The decision to institute a clinical research program should be made at the governing board level. Once the commitment is in place, the first step is to gather together the administrative and human resources necessary to support the program.
It is imperative to emphasize the importance of starting by building the internal administrative structure of the program, rather than by just announcing that the hospital is willing to encourage clinical research activity among its professional staff.
While it is clear that hospital-based clinical research has manifest, tangible benefits for its home institution, it is equally true that a poorly run, haphazardly developed clinical research program can cause tangible damage to the hospital's ethical, legal and managerial functioning. Most significantly, clinical research directly affects patient care. It can also directly affect professional staff liaisons, and the cash flow position of the hospital, as well as human resources, facilities, equipment and material management.
A well-run program will plan for contingencies and grow in considered directions; a poorly run program will be forced to play many extra innings of catch-up ball. As is the case with any new program that is directly related to the most basic aspects of the hospital's mission, a secure, mature, flexible plan to manage growth must be in place before the hospital considers developing its first protocol.
There are two other significant reasons why managed growth is of prime importance. First, when you are building a research base by encouraging systematic expansion of your existing medical and professional staffs activities, the implicit agreement is that the administration will provide the staff with the support system necessary for the successful development, growth and management of those projects. In short, the hospital agrees to provide service and assistance to the staff to augment and improve the research functioning.
In return, the medical and professional staff agree, collectively and individually, that policy-level patient care decisions, as well as those decisions that affect the material, human resources and financial functioning of the institution, will be made with administrative input and approval. It goes without saying, then, that neither the service functions of research administration nor the oversight aspect of research management can be properly provided unless the management structures are in place to provide them.
The second reason why the hospital should create an appropriate structure to manage the clinical research program, before creating the program itself, is that clinical research, like all other aspects of health care delivery these days, is a regulated business. Therefore, it is important for the institution, as well as for its governing board and for its professional staff, to understand in advance and, of course, to comply with those state, local and federal governmental regulations that affect the ethical, operational, financial and reimbursement aspects of a new clinical research program.
MANAGEMENT MODELS
Although it is possible to spread out the responsibility for administrative research development and support among several hospital departments (medical administration, development, public relations, finance, etc.), the best management models come from the university systems, which have traditionally serviced their research efforts through unified offices that usually bear labels similar to the "Office of Research Development and Administration."
Assessing the various models for internal organization is not a difficult task; universities, university teaching hospitals and private non-profit university-affiliated teaching hospitals are logical beginning points. Now that clinical research is becoming more community-based, large community hospitals are also developing internal mechanisms for clinical research support. There are also a few professional societies that might serve as starting points, most particularly The Society of Research Administrators.
When looking at models for their transferable characteristics, remember that there are large and important differences between research administration programs that are centered in universities and ones that are strictly and solely based in private, non-profit hospitals. Size, scale, mission and reimbursement profiles are only four of the more obvious differences.
Of course, very few models can be adopted wholesale, but in general, the most successful clinical research support programs are in a crucial position between the medical and professional staff and the administration with direct implications for patient care; therefore, immediate access to each is of vital importance.
There are a few prerequisites for a successful research support program:
* The director of the office of research must always remember that the function of the office is to provide assistance and support to the research aspect of the hospitals mission, to the researchers who carry it out and to the hospital governing board, which must bear ultimate responsibility for it.
Clinical research is not a direct profit center. A mature clinical research program should be able to recoup its operating expenses from overhead allocations, and a careful administrator should always be able to assure that the research programs are not a fiscal drain on the cash flow. However, the institution and the personnel involved in the line management of a research support and development program must always bear in mind that the ultimate goal of the program is to improve patient care by improving the environment, the procedures and the programs through which that care is rendered.
Therefore, finding an administrator with powerful communication skills, with experience in the field, with the financial skills necessary to balance an always-evolving "soft money" program, and with the personal characteristics to balance the impulse to expand scientific curiosity with the conservative needs of a sound fiscal management program is of prime importance.
* The director of the office of research must be able to understand the process and products of clinical research and must be able to translate those ideas into the concrete language of a responsible administrator.
The most important fiduciary responsibility of the director of the office of clinical research is to ask a series of questions related to the impact of the proposed research program on patient care, on facilities, personnel, material and financial management: Can my institution afford to carry out the project described in this proposal? what are its short-term implications for patient care, personnel allocation, resource allocation and day-to-day fiscal management? Does the program being described fit into the current mission statement of my institution? what are its long-term implications for patient care, personnel allocation, resource allocation and long-term fiscal management?
* The director must have direct access to the highest administrative and medical levels of decision making.
The person at the head of this office must have immediate, direct collegial access at the highest level of the administrative and medical staff. A hospital research program can have immediate and dramatic impact on personnel allocation, resource management, space management, strategic planning and fiscal management. The successful administrator of "soft money" from outside granting agencies (whether they are profit-making or non-profit agencies) can have serious cash flow and resource allocation implications for the length of the granting period, which can stretch out for five years or even longer.
The director must have adequate internal resources with which to develop a flexible, responsive program.
The office of clinical research development and administration will directly affect the institution's mission and, ultimately, the office will become a crucial communications and programmatic link to the most active and forward-thinking segment of the medical and professional staffs. Since it also directly affects the institution's long-range strategic planning process, the office must be established with sufficient internal resources (in terms of budget, personnel allocation and space allocation) so that the job can be done more than adequately.
HOW TO DEVELOP, ADMINISTER AND SUPPORT CLINICAL RESEARCH
The director of the office of research should be selected according to the basic criteria up for the selection of all other senior manager in terms of experience, education and personal characteristic. In addition, the person for the office will have certain unique educational and experiential backgrounds, most particularly
* the ability to write tightly constructed, scientifically well-founded prose;
* the ability to teach medical professionals how to write scientific prose;
* the ability to understand the basic tools of clinical research, including ethical analysis of human research, protocol generation, statistical analysis, experience with managing the intellectual development of a project from its inception through its prototype stage to full scale development, including testing analysis and publication;
* mastery of the tools of research development administration including all the elements of a technical proposal such as budget generation, projection and analysis for monetary, human and material resources;
* mastery of the tools of research funding development, including knowledge of current trends among a broad spectrum of public and private nonprofit and for-profit funding agencies;
* mastery of the tools of post-award research administration, including the ability to developing ongoing, effective project-specific monitoring systems and the ability to understand the scientific progress of a particular project and then to report on its progress to the hospital's administration as well as to the funder.
HUMAN RESOURCES POOLS
As is the case for all important personnel decisions, the successful candidate for director of research development and administration can come from many quarters: from other institutions, from the university research community, from the medical staff, from inside your own institution, or from the community of research development consultants.
The most important factor to consider when hiring from a larger, more sophisticated system, is that often, university research administration programs develop an adversarial tinge in their relationships with the research community.
In addition, university-based research administrators might not have real, direct knowledge of how to grow a program from scratch, since many of their notions are entrenched in the highly technical and sophisticated NIH-based funding mode.
Finally, university systems are quite often highly specialized. For instance, most research administration programs are strictly divided into pre-and post-award sections. It is relatively rare for an administrator to have experience in both aspects of research administration. Such narrowness of experience is a distinct disadvantage for a small, new program whose administrative staff will need to be flexible and well-grounded in general principles. This strategy will quite often produce good results, especially if the search committee is well-schooled in the possible pitfalls.
There are three other possible strategies. First, recruit among hospital-based programs that are at the next stage or two beyond yours. This sounds like the ideal solution, particularly since hospital-based research is a very different entity from university-based research. The problem here is that there is no organization connecting hospital-based clinical research administrators (there are at least two for university-based research administrators), so finding and assessing such programs involves networking among a variety of colleagues, many of whom will not have a precise understanding of exactly what you are looking for.
The solution to the difficulty is to make creative connections. Call on professional contacts in associated fields for advice, information and leads. Look first in connected and/or contiguous fields. For example, making approaches to leaders in such organizations as the National Association for Hospital Development might be helpful.
Secondly, recruit among the research community. Most university-based research administrators are junior-level scientists who, for one reason or another, have science Ph.D.s, but have given up their investigative careers and become administrators. This works well for universities, because such people are readily available and relatively inexpensive. It is quite rare among clinical researchers, because usually clinical researchers who give up their careers as investigators are at a much later stage in their careers, they are much more highly paid, and they are naturally much more attracted to patient care and medical administration than they are to research administration.
However, using the services of an experienced clinical researcher on a part-time basis is quite feasible and it might provide valuable transitional structure for your new program. There are also many non-physician clinical researchers whose administrative expertise may provide even more in-depth experience to your new program.
Thirdly, recruit among your existing administrative staff and grow your own specialized research administrator. Successful research administrators have come from development, public relations, communications, marketing and strategic planning, medical staff administration and from specific programmatically oriented administrative centers. Look for an administrator who demonstrates a good knowledge of clinical programs and define their long range strategic plans and to technically oriented firms that who has knowledge of clinical innovation. Pay particular attention to undergraduate education--does the candidate have a strong science and communications background?
Try to assess research-related personality characteristics--do you have an administrator who demonstrates a great degree of curiosity and eagerness to follow technical and managerial innovation and who can synthesize data and trends into successful new programs? Do you have a manager on hand whose ability to create complex new programs is excellent and who is highly regarded by the medical and professional staff?
In fact, the personal characteristics of a good research administrator are almost exactly the same as those of a good clinical researcher--entrepreneurial, creative, syncretistic, flexible and willing to take reasonable risks.
The successful administrator can quite often be trained, especially if the program is young and if the upper level hospital administration is sensitive to the need for the newly appointed director to school himself in his craft by frequent attendance at the scientific and administrative meetings at which issues of research development and administration are discussed.
Finally, recruit among the community of research development consultants who work with a variety of hospitals. Such personnel are often connected to the Big Eight accounting firms, to smaller, more specialized firms helping hospitals to define their long range strategic plans and to technically oriented firms that specialize in contract research development and management.
As is the case for all upper-level recruitment, there is no magic formula to describe the perfect person for the job. The most important factors here are broad-based education, the personality required to lead a service-generating department, the ability to manage ideas, people and funds creatively, and the ability to teach, to mentor and to cheerlead among all levels of the professional, medical and administrative staffs.
As is almost always true in such complex hiring situations, you can beg such people, borrow them, bribe them, steal them, or just stumble over them while wandering around somewhere. Research administrators are internal entrepreneurs whose effectiveness will have great impact on the hospital's long-and short-range strategic plans; their programs will have direct effect on the institution's image in the community on a local, regional, and even a national scale. Finding such people is a creative process that should proceed along flexibly innovative lines.
DEFINING JOB, RESPONSIBILITIES
Creating a valid, viable job description is just as important as developing a rewarding search process. The most important thing about the job is that it will be difficult to fit it into the standard administrative flow chart for the following reasons:
1) A research administrator has significant affect on the highest level of the medical and professional staff.
2) The job requires significant contact with outside funding agencies on the local, regional, state and national levels.
3) The job can impact long-range strategic planning decisions.
Therefore, it is important that the person holding such responsibility be placed so that access to decision makers, to important proprietary information and to clear-cut knowledge of the planning process is open. Therefore, the administrator must be highly placed within the organization. Just as important, however, is that the successful research administrator cannot afford to be insulated from routine levels of operation. Some of the most interesting and rewarding research projects in health care are in fields such as material management, waste management and resource allocation.
PRINCIPAL RESPONSIBILITIES
The job is multidisciplinary, and no one description will be able to fit all circumstances, given the variety of institutions and research models that currently exist. However, in broad outline, a job description would characteristically include the following areas:
1) To assure that all proposals and projects issued in the name of the institution are approved through a clearly delineated administrative review process in advance of submission to an external funding agency.
2) To assure that all funds accepted from an outside funding agency for specific research projects and/or on behalf of a specific clinical research project director or program are properly and appropriately expended and that the programs are managed according to any proposal, schedule or other stipulated agreement.
3) To assure that all programs, projects and activities engaged in under the institution's clinical research program comply with all governmental regulations concerning the ethical, administrative and financial aspects of research operation.
4) To assure that communication between the institution and the outside funding agencies who are sponsoring clinical research programs, projects or researchers are meeting any existing criteria for administrative and scientific reporting of status.
5) To initiate the flow of information to the clinical research community regarding appropriate individual, private and governmental funding agencies.
6) To assist in the formulation of new programs and proposals by obtaining technical writing support, by initiating a variety of supportive continuing educational programs, and by giving input on the administrative and financial feasibility of proposed new programs and projects.
7) To represent those new programs, projects and proposals to the institution's administration to assure compliance with existing and project constraints on patient care, financial, human, material and facilities management.
8) To represent approved proposals to outside funding agencies so that all queries and negotiation surrounding the decision to fund a particular project is centralized within one clearly delineated administrative center.
While it is difficult to manage a job that has so many different levels of responsibility, the basic daily activities are usually divided into five or six relatively manageable segments: pre-proposal assessment; proposal development; medical, professional and administrative liaison; project management (fiscal, personnel, facilities and material management, and technical and financial reporting); continuing educational programs; and funding agency research and liaison.
Beyond that, each office will evolve according to the characteristics and peculiarities of the actual people and institutions involved. As an example, some research administrative programs are headed by individuals who have strong technical writing and information management skills. In such an instance, the office will serve as an in-house consultant in the proposal development stage.
This will assist the medical and professional staff in generating a greater number of proposals with more highly polished textures than would be possible if the office were weak in that area but strong in finance or in information and systems development. The level of service required by the staff and the kind of service available from the office of research administration will evolve as the interactions between them mature.
RESOURCES FOR AN EFFECTIVE RESEARCH ADMINISTRATION OFFICE
The most important non-human resource that any such high level office can have is an office. This sounds like a facetious statement, but it is not. The processes of proposal development, of research administration, and of research dissemination require long, hard detailed work between the scientific and administrative community. Such work cannot be done if the medical practitioner is being besieged by the phone, by the pager, by extraneous clinical or administrative demands.
The most important requirements of research are time and quiet. So, in our office, we usually insisted that a clinical researcher who wanted our help in proposal development would leave his office, clear his calendar for a specified period of time and agree to engage in the collective process of technical writing.
To facilitate this agreement, we provided a quiet, comfortable place to work; bibliographic and scientific resources; adequate computer support for word processing, data base analysis and financial reporting; and the secretarial support for easy proposal and report submission. Our strategy was to make the process of clinical research easier so that we, therefore, made compliance with our administrative demands much more attractive. "Quid pro quo" is the only Latin that a truly effective clinical research administrator needs to know.
The other two resources that were crucial to the successful functioning of our office were an adequate budget to assure that the information available through the administrator and in our office was as complete and up to date as possible. Our budget included a wide variety of subscriptions to professional journals; to statistical and computer-related journals; to those highly technical journals, services and government documents related to funding opportunities; and to a wide variety of computerized data bases that might make our proposals more sophisticated.
There was also an adequate budget to assure that the continuing education programs that we offered and those that we participated in ourselves were adequate to keep us all up to date and to assure that the our skills expanded as our projects and programs became more sophisticated.
In general, we offered one 10-week technical or administrative seminar per year. These seminars were free to our medical, professional and administrative staff to encourage multidisciplinary involvement. They were held at convenient times. We provided free breakfast or snack, and the faculty (who were recruited from our affiliated university) were experts both in their fields and as teachers. We created special texts, handouts and slides, which were freely distributed and widely copied.
In addition, the director of the office traveled to one major administrative and two major scientific meetings per year; there were also funds available for face-o-face meetings with outside funding agencies on an ad hoc basis.
As our office evolved, the kinds of responsibilities that we handled increased. In general, we were completely responsible for project administration, for research facilities and personnel administration, for the animal facility, for the institutional review board, and ultimately for the operation of what became a separately incorporated, wholly owned research foundation.
There is no reliable rule of thumb that might indicate the level of staff, the growth of the budget or the kinds of facilities that are absolutely required. In general, one person can handle the administrative requirements of 50 externally sponsored research projects whose budgets average more than $25,000 each. Depending on the level of involvement, one person can do an adequate job assessing the administrative, and technical aspects of 300 proposals per year. One person can serve as an in-house consultant on about 50 proposals per year. One person can handle the major responsibility for three to five very large-scale, very complicated institution-wide proposals to major funding agencies per year.
ASSESSING PRODUCTIVITY
Every office of research administration should be particularly sensitive to the administrative review process. We developed criteria in advance to assess our productivity. The most important of these data points included:
* Number of proposals submitted to external funding agencies, categorized by type of funding agency.
* Dollar amount of proposals submitted to external funding agencies, categorized by type of funding agency.
* Number of proposals funded by external funding agencies, categorized by type of funding agency.
* Dollar amount of proposals funded by external funding agencies, categorized by type of funding agency.
Although these are the criteria by which success in clinical research is most easily judged, the monetary aspect is not the only area of functioning that must be assessed and evaluated on a yearly basis.
We also kept track of the numbers and length of investigator contacts, categorized by the profession, age and rank of the investigator. We kept track of the number of informal informational queries to our office. We kept track of the number of people who participated in our continuing education programs and of the number of people for whom we tailored research funding profiles.
In addition, we tracked the length of time required for various proposals to go through the administrative review process, our independent contacts with funding agencies and the queries that funding agencies posed to us.
We assessed this data on an interim and yearly basis and we readjusted and reallocated resources accordingly. So, for instance, when we discovered that we were getting fewer and fewer inquiries from second-and third-year fellows, we held a special meeting with the fellows and determined that they would be benefited by seminars in critical scientific reading and writing.
When we realized that certain investigators were eating up all of our in-house consulting resources on relatively unrewarding projects, we developed more carefully defined criteria for technical writing support. Finally, when we realized that a number of investigators were having problems understanding and dealing with our financial reporting system, we reconfigured the print-out to better meet their needs.
Research administration functions between the professional and administrative staffs. It provides service to the first and oversight for the second. It must satisfy both parties in order to be successful. Ultimately, it must also satisfy the requirements of outside funding agencies. There is no one, true, complete pattern that will accomplish all of these potentially conflicting demands. Most importantly, the office, the personnel and the resources available must be flexibly and creatively managed because, after all, the world of clinical research changes even faster than the general hospital environment does.
