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Biomedical
News
July 2003, Vol. 21 • No. 7
Table
of Content
Don’t
Miss Out on These Important Award Opportunities
2004 PEW
Scholars Program
Internal Deadline August 15, 2003
The purpose of the PEW Scholars program is to support young
investigators of outstanding promise in basic and clinical sciences
relevant to the advancement of human health. The award is intended
to provide support for junior members of the faculty as they
establish their laboratories. Candidates must hold a doctorate
degree in medicine, other health-related professions, or biomedical
sciences. As of November 1, 2003, candidates must hold full
time appointments at the rank of Assistant Professor. On July
1, 2004, candidates shall not have been at the Assistant Professor
level for more than three years. Time spent in clinical internships,
residencies, or in work toward board certification does not
count as part of this three year limit. The university is allowed
to submit two nominees— one for basic science research
and one for clinical research. Nominations of faculty from all
units of the University are welcome.
2004 SEARLE
Scholars Program
Internal Deadline August 15, 2003
The 2004 Searle Scholars Program supports the independent research
of outstanding individuals who are in the first or second year
of their first appointment at the assistant professor level.
The current appointment should be a tenure-track position in
the areas of biochemistry, cell biology, genetics, immunology,
neuroscience, pharmacology, and related areas in chemistry,
medicine, and the biological sciences. Selection focuses on
the potential of the applicant to make innovative and high-impact
contributions to research over an extended period of time. The
University is allowed to submit two nominees. Nominations of
faculty from all units of the University are welcome.
Nomination Procedure for PEW and SEARLE Scholars Programs
The Biomedical
Research Council will select the University nominees for
these prestigious awards. Nomination materials for selection
of university nominees should include the following:
-
A
1 to 5 page research statement including current areas of
research, and an overview of research areas (and their significance)
that the nominee would like to pursue with Pew or Searle
funding
-
A
letter of nomination from the appropriate department chair
or unit head
-
A
current copy of the nominee’s curriculum vitae
-
Any
recent letters of support attesting to the potential of the
nominee and the quality and scope of his/her research
Send 22 sets of nomination materials to Camille Mrozowski, Office
of Research & Graduate Studies, 4107 Med Sci I, Box 0624
by August 15, 2003. Anyone interested in being considered for
both PEW and Searle Scholars Programs only needs to submit 22
sets of the nomination materials. Please indicate in the cover
letter which program you are interested in. Faculty members
who were nominated but not selected for the 2003 programs may
apply for the 2004 programs if they continue to meet program
eligibility requirements. For more information, contact Camille
at 615-8802 or cmrozow@umich.edu.
PEW and SEARLE Scholars at Michigan
Since 2000
| PEW |
SEARLE |
| 2002-Arul
Chinnaiyan-Pathology |
2000-
Sean Morrison - Internal Medicine and Cell & Developmental
Biology |
| 2001-Zhaohui
Xu - Biological Chemistry |
|
| 2000
- Thomas Wilson - Pathology |
|
Research
Responsiblity: Office of the Vice President
for Research (OVPR) Launches Online Courses
"The Program
for Education and Evaluation in Responsible Research and Scholarship
(PEERRS)" is a new web-based instructional and certification
program about responsible conduct of research. It is being offered
to the U-M community and will become required for, certain Principal
Investigators (PIs) and Co-Investigators (Co-Is). The program
provides a series of modules designed to help researchers and
administrators understand their responsibilities to subjects
and the research community.
PEERRS will present modules on the following subjects:
-
Foundations of responsible research conduct (publication/authorship,
intellectual property, conflict of interest, signatures, plagiarism,
misconduct reporting);
-
Research administration (U-M procedures/forms, PI responsibilities,
pre- and post-award activities, federal regulations, and important
contacts);
-
Conflict of interest guidelines (definitions and recognizing
potential conflicts, responsibilities toward students/colleagues,
consulting and conflict of commitment, sponsored project and
technology transfer issues);
-
Human research, regulatory and ethical obligations (basic
module covering definition of human subjects research, why
human subjects research is regulated, and regulatory responsibilities
of the PI, IRB, and University);
-
Animal research, regulatory and ethical obligations (principles
and regulations for animal care and use, reporting requirements
and obtaining approval).
Each module consists of 20-30 web pages containing the core
material, short case studies with questions, and pop-ups with
additional information to provide greater depth and elaboration.
A certification test also is provided for each subject area.
The modules and tests have been developed by expert faculty
and staff, reviewed by the relevant campus oversight committees,
and approved by the deans and executive officers.
As of December 1, 2003, Principal Investigators (PIs) and Co-Investigators
(Co-Is) on certain sponsored projects (see table) must be certified
in the PEERRS system before they are allowed to spend funds
from newly established sponsored research projects. Other faculty,
staff, and students also may need PEERRS certification, depending
on their research roles and a determination by the dean of their
school or college. PIs will be responsible for identifying research
staff and students from his or her research team who should
have PEERRS certification.
Additional information can be found on the PEERRS website,
where one can view the modules and become certified as well.
Logon requires a U-M uniqname and password.
The first time a user logs onto PEERRS, the system asks a few
questions about the users’ home units and roles in research.
Based on the responses, a customized curriculum is presented,
with courses either "required," "recommended,"
or "optional." "Required" means that the
user must pass a certification test of 5-10 questions with a
score of 80 percent or better. The tests are generated randomly
from a bank of questions developed for each module. Users may
take a test as many times as necessary to attain a passing grade.
In brief, certification will be required for the following groups
on campus.
General
PEERRS Requirements
| |
Foundations |
Research
Administration |
Conflict
of Interest |
Human
Research |
Animal
Research |
| PI/Co-I
on DHHS grant or contract |
Required |
Required |
Required |
Required,
if applicable |
Required,
if applicable |
| New
Faculty who plan to become PIs |
Required |
Required |
Required |
Required,
if applicable |
Required,
if applicable |
| Staff
& students involved in human research |
Recommended |
|
Recommended |
Required |
|
| Staff
& students involved in animal research |
Recommended |
|
Recommended |
|
Required |
Questions about PEERRS should be directed by email to peerrs@umich.edu
or by calling Lee Katterman, Office of the Vice President for
Research, at 734-647-9085.
IRBMED:
Use of Telephonic Consent in Research Involving Human Subjects
The federal government has recently provided guidance indicating
that the use of telephonic consent procedures, whether or not
they are witnessed and/or recorded, may not meet the regulatory
requirements for written documentation of informed consent.
Written documentation of informed consent is a requirement of
all human subjects research unless a specific waiver or alteration
has been granted by the IRB. Telephonic consent procedures should
therefore only be used in research projects where this form
of consent has been specifically authorized by IRBMED. The conditions
under which the IRBMED may approve use of telephonic conversations
as part of the consent process for research involving human
subjects are as follows:
1. As part of a specifically authorized, IRBMED-approved alteration
of the informed consent process for projects meeting all of
the following criteria:
a) The research has been found by IRBMED to present no more
than minimal risk of harm to subjects.
b) Any use or disclosure of protected health information (PHI)
involves no more than minimal risk to subjects’ privacy
(special HIPAA criteria apply).
c) The rights and welfare of the subjects will not be adversely
affected by the use of telephonic rather than written consent.
d) The research cannot practicably be carried out without the
use of telephonic consent.
e) Whenever appropriate, the subjects will receive additional
information about their participation in the research after
completion.
Please note that some research meeting all these criteria
may be eligible for waiver of the entire consent process, and
hence may not require telephonic consent.
2. As part of a specifically authorized, IRBMED-approved waiver
of the requirement for documentation of informed consent when
the research meets one of the following criteria:
a) The only record linking the subject and the research is the
consent document, and the principal risk is the potential harm
resulting from a breach of confidentiality.
b) The research has been found by the IRBMED to present no more
than minimal risk of harm to subjects, and does not include
any procedure for which written consent would be required if
it were to be performed for clinical management.
Please note that administration of investigational or approved
medications, or diagnostic or therapeutic doses of radiation,
would not qualify for this waiver of documentation even if written
consent would not ordinarily be required for clinical purposes.
3. As part of the following specifically approved process involving
the use of a ‘short form’ for documentation of informed
consent:
a) The IRBMED approves a written summary document that contains
the information necessary for granting informed consent.
b) The summary document is presented to the subject or subject’s
legally authorized representative in writing, by fax, email,
or via the Internet.
c) After providing the written summary information, the investigators
must make a telephone presentation to the subject or the subject’s
legal representative in the presence of a third person who will
act as a witness to the presentation. (The IRBMED recommends
using the Health System’s witnessed telephonic consent
operator for this purpose.)
d) After answering any questions the subject or their representative
may have, an IRBMED-approved separate written form documenting
the execution of the consent process must be signed by the subject
or the subject’s legally authorized representative, returned
by fax to the investigator, and then signed by both the investigator
obtaining the consent and the witness. The witness must also
sign a copy of the approved written summary of the information
presented to the subject.
e) A copy of the written summary of the information, and of
the short form documenting the consent, must be provided to
the subject or the subject’s legally authorized representative.
Additional guidance about telephonic consent is available on
the IRBMED website.
If you feel that your research might qualify for the use of
telephonic consent, but this has not been specifically authorized
by IRBMED, please submit an amended application describing the
technique(s) you will employ, any required associated documents
(such as the written short form summaries), and an explanation
of why you think the use of telephonic consent is necessary
and justified. If you are not sure whether telephonic consent
is appropriate for your research, or have questions about any
aspect of the informed consent process for research, please
do not hesitate to contact the IRBMED Office by email at irbmed@umich.edu.
Research
Responsibility
Web-Based Lecture on Conflict of Interest Issues in Technology Transfer
Activities
Robin Rasor, Director of Licensing for the Office of Technology
Transfer and Elaine Brock, Director of the Office of Technology
Transfer and Corporate Relations for the Medical School spoke at
a recent in-service for the Medical School Conflict of Interest
Board. The session was videotaped and can be viewed here.
This is the first in a series of in-service presentations on conflict
of interest issues. If you have suggestions or questions, please
contact Connie Bridges, Director of Administration for Research
and Graduate Studies (cbridges@umich.edu,
3-4086).
Office
of Research and Graduate Studies—Who We Are and What We Do
The Medical School’s Office of Research and Graduate Studies
(ORGS) is responsible for the facilitation, development, and oversight
of biomedical research activities and education (graduate and postgraduate)
within the Medical School. Research-related activities include the
development and implementation of strategic planning, policies,
and procedures regarding research investigation; allocation of space
and resources to facilitate investigations; oversight of the shared
Biomedical Research Core Facilities, the Medical School’s
Institutional Review Boards, and the Center for Advancement of Clinical
Research. Functions related to biomedical graduate education include
the oversight of the Medical School’s Program in Biomedical
Science (PIBS). PIBS coordinates recruitment and admissions for
13 degree granting Ph.D. programs and provides incoming graduate
students with a first-year experience.
Leadership for ORGS is provided by Associate Dean Steven A. Goldstein
(stevegld@umich.edu).
The office staff includes Connie Bridges, Director of Administration
(cbridges@umich.edu);
Sarah Laverty, Conflict of Interest Manager (sgrace@umich.edu);
Camille Mrozowski, Staff Assistant for Committees and Events (cmrozow@umich.edu);
Denise Swayze, Office Assistant for Publications, Awards and Grants
(dswayze@umich.edu); and
Gale Nicolai, Department Secretary (gnicolai@umich.edu).
Some of the specific activities and projects currently managed by
Research and Graduate Studies:
• Major committee support: Advisory Council on Clinical Research,
Biomedical Research Council, Medical School Conflict of Interest
Board, Associate chairs for Research, and the Research Advisory
Board.
• Management of special award and grant opportunities, such
as the Searle and Pew Scholars Awards, and the Wilson Foundation
Research Grants
Program.
• Overall management of the research compliance infrastructure
for the Medical School.
• Allocation and management of research space; including planning
for the new Biomedical Sciences Research Building.
• Implementation of research policies; such as the Outside
employment disclosures, Cost-sharing, and Indirect Cost Waivers
• Publication of the Biomedical News!
Call or email us if you have any questions or comments, we are available
to provide assistance: 764-3611 or at the e-mails noted above!
The
Center for the
Advancement of Clinical Research (CACR) has Moved!
The Center for the Advancement of Clinical Research (CACR), including
the offices of Dorene Markel and Dr. Daniel Clauw, have relocated
from 101 Simpson to Domino's Farms. This move provides additional
space for the continued growth of this unit which provides impoertant
services to the clinical research community. The following includes
new information for your records:
New Address:
Center for the Advancement of Clinical Research (CACR)
Domino's Farms
24 Frank Lloyd Wright, Lobby M
Box 0738
Ann Arbor, MI 48109
Additional contact information:
Main Phone: 998-7474
Main Fax: 998-7228
Email: umcacr@umich.edu
PLEASE NOTE: The Study Coordination and Conduct (SCC) Unit of CACR
will not be moving from the Upjohn location at this time. To contact
SCC, please call 647-4422 or visit the CACR website.
Funding Opportunities
Internal
Submission
Jody
C. Ungerleider Memorial Award
Internal Deadline: July 11, 2003
The University of Michigan Committee on Use and Care of Animals
and the Biomedical Research Council are soliciting nominations for
the Jody C. Ungerleider Memorial Award. This award is given for
outstanding contributions toward the humane use of laboratory animals.
Jody Ungerleider was a Research Assistant at The University of Michigan
for many years. In that capacity she carried a significant share
of the responsibility for the care and treatment of animals used
in the laboratory in which she worked. She believed profoundly that
the humane care and welfare of all animals used in research should
be one of the highest priorities of those involved in biological
experimentation. The purpose of the Ungerleider Award is to recognize
individuals within The University of Michigan whose activities and
attitudes toward the use of laboratory animals in research are consistent
with those high standards. Research staff and students who participate
in any aspect of animal research or use of animals for education
and training are eligible. The award consists of a plaque appropriately
inscribed and a cash award of $200.
Nominees for the award should meet at least one of the following
criteria:
1. Nominees should have demonstrated through their actions concern
and compassion for laboratory animals and advocacy of humane treatment
of animals as an essential component of laboratory research;
2. Nominees should have made specific research or technological
contributions to the humane use or treatment of laboratory animals;
3. Nominees should have made specific contributions to the education
of researchers, animal handlers, and/or the general public with
respect to biological research using laboratory animals in general
and to the humane treatment of laboratory animals in particular.
Nominations should be sent to the Committee for the Jody C. Ungerleider
Memorial Award, Office of the Vice-President for Research, 4080
Fleming Administration Building, Box 1340. The letters should document
the nominee's specific contribution(s) in reasonable detail. Any
additional material that supports or more fully details an individual's
qualifications may be included. Several letters of support of a
nominee are invited.
External
Limited Submission
Gustavus
and Louise Pfeiffer Research Foundation
Internal Deadline July 11, 2003 (Letter of Inquiry)
The Gustavus and Louise Pfeiffer Research Foundation furnishes grants
for the improvement of the public health through the advancement
and promotion of medicine and pharmacy, including scientific research,
post-graduate scholarship and fellowship assistance, and studies
in nutrition, blindness, deafness and other physical disabilities.
The grants are $75,000 for a period of one year with requests for
renewal for up to two additional years. Institutions wishing to
apply for a grant should send a letter of inquiry to the Foundation
first. Three letters of inquiry are allowed per institution. Deadline
for the letters of inquiry to the Foundation is July 25, 2003. See
the website for details. For consideration as the three institutional
nominees, please send a copy of your letter of inquiry to the Office
of Research and Graduate studies, 4107 Med Sci I, Box 0624 by July
14, 2003. Contact: Denise Swayze, 763-4086 or dswayze@umich.edu.
Warren
Alpert Foundation Prize
Internal deadline: July 21, 2003
The Warren Alpert Foundation Prize is awarded each year to a scientist
who has made a significant discovery leading to the prevention,
cure, or treatment of a disease or disorder that afflicts humankind.
The Warren Alpert Foundation Prize includes an award of $100,000.
UM may submit one nomination. The Foundation deadline is August
1, 2003. For consideration as the internal nominee, send a letter
of nomination from the department chair and a copy of the nominee’s
CV (with bibliography) to the Office of Research and Graduate Studies,
4107 Med Sci I, 0624 by July 21, 2003. Contact: Denise Swayze, 3-4086
or dswayze@umich.edu.
Burroughs
Wellcome Fund (BWF) Career Awards in the Biomedical Sciences
Internal Deadline: August 29, 2003
The purpose of the BWF awards is to help researchers who are early
in their careers make the transition to independent investigators.
Researchers may be involved in any of the basic biomedical sciences
with 80 percent of their time devoted to research-related activities.
Candidates must have completed at least 12 months but not more than
48 months of postdoctoral research training by the application deadline.
The Awards provide $500,000 over five years. UM may nominate up
to six candidates.
Internal applications to the Medical School require:
• A 1-2 page research summary
• A CV for the nominee
• A nominating letter from a department chair
Submit all internal applications to the Office of Research and Graduate
Studies, 4107 Med Sci I, Box 0624 by August 29, 20023 Contact: Denise
Swayze, 763-4086 or dswayze@umich.edu.
External
Open Submission
Wiley
Prize in Biomedical Sciences
Deadline: July 31, 2003
The Wiley Prize recognizes contributions that open new fields of
research or advance novel concepts or their applications in a particular
biomedical discipline. The award may recognize a specific contribution
or a series of contributions that demonstrate the nominee’s
significant leadership in the development of research concepts or
their clinical application. The award includes a $25,000 grant and
an invitation to deliver a lecture at Rockefeller University. See
the Foundation website for nomination guidelines.
Research
! America’s Advocacy Awards
Deadline: July 31, 2003
The Research ! America Advocacy Awards Program honors outstanding
advocates for a strong national medical and health research enterprise
and recognizes individuals and organizations who exemplify the leadership
required to assure that this enterprise will flourish. Awards will
be presented in four categories: Sustained Leadership at the National
Level; Exceptional Contributions as a Volunteer Advocate for Medical
or Other Health-Related Research; Isadore Rosenfeld Award for Impact
on Public Opinion Through the Media; and An Institution or Organization
that has Distinguished Itself by Its Advocacy. The awards (Steuben
crystal sculptures) will be presented on March 16, 2004 in Washington,
D.C. at the National Academy of Sciences. An Edwin C. Whitehead
Award for Medical Research Advocacy may also be presented at the
discretion of the Research ! America board of Directors. For detailed
information, visit their website.
Alliance
for Cancer Gene Therapy (ACGT)
Deadline: August 6, 2003 (for electronic application)
ACGT is currently accepting grant applications for their Young Investigator
Award. The awards will be up to $500,000 allocated over three years
(inclusive of 10% indirect costs). The grant will fund researchers
holding an M.D., M.P.H., Ph.D. or equivalent degree at the tenure-track
assistant professor level who have demonstrated a commitment to
original cancer gene therapy research as an independent investigator.
Detailed information can be found at the ACGT website.
March
of Dimes Research Prize in Developmental Biology
Deadline: September 15, 2003
The March of Dimes Prize consists of a medal and $250,000. It is
awarded to investigators whose research has profoundly advanced
the science that underlines the understanding of birth defects.
Complete details and the nomination form can be found on their website.
The
Dickson Prize in Medicine
Deadline: September 30, 2003
The University of Pittsburgh School of Medicine is accepting nominations
for the 2003-2004 Dickson Prize in Medicine, awarded annually to
a leading American investigator in biomedical research. Strong preference
will go to honoring paradigm-shifting biomedical research that is
not yet highly rewarded, but will be. The prize consists of a: bronze
medal, an honorarium of $50,000, and travel expenses. Presentation
of the award will take place in the fall of 2004. Over a two-day
period, the award winner will present a lecture and a seminar at
the University of Pittsburgh School of Medicine and will meet informally
with students and other investigators. Visit their website for nomination
requirements.
Seminars/Workshops
Bioinformatics
Program Short Course in Computational Molecular Biology
Bioinformatics July 21-25, 2003
Proteomics July 28-30, 2003
Laboratory Information Management Systems August 4-6, 2003
See
the Bioinformatics website for additional information.
Annual
Pediatric Urology Duckett Lectureship
The Annual John W. Duckett, Jr., MD, Pediatric Urology Lectureship
will be held on Friday, July 18th, 2003 at 9:30 am in the MCHC Auditorium.
The keynote speaker is Barry A. Kogan, MD, Falk Professor or Urology
and Chief of the Division of Urology at Albany Medical College.
He will be speaking on the evaluation and management of urinary
tract infections and reflux in children. All faculty, residents,
and staff are welcome to attend. For registration information, please
contact Mary Borgerson at 615-3038 or maryborg@umich.edu.
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