Research Report and Recommendations for Clinical Trial, Population Health, and Telehealth Research

Research Action Committee
of Atlantic Health Sciences Corporation

September, 2003

• Executive Summary

• Background

• Membership - Research Action Committee

• Current Infrastructure

• Workgroup Recommendations

• Population Health Research Working Group

  • Recommendations of the Population Health Research Working Group

• Telehealth (e-Health) Research Working Group

  • Recommendations of the Telehealth Research Working Group

• Workgroup Key Recommendations: Common Threads and Concluding Thoughts

• Appendix I - Working Groups of the Research Action Committee

Executive Summary

The Research Action Committee, an Ad-Hoc Committee of the Board of Directors, Region Health Authority 2, has developed in concert with its Working Groups, Research Foci in the areas of Clinical Trials, Population Health, and Telehealth. Emanating from our discussions with the clinical research community within AHSC, and with various stakeholders at the Department of Health and Wellness, the University of New Brunswick, New Brunswick Community College, National Research Council e-Health, and the Business Community of Saint John, a series of recommendations have been developed. 

The recommendations set forth comprise the core of the Research Action Plan. In developing these recommendations, our criteria were based, for the most part, on our areas of clinical strength, existing pockets of research and niche areas, the integration between clinical priorities and research, research partnerships (existing and potential collaborations) and funding opportunities. 

In essence, the recommendations of the Research Action Committee build on our strengths, expertise and long history in Clinical Trial Research. In our recommendations, we support the continued growth and allocation of additional resources to this area. We believe that a healthy clinical trial research environment can support other research initiatives at the local level, or more globally. The return and support of the 'Seed Fund', with matching funds from research overhead, our research partners, and the Board, will provide leverage to increase collaborative research activity within the domains of Population Health, and Telehealth. 

Our key partners in research, the University of New Brunswick, the National Research Council e-Health, and the New Brunswick Community College among others, are committed to the research enterprise in health and it will be through the integration of our efforts across research foci that we will succeed. 

The recommendations that are presented below for your consideration will lead us towards our goals. Ultimately, it is through such research that we offer our patients increased care and treatment options and determine the true standards of care.

Background

Research Action Committee 

The Research Action Committee, an Ad-Hoc Committee of the Board of Directors, Region Health Authority 2, emanated out of the recommendations set forth by the Research Focus Workshop held February 10, 2003, reflecting the Boards intention to designate Research as a corporate priority. The Workshop, facilitated by Dr. Arthur Slutsky, VP Research, St. Michael’s Hospital, Toronto, initiated discussions around the criteria for establishing research priorities at AHSC and the identification of potential research foci. Criteria were based, for the most part, on AHSC’s areas of clinical strength, existing pockets of research and niche areas, the integration between clinical priorities and research, research partnerships (existing and potential collaborations) and funding opportunities.

Emanating from these and subsequent discussions with Workshop participants and various stakeholders, three potential research foci were identified and subsequently put forth to the Research Action Committee for consideration. These research foci are: 

Identified Research Foci 

• Clinical Trials Research 

• Population Health Research 

• Telehealth Research 

Membership, Research Action Committee

The Research Action Committee, chaired by Mrs. Sandra Irving, included broad representation from AHSC, the Board Regional Health Authority 2, and various stakeholders at the Department of Health and Wellness, the University of New Brunswick, National Research Council e-Health, and the Business Community of Saint John. The following members served on this Committee:

Sandra Irving, Chair

Dora Nicinski, CEO
Atlantic Health Sciences Corporation

Michael Chisholm, VP Corporate Affairs & CFO
Atlantic Health Sciences Corporation

Barb McGill, VP Planning & CNO
Atlantic Health Sciences Corporation

 Dr. James O’Brien, Chief of Staff
Atlantic Health Sciences Corporation

Dr. Mohan Iype, Assistant Dean
Medical Education, New Brunswick

Dr. Frank McCarthy, Director Research Services
Atlantic Health Sciences Corporation

 Dr. Pamela Jarrett, Clinical Head
Geriatric Medicine
Atlantic Health Sciences Corporation

 Dr. Margot Burnell
Department of Oncology
Saint John Regional Hospital

Dr. Keith De’Bell, Dean
Faculty of Science
Applied Science and Engineering
University of New Brunswick, Saint John

Mr. John Boyne, Acting Director
Program Analysis & Evaluation
Department of Health & Wellness

Verle Harrop, Ph. D
Group Leader, e-Health

Todd Stephen
Owens & McFayden Benefits Inc.

Mr. Kerry McLellan, Chairman & CEO
Kinek Technologies

This Committee was entrusted with the mandate to submit a Research Action Plan Report to the Board. To this end, three research working groups of the Research Action Committee, Clinical Trials, Population Health and Telehealth, have been created to carry out a SWOT analysis (Strengths, Weaknesses, Opportunities, and Threats) of the three identified research foci. Their findings are presented below in the form of a series of recommendations, which comprises the core of the Research Action Plan. The Working Groups, when possible, addressed the following areas:

• Access to funding; internal and external sources to support AHSC research
• Infrastructure needed to support AHSC research
• Partnerships required in order to facilitate and support AHSC research

The Workgroup reports reflect the current stage of development within AHSC of the respective research foci. Although there is now considerable evidence in support of our expertise in Clinical Trial Research, and our recommendations support continued growth and allocation of additional resources to this area, significant resources must also be designated in support of research in Population Health and in Telehealth. The distinctions that we have drawn among these research foci are arbitrary, as it will be through the integration of our efforts across research foci and through our collaboration efforts with our partners, that we will succeed.

Among other measures, the number of our research grants and research publications, and the numbers of patients recruited to clinical trials will be the yardstick against which our success will be measured. The recommendations that are presented below for your consideration will lead us towards these goals.

Current Infrastructure

To provide context for the Work Group Recommendations, the Research Services Department, AHSC will be briefly described in terms of its staff complement, its documented support of local and provincial research and evaluation initiatives, its main administrative functions and its sources of revenue.

• G. Frank McCarthy, PhD, Director Research Services
• Diane E. Strong, Research Pharmacist, Member, RRC
• Jacquelyn Legere, Research Services Liaison Officer to RRC
• Barbara Marshall, Pharmacy Assistant
• Joanne Arthurs, Financial Coordinator to Research Services
• Melody McKay, Secretary to Research Services
• Erika Molina-Salazar, Data Base Design and Management to Research Services

As a Department, we have actively supported and provided key resources to a number of projects and research and evaluation activities in Health Region 2 and the province. Over the past few years, these have included:

• Member, Accreditation Committee, AHSC
• Researcher, Greater Saint John Area Roundtable on Primary Health Care
• Member, Community Health Center, Steering Committee and Evaluation Workgroup
• Member, Integrated Service Initiative, Steering Committee, ‘Ad Hoc’ Committee
• Chair and Recording Secretary, Integrated Service Initiative, Evaluation/Quality Workgroup
• Chair, Research Review Committee
• Chair, Minimal Risk Review, Research Review Committee
• Member, Provincial Community Health Center, Evaluation Workgroup
• Chair, NB Regional Partnership Program, Advisory Group
• Data Entry and Data Base Support to the Planning (AHSC, Health Status Report, 2001; Community Needs Assessment, 2001; Strategic Planning Process, 2003) and Finance Department (Parking Database) and the Community Health Center (Breast Health Program, Osteoporosis Research)

In the continued support and promotion of health related research by and for AHSC, we currently provide data entry, research design and statistical support with our partners at UNB Saint John. Limited grant writing (critique) is also available through our office.

Administrative Functions

The Research Services Office has provided administrative support of over 164, 161, 156 (2000, 01, 02) clinical trials and original research studies over the past three years. Our clinical trial research included pharmaceutical and academic–sponsored studies and prestigious affiliations with such cooperative groups such as National Cancer Institute of Canada, Radiation Therapy Oncology Group, and National Surgical Adjuvant Breast and Bowel Project. The breadth of our research studies span 25 AHSC Departments involving over 52 Principal Investigators and 34 Research Coordinators.

We support the Research Review Committee, in terms of the pre-approval process for clinical trials and original research submissions (research study applications, informed consents, SAE’s, CIA’s, amendments, re-approvals and changes-in-study-status). The Research Services Office reviews clinical trial and clinical trial financial agreements while the Research Review Committee provides ethical and scientific review (risk assessment). The administrative and ethical approval (conditional approval/ approval/ not approved) of research studies is conferred by these groups through the Letter of Final Approval.

Revenue Sources

We are funded from base budget. Our additional revenue sources include the overhead charges we levy on contracts (30% of total contract value), the Research Review Committee fee of $1750 / study (where applicable), the CIA process that ensures cost recovery for all AHSC departments that support research, and the savings (cost avoidance) of drugs to AHSC. The funds generated from these sources approximated $360,000.00 ($189,000.00 in overhead; $32,750 in review fees; and $145,749.00 in cost-avoidance in drugs) in fiscal year 2002. This occurs in addition to the significant 'in kind' contribution we make to the research process. For example, in 2002, 60% of the study submissions that we have reviewed and processed were carried out at no charge to the investigators. Given full patient recruitment, the Clinical Trial Agreements that we endorse have the potential of generating over $1,000,000 in research dollars for AHSC (2002 projection).

Work Group Recommendations

The Work Groups have made the following recommendations that have been reviewed, discussed and endorsed by the Research Action Committee. They are presented below and then further elaborated for your information (See Appendix I for list of members).

Recommendations of the Clinical Trials Research Working Group

Chair, Dr. G. Frank McCarthy

1. The allocation of Clinical Trial Research Coordinators to Clinical Departments demonstrating enhanced Clinical Trial Research Activity
2. Support of a Research Review Committee administrative structure through the office of Research Services that would ensure quality and timely reviews of research studies (6-week turn-around time)
3. Development of a ‘Seed Fund’ in support of investigator-initiated and other research funding opportunities (letters of intent, calls-for-proposals etc.)
4. Reactivation and expansion of the Research Advisory Committee
5. Changing the ‘Mindset’ of the Non-Research AHSC Community
   • Provide clinician-researchers ‘protected time’ for research activities
   • Publish and present research accomplishments
   • Create a Research Report to demonstrate progress

Rationale / Solution(s) in support of Recommendations in Clinical Trial Research

1. The allocation of Clinical Trial Research Coordinators to Clinical Departments demonstrating enhanced Clinical Trial Research Activity

Rationale:
The continued growth of clinical trial research within AHSC is hampered by the lack of a system-wide research coordinator recruitment and retention program. There are a select few permanent nursing research coordinator positions within AHSC as most are now conferred by ‘contract’ between the PI (or Professional Corporation) and the research coordinator. Research Coordinators may be AHSC employees or they may not be. These ‘contracts’ rarely involve AHSC and often raise liability concerns. Currently, AHSC nurses who seek research coordinator positions within the corporation (nurses occupy the majority of these positions within AHSC) must take leaves of absence from their respective clinical units to acquire clinical trials research experience. As leaves of absence draw to a close, usually within 1 year of initiation, nurses must return to their respective clinical departments. Failure to do so may lead to a loss of seniority and benefits. This continued interruption of the research coordinator workforce, significantly hampers patient recruitment to trials, the continuity of care within trials, and the establishment of an experienced research coordinator workforce. Equally as important, it sends a discordant message within the corporation, that care within a clinical trial is a separate and distinct entity than ‘normal’ hospital care. It also alters the requisite relationship within and between clinical departments that is integral to the efficient conduct of clinical trials.

Solution:
Research ‘Contract’ positions should be retained, as they may be appropriate in certain circumstances (part-time clinical trial opportunities). Contract positions, however, are inadequate to resource AHSC’s clinical trials growth and should be supplemented. We propose that departments currently engaged in the clinical trial research would, through the normal budgetary process, request that a nursing position within their unit be designated for clinical trial research. These positions would be created specifically to develop local clinical trial research capacity and to develop local ownership of clinical trial research. The nurse research coordinator would report to the department in which she was hired.

The research coordinator would be funded through a research allocation. A component of this allocation would support the hiring of a dedicated research coordinator. The cycle of funding would be contingent on future clinical trial performance of the respective departments (# of trials, $ value of trials, and performance to recruitment targets (patients screened, patients enrolled). With growth in the number of research coordinators, one might then move to a more centralizing mechanism to recruit, retain, and educate this human resource.

A centralized mechanism administered through the RSO would also promote related activities such as:

• Support for Clinical Trial Research Coordinator monthly meetings
• Affiliation with Association of Clinical Research Professionals and/or other professional bodies
• Research Coordinator training and educational opportunities within and outside the corporation
• Good Clinical Practices (GCP) ‘Day’

Additional Benefits:

• Provide increased treatment (care) options for patients
• Assist in the recruitment and retention of clinical trial research coordinators while at the same time maintaining current relationships
• Provide research coordinators an opportunity for a common voice, certification and educational opportunities
• Develop a stable, ‘within house’ (departmental) clinical trial research environment
• Aid in the development of a ‘ground up’ based research culture within Region 2

Rationale:
The ability to conduct clinical trials and indeed all types of health services and medical research within AHSC is dependent on a stable research review process. The Research Review Committee functions as the ‘Institutional Review Board’ (IRB) for AHSC. The Research Review Committee is a standing committee reporting through Research Services and the Medical Advisory Committee (MAC) to the Board of AHSC. The role of the Research Review Committee is to protect the rights, well-being and safety of research participants. This Committee has a long-standing history within AHSC and has developed considerable experience and expertise in the review of research proposals. The Committee is structured to comply with a complex regulatory environment (Declaration of Helsinki,1996; ICH-GCP, promulgated by Health Canada, 1997; Tri-Council Guidelines on Research Involving Humans, 1998; and additional regulations such as FDA emanating from the USA).

The regulatory environment for medical research has become increasingly complex since September 2001, when Health Canada made significant changes to the regulations governing the conduct of clinical trials. Review Boards must now operate in accordance with written operating procedures and policies must also be developed showing clear lines of authority and accountability surrounding the conduct of clinical trials.

The Research Review Committee, however, within its current resource base cannot support this new regulatory environment. At a more fundamental level, it struggles within its mandate of 'timely' approval of 'full-board' submissions of industry-based clinical trials. As these submissions are managed largely by a 'volunteer-based' committee of AHSC (medical and surgical groups, nursing, pharmacy, quality risk management and laboratory) and non-AHSC members (3 of 10 members are from outside AHSC (community, legal, and science), the current demands placed on these dedicated members is excessive. The immediate effects result in a high turnover of members, difficulties in reaching and maintaining quorum for its once-monthly meetings, and review delays that are considered to be unacceptable to the research community at large. This draws into question our credibility within the industry, and significantly hampers our research productivity.

The dollar value of research to a PI within a clinical trial and by extension, to Research Services (overhead of 30% on total contract value) is based on a per patient dollar amount and competitive patient recruitment targets. In order to support such a process the review process must be timely and efficient. The Research Services Office should institute the following solutions in order to remain competitive within the industry, both nationally and internationally.

Solutions:

(a)

The creation of a Research Service Liaison Officer position between Research Services and the Research Review Committee to complement the processing of Research Study Applications for "Full-Board" review and to provide initial review and continuing review of all trial related documents. This would significantly lighten the administrative load of the RRC and its Chair, assist research coordinators and investigators in the preparation of study submissions, and support the timely review and approval of new trial submissions. This would also enhance the overall administrative support to the Research Review Committee through our office and would maintain the all-important ‘arms length’ decision-making autonomy of this committee. This individual would be a non-voting member of the RRC.

(b)

The creation of a Research Review Committee Chair position to enhance the functional capabilities of the Chair and the Committee. Administered by the Research Services Office, but autonomous in decision making, this individual would significantly reduce the potential for perceived conflicts of interest. Working directly with the Director, Research Services, they would contribute to the continued development of written operating policies and procedures governing the conduct of clinical trials and other research activities within AHSC. It would be the first step in the cooperative development of a possible provincial institutional review board structure subsequent to the development of a business and functional plan.

(c)

Increase the number of clinical trial researchers on the RRC to maintain the credibility of the RRC to the research community at large (a committee of one’s own peers philosophy).

(d)

Over the longer term, provide expertise in consultation with other RHAs in the development and implementation of a Provincial Institutional Review Board Structure. This concept must be compatible with the philosophy of "local review" and produce significant efficiencies in the clinical trial review process by creating a credible, province-wide, review process within the RHAs.

Rationale:
The existence of a ‘Seed Fund’ would significantly build research capacity as research dollars could be directed to support investigator-initiated research proposals, specific research priorities within the corporation (calls for proposals) and also provide support for existing research labs (annual ‘Seed Fund’). Collaborative research projects could also be supported through a similar mechanism of ‘Seed Fund’ cost sharing by AHSC and our research partners. Such a model would also link well with established Canadian Institutes of Health Research (CIHR) funding opportunities such as the NB Regional Partnership Program (50/50 cost sharing agreement between CIHR and NB for projects approved but not funded through the regular CIHR competitions).

Solution:
The recovery of indirect costs associated with carrying out clinical trial research within AHSC is through the provision of overhead on contracts and clinical trial agreements (30% of total contract value linked to recruitment) to the Research Services Office. It is recommended that these overhead funds be used to support funding competitions and associated research infrastructure requests. The Board may consider providing matching funds (1:1 ratio to a maximum of $125,000 Board: $125,000 RSO / for a total fund of $250,000/ annum). Funds would be awarded annually through a ‘peer review’ process. Research endowments could also be directed in support of such a fund.

Additional Benefits:

• The creation of a sustainable ‘first-step’ research funding opportunity
• Foster research projects at a level that would ultimately support entry at the provincial then national stage
• All projects would undergo a "peer-review" process that would ensure quality research submissions
• Research projects could be driven by corporate goals and objectives as reflected through documents such as the Needs Assessment
• Research projects could potentially be driven by collaborative research teams (research partnerships) both within and outside AHSC
• A clear deliverable to investigators and the research community from overhead
• A further development of research based culture within the Corporation

4. Reactivation and expansion of the Research Advisory Committee

The committee structure and terms of reference are currently in place. Its membership would be expanded to include our research partners and other stakeholders with a vested interest in the research process. The composition of the Research Advisory Committee should reflect the broad-based research community and as a committee of the Board, it would link the Board directly to the research process. The administrative support for this Committee would be through the Research Services Office.

5. Changing the ‘Mindset’ of the Non-Research AHSC Community

• Provide clinician-researchers ‘protected time’ for research activities
• Publish and present research accomplishments
• Create a Research Report to demonstrate progress
• Development of a ‘Research Chair’ in Health Services research

Changing the ‘mindset’ within AHSC requires a fundamental shift to an evidence-based decision making model in all that we do. This shift is already in place and will be further evidenced by the decisions and actions of the Board, Research Services and the Research Action Committee. Current initiatives within AHSC, such as the Saint Joseph’s Community Health Center, the Integrated Service Initiative and the Telehealth Program are only a few of the examples that reflect a movement towards research, evaluation and measurement.

Population Health Research Working Group

Co-Chairs: Dr. Mohan Iype and Mrs. Barbara McGill

As an approach to health, population health aims to maintain and improve the health of an entire population and to reduce inequities in health status among population groups. To reach these objectives, it considers the entire range of factors and conditions (determinants of health), and their interactions that determine the health and well being of Canadians. The resulting knowledge (gained through research) is used to develop and implement policies and actions that that may apply across the entire population, or to particular subgroups within a population in order to achieve health gains.

The outcomes or benefits of a population health approach extend beyond improved health status outcomes. A healthier population makes more productive contributions to overall societal development, requires less support in the form of health care and social benefits, and is better able to support and sustain itself over the longer term. Actions that result in good health also bring wider social, economic, and environmental benefits for the population at large (Health Canada, 1996; Health Canada, Strategic Policy Directorate, Population and Public Health Branch-July 2001 Draft).

The determinants of health that are the basis of a population health approach are the following:

• Income and social status
• Education
• Social and physical environment
• Healthy child development
• Health services
• Culture
• Social support networks
• Employment/working conditions
• Personal health practices and coping skills
• Biology and genetics
• Gender

There are some underlying assumptions inherent within the population health approach. These need to be considered in order to understand the nature of the research to be undertaken. These assumptions include:

• Population health interventions should focus on populations
• A series of complex interactions exist within the determinants of health
• As determinants do not exist in isolation, strategies that are meant to address them need to consider this 
  (Towards a common understanding, December, 1996)

 Population health requires evidenced-based decision making. "The search for supporting evidence related to the various determinants of health and the relationship between them is still primarily conducted in academic and policy circles and they are usually outside the loop." By conducting Population Health Research, AHSC will not only contribute to the body of knowledge but in effect, close the loop.

There are broad challenges to conducting Population Health Research within AHSC. They include a need to:

• Understand the broad base determinants of health and a attitudinal change about what influences the health of our community and the value of approaching change through a population health perspective
• Adopt the appropriate time frames in order to achieve long-term outcomes
• Develop community participation and intersectoral collaboration. Fortunately there is already good evidence of partnerships within the communities of Region 2
• Provide adequate time and resources, and ensure that these will be available over the longer term

The recommendations of the Population Health Research Working Group were predicated on our specific strengths and weaknesses in relation to population health research. Our strengths were:

• Stable population base
• Ethnic diversity (some)
• Community commitment including organizations (Business Community Anti-Poverty Initiative, Urban Core Support Network)
• Strong university links interested in social / cultural determinants

Our Weaknesses were:

• Undetermined levels of commitment to research in general (and population health research in particular)
• Lack of strong Population Health Research leadership (currently)
• Determination of resources; is there financial and human resource support for this work

6. To develop research capacity in Population Health in Region 2
7. To add an evaluative component to any new / existing program or service
8. To present and publish population health research and program evaluation outcomes

Rationale:
This recommendation centers on the main objective of exploring new and existing opportunities in research arenas specific to the health determinants. Further areas of focus need to be identified. The identification, therefore, of specific opportunities is not at issue here, but what is, is our ability to act on any one of a number of valid research proposals and initiatives that may arise from both internal and external sources. A preliminary action plan in Population Health Research would be comprised of the following steps:

• Determine areas of priority within Population Health Research to investigate (research on poverty was considered to be area of considerable importance with key partnerships currently in place) and areas where we would want to take a lead role
• Identify multidisciplinary research teams associated with research priority areas and where possible determine lead investigator(s)
• Through detailed survey of existing resources, identify gaps in human and physical resources
• Investigate opportunities for research partnerships and collaboration in priority areas (fill gaps / complement research teams)
• Investigate opportunities for research partnerships and collaboration while recognizing that initially, developing capacity within current resource restraints, may limit us to secondary roles within larger research projects
• Identify basic infrastructure required to proceed and those that are project specific. Infrastructure needs may include grant writer, space and supplies (office and computer), publishing mentorship and assistance
• Hire the required research expertise

7. To add an evaluative component to any new / existing program or service

This recommendation provides the initial steps required to evaluate current population health and health promotion programs. Examples such as the CHC, ‘Baby Think It Over’, ‘First Steps’, ‘Roses, Rubbers, and Rainbows’, ‘Teen Resource Center’ and ‘BCAPI’ were offered. The Working Group suggests that future population health and health promotion programs not be considered if evaluation is not an integral component of program design. The action plan includes the following steps:

• Develop a detailed inventory of current population health programs and services
• Invite local or other experts (Dr. George Kephart, Dalhousie; Dr. Gina Browne, McMaster University) to provide education and awareness on population health research
• Hire a population health / program evaluator

The action plan in support of this recommendation is a logical extension of recommendation number 8. In fact, a population health researcher or program evaluator on staff would provide the skills necessary to fulfill this role. The preliminary action plan in support of the recommendation is comprised of the following steps:

• Develop an inventory of current work in PHR that is complete and could be prepared for presentation and/or publication
• Identify research teams involved, and their limitations in fulfilling this role
• Develop resources (time, human, financial) to support the presentation and publication of identified PHR

Telehealth (e-Health) Research Working Group

Telehealth involves the use of communication and information technologies as a mechanism of providing health care and health care services when distance separates the participants. The majority of telehealth initiatives can be broadly classified into two categories: remote diagnosis and consultation (usually involving a specialist and a primary care physician) and distance learning for continuing health education. The primary rationale for the development of telehealth is to serve those populations that, for one reason or another, have limited access to health care. In this regard, telehealth has the potential to dramatically reshape the ‘face-to-face’ medical model of health care delivery that has existed since its inception.

AHSC has had considerable experience in the design, implementation and evaluation of telehealth initiatives. In posing the question in 1997– "if we were to design a healthcare system where time, distance, and location of resources were neutral factors, what would the system look like?", AHSC embarked on a provincial research and development project based out of the New Brunswick Heart Center (NBHC). Using technology as a process enabler, VITAL (Virtual Interactive Telehealth Assistance Links) created a telehealth infrastructure throughout the province, that improved access to and efficiency of specialized cardiac services of the NBHC. Transitioned from project to program in 1999, VITAL now offers a ‘Living Lab’ for the demonstration and continuous development of other telehealth initiatives.

IRIS (Interactive Real-Time Imaging and Data Solution) is further evidence of the dedication of AHSC to the development of innovative telehealth solutions for long-distance applications in health care. IRIS is a custom-made diagnostic and consultation system that has been used by specialists to examine patients over a secure local area networks with virtual stethoscopes and real-time video. It also offers storage technology that enables nurses to cache pictures and data until a doctor is available to examine them. Health care uses currently range from speech pathology, postoperative cardiology, to psychiatric assessments.

Recommendations of the Telehealth Research Work Group

The Telehealth Work Group expanded the research focus of ‘Telehealth’ to include the ‘Electronic Health Record’ and a number of recommendations were offered for consideration within each research foci. The recommendations include:

 The preliminary action plan proposed by the Telehealth Workgroup was not linked to a specific research project, but would provide the basic support for telehealth research. It comprised the following steps:

• Dedicate a resource to support and drive the activity at AHSC
• Take inventory and prioritize existing and planned initiatives
• Implement a knowledge management tool to capture research-based information
• Implement online research/outcome evaluation tools
• Partner with UNB/NBCC/NRC and others to gain access to expert resources

The administration and support of Clinical Trials Research within AHSC ensures that patients can benefit from the most current and effective drug or device. To many it is viewed as the standard of care. Building on a history of over 25 years, the recommendations that have been proposed in this report are designed to support a more responsive system - responsive to an ever changing and demanding regulatory environment, responsive to our pharmaceutical partners and affiliations, responsive to the needs of our clinical research professionals and responsive to the health needs of our patients.

The human and physical infrastructure enhancements that we propose in support of the clinical trial programs will be funded internally from base budget and through the funds generated from our overhead charges, research review fees, and savings in drug costs.

The distinction between clinical trials research and original research is arbitrary. A healthy clinical trials research environment can support other research initiatives at the local level, the lab, or more globally. The return and support of the ‘Seed Fund’, with matching funds from research overhead, our research partners and the Board, will provide leverage to increase collaborative research activity within the domains of Population Health, Telehealth and support independent investigator initiated research proposals. Our key partners in research, UNB, NBCC, NRC e-health can benefit by providing similar matching fund programs and/or research expertise.

The recipe for initiating research foci within Population Health and Telehealth requires two main ingredients: time and money. At the very least, resources will be required to support the hiring of two PhD/Postdoctoral research fellows or equivalent, in the life sciences with evidence of early research productivity and publication. These individuals will be hired to direct, initiate and support population health and telehealth research programs. Sustained funding periods of at least three to five years' duration from internal sources, will be required to develop a independent research program. During this time, teaching and administrative duties should be kept to a minimum. Links with the academic sector will provide the student base required in order to sustain an active research program.

Sharing such resources with our research partners and collaborators will produce greater gains in both the short and long term and will lead to the formation of multidisciplinary, collaborative research teams. In the formation of such teams, integration of the existing clinical and academic-based researchers should occur. The resource inventories that we carry out will support the formation of these teams and determine our respective contributions (human and physical resources).

Natural partnerships are now beginning to emerge in light of our discussions with our research community. Population Health Research Team addressing poverty in the Saint John area include the St. Joseph’s, CHC; Vibrant Communities, Saint John; Business Community Anti-Poverty Initiative, Urban Core Support Network, Human Development Council, UNB, Atlantic Health Promotion Research Center, St. Michael’s Hospital, Toronto; Health Canada, and Research Services, AHSC.

Telehealth Research partnerships include the Telehealth Program, AHSC, National Research Council e-Health, NBCC, and the Health Telematics Unit, University of Calgary.

These and other partnerships must be strengthened so that together we will meet the challenge of today’s competitive research environment. The recommendations that we present and endorse, build on our achievements of the past, as we move forward towards a new era in research in Clinical Trials, Population Health, and Telehealth. AHSC embraces the challenge.

Appendix I