Consulting Services
The University of Rochester CTSI provides a consulting service to assist investigators at the University of Rochester Medical Center who are planning or conducting a clinical or translational research project. Consulting services are offered in the following six areas listed in the box on the right. Consultations are provided without cost for assistance in the following five categories:
- preparation of a federal grant application in which the Consultants providing services will be a co-investigator on the grant with appropriate budgetary support.
- preparation of an investigator-initiated industry-sponsored study.
- a collaboration that is proposed by a CTSI-Sponsored Trainee for the purposes of completing a course or degree requirement.
- preparation of an invited full proposal for a CTSI-Sponsored Pilot Project in which the Consultants providing services will be co-investigators on the grant with appropriate budgetary support.
- review of a proposed GCRC protocol or the analysis of data resulting from an approved GCRC protocol.
If you do not meet the above criteria for free consultations you are eligible for consultations with the first hour free of charge.
Other CTSI consultations may be charged a fee for service, at the discretion of the department providing the service. Consultation requests should allow adequate time for the consultant to assist the investigator. In particular, investigators who wish to request assistance for grant preparation should make such a request at least one month prior to the application deadline. Investigators who use the CTSI consulting service will be asked to complete an evaluation form at the end of the consulting assignment.
The Epidemiology Consultation Service for clinical and translational research, a component of the CTSI, offers consultation and collaboration related to the epidemiologic aspects of clinical and population based research. The services are available to University of Rochester investigators as well as individuals conducting research at institutions included in the Upstate New York Translational Research Network (UNYTRY). The cost of consultation is supported by the CTSI, therefore there is no charge to investigators. Collaborative agreements with EpiCore staff are established with each investigator on an individual basis at the start of the collaboration. Arrangements typically evolve around commitments for authorship and co-investigator status on grants. Epidemiologic services include the provision of skills and expertise related to formulation of testable research hypotheses, sample size estimation and power analysis, design of both observational and experimental human studies, estimation of risk and risk adjustment, data collection methodologies and study implementation. In order to maintain continuity and efficiency in projects in which EpiCore staff have had significant involvement, assistance may also be provided regarding data management and standard statistical analyses such as multivariate modeling.
The CTSI Biomedical Informatics Programis devoted to biomedical informatics research, education, and service at the University of Rochester. Our mission includes:
- coodination of the existing biomedical informatics resources at the University of Rochester
- providing routine consulting service to investigators and trainees
- integration of the existing resources and development of an institutional information infrastructure to support clinical and translational research
- collaborating with external partners to develop and adopt informatics technical standards
- assessing and optimizing the use of biomedical informatics services. Our specific areas of service include:
- database development and data management for biomedical research
- implementation of information system to support biomedical research and clinical trial protocols
- using information technology to facilitate implementation of healthcare standards, management of healthcare process, and delivery of behavioral interventions
- modeling and simulation
The Biostatistics and Computational Biology of the School of Medicine and Dentistry offers a statistical consulting service to provide help with study design, sample size considerations, and data analysis, for all phases of projects, including grant preparation. Services range from purely advisory assistance to complete mathematical/statistical analysis and data management support for projects. Faculty members of the department serve as research collaborators and statistical consultants, with support from research associates and graduate research assistants. The Departments Programming Group, including programmers and information analysts also work with
statisticians to provide progrramming and data management support.
Cost-Effectiveness Consult Service The goal of the cost-effectiveness consultation service is to provide investigators and trainees with research collaboration, education, and consultation on questions pertaining to economic evaluations of translational medical innovations broadly defined. These could include drugs, devices, medical procedures, or health programs and interventions either in development or already approved and in current use. Such investigations can examine economic consequences and cost-effectiveness of existing technologies given existing utilization patterns, pricing structures, and financing arrangement of the technology under study or model potential economic consequence if data are not available. For instance, investigations may take the form of “what if”
- What are the different research methods and options to address the economic consequences of translational technologies and treatments? What are there strengths and limitations?
- What are the different research methods and options to estimate the impact of translational technologies and treatments on health care utilization? What are the strengths and limitations?
- When conducting a clinical trial, when is it appropriate and feasible to consider an economic component? What are the approaches to collecting, monetizing and analyzing costs alongside a clinical trial?
- What are the analytic approaches to quantifying and presenting uncertainty in estimates of cost-effectiveness? How can results of economic evaluation be interpreted for clinical practice or health policy?
Clinical Research Ethics Consult Service The goal of the clinical research ethics consult service is to provide investigators and trainees with research collaboration, education, and consultation on questions that address ethical issues in the design and conduct of translational and clinical research, as well as to heighten awareness and promote a dialogue and a culture of research integrity while furthering the mission of the UR CTSI.
The intent is to consider and involve clinical research ethic up stream in the process of research planning and design and when appropriate involve clinical research ethics personnel as consultants and eventually collaborators. However, consultation may be requested during any phase of a study from conceptualization, planning, implementation, analysis, and reporting. The topics of potential coverage are broad and include, but are not limited, to the following:
- Clinical trial design. (eg, sham surgery, choice of outcome measures, "me too" studies, underpowered studies)
- Informed consent (eg, impaired decision-making, subject understanding, high risk interventions, disclosure of conflict of interest)
- Faculty/institutional conflicts of interest. (eg, does a conflict of interest exist and if so what are the options for management?)
- Clinical trial monitoring/adverse event reporting (eg, incidental findings, ethical issues with data safety monitoring boards)
- Research in vulnerable populations (ie, drug users, seriously ill, prisoners)
- Genetic information/biorepositories. (eg, communicating study-acquired genetic information to affected non-participants)
The Laboratory Support Service offers consultation to assist the researcher with
research study design, sample collections, sample analysis, issues of obtaining
the best possible data set for supporting data sections (for extramural grant applications),
questions for technology transfer issues (patent applications), and questions regarding
all CTSI pilot grant applications. Additionally, assistance is provided for identifying
research equipment needs for the research project, promoting collaborations with
other researchers, and locating equipment and resources currently available at the
University. Finally, information is provided regarding all University Core resources,
and other laboratory services provided by other departments. The goal of this consultation
service by the Support Centeris to provide the researcher with the tools necessary and the best opportunity to
obtain clinical data that will ultimately translate into new therapeutic strategies
and innovative technologies that will improve clinical care.
The Recruitment and Retention Center consulting service provides access to evidence-based approaches for human subject recruitment and strategies to retain subjects for clinical investigations. Ann Dozier, PhD, is the lead consultant for this service. Dr. Dozier will review proposed study protocols and offer guidance on specific suitable recruitment and retention strategies. She will also direct investigators to other appropriate resources, such as a new recruitment and retention ”users‘ group” available at the Medical Center.
The Regulatory Support Service The Office of Regulatory Support is the home of the URMC Investigator Advocacy Program, which assists investigators to facilitate the translation of a research idea into an implemented research protocol, working through the required regulatory, compliance, and financial steps. Services provided include the development of solutions to resolve encountered challenges with regulatory processes, including IRB and FDA requirements.
