Because of the highly competitive nature of drug and device development studies, speed and efficiency at the trial sites are critical to the sponsor and the reputation of the investigative site. In response to these needs, the Swedish Center for Research and Innovation's goal is to ensure that the clinical trial administrative process can be managed as smoothly and rapidly as possible.
Swedish Center for Research and Innovation Policy requires that all research contracts and agreements, letters of intent or support, grant submissions, and any documents committing Swedish resources to the support of research be reviewed by a research administrative officer prior to release to external entities. Research center staff will assist with the development, or must provide approval, of all budgets submitted as part of a grant application. This includes the proper allocation of Direct and Indirect cost allocations (F&A) as per the intent and allowability of the awarding entity. Gift funds cannot be used to reimburse Indirect costs to external entities.
For Principal Investigators:
When conducting a study, there are many responsibilities that are included with the title of "Principal Investigator" or "PI". The following links are provided as references tools for you as a PI.
New Research Regulations regarding Conflict of Interest
Federal regulations regarding financial conflict of interest disclosure have changed and institutions receiving federal funds must comply with the new regulations. The new Conflict of Interest policy will apply to all researchers who conduct research under our oversight. The new regulations the definitions of ‘Investigator’ include a relationship to institutional responsibilities rather than related to a specific project, and also the requirement to report travel reimbursed by an outside non-federal entity. More information and tools can be found below.
Definitions for purpose of disclosure:
Investigator: the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct or reporting of research, funded by a government agency or other entity or proposed for such funding, or who participates in research activities conducted in whole or in part at Providence, funded or not. Investigator includes the investigator’s spouse and dependent child/children and may include subrecipients, collaborators, consultants, staff, post-docs, fellows, residents or students. Others living in a residence owned by the Investigator are included under this definition (e.g., a significant other or foster children).
Institutional Responsibilities: an Investigator's responsibilities on behalf of Providence, such as research, teaching and institutional committee memberships.
What is needed NOW?
All Researchers and staff need to complete conflict of interest training prior to applying for new funding and grants, beginning new research projects, or receiving new funding from federal sponsors. Please note this is in addition to the required Human Subjects Protection training that all investigators now take. Training should take between 30-45 minutes and is valid for 4 years. There are 2 required modules:
- Financial Conflicts of Interest: Overview, Investigator (Researchers) Responsibilities, and COI Rules.
- Institutional Responsibilities as They Affect Investigators (Researchers).
These training modules are available through CITI. You can use your existing log-in or self-register. If you are new to CITI please designate “Swedish Medical Center” as an institutional affiliation during the registration process so Research Administration will receive notice of your training completion.
To access the new COI modules:
Log into the CITI Program: https://www.citiprogram.org/Default.asp
Select “Add a course or update your learner groups for Swedish Medical Center.
Select “yes” to Question 5 “Would you like to take the Conflict of Interest, mini-course”
Complete both modules and the required quizzes.
Information on how to report conflicts of interest:
An email will be sent directly to those Investigators identified within our research program with instructions on how to access and complete the new disclosure through an on-line system. Investigators will have 30 days to complete.
Grant applications that do not have documentation of the required reporting and training will be delayed until training is completed.