- NEW ADDITION TO INSPIR APPLICATION: Drug Schedule Information
- REMINDER: Requirement for a Detailed Protocol and ClinicalTrials.gov Posting
- REMINDER: Clinical Research Unit at BMC Now Open
- Zoom Replacing IRB Office Drop-In Hours
NEW ADDITION TO INSPIR APPLICATION: Drug Schedule Information
As part of our ongoing institutional oversight of compliance with Massachusetts state law for MA Controlled Substances Registration (MCSR) Research licensure, it is important for the HRPP to understand the types of drugs that are being used in research, and where they will be stored. In order to adequately capture this information, the Drugs or Biological Agents Information section of the IRB application has recently been updated to add two new fields:
1) Drug Schedule (i.e., I, II, III, IV, V, or VI) and Administration Instructions:
NOTE: For this field, make sure to specify the Drug Schedule and where the drug is being stored. The IRB application provides a link to the comprehensive list of Controlled Substances drug schedules for reference here: https://www.deadiversion.usdoj.gov/schedules/orangebook/c_cs_alpha.pdf
2) Storage Location
Please select one of the options:
- Investigational Pharmacy Services at BMC
- Internal BMC-affiliated Commercial Pharmacy
- External non-BMC-affiliated Commercial Pharmacy
- Other
NOTE: Please select the correct radio button. If none of the first three options are applicable, then please check Other and enter the storage location in the textbox.
Please ensure that you fully complete these two new fields when filling out your application.
REMINDER: Requirement for a Detailed Protocol and ClinicalTrials.gov Posting
As outlined in Section 7.2.2.20 Protocol Requirements, the BMC/BUMC IRB requires you to use a separate detailed protocol for studies that meet the definition of a clinical trial involving a medical or surgical intervention intended to modify a health outcome; or, for any clinical trial that is multi-site or receives NIH funding.
However, you should also use a detailed protocol if your funder requires that you post your study results on ClinicalTrials.gov (CTgov). This is because in order to post results on CTgov, you must also upload and post your detailed protocol as part of your CTgov registration record. By creating and using a detailed protocol from the beginning of the study, you will then be ready to upload your detailed protocol in your CTgov record at the time of results posting.
As an example, the Patient-Centered Outcomes Research Institute (PCORI) often requires that you post your results on CTgov as a condition of the funding. Therefore, you should submit your PCORI-funded clinical trial study to the IRB with a detailed protocol.
In order to fulfill this sponsor requirement, you may use our Protocol Template, found here:
You should also check YES in IRB application Section 8.1 Separate Protocol. This will hide many application sections that are redundant when you use a separate detailed protocol.
REMINDER: Clinical Research Unit at BMC Now Open
BMC’s new Clinical Research Unit (CRU) is 3,000 sq. ft. of state-of-the-art clinical research space located on the 6th floor of the Yawkey building. The CRU at BMC is an extension of the hospital’s mission to advance science for all by engaging underserved communities in innovative research on today’s most pressing health issues.
Through the launch of the CRU at BMC and the existing Boston University Clinical and Translational Science Institute General Clinical Research Unit (GCRU), researchers will have continued access to an expansive array of services that adhere to the highest standard of safety and clinical efficiency. If you are a BMC or BU researcher interested in initiating a trial, please fill out the intake form. Reviewers will decide if the CRU at BMC or GCRU at BU is more appropriate based on your responses.
To learn more about the CRU at BMC, check out the story on HealthCity.
Zoom Replacing IRB Office Drop-In Hours
Due to the increased shift to using remote meeting technology, the IRB is discontinuing its once-a-week in-person drop-in office hours in order to expand its availability and service through Zoom meetings. Please contact the IRB by email at medirb@bu.edu to request a Zoom meeting with an IRB representative, and provide these details so that the IRB can pre-assess your needs: type of research study (and INSPIR study # if available); your questions; and your availability dates and times.