Biomedical
News
March 2003, Vol. 21 • No. 3
Table
of Content
Managing
Conflicts of Interest
This
is the first in a series of short articles about issues related
to management of potential conflicts of interest in research
activities. These are updated articles, which first ran in the
Biomedical News in 2002.
Since 1993, the Medical School has had an active Conflict of
Interest Board reviewing and managing potential conflicts in
research activity. The current Board has 14 voting members,
13 from the faculty, and the chair, James Woolliscroft, Executive
Associate Dean. The Board’s authority to review and approve
conflict management plans derives from the Dean and the Medical
School Executive Committee, who approve Board appointments and
operating procedures. The Office of the Vice President for Research
(OVPR), who authorizes the Medical School to have its own COI
Board, is responsible for institutional compliance with Federal,
State and University regulations, laws and policies on conflict
of interest. A second campus board within OVPR reviews conflicts
for individuals in units outside the Medical School.
Typically, the Medical School COI Board is notified
of potential conflicts in one of three ways:
1. Proposal Application Form (PAF): Investigator may
disclose a significant financial interest involving the sponsor
when submitting a proposal for externally sponsored funds.
2. Annual Outside Employment Disclosures: COI Board
staff review faculty disclosures and assess any potential conflict
situations. (See separate article in this issue describing how
to disclose outside employment activities.)
3. Technology Transfer: Faculty activities related
to the disclosure or licensing of inventions, or the establishment
of "start-up" companies, are reported to the Board
by the Office of Technology Transfer.
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 by the COI Board. There are standard management strategies
that meet most common conflict situations. More complex interactions
may require a lengthier review in order to develop oversight
that protects the integrity of the research.
Some conflict situations, for example, technology transfer related
issues, require approval of the University’s Board of Regents.
The Vice President for Research communicates these items to
the Board of Regents for their consideration, but only when
there is assurance from one of the Conflict of Interest Boards
that sufficient management has been put in place.
Board Philosophy
The Board recognizes the need to manage rather than prohibit
potential conflicts of interest when it is expected to serve
the interests of the University and the School. Disclosure of
a potential conflict does not necessarily mean an investigator
will be prohibited from the activity. Often there are management
strategies that permit the activity to continue. With adequate
disclosure and management, along with regular follow-up from
the investigator updating the COI Board on the activity, important
collaborations and relationships are likely to be permitted.
Next month: Conflict Management Strategies
*Medical School COI on the web:
http://www.med.umich.edu/medschool/orgs/ResearchPolicies/
For questions or comments, contact Connie Bridges, 764-3611.
It's
Time To Make Your Annual Outside Activity Disclosure to the
Medical School Deadline: April 1, 2003
In 2001 the Medical School updated its policy for disclosure
of outside activities. All faculty members (instructional, clinical
and research tracks) are required to electronically submit at
least one disclosure per year indicating whether they do or
do not have additional activities outside the scope of their
primary responsibility as a University faculty member.
Access to the web form is at: https://soleus.msis.med.umich.edu/oeac/logon.jsp.
This electronic format provides an easier mechanism for submitting
disclosures and allows faculty to copy activities disclosed
in 2002 into their 2003 record. Please contact your Department
if you have not received specific guidance on the approval process
for your particular unit. Additional information can be found
on the ORGS Research Policies web page: http://www.med.umich.edu/medschool/orgs/ResearchPolicies/index.html.
The Medical School recognizes the value of an active faculty
participating in intellectual activities outside the obligations
of research, teaching and scholarly activities at the University.
However, each faculty member is also obligated to ensure that
outside activities meet all of the standards set by the University
and Medical School.
Please contact the Office of Research and Graduate Studies at
764-3611 if you have any questions about the policy.
Steven
Goldstein Receives Marshall Urist Award
At the national meeting of the Orthopaedic
Research Society, Steven A. Goldstein, Ph.D., Associate Dean for
Research and Graduate Studies and Henry Ruppenthal Family Professor
of Orthopaedic Surgery and Bioengineering received the Marshall
Urist Award for Excellence in Tissue Regeneration Research. The
Marshall Urist Award recognizes investigators who have demonstrated
major achievements in the area of tissue regeneration. Dr. Goldstein
received the award in recognition of his outstanding achievements
over the years in the areas of bone and mineral metabolism and
growth factors. Dr. Goldstein was also named President-elect for
the Orthopaedic Research Society for 2003-2004.
Larry
Gruppen Named Chair of Medical Education
The Dean has announced that Larry Gruppen,
Ph.D., will serve as Chair of the Department of Medical Education
and the Josiah Macy Jr. Professor of Medical Education, pending
approval by the U-M Board of Regents. His term will begin April
1, 2003.
CACR:
New Study Coordinator Training Workshop
The Education and Certification Core (ECC)
from the Center for the Advancement of Clinical Research (CACR)
delivers a monthly program for NEW study coordinators (less than
six months on-the-job experience). ECC will also host the same
program periodically for others interested and engaged in clinical
research (like experienced study coordinators, investigators,
and other administrators). All workshops cover 3 primary education
modules:
• The ABC's of Good Clinical Practices (GCP) 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 workshop on Wed, March 26 from 8:30-12:30 in LRC 2903
is for experienced study coordinators, investigators, and administrators.
The following workshop on Tues, April 15 from 8:30-12:30
in LRC 2903 is for "NEW" study coordinators.
Contact: Erich Jensen at 647-4438 or ejensen@umich.edu
with workshop content questions. Monica Healy at 647-3815 or mhealy@umich.edu
with registration questions.
Visit http://www.med.umich.edu/cacr/
for registration forms and future class dates. There is a $50
per person fee to cover materials. Please register by March 20
for the March 26 class and by April 9 for the April 15 class.
UMMS CMEs (4.0 Category I credit hrs) and UMHS CEUs (4.2 contact
hrs) are available.
Funding and Award Opportunities
Internal
Opportunities
Cancer
Research Committee (CRC)
Deadline: September – June
The John and Suzanne Munn Endowment:
1. Research Grants are available for any senior investigator who
is taking a new direction in his/her cancer-related research,
or for any interesting and innovative collaboration between scientists.
2. DEA Grants are available for any level of investigator who
has a novel and innovative idea for cancer research.
Deadline for Munn funding application submission is the first
Thursday of each month, September through June.
Attention clinical investigators:
The CRC is particularly interested in soliciting grant applications
to support clinical trials investigation. Funding for approved
projects can be applied to data management, cancer center cores
requiring paybacks, and technical and consultative support for
collaborative studies that are part of a clinical trial.
See the Comprehensive Cancer Center website for complete details
and application forms: http://www.cancer.med.umich.edu/i/researchfunding.htm
or email Ginny Schneider at ginnysch@umich.edu.
LSVSP-OVPR
Annual Seed Grant Program
Deadline: March 15, 2003
The Life Sciences, Values and Society Program
(LSVSP) and the Office of the Vice President for Research (OVPR)
invite applications for the LSVSP Annual Seed Grant Program (due
March 15, 2003). Four awards of $5,000-$20,000 are available to
fund faculty activities that explore the ethical, legal or social
implications of developments in the life sciences, including genomics,
bioengineering, and evidence-based medicine. Social implications
include the ways in which these developments affect society as
well as their impact on the humanities, performing arts, social
sciences, and training and practice in professional fields, such
as nursing, public health, education, information science and
natural resource management.
For more information on the purpose of the grant, eligibility,
criteria for evaluation, and application forms, see the OVPR website:
http://www.research.umich.edu/research/funding/UM_Sources/life_sciences_values.html.
For examples of previously funded projects and more information
about LSVSP grants and awards, see the LSVSP website: http://www.lifesciences.umich.edu/values/awards.html
or contact Deborah DeZure(ddezure@umich.edu,
or call 615-7871). Applicants are encouraged to contact Deborah
to discuss their proposals before submission.
Limited
Submissions
Herbert
W. Nickens, M.D. Minority Faculty Fellowships
Internal Deadline: April 7, 2003
Association of American Medical Colleges (AAMC) seeks nominations
for the Herbert W. Nickens, M.D. Minority Faculty Fellowships.
These fellowships recognize outstanding minority junior faculty
committed to careers in academic medicine. Grants of $15,000 will
be awarded to support academic and professional activities. The
funds can be spent over a two-year period. Medical Schools may
nominate one candidate. The candidate must:
• Be a United States citizen or permanent resident
• Be a Black American, Native American (American Indian,
Alaska Native, Native
Hawaiian), Mexican American and Puerto Rican
• Hold the rank of Assistant Professor or Instructor
• Held a faculty position for no more than 3 years
• Hold either a M.D. or Ph.D.
See http://www.aamc.org/about/awards/start.htm
for complete details. Deadline for submission to AAMC is May 9,
2003. For consideration as the institutional nominee, submit the
following by April 7, 2003: a statement from the applicant describing
career objectives, research interests, and how the funds will
be used (no more than 5 double-spaced pages), two letters of reference
(one from a department chair), and a current CV. Submit all internal
applications to David Gordon, M.D., Assistant Dean for Diversity
and Career Development, 764-8185 or shirphil@umich.edu.
Herbert
W. Nickens, M.D., Minority Medical Student Scholarships
Internal Deadline: April 7, 2003
Association of American Medical Colleges
seeks nominations for the Herbert W. Nickens, M.D. Minority Student
Scholarships. These awards consist of five scholarships given
to outstanding third-year minority medical students who have demonstrated
leadership in eliminating inequities in medical education and
health care. Each recipient receives a $5,000 scholarship and
an award certificate. A medical school may nominate one (1) student
for these awards. A candidate must:
• Be a United States citizen or permanent resident;
• Be from a minority group designated by the AAMC as underrepresented
in medicine (Black, Native American [American Indian, Alaska Native,
Native Hawaiian], Mexican American, and mainland Puerto Rican)
• Be entering the third year of study at an accredited United
States medical school
Deadline for submission to AAMC is May 9, 2003. For consideration
as the institutional nominee, submit the following by April 7,
2003:
• One (1) letter of recommendation for the nominee from a
faculty member
• A written essay by nominee that does not exceed 250 words
discussing his or her motivation in pursuing a medical career
and future plans;
• A curriculum vitae (CV) for the nominee
• The nominee's official medical school academic transcript.
See http://www.aamc.org/about/awards/start.htm
for complete details on the scholarships. Submit all internal
applications to David Gordon, M.D., Assistant Dean for Diversity
and Career Development, 764-8185 or shirphil@umich.edu.
Open Submissions
Lance
Armstrong Foundation (LAF) Grant Program
Deadline: March 1, 2003
The Lance Armstrong Foundation offers grants
through its Community Program to nonprofit organizations that
positively impact the quality of life for those living with, through,
and beyond cancer. Each RFP will seek proposals that address specific
survivorship needs. In spring of 2003, the LAF has identified
three areas of survivorship in which to direct its support through
the Community Program: adolescent/young adult issues, physical
activity, and survivorship education. Grants are awarded in the
range of $5,000 to $25,000. Complete program guidelines and application
forms are available on the LAF website: http://www.laf.org/community.html.
National
Patient Safety Foundation Research Grants
Deadline: March 28, 2003 (letters of intent)
The National Patient Safety Foundation's
Research Grants Program seeks to stimulate new, innovative projects
designed to enhance patient safety in the United States. The program's
objective is to promote studies leading to the prevention of human
and/or system errors in health care and the adverse consequences
to patients that may result.
The foundation is currently accepting letters of intent for research
and development broadly related to identifying the causes of preventable
injuries and errors and/or developing prevention strategies and
methods to implement them. Highest priority will be given to investigations
that apply to a broad spectrum of problems and patients and that
are clearly relevant to patient safety. Priority also will be
given to projects with the promise of improving methods of patient
safety via a defined and direct path to implementation.
Budget requests must not exceed $100,000 for the entire term of
the project, and projects may last up to two years in duration.
For more information and application guidelines, visit the NPSF
web site: http://www.npsf.org/.
Alton
Ochsner Award Relating Smoking and Health
Deadline: March 31, 2003
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;
and the prime criterion for award selection is its scientific
impact on this major health threat. All nominations, whatever
the category of scientific inquiry, must be supported by letters
and copies of peer-reviewed scientific publications. The Institutional
Sponsor is the Ochsner Clinic Foundation. Contact Denise Swayze,
763-4086 or dswayze@umich.edu
for a faxed copy of complete information and the nomination process.
Louis
and Artur Lucian Award for Research in Circulatory Diseases
Deadline: April 1, 2003
The purpose of this Award is to honor a scientific
investigator or group of investigators whose contribution to knowledge
in Circulatory Diseases is deemed worthy of special recognition.
The successful candidate is invited to spend a period of time
at McGill University. This is for a minimum of two weeks during
the academic year to have interchanges with members of the McGill
community, and possibly to undertake a research collaboration
with McGill investigators in the field of circulatory disease.
The awardee or awardees receive $50,000 (Can.) as a prize. The
Louis and Artur Lucian Award was established in 1978 under the
will of the late Olga Leibovici through a bequest to McGill University
and to honor the donor’s two brothers. For a faxed copy of
the nomination form and complete details, contact Denise Swayze
at 763-4086 or dswayze@umich.edu.
AAMC
Seeks Nominations for Several Awards
Deadlines: April 4, May 9, and May 30, 2003
The Association of American Medical
Colleges seeks nominations for its major awards honoring individuals
and programs making significant contributions to the community
in the fields of medical education, research, and community service.
For details on each award, visit http://www.aamc.org/about/awards/start.htm.
United
Negro College Fund (UNCF) and Pfizer Postdoctoral Fellowships
Deadline: April 15, 2003
This partnership program offers postdoctoral
fellowships of $53,500 each, for support, which includes a stipend
of up to $44,500, fringe benefits of up to $4,000 and supplies,
equipment, and travel of up to $5,000. They are intended to provide
12-24 months of support.
To be eligible for a UNCFoPfizer Postdoctoral Fellowship, you
must be: A member of a minority group under-represented in the
biomedical research fields; A postgraduate holding a Ph.D. or
equivalent doctoral degree in a life or physical science currently
or by the end of the 2002-2003 academic year; Appointed as a postdoctoral
fellow during the 2003 calendar year.
For complete details and an application form, visit http://www.uncf.org/pfizer/.
Seminars
Research Responsibility Program Sessions in March
The Research Responsibility Program (RRP)
will present a new program on "Bio-Safety" from 5-7
p.m., on Thursday, March 6 at G2314 Towsley Center, Medical campus.
This topic will be presented by Michael J. Imperiale, Chair, Institutional
Biosafety Committee and Professor of Microbiology & Immuniology
at the Medical School.
Susan Dorr Goold, Associate Professor of Internal Medicine and
Director of the Bioethics Program, Medical School, will present
another new RRP session on "Informed Consent." It will
be presented Thursday, March 20, 5-7 p.m. at G2314 Towsley Center.
Signage will be provided.
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.
The full RRP schedule is online at http://www.responsibility.research.umich.edu.
Sessions are free and open to all faculty, students, and staff.
For more information about the RRP, call the OVPR at 647-9085
or send e-mail to: research.responsibility@umich.edu.
Center
for Organogenesis Seminar Series
March 6, 2003
3:30 PM
Room 5915 Buhl Bldg.
Maria S. Soengas, Ph.D., Assistant Professor, Dermatology Department
Melanoma Program will speak on "Cell death factors in melanoma
progression and Chemoresistance".
March 20, 2003
3:30 PM
Room 5915 Buhl
Philippe Soriano, Ph.D., Program in Developmental Biology, Division
of Basic Sciences at the Fred Hutchinson Cancer Research Center
in Seattle, Washington will speak on "Growth factor signaling
specificity in vertebrate development". Contact: Rebecca
Pintar, 936-2499 or rpintar@umich.edu.
Cellular &
Molecular Therapuetics Seminar Series
March 10, 2003
1:00 PM
Room 2901 LRC (2nd floor of Taubman Medical Library)
The Cellular and Molecular Therapeutics Seminar Series presents:
"Neuro-Attenuated HSV-1 as Primary Brain Tumor Therapy: A
tightrope walk between the immune response and oncolysis",
presented by Cathie G. Miller, Ph.D., Director, Laboratory of
Viral Onco-Therapeutics, Hermelin Brain Tumor Center, Henry Ford
Hospital. The Cellular and Molecular Therapeutics Seminar Series
is sponsored by the Center for Gene Therapy. Contact: atisleri@umich.edu
or 7-3413.
U of M Bone Research
Center Seminar Series
March 10, 2003
12:00 Noon
Room 2903 LRC (Taubman Library)
Michael W. Lark, Ph.D. Senior Director of Cardiovascular and Metabolic
Diseases Centocor, will give a talk on "Inhibition of osteoclast-mediated
bone resorption as a means to inhibit bone loss in osteoporosis."
Contact: Michelle Nasers, 615-6835.
Functional Neuroimaging
Speaker Series
March 11, 2003
3:30-5:00 p.m.
East Hall, 4448
Sharon L. Thompson-Schill, Ph.D., Assistant Professor of Psychology
and Neurology
University of Pennsylvania will speak on "Broca’s Area
Revisited: Selection, Language, and the Inferior Frontal Gyrus".
Light refreshments will be served. Sponsored by the Functional
MRI Lab. Contact: Eve Gochis, 6-0558 or egochis@umich.edu.
Biological Chemistry Seminar
March 18, 2003
12:00 Noon
Room 5330 Med. Sci. I
Co-hosts: Dr. Dennis Thiele, 763-5717, dthiele@umich.edu,
Dept. of Biological Chemistry and Dr. Gabriel Nunez, 764-8514,
bclx@med.umich.edu,
Pathology. The presenter will be Dr. Joel H. Rothman, Professor.
March 25, 2003
12:00 noon
Room 5330 Med. Sci. I
Hosted by Dr. David Engelke, 763-0641, engelke@umich.edu,Department
of Biological Chemistry. The presenter will be Dr. Daniel R. Schoenberg,
Professor.
Contact: Pat Haines, phaines@umich.edu
or 763-4958.
Immunology Seminar
March 12, 2003
12:00 - 1:00 p.m.
2901 LRC
The Experimental Immunology Training Grant, and the Graduate Program
in Immunology present Paul J. Leibson, M.D., Ph.D., Professor
of Immunology, Mayo Clinic. His topic is "Regulation of Natural
Killer Cell Activation: Inside the Mind of a Killer." Contact:
Ellen Elkin, 5-4846 or eelkin@umich.edu.
