The document summarizes how a radiology research administration department supports investigators through various services. These include educating and mentoring investigators, assisting with grant proposals, managing awarded funds, coordinating projects, and reviewing protocols that utilize radiology resources. The goal is to allow investigators to focus on science by handling regulatory requirements and other administrative duties behind the scenes. Services cover all stages from developing ideas to fiscal management of funded projects.
1. How Does Radiology Research Administration Support Our Investigators?
Lois Mannon, Director of Research Operations
Department of Radiology, Center for Biomedical Imaging
I’m glad you asked that question. Approximately fifty years ago the profession of
research administration first began to appear. Back then the mission had a narrow focus:
Assist the investigator in getting their grant proposal out on time, and when it was
awarded rout it to the correct department to be managed successfully. Today, this simple
beginning has parlayed into multiple branches of research specialization. It is a complex
and challenging environment in which the regulations and the business standards are
always increasing in demand. Today’s investigator has to be as financially astute, as s/he
is scientifically gifted. The responsibility for taking an idea from blackboard to fruition
by turning a noteworthy hypothesis into a comprehensive budget, hire and manage
appropriate personnel, conduct the research according to good clinical practices, ensure
the integrity of the data, and oversee fiscal management of the funds is a daunting task.
Given the gravity and detail of the work, combined with the administrative
complexity embedded in every aspect of the investigator’s research program, you have to
ask the question: Where is there time for the science and invention?
That’s where the department’s research administration comes in. In order for
research programs to promote success and generate novel ideas and collaboration, the
investigator and junior investigators have to have time for science. Our departmental
research model takes into consideration the needs of the investigator from the moment
the idea is born through processes of education, mentorship, grant submission, project
management and proper allocation of research costs. All these details are orchestrated
‘behind the scenes’ of research, but are conducted with the investigators knowledge and
input so that they can concentrate on what they have dedicated their lives to – science.
Starting with Education and Mentorship:
The department’s research surge has attracted outstanding faculty with extensive interests
throughout the vast field of radiology. This faculty creates an atmosphere of active
discussion and wide-open possibilities, and their interests in turn encourage junior faculty
and students in the development of new research ideas. To further encourage these ideas,
there are several educational outlets available that are unique to our department. Seminars
dedicated to radiology research include our Research Seminars, where notable speakers
in the profession share their research on a variety of important topics. Research Forums
provide a chance for departmental members to present their early results and to get input
from other researchers. Journal Club identifies and discusses published topics of interest
as well as assists junior investigators critique there own submissions. There is a new
Advanced MR Problem Solving Seminar, a program that brings together investigators,
engineers and physicists to discuss technical problems and brainstorm solutions in MR
research and development. Also provided, is a variety of short course programs in
statistical considerations and software use for compiling, analyzing, and presenting data.
In addition, we have recently collaborated with the Sackler Institute and are initiating a
2. training program to encourage students in the field of biomedical imaging, giving them
the opportunity to assist and contribute to research in our department.
One of the most impressive tools we have is the personal mentorship provided by
research faculty whose experience in radiology and grant writing has the potential to
propel important ideas into viable funded research. By bringing together educational
programs and experienced faculty, the result is a profound impact on our profession as a
whole, which ultimately can equate to discoveries that improve diagnostic services to
clinicians.
Pre Award: Proposal Preparation
After an idea has been fully developed and reviewed by mentors and a statistician,
the scientific interests of that proposal must be matched with a funding body that will
appreciate its merits. This is the hand-off to the Pre-Award division of Research
Administration and our grants specialist. The grants specialist works with the
investigator to help identify potential funding opportunities and create a detailed budget
that covers all costs associated with completing the research project. Beyond the costs of
personnel and the amount of commitment to the project in time and effort, there are
fringe benefits, facilities and administration costs, (better known as F&A or indirect
cost), procedural costs, patient reimbursement, equipment, travel, supplies, and
publications that need to be considered. The Pre-Award division works with the PI to
identify the unique needs of their project to make sure that we are asking for enough
money to cover the costs necessary to successfully complete the scope of the work in the
time period requested.
The division is responsible for helping to complete the forms necessary to rout the
grant through institutional signoff (Sponsored Programs Administration or SPA), and on
to the funding agency. This involves complying with the sponsoring agencies submission
requirements which vary from agency to agency. Many applications for funding include
collaborators outside the institution which may necessitate a subcontract upon award
notification. The grants specialist is involved with negotiating contractual agreements
with sponsors, industry, or with other institutions contributing to the research. The
division handles all correspondence with outside administration and investigators. These
collaborations and contracts require negotiation and information to complete the
requirements for each sponsor, whether it be the NIH, a foundation, or industry funded
research. It should also be noted that each funding agency has a specific set of rules that
must be adhered to, from budget preparation criteria, allowable expenses, to the font used
on the application itself, and number of pages that can be submitted. Each requirement
must be met or the application risks immediate rejection. Recently, the Research
Administration helped a number of investigators make the transition to electronic
submission of their NIH grants. Our Grants Specialist met and prepared each investigator
for this new process and the result paid off with a minimum of submission problems.
Upon notification that the award has been funded, more information and
clarification of personnel time commitments and institutional policies is required from
funding bodies that can be supplied by our grant specialist in order to accept the funds.
In addition to the tasks of applying for funds, there is a constant vigilance over
existing funded awards, including preparing continuation budgets, drafting progress
3. reports to sponsors, requesting carryover funds from previous years, submitting re-
budgeting requests, requesting no-cost extensions, and planning renewal applications.
In one calendar year our pre-award division has submitted over one hundred
applications to agencies and sponsors, in addition to the annual completion of
subcontracts and progress reports on 40 existing awarded grants and clinical trials.
Post Award: Fiscal Management
Once the funds are received by the University the responsibility shifts from Pre-
Award to our Post-Award division for financial management of the funds. Good
stewardship of research monies requires that our financial analyst communicate regularly
with the investigator and SOM finance to ensure and document a number of critical items
that have become the focus of recent audits.
Time and effort committed to the project by research staff has to be reliable,
timely and accurate. Making sure that all research staff concurs with the institutional time
and effort reports ensures that each grant is receiving the attention that was contracted
with the funding agency. Expenses allocated to that funding source need to be allowable
by that particular agency. This process can be complicated as the rules can be different
from one sponsor to another – and even from one contract to another.
Expenditures are tracked by the financial analyst and approved by the PI
regularly. Internal reports are reconciled quarterly against the institutional financial tools,
so that the investigators can be made aware if they are overspending or under spending
and adjust appropriately. The analyst verifies expenditures to ensure expenses are
allowable, allocable, and reasonable in compliance with institutional and federal policies.
The analyst highlights variances and initiates strategies to correct misstatements in the
financials. In addition, he is responsible for reporting financial milestones in contracts so
that our accounts continue to receive the funds promised from the sponsor. Our analyst
creates reports for internal users such as the PI and other NYU staff. Our analyst is also
responsible for reconciling reports generated by School of Medicine Central Finance,
which are reported to external users such as the federal government and other sponsoring
organizations. The Post-Award division has a good understanding of the financial
policies of the federal government and institution working with the sponsor and the
investigator to ensure complete financial compliance. Our analyst oversees more than 80
accounts and has the signatory authority over financial transactions within the research
division, including auditing and internal control processes and the allocation of personnel
to research accounts.
It stands to reason that the hiring of research personnel falls into a segment of post
award. The hiring process, which includes identifying the title commiserate with the
candidates experience, establishing salary level and working with institutional
departments to process the visas for candidates who are not U.S. citizens is essential to
both project initiation and post award. All the human resource effort ties back to proper
allocation of personnel charges on the investigator’s research funds.
Coordinator Division: Project Management
4. The department supports a team of highly trained coordinators with various
backgrounds of expertise all operating under our institutional guidelines and federal
requirements for good clinical practices. Coordinator assistance is crucial to investigators,
especially those with large complex projects that require extensive regulatory oversight,
subject monitoring and data collection. An important component of coordinator
assistance is obtaining proof of Institutional approval whether for human subjects (IRB),
or for animal controls (IACUC), which is required before any research can begin and
before awarded funds will transfer to the institution. The PI is encouraged to submit an
IRB/IACUC application upon receiving a good score on his or her grant, although it is
common to have already received approval as part of the process of collecting pilot data.
The coordinator reviews the project requirements, fills out the IRB applications, develops
a consent form, sets up petty cash for subject payments, communicates and schedules the
subjects, meets regularly with the investigator, and maintains all regulatory documents in
good standing. Under the investigators direction they assist with the details of capturing
the subject cohort, populating databases, and managing patient and project problems.
Coordinators are the ‘person on the ground,’ meeting the subject and walking them
through the procedures necessary to collect the data. They identify logistical problems
with data collection and difficult subject cohorts. Under the investigators direction, they
perform proper screening and recruitment techniques according to the protocol, comply
with institutional billing guidelines, subsequent data management and subject follow ups.
Coordinators are assigned to funded projects in proportion to the amount allocated
in the proposal. They are the liaison between the investigators study needs and the
subjects safety and advocacy and an important part of research compliance.
The coordinator section also provides limited support for non-funded
investigators seeking suggestions or guidance on their IRB submission, recruitment,
study set up, binder maintenance, and advice. They can be an invaluable asset to a young
investigator not familiar with the details of administering a research protocol and what
may be needed to ensure its success. The section houses a combination of nurses,
radiological technologists and data personnel who stay current on new human subject
regulations and are required to take and pass the Association of Clinical Research
Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Clinical
Coordinator Certification at the end of their first two years with our department. At the
time of this report, there are currently 50 active radiology protocols all contributing to
coordinator support.
Radiology Research: Managing Resources
In addition to the support the Research Administration office provides our
radiology investigators, we also provide support and assistance to external departments
utilizing radiology services as a marker for their own research.
The Radiology Resources Review process was created to guide both internal and
external researchers through the maze of imaging areas in the department. Research
Administration, along with the Radiology Research Committee, offers multiple services
to the NYU community in support of research utilizing imaging components in all
radiology divisions. This means that a clinical trial requiring a bone scan, an MRI, a CT
and a mammogram, only need to go through one source to make sure the correct imaging
5. protocol is conducted as per the sponsor’s protocol, and the studies are billed to the
correct research accounts.
The protocol is reviewed, budgeting prices assigned, and depending on the needs
of the protocols, the coordinator and PI are instructed on how to schedule the subjects and
how to collect their data. The goal is to provide a ‘one stop shopping atmosphere’ so that
investigators and coordinators no longer need to have multiple discussions with various
divisions of radiology in order to have a successful study.
By utilizing this process it is possible to simplify the often complex technical
requirements of a sponsor. Radiology has become a digital enterprise of innovative
cutting edge equipment. Sponsors will often request specific scanner models, equipment
manufacturers and software levels. Sometimes the sponsor will create their own
predetermined imaging protocols so they can standardize their data collection across
many imaging sites. The committee recognizes the frustration that an investigator or
coordinator not familiar with radiology would experience in trying to navigate the
scheduling, billing, imaging preps and ordering routines that are different for each
procedure. In addition, we alert and disseminate the research protocol to the radiology
sections involved in the study, making sure each divisions research representative
receives the imaging requirements, and are aware of the special considerations.
Radiology Research Administration works with the Office of Clinical Trials to
identify projects that need radiology review and upon approval, our goal is to make
research in our department more accessible, by lessening confusion and improving
services to our colleagues and research subjects. In total, the department performs more
than 114 separate research protocols utilizing imaging resources throughout the
department.
In summary, Research Administration’s goals are to assist support and augment
research programs within our department and to expedite use of our systems by outside
users. Our department has prioritized its support of investigators by putting in place a
structure that is dedicated to obtaining and moving awards through the system with an
eye toward their compliance and success. We act as the liaison between the investigator’s
research and the federal and institutional regulations that we are bound to follow. We
have assembled a cohesive team of professionals whose purpose is to nurture the project
through the appropriate branches of oversight and simplify the often daunting
administrative questions along the way.
Research projects are each unique in scope and challenges. Therefore each project
requires the combined attention of our office through every phase of project management
and grant lifecycle. You may not know who we are, you may not know what we do, but
we stand behind our scientists and take satisfaction in knowing that we have helped move
the profession of Radiology along – one project at a time.