As an academic medical center, Ochsner Clinic Foundation is committed to patient care, research, and education. Although we often speak about these commitments as independent activities, the reality is that these are interdependent functions. As we look at our commitment, perhaps even our obligation, to support our current investigators and to train the next generation of scholars in medicine, we must look critically at the current research environment. As mentioned in the previous articles in this issue of the Ochsner Journal, it is clear that the regulatory environment for research has intensified. Physicians and other healthcare professionals are faced with increasing demands on their time for clinical care, including mandatory documentation of all activities to meet regulatory requirements. Those wishing to participate in research are often faced with many barriers. Some of the barriers that are frequently cited by various members of a research team (e.g., investigators, clinical research coordinators, residents, and fellows) are as follows: lack of time, lack of interest, lack of a mentor, inadequate or no funding, or inadequate or no access to resources such as audiovideo services, medical editing, and information technology.
Increasing regulatory requirements coupled with barriers to proper conduct of clinical research have affected the clinical research enterprise. In the late 1990s and early 2000s, there were numerous examples of improperly conducted research at major medical institutions across the country. It became apparent that penalties not only damaged the reputation of an institution or an investigator, but also resulted in significant costs in correcting the problems identified. In some cases, investigators or institutions were barred from doing research, and in other instances, criminal investigation was indicated.
In 2001, the Academic Division of the Ochsner Clinic Foundation made a commitment to provide institutional support to overcome some of the barriers for clinical research. With changes in the regulatory environment resulting in increased accountability of investigators and institutions for responsible conduct of research, the institution realized the following:
Barriers identified are common across the spectrum of research personnel.
A multifaceted approach to overcoming barriers and integrating research personnel into research activities would be necessary.
Institutional resources to support educational programs and services for research would be key to the success of the clinical research activities. It was believed that by providing institutional resources, services could be maximized, costs minimized, and reinventing the wheel for education by different departments could be prevented.
The infrastructure for the institutional support was provided in the establishment of the Clinical Research Department which was charged with developing an educational program and providing assistance to investigators. A director of the department was named and two coordinators were hired to work with the director to establish the educational program and assist investigators.
In developing an educational program to help facilitate research at Ochsner, we conducted a needs assessment with a variety of research personnel to include staff investigators, clinical research coordinators, residents, fellows, and Institutional Review Board (IRB) staff. We worked with the Compliance Office at Ochsner to identify regulatory requirements and pitfalls. A goal of the needs assessment was to identify what worked and what did not work. Through this process, major and minor facilitators of research, major and minor roadblocks to research, and common themes across the categories of research personnel were identified.
In reviewing the information obtained from this assessment, the educational needs for clinical research became clear. Core training in responsible conduct of clinical research to include regulatory requirements, ethical principles, informed consent processes, and study documentation was needed. Additional training in research methods to include appropriate study design, data collection techniques, and survey research approaches would be required. With the growing demands on the Institutional Review Boards to ensure protection to human subjects participating in clinical research activities, the IRB application became more complex. It was evident that assistance would be needed to meet IRB requirements and complete IRB applications. Access to the institutional resources for audiovisual services, medical editing, medical illustrations, and statistical analyses was identified as important to the clinical research enterprise. Although these resources were already available at Ochsner, ongoing communication regarding these resources was sub-optimal. There was also a need for investigators and all research personnel to understand their roles and responsibilities with regard to the proper conduct of research.
The needs and themes described above and recognized as critical to the clinical research enterprise became the cornerstones of the comprehensive educational program for clinical research at Ochsner. The core educational program was developed with multiple components to respond to the varying needs of the research personnel. Oversight was provided by the Clinical Research Advisory Committee (Figure 1). A core program was initially developed; a supplemental program was later added.
Figure 1: Research Educational Program Oversight
M. A. Krousel-Wood, MD, MSPH, Director, Center for Health Research
EDUCATIONAL PROGRAM (TABLE I)
Table I. Components of the Core Educational Program in Clinical Research.
Basic training for clinical research is provided with an internet-based, modular course developed by the University of Miami (i.e., CITI course). This course provides information regarding key ethical considerations, basic regulatory requirements and acronyms, and critical components (e.g., informed consent) in the responsible conduct of research. Orientation sessions are held to provide research personnel with the handson opportunity to review key research concepts, introduce institutional resources, review institutional policies and procedures, and establish a mechanism for communication between Research Administration and research personnel (Table II). An institution-specific clinical research handbook was developed in 2001 and is updated annually (Table III). This handbook integrates research methods and regulatory requirements with institutional policies and procedures and highlights institutional resources to accomplish research goals. The handbook is available in hard copy as well as online through the Ochsner Research website. A clinical research website was developed for posting of key information, relevant website links, handouts for research lectures, and links to institutional resources and contacts. Institutional research policies and procedures were developed to provide guidance to research personnel with regard to the institutional interpretation of regulatory requirements as well as an outline of what the organization expects with regard to research procedures (Table III). A responsible conduct in clinical research lecture series was developed in 2001 and is delivered annually (Table IV). The lectures focus on topics such as informed consent, regulatory requirements, research methods, mentorship, etc. Although the lectures are live presentations that are broadcast to satellite facilities in Baton Rouge and the Northshore, videotapes of the lectures are made available to departments, individuals, and programs that are unable to attend the live lectures. The last component of the core educational program is Research Night. This annual activity provides faculty, residents, and other research personnel the opportunity to showcase their research and present their findings in a collegiate, non-threatening environment.
Table II. Sample topics for Clinical Research Coordinator Orientation Sessions.
Table III. Institutional policies governing clinical & fundamental research activities chapter topics in Clinical Research Handbook.
Table IV. Sample Topics for Responsible Conduct in Research Lecture Series.
A supplemental program to facilitate resident research at Ochsner was also developed. Components of the supplemental program were derived from feedback from residents and program directors which revealed additional needs. We developed resident oriented lectures to address topics such as critical review of the medical literature, appropriate study design, and understanding of basic statistics. To accommodate resident schedules, resident-specific orientation sessions were designed. Lastly, the need for “one-stop shopping” for residents and fellows to funnel questions and concerns as well as to obtain assistance for development of research protocols was identified. Resources were then found to support a coordinator for resident research. The desired qualifications for the resident research coordinator are as follows: a masters-prepared individual with research experience and multitasking capability. It is important that the coordinator enjoy working with residents and that he or she possess excellent communication skills (written and oral). Computer proficiency (Word Processing, Excel Spreadsheet, basic analytic tools) is considered critical for this position. The responsibilities of the coordinator are varied. The individual participates in resident orientation, coordinates resident lectures, assists with study design, statistical analysis and data collection as needed, facilitates handling of IRB requirements, and assists with development of research protocols. In addition, the individual assists with the preparation of posters, manuscripts, and presentations which highlight research findings. Periodic updates by the coordinator to program directors and the Clinical Research Advisory Committee regarding resident research efforts is also important The coordinator facilitates interdepartmental research collaboration and outreach to residents in all departments.
Since its inception in 2001, the Clinical Research Department expanded to include the director, 2 senior program coordinators (one for education and one for administration), a parttime secretary, and over 15 clinical research coordinators who provide assistance to investigators. The research education program has realized an increase in the number of research personnel completing the online research educational requirement, an increase in the number of personnel attending research lectures and an increase in research activities. A critical component of the education program is the commitment to continuous monitoring of the program for opportunities for improvement. Feedback is sought on a regular basis from investigators, residents, coordinators, and program directors. In addition, the Clinical Research Advisory Committee launched an ambassador program in 2003 in order to provide an outreach by Research Administration to the investigators and coordinators conducting the research. Opportunities for improvement are continuously identified. In many situations, we have found that inadequate communication, not lack of resources, is a key barrier to facilitating research.
Clinical research is alive and well at Ochsner. The institution continues to provide support and resources to facilitate the enterprise. Education is a critical component of an organization's commitment to academic medicine, and Ochsner is well-positioned to meet the educational needs in the current regulatory environment.
- Ochsner Clinic and Alton Ochsner Medical Foundation