LOS ANGELES BIOMEDICAL RESEARCH INSTITUTE at HARBOR-UCLA MEDICAL CENTER
GENERAL CLINICAL RESEARCH CENTER
Medical and Dental Students Program
Policies
I.
PURPOSE
The purpose of this program is to provide funding for up to five awards per year to medical students so
they may take time off from medical school to engage in a mentored program of up to one year of
supervised participation in clinical research, didactic coursework related to patient-oriented research,
and/or acquisition of laboratory skills that can be applied to patient-oriented clinical research efforts.
II.
AMOUNT OF FUNDS AVAILABLE
The maximum that can be requested or funded for one year is up to $20,000 in salary exclusive of fringe
benefits and indirect costs, plus up to $5,000 for relevant expenses. Salary, fringe benefits, and indirect
costs are paid for by the GCRC and administered by the Los Angeles Biomedical Research Institute
Grants and Contracts Office.
III.
ELIGIBILITY
A.
B.
IV.
The applicant must be:
1.
Currently enrolled in an accredited Medical School, preferably between years three and
four of medical school. Medical school transcripts are required at time of submission
2.
However, students will be considered for acceptance at the following times as well: after
the fourth year of medical school prior to the commencement of internship, between years
one and two of medical school and between years two and three of medical school.
The mentor must:
1.
Be an LA BioMed member
2.
Have an M.D., Ph.D., D.D.S., D.V.M. or equivalent doctorate degree.
3.
Be an active GCRC investigator.
C.
Use of the General Clinical Research Center resources is a mandatory requirement of the project.
D.
The student may only hold one mentoring award at any time.
ALLOWABLE AND UNALLOWABLE COSTS
A.
Funds may be used for:
- student’s salary of up to $20,000 per year
- animal purchase and housing
- supplies
- research equipment purchase, maintenance, and repair costs
- publication and reprint expenses
- testing costs
- travel necessary for the conduct of the research project
B.
Funds cannot be used for:
- technical personnel costs (salary and fringe benefits)
- personnel costs of mentor (salary and fringe benefits )
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V.
VI.
stipends and health insurance
travel to attend general scientific meetings
furniture (regardless of cost)
dues, journals, and books
OTHER CONDITIONS OF AWARD
A.
Rebudgeting is allowable but must be approved administratively by the Program Director of the
General Clinical Research Center with adequate justification. Be aware that rebudgeting of costs
from salary does not make available to the awardee the fringe benefits and overhead costs
originally budgeted. A maximum of $25,000 in Direct Costs EXCLUSIVE of fringe benefits is
available.
B.
Cost overruns previously incurred on other accounts (cost transfers) are not allowable.
C.
All funds not spent at the end of the budget period will revert to the General Clinical Research
Center administrative account.
APPLICATION AND REVIEW PROCESS
A.
Applications must be submitted on LA BioMed Form F-506 electronically to
gcrcinfo@labiomed.org. The application is available in the GCRC website at
http://research.labiomed.org.
B.
Application Deadline:
Deadline
March 1
Earliest Start Date
July 1
The deadline is 5:00 p.m. for receipt in the GCRC Office, and it is strictly enforced. If the deadline
date falls on a weekend or holiday, the deadline is extended to the next working day.
ALL FINANCIAL ENCUMBRANCES MUST BE MADE BY THE NIH GRANT BUDGET
PERIOD END DATE OF NOVEMBER 30.
Depending upon fund availability, applications may not be accepted for every deadline.
Check with the Program Director of the General Clinical Research Center before preparing
an application.
C.
The application may be a new project designed for the student, if this is the case, the project
should also be planned for completion within the time-constraints of this grant. The application
may also be focused on a specific and defined portion of the mentor’s current approved research.
In that case, the student’s application must clearly define which part of the mentor’s currently
approved research project will be pursued by the applicant. The portion of the protocol assigned
to the student should be feasible, completed and analyzed within the funding year. In either case,
the mentor should provide in detail the student’s role in the project, how this experience will
enhance the development of the candidate’s research career, what the candidate will likely learn
from working on the protocol, and to what extent the candidate will be involved with the project. It
is anticipated that the student will have an opportunity to present his/her data in a research
setting or be co-author on a manuscript. The mentor should indicate how he/she will make this
year a rewarding experience for the student.
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D.
Each application is sent to two (2) ad hoc scientific reviewers who are members of the General
Clinical Research Center Advisory Committee. The reviewers provide critiques and assign
separate scientific and administrative ratings, using a scale from 1 to 9. (1= exceptionally strong,
5 = average, 9=substantial weakness). The reviewer’s scores are then averaged to reach
separate total scores for scientific rating and administrative rating. The reviewers can also decide
to either disapprove or defer the protocol. The areas that are rated are as follows:
1.
Scientific Ratings:
Overall Impact. Reviewers will provide an overall impact/priority score to reflect their
assessment of the likelihood for the project to exert a sustained, powerful influence on the
research field(s) involved, in consideration of the following five core review criteria, and
additional review criteria (as applicable for the project proposed).
Core Review Criteria. Reviewers will consider each of the five review criteria below in the
determination of scientific and technical merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to have major
scientific impact. For example, a project that by its nature is not innovative may be essential
to advance a field.
Significance. Does the project address an important problem or a critical barrier to progress
in the field? If the aims of the project are achieved, how will scientific knowledge, technical
capability, and/or clinical practice be improved? How will successful completion of the aims
change the concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?
Investigator(s). Is the applicant researchers well suited to the project? Does the
Investigator have appropriate experience and training? Does the mentor have demonstrated
an ongoing record of accomplishments that have advanced their field(s)?
Innovation. Does the application challenge and seek to shift current research or clinical
practice paradigms by utilizing novel theoretical concepts, approaches or method ologies,
instrumentation, or interventions? Are the concepts, approaches or methodologies,
instrumentation, or interventions novel to one field of research or novel in a broad sense? Is
a refinement, improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?
Approach. Are the overall strategy, methodology, and analyses well-reasoned and
appropriate to accomplish the specific aims of the project? Are potential problems,
alternative strategies, and benchmarks for success presented? If the project is in the early
stages of development, will the strategy establish feasibility and will particularly risky aspects
be managed?
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If the project involves clinical research, are the plans for 1) protection of human subjects from
research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as
the inclusion of children, justified in terms of the scientific goals and research strategy
proposed?
Environment. Will the scientific environment in which the work will be done contribute to the
probability of success? Are equipment and other physical resources available to the
investigators adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative arrangements?
Resubmission Applications. When reviewing a Resubmission application (formerly called
an amended application), the committee will evaluate the application as now presented,
taking into consideration the responses to comments from the previous scientific review
group and changes made to the project.
Renewal Applications. When reviewing a Renewal application, the committee will consider
the progress made in the last funding period.
2.
E.
VII.
Administrative Ratings:
a.
Reasonableness of the budget.
b.
Reasonable availability of necessary resources.
c.
The likelihood of this pilot project leading to an extramural grant proposal.
e.
The likelihood of obtaining extramural support for follow-up studies.
f.
Overlap with studies previously submitted.
The scores and comments will be presented by the primary and secondary reviewers to the
GCRC Advisory Committee at its next regular meeting or at another meeting with scientific
members of the GAC if there are many applications to review, with a discussion and full vote on
scientific merit by all members documented in the minutes
NOTIFICATION OF FUNDING
A.
If a grant is approved for funding by the General Clinical Research Center Advisory Committee,
the applicant will be notified in writing by the GCRC Program Director on matters regarding the
scientific review of the project and the possibility of funding.
B.
Once the protocol is formally approved by the General Clinical Research Center Advisory
Committee, the candidate along with his/her mentor needs to complete all applicable compliance
forms (e.g. Human Subjects Committee) and the GCRC application form. Please note that the
GCRC application form must contain a Data and Safety Monitoring Plan. Funding will NOT
commence until ALL committees have approved ALL forms and documentation.
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VIII.
C.
The GCRC Advisory Committee reviews all submitted documents once more for a final vote by all
members on funding.
D.
Upon receipt of approval from ALL committees involved, the candidate will be formally notified by
the Director of the GCRC. Following the award notice, the application and required LA BioMed
forms must be submitted to the Office of Research Administration (ORA) Following that
submission, a notice of the LA BioMed project number assigned, the amount awarded, the budget
period during which expenditures are authorized, and any conditions of the award will be sent
electronically from ORA.
E.
If a request is not approved for funding, the applicant will be notified by memo from the Program
Director of the GCRC.
REPORTING REQUIREMENTS
A final progress report is due 30 days after the termination of the project. The report must include the
following information:
A.
A concise summary, in terms understandable to a non-scientist, of the training experience.
B.
A short description of whether the clinical research activities resulted in an abstract or a
publication. All publications must acknowledge the GCRC grant.
C.
A short description with updated contact information must be submitted annually to the GCRC by
the awardee for ten years, to inform the GCRC Advisory Committee of the student’s scientific
progress in patient-oriented clinical research.
The mentor should submit an evaluation form of the student’s performance at the end of the
year. (There are evaluation forms in the GCRC renewal)
The student should provide a final report stating his/her involvement in the project and the
experience acquired, and describe the setting in which the work was or is to be presented.
D.
E.
IX.
QUESTIONS
Questions regarding funding or further program information may be directed to Christina Wang, MD,
Program Director, General Clinical Research Center at extension 2503 or Allison Weber, Director of the
Office of Research Administration at extension 3621.