical Research (CACR) has a monthly program for NEW study coordinators (less than six months on-the-job experience) with 3 primary education modules:

° The ABC's of Good Clinical Practices Requirements
° The Roles and Networks of Study Coordinators
° The "How to's" of Clinical Research Study Files
This interactive workshop also provides basic GCP aides and tools:

° GCP regulations booklets for Investigators and Coordinators
° FAQs Guide for Study Coordinators
° Investigator Study File Notebook Prototype and Templates of Common Forms
The next program will be held on Tuesday, April 15, from 8:30-12:30 in LRC 2903. Register by April 9. There is a $50 per person fee to cover materials. UMMS CMEs (4.0 Category I credit hrs) and UMHS Nursing CEUs (4.2 contact hrs) are available.

Contacts: Erich Jensen at 647-4438 or ejensen@umich.edu with module context questions or Monica Healy at 647-3815 or mhealy@umich.edu with registration questions.
Forms (and future class dates) may also be obtained from the CACR website.

Conflicts of Interest in Research: Management Strategies
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 previous article, view the March 2003 Biomedical Newsletter.

The translation of research results into patents and licenses to commercial companies benefits the public and increases the value of investment in basic science research activity at universities. This academic-industrial partnership is promoted by the federal government through the 1980 Bayh-Dole Act,1 which transferred ownership of intellectual property developed with federal research dollars to universities with the mandate to license them to companies. The Medical School also believes there is value in an active faculty engaged in consulting activities or service on boards of commercial enterprises, such as pharmaceutical companies. However, the increased opportunities afforded University researchers through these outside activities come with obligations to protect the interests of the University. The policies of the University, described in the Regental By-Laws, the Faculty Handbook, Standard Practice Guide as well as in other sources, all remind the faculty of his/her primary obligation to the University.

The Medical School Conflict of Interest Board (MedCOI) recognizes the need to manage rather than prohibit potential conflicts of interest when it is expected to serve the interests of the University of Michigan and the Medical School. When potential conflicts of interest are presented to the MedCOI (see the March 2003 Biomedical Newsletter for a description of the ways conflicts are presented to the Board), a management plan may be developed for the conflicted individual(s) in order to provide a framework allowing the proposed activity to occur. MedCOI management plans are constructed around core principles: (1) protection of the integrity of the research, (2) protection of the obligations to trainees, (3) protection of obligations to participants in clinical research and (4) protection of the resources of the University. Each of these is described in more detail below.

Protection of the integrity of research: Objectivity, reliability and management of research directions
Any research project undertaken in which an investigator has a conflict of interest (i.e., the potential for financial gain through licenses or consulting income, or financial interest in the sponsor in excess of $10,000) presents a risk for bias in the research results. Open, timely and complete dissemination of research results through publications and presentations, with full disclosure of the potential conflicts, helps to preserve the integrity of the research.
The MedCOI is cautious about permitting conflicted individuals to accept sponsored research projects from a company in which they have an interest. For consulting activity, there has to be clear and distinct separation between the scientific area of the consulting agreement and the scientific area of the research project. If this distinction cannot be made, the researcher may be asked, for example, to withdraw from consulting for the company while conducting the study. Other management strategies may be to identify another individual to serve as the principal investigator of the study or the appointment of a non-conflicted individual or committee to oversee the kirection of the research project.

Where to read more about Conflict of Interest:
UM Medical School COI webpage

UM Office of the Vice President for Research COI webpage

National Institutes of Health COI webpage

National Science Foundation COI webpage



Protection of the obligations to trainees, staff and other faculty who participate in the research
The researcher who serves as a mentor to graduate students or postdoctoral fellows has a special obligation to ensure that the progress to degree or completion of research training continues without interference from any external obligations due to conflicts of interest. If trainees are supported or participate in research funded by a sponsor that presents a conflict for the mentor, the mentor is especially reminded that limitations on the publication or presentation of research results is strongly discouraged and detracts from the primary educational responsibility of the mentor and University.

If the mentor proposes a reduction in faculty appointment or leave of absence to participate more actively in a company related to technology transfer agreements, the Board will carefully examine the potential impact of this change in appointment on trainees.

If researchers propose hiring trainees into a company related to a technology transfer agreement, the dual roles of university mentor and industrial employer can lead to confusion of responsibilities. The Board is extremely cautious in permitting overlap of responsibilities in this manner. If there are compelling reasons to engage in the conflicted activity, significant oversight needs to be in place to ensure the primary educational responsibility to the individual.

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 by the individual under management.

Protection of obligations to participants in clinical research
There are situations in which the safety of the research participants necessitates involvement of the conflicted researcher in a clinical research project. The MedCOI is particularly sensitive to transparency of the research process to protect individuals who consent to engage in clinical research at the University.

The MedCOI typically requires disclosure of potential conflicts to research participants and may exclude the conflicted individual from consenting subjects to the study. Conflict management plans in clinical research are disclosed to the Institutional Review Board for their consideration when approving clinical protocols. The IRB may not reduce the management proposed by the MedCOI without its approval. However, the IRB may impose more stringent management in order to maximize the safety of the research participants.

Protection of the resources of the University
The researchers primary obligation is to the University in overseeing the fiscal management of research projects conducted under their supervision. When the researcher has responsibilities to outside entities, such as service on the Board of Directors or equity interest in a company from a technology transfer agreement, the separation of roles may become blurred. The most typical management strategy involves identification of another individual at the University to oversee and approve financial transactions for any contracts with the outside entity. The MedCOI may also impose restrictions on the personal contract of the researcher with the outside entity. Examples include recusal from any discussions or decisions related to University business or amendment of a consulting contract to eliminate any overlap with University responsibilities.

Reporting to Departments and Regular Progress Reports
° Management plans approved by the MedCOI 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, including IRBMED, Contracts Administration and UCUCA.

° Management plans are not static documents and therefore, the Board requires regular progress reports to review changes in activities relative to the conflict. Progress reports provide an opportunity to request additional documentation, such as reprints of research publications.

COI on the web For questions or comments, contact Connie Bridges, cbridges@umich.edu or 763-4086.
___________________

1 Bayh-Dole University and Small Business Patent Procedures Act of Dec. 12, 1980, Pub. L. No. 96-517, 94 stat. 3015-3028 (codified as amended at 35 U.S.C. § § 200-211, 301-3007 (1994)).

UM Ford Nuclear Reactor to be Decommissioned
The University is the process of decommissioning the Ford Nuclear Reactor (FNR). The reactor may continue to operate until July when it will be deactivated and will no longer be available for research use.

Researchers who are in the process of writing up proposals, which require the reactor facilities, should include the costs of alternate reactor facilities in their research budget. Researchers with currently funded projects requiring use of the FNR should begin exploring alternative sources. The Office of the Vice President for Research (OVPR) will offer assistance in locating alternative sources and will provide funds for the unbudgeted cost of those services to researchers, through the end of currently funded grants.

For questions concerning the decommissioning, or about support for alternative reactor facilities, contact the OVPR at 763-1290.

External Funding Opportunities
Tylenol Scholarships for Students in Health
Deadline: April 30, 2003

The 2003 Tylenol Scholarship will be awarding grants totaling $250,000, (ten $10,000 scholarships and one hundred fifty $1,000 scholarships) to outstanding students pursuing undergraduate or graduate studies in a variety of health-related fields.

Applicants must be in an undergraduate or graduate course of study in the fall of 2003 at an accredited two or four-year college, university, or vocational-technical school. This includes those students currently enrolled in an undergraduate or graduate course of study who have one or more years of school remaining.

Winners will be selected on the basis of leadership in community and school activities, grade-point average, and intended focus on healthcare-related areas of study. Scholarship America, a national nonprofit educational support and student aid service organization, administers the fund and is responsible for screening and evaluating the applications and selecting the scholarship recipients. Complete guidelines and application forms are available at the Tylenol Scholarship website.

Association for the Cure of Cancer of the Prostate (CaP CURE)
Deadline: April 30, 2003
The organization currently is soliciting proposals for a round of accelerated prostate cancer research projects, although it will continue to fund outstanding and novel basic science devoted to finding a cure for prostate cancer. CaP CURE will favor research applications focused on translational and clinical programs that will benefit patients ith advanced prostate cancer in the near term. Prior work in the area of cancer is not a prerequisite. Applications from individuals with or without institutional affiliations will be considered. Applications from for-profit organizations are not eligible for consideration. See the CaP CURE website for complete guidelines and to download the application.

Sontag Foundation Distinguished Scientist Awards
Deadline: May 30, 2003
Each award will provide up to $500,000 in brain cancer research funding. Applicants must hold a doctoral degree and be within the first three years of their initial full-time faculty appointment as assistant professor or an equivalent position. More than one candidate may apply from an institution.

Funding limits are as follows: $150,000 in the initial year, $175,000 each of the two remaining years. Institutional overhead (indirect costs/f & a) will be capped at 15% and will be calculated as part of the Award total. Proposed research should be the applicant's primary focus and should have the potential to generate new knowledge regarding the causes or cure of brain tumors or lead to improved rates of survival and/or improved functional recovery for ndividuals with brain tumors.

Department of Defense Breast Cancer Research Program (BCRP)
Deadline: various
The fiscal year 2003 Defense Appropriations Act provides $150 million to the Department of Defense Breast Cancer Research Program. Awards will be made for up to $5 million for 5 years. Consideration for this award involves a nomination process, no self-nominations will be accepted.

The FY03 BCRP has nine different funding mechanisms and those with pre-proposals and full proposals are due by 5:00 p.m. Eastern Standard Time on the dates indicated. Detailed descriptions of each of these mechanisms, evaluation criteria, and submission requirements are available on the website. All applicants will be equired to submit an electronic version of their proposal as a PDF. For a reference table summarizing the nine BCRP funding mechanisms showing experience required, key elements, dollars available, and deadlines visit http://cdmrp.army.mil/funding/pdf/03bcrpreftable.pdf.

Local Initiative Funding Partners Program (LIFP)
Deadline: July 15, 2003
The LIFP program, a partnership between the Robert Wood Johnson Foundation (RWJF) and local grantmakers, supports innovative, community-based projects designed to improve health and healthcare for under served and at-risk populations. Through the program, local grantmakers such as community foundations, family foundations, and corporate grantmakers are invited to propose a partnership to be co-funded by RWJF.

Grants may be made to community nonprofit organizations or institutions. Projects funded through the program must be nominated by a local funder. The program will provide grants of $100,000 to $500,000 per project (funds that must be matched by local grantmakers). The total amount will be paid out over a three- to four-year period. In 2004, up to $8 million will be awarded through the program. For more information on the program, eligibility requirements, and the application process, see the RWJF website.

Seminars
Center for Organogenesis Seminar Series

April 3, 2003
3:30 PM
5915 Buhl Bldg.

Gisela F. Wilson, Ph.D., Assistant Professor, Molecular, Cellular and Developmental Biology will speak on: "Drosophila ethera go go potassium channel mutants: Do they do more than dance?"

Contact: Rebecca Pintar, 936-2499 or rpintar@umich.edu.

Department of Human Genetics Third Annual James V. Neel Lectureship

May 14, 2003
3:00-4:00 PM
James V. Neel Lecture Hall, Room 2901

"Jim Neel’s Heritage: Human Mutation Rates" presented by James F. Crow, Ph.D., D.Sci., Professor Emeritus, University of Wisconsin.

A reception will immediately follow the Lectureship in room 4917 Buhl (Human Genetics Conference Room) from 4-5 PM.
Contact: Karen Grahl, 764-5491 or kgrahl@umich.edu.

The James Neubacher Award Call for Nominations
Deadline: May 31, 2003
Each October, during Investing in Ability Week, the James Neubacher Award is presented to a University of Michigan faculty or staff member, student, or alumna/alumnus for significant achievements in:

* promoting acceptance and awareness of people with disabilities,
* advocating for the civil rights of people with disabilities, or
* removing barriers to full participation in programs and services by people with disabilities.

Established by the University of Michigan's Council for Disability Concerns in October 1990, the Award is a memorial to Jim Neubacher, an alumnus of the University. Jim was also a columnist for The Detroit Free Press and an advocate for equal rights and opportunities for people with disabilities. The Award includes a stipend provided by the Office of the President. See the website for complete details.

Research Responsibility Program, final "Wrap-Up" Program

Tuesday, April 1, 2003
5-7 PM
Ford Auditorium, UH

The Research Responsibility Program (RRP) presents their final "Wrap-Up" session. The RRP caps off the 2002-2003 season with a panel discussion with previous RRP presenters, touching on various themes covered earlier this year. Fawwaz Ulaby, Vice President for Research, will introduce the program. Nick Steneck, Professor of History, and Judy Nowack, Associate Vice President for Research, will serve as panel moderators. Refreshments will be served.

The RRP, sponsored by the U-M Office of the Vice President for Research, is a series of information and discussion sessions on responsibility in the conduct and administration of research. To view the entire RRP schedule, see website.

Sessions are free and open to all faculty, students, and staff. For more information about the RRP please call the OVPR at 647-9085 or send email to research.responsibility@umich.edu.

 


 

 

 

 

 

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