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What is an IRB?
An Institutional Review Board (IRB) is a committee that reviews, monitors, and approves research that involve human subjects. IRBs exist to help protect the rights and welfare of human subjects. IRBs are regulated by federal and state regulations. IRBs work with investigators to ensure that their research is conducted in accordance with the policies and regulations that relate to human subject research.
What is a Federalwide Assurance?
A federalwide assurance (FWA) is an agreement between an institution and the federal government. In the FWA, the institution certifies that it will subscribe to the federal regulations that govern human subject research. If an institution receives any federal funding and conducts human research, it must hold an FWA. Investigators may be required to provide the institution’s FWA information on certain grant applications. See the CRC IRB Federalwide Assurance page for more information.
PERSONNEL & TRAINING
I took the NIH training. Does this satisfy the training requirement?
If you have NIH funding, you can take their training. Remember, individuals need to take a refresher training every 3 years. When you are ready to take the refresher training, you will need to take the standard CITI training course. See our training policy on the main Office of Research Compliance website.
I have an exempt study and I need to add staff. Am I required to submit an amendment?
No, study staff amendments are not required for Exempt studies. However, if the new staff is at another institution, they should check with their institution’s IRB to see if there are any requirements at the other institution.
Why am I being asked to take an “optional” module within the CITI program?
In addition to the required modules, the CITI program also offers optional training modules. These optional modules cover additional topics such as research involving children, prisoners, the internet etc. Investigators and research staff are responsible for ensuring that they take all applicable modules. The Principal Investigator (PI) should review the optional modules and identify any that may apply to his/her research study. The IRB will review the application once it has been submitted to ensure that the appropriate modules have been completed. If the IRB identified a module that is applicable for your specific research, we will request that you take the additional module(s).
SUBMISSION & REVIEW
What difference does it make if my research is considered Exempt or Non-Exempt research?
No matter how your human subjects research is classified, you are still obligated to conduct your research with the highest ethical standards.
Administratively, the biggest difference is that Exempt studies do not need to have annual re-approvals conducted. Studies that are classified as Expedited or Full Board are required to have annual re-reviews completed in order to remain active.
Additionally, the regulations are a little different for the kind of consent documentation that is required. See tips for creating a consent document for more information on requirements needed in the consent form.
I am working with an outside investigator and only being sent a limited amount of information from them. Do I need to submit my own IRB application to the BU IRB?
If the data you receive is stripped of any identifiers and you do not have access to the code or link to those identifiers, than you might not need to submit. Call our office to discuss your specific case.
How long will it take for my IRB application to be reviewed?
The review times vary on the submission type, the completeness of the application and the volume of other submissions pending review. Generally, submissions are reviewed within 4 weeks. To get a general sense of the average times to approval, please see last month’s submission metrics.
Do classroom projects require IRB review?
No, classroom projects do not require IRB review. See the IRB classroom protocol news bulletin that discusses this policy.
Is there a way to obtain documentation that my project does not require IRB approval?
Yes. Submit a summary of your project via email, including detailed information about any access to identifiable information. We will let you know if additional information is needed and whether or not the research actually does require IRB approval. If the project does not meet the definition of human subject research and does not require IRB review, we can issue you a Not Human Subject Research determination letter for your records and/or your sponsor’s records.
What is a Certificate of Confidentiality?
Certificates of Confidentiality (COCs) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. To learn more, visit our certificate of confidentiality guidance page.
What is Clinical Trials Registration and which research needs to be registered?
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Research that includes the study of drugs, devices or biologics that were either initiated after September 27, 2007, or initiated on or before that date and were still ongoing as of December 26, 2007 must register with the registry. Trials that were ongoing as of September 27, 2007 and reached the Completion Date (see Primary Completion Date data element on ClinicalTrials.gov) before December 26, 2007, are excluded. (source)
Can the CRC IRB review my project even if I do not work for or attend Boston University?
No, the CRC IRB will not serve as the IRB of record for an unaffiliated member of the community at large. However, if the unaffiliated community investigator collaborates with a University Faculty or Staff member and the faculty/staff will serve as the Principal Investigator, there may be some options that we can explore. Contact us to get the conversation started.