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Institutional Standard Operating Procedures (SOPs)

­­­­­­­­­Institutional Standard Operating Procedures (SOPs) for human subjects research are available and effective as of January 1st, 2023. These SOPs will guide members of the research community at BMC and BU Medical Campus that work on studies that are within a specific scope – but it should be recognized that all research teams can benefit from reviewing these for best practices. 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 will specifically guide clinical research studies that target BMC patients, use BMC patient data, or utilize BMC facilities and/or services.

  • BMC patient: any individual with a clinical encounter generating a BMC-specific medical record
  • BMC patient data: patient data that is derived from BMC medical records and/or systems
  • BMC facilities: clinical or non-clinical space owned or operated by BMC
  • BMC services: a unit or group operated or managed primarily by BMC staff

If the research that you are doing does not fit into this scope, these SOPs are still highly recommended as a good foundation for anyone working with human subjects. If you are unsure if any of the SOPs apply to you, contact the BMC Clinical Research Network (CRN) for guidance.

Training will be required and the courses are available within CITI currently. Those wishing to complete the training should log into CITI using their Boston University Medical Campus/Boston Medical Center-affiliated account. After choosing View Courses for Boston University Medical Campus/Boston Medical Center, navigate to the bottom of the page under the Learner Tools heading and choose Add a Course. SOP Training is listed under Question 10.

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

Training requirements have been designated into two tiers with specific SOPs required for each tier. Within the CITI training, there will be a course for each tier level. Researchers should choose which training course to complete based on the tier that applies to their research, as described below. The two tiers are based on the study category that individuals are working on. If you are unsure what categories apply to your research, the initial IRB outcome letter for each study will list the category or categories.

  • 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, 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, 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.

The SOPs are posted within INSPIR II, the electronic IRB research application system. To access the SOPs, you will need an INSPIR II account. Once logged in, 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.

Feedback on the SOPs are welcome, including identification of typos or errors and suggestions for additional SOPs. Anyone can submit suggestions or recommendations by completing the Feedback Intake Form. Not all feedback will be able to be implemented but all submissions will be reviewed and are appreciated.

More information on the SOPs can be found at the following places:

Standard Operating Procedures – Effective as of January 1st, 2023
Institutional Clinical Research Policies and Guidance Library
Serve as an overarching index of SOP documents. Also describes general research responsibilities and requirements.
Research Training
Provides 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.
Research Team Competency
Describes an investigator’s oversight responsibilities to ensure that all research team members have been trained on their delegated tasks and are competent to perform those tasks.
Quality Management
Provides best practice recommendations for conducting self-assessment monitoring of study documentation and processes.
Site Monitoring
Describes the purpose and procedure involved with a Sponsor or Lead Team monitoring visit. It describes the activities by the research team at study site from the time the monitor requests to schedule a visit, until all follow-up activities have been completed.
External Audit Preparation
Describes the purpose and types of external audits that can be expected within clinical research, and the preparations and procedures for those audits.
Essential Research Documents
Describes what constitutes essential documents that make up the regulatory and participant files, and provides guidance in their management throughout the course of a study.
Delegation of Authority and Responsibilities
Describes an investigator’s oversight responsibilities to ensure that all research team members have been trained on their delegated tasks and are competent to perform those tasks.
Participant Recruitment
Ensure that the PI and research team members assisting in the conduct of clinical research are informed about their obligations, responsibilities, and available resources related to participant recruitment.
Informed Consent Process
Describes the requirements for conducting the informed consent discussion and documentation of informed consent for non-exempt research with human participants that involves prospective interventional or observational research and prospective consent from the participant or (LAR) or parent/child.
Case Report Form Completion
Describes the process for use of CRFs, including recording data, corrections to data, responding to queries, and requirements for signing CRFs.
Adverse Event Monitoring, Assessing, and Reporting
Supports the PI and research staff in identifying, assessing, documenting, and reporting all adverse events, serious adverse events, and unanticipated problems.
Protocol Deviation Reporting
Provides guidance on the proper reporting of deviations that occur during the research that are not part of or are inconsistent with the IRB-approved protocol and study plan, BMC/BU Medical Campus HRPP Policies & Procedures, or federal regulations.
Participant Withdrawal
Describes the process for a research participant’s voluntary withdrawal from a study completely, an investigator’s decision to terminate the participation of a participant before the study is completed, and early discontinuation of a study intervention.
SOP Management
Describes the development of centralized SOPs, the review and approval process of SOPs, and procedures for maintenance of SOP.