DEVELOPING A NEW RESEARCH PROGRAM

Partner with an academic centre.
Speak with study investigators at nearby academic centres that may be interested in partnering with your community ICU to help recruit study participants for their studies. This type of relationship can also allow for support and knowledge exchange as you start your research program.

Support from affiliated university.
If your hospital is affiliated with a local university, its faculty of medicine may have funding available to support the development of a research program.

Obtain sponsorship from an individual study sponsor.
Approach a study sponsor that might be interested in recruiting in your community ICU and request a larger start-up package to help get your program up and running. Industry-sponsored trials usually have more funds available than do investigator-led studies. However, their trials are more complicated and require more oversight, so beginning with an industry trial may necessitate an experienced RC.

Support from local hospital administration.
Request funds from the hospital administration or research department to support the research program through a pre-determined start-up period (e.g., first 1-2 years of functioning).

Support from hospital foundation
The hospital foundation may be interested in creating a research program as good community relations for the hospital. Or they may be aware of donors who are specifically interested in funding research. The foundation may also work with you to run a fundraising campaign or event to generate base funds to begin your research program, or to locate donors that have a specific interest in ICU research.

Other hospital funding support.
Look for “initiative” funds or “education” funds within the hospital that could be accessed for program start-up.

Research programs within other hospital departments.
If your organization has research programs in other departments, they may be willing to share an RC or other research resources and perhaps, provide additional program support.

External support.
Entities such as regional health authorities or research networks (e.g., The COVID-19 Network of Networks) may be able to offer in-kind or financial support to initiate your program.

Donations from MD group.
If your ICU physician group participates in “group” billing, the group may be willing to contribute a small start-up fund to support initiation of a research program.

Grant revenue to local investigators.
If local investigators have grant support, they may be able to use some of this money to support a research coordinator.

Indirect funding from granting agencies.
When investigators have personal research grants, there are indirect funds that go to the institution to support local research infrastructure. These funds could potentially be used to support research program start-up.

Clinical research organizations (CROs).
Companies that run clinical trials on behalf of pharmaceutical companies or large hospitals may be sources of initial revenue for your program. CROs tend to have generous budgets and you may be able to negotiate a higher start-up budget for your site. Note that pharmaceutical trials tend to be more complicated than investigator-lead studies and require more infrastructure (e.g., research pharmacy, contract review, budget negotiation, etc.) so be sure to assess requirements and feasibility before committing to a specific study.

Create a financial buffer.
Ideally, it is good to obtain 6 to 12 months of salary buffer when hiring your first RC because study recruitment will be slow initially and study payments are always delayed by 3-6 months. Many hospitals will require that this money is available prior to allowing you to hire.

Be ready for patient recruitment prior to hiring.
Try to have your first study as close to recruitment as possible when you hire your RC so there isn’t a lot of lag time in which you are paying your RC and there is no study. Activities that can be completed by investigators prior to hiring the RC include REB approval, impact analysis, and contract negotiations. You could also request part-time help from an RC in another department if you don’t want to complete these activities yourself.

Start with a part-time or shared staff.
Consider starting with a half-time RC/RA or an RC/RA who is shared with another program (e.g., cardiology, infectious diseases, GIM, etc.).

Use local clinical staff. In provinces where union rules allow clinical staff to hold non-clinical positions, you can consider hiring a part-time RC/RA who is also a bedside RN and will divide their time between research and clinical duties. This might entail 2 days of research time and 2 clinical shifts per week, for example. We do not recommend hiring clinical staff to do research on their days off as this leads to poor recruitment and inconsistent follow-up.

Enrol in the LifTING / Sepsis Canada Training Programs.This online training platform focuses on life-threatening illnesses research and includes an RC stream. The program is part-time over two years.

Connect to CCCTG mentorship.
Have your RC connect with the Canadian Critical Care Research Coordinator Group (CCCRCG) to build a support system and learn from RCs with experience running similar trials.

Shadow an RC at another institution.
Consider sending your new RC to shadow an RC at another hospital for hands-on training with an experienced RC who is operationalizing the same trials they will be working on.

Pair your RC with another RC in your home institution.
Consider pairing your RC with an experienced RC in your hospital who is working in another department. Research programs in different departments may run differently from ICU, so try to find a program with reasonable overlap or be mindful of the differences.

Access local hospital human resource training opportunities.
Seek out training offered by your hospital and have your RC enrol. This may include project management courses or other relevant training opportunities.

Join an RC professional society.
Have your RC become a member of the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) and encourage working towards certification. You can seek affiliation and post positions through these organizations as well.

Mandatory research training certifications include Good Clinical Practice (GCP), the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), and Health Canada Division 5 Training. Many hospitals have arrangements with the Collaborative Institutional Training Initiative (CITI Program) to provide this online training free of charge to their staff.

• Investigators and co-investigators
• Research coordinators
• Research assistants and volunteers
• Pharmacists and pharmacy technicians who are assisting with interventional studies involving medications (randomization for these studies is usually done by the pharmacy as is medication preparation and monitoring)
• Nurse Educator (if named on study delegation log)
• Allied health care professionals (if named on study delegation log)

General needs
Workspace, storage, cabinets, locked room, computers, printers, confidential shredding.

For interventional studies
Pharmacy with research-trained pharmacists and pharmacy technicians (with research training - e.g., Good Clinical Practice (GCP), Health Canada Division 5 Training) who can perform randomization and provide tracking of study medications.

For biological sample collection (optional)
Freezer, centrifuge, pipettes, etc.
Buy-in from laboratory staff with respect to processing and storage of samples.

Standard Operating Procedures (SOPs)
Sponsors and GCP require that there are SOPs in place. Over time, the institution should develop their own operating procedures but to start, they should be affiliated with N2. B. N2 is quite broad and some things in there may not apply but it is a good place to start. (See N2 Resources)