Research Training
Institutional Standard Operating Procedures (SOPs) for human subjects research are available and effective as of January 1, 2023. Covering a wide range of topics, the SOPs include guidance on how to complete some of the daily activities of a research team, and also address overarching structural activities.
The SOPs specifically guide clinical research studies that target BMC patients, use BMC patient data, or utilize BMC facilities and/or services.
The SOPs are posted within INSPIR II, the electronic IRB research application system. To access the SOPs, you will need to log in to INSPIR II, and click the (?) Help Icon in the upper-right hand corner of your INSPIR home page. This will open a separate window that includes links to the SOPs.
This section of the monthly CR TIMES reviews a specific SOP and highlight some of the best practices from that SOP. For this month, we are focusing on: Research Training.
Various types of training are required or recommended for individuals working in human subjects research. Some of these trainings are study-specific for delegated tasks, some are institutional requirements, and some are actually guidance on best practices. This SOP works to bring together all of these into one place so that study teams can easily see what is required, and where resources might be found. Most importantly, this document includes information on the training requirements for the SOPs that took effect one year ago, in January 2024.
Purpose
The purpose of this SOP is to provide detail on available training to conduct clinical research. This includes required training, and additional training that may be applicable based on the roles delegated to investigators and research staff.
Responsibilities
It is the responsibility of the PI to ensure appropriate and adequate training for those on the research staff who are delegated research tasks, before they have contact with subjects or data. Ensuring staff are adequately trained so they can confidently and competently perform study-related tasks leads to ethical conduct of research, safety of participants, and quality and reliability of the study data.
Highlights
The most important part of this document is that it explains what type of training is required on all of the Standard Operating Procedures. Study teams should review this carefully and determine which training tier applies to them, and complete training as required. If you are unsure what categories apply to your research, the initial IRB outcome letter for each study will list the category or categories. All training is completed within the CITI system.
-
Abbreviated Training Level: Researchers who only work on studies within Exempt Categories 4, 9, 10 or Expedited Non-Exempt Category 5 will need to complete training on a smaller subset of SOPs.
-
Fundamental Training Level: Researchers working on any other type of study other than listed above will need to complete training on the full set of SOPs.
In practical terms, generally speaking, Fundamental Training is required if you work on any studies that involve interaction with human subjects. Abbreviated Training is required if your research only involves use of data or biospecimen collection, with no human subject interaction. For those working on a mix of studies, if at least one study involves interaction with human subjects, then Fundamental Training is required.
If there are questions about which level of training to complete, contact the BMC Clinical Research Network (CRN) for guidance. Individual research teams, departments, or other groups wishing to receive customized-SOP training should contact the CRRO for information.
Training will be required to be completed according to the following time-frames:
-
January 1, 2024: all new studies targeting BMC patients, utilizing BMC facilities and/or services, or using BMC patient data will require completion of training prior to IRB approval
-
January 1, 2024: new BMC employees working on studies within scope are required to complete training within 90-days of employment start date
-
December 31, 2024: existing clinical research investigators and staff are encouraged to complete
As we continue to try to stay warm during the winter, why not schedule time with some hot chocolate and training modules? No time like the present to make sure you and your team are compliant with all training requirements, including the Standard Operating Procedures!