Research

FAQs About the IRB

  1. How do I know if my study requires IRB review? Federal regulations define research as “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge”. A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual, or identifiable private information. If you are conducting research with human subjects as defined in the federal regulations, you must submit your proposal for IRB review. If you are unsure whether your proposal will require IRB review, contact the IRB office for more information.
  2. Does student research require IRB review? All research, including research conducted by students, which involves the use of human subjects, must be reviewed by the IRB.
  3. Does my project need IRB review if I am not receiving federal funding? Yes. All research involving human subjects must be reviewed by the IRB regardless of funding source.
  4. How do I know if my proposal can be expedited? Federal regulations specify the types of research that can undergo expedited review. You can review the criteria for expedited review and determine if your proposal qualifies. It is important to note that the IRB may send any proposal for full review even if it falls under an expedited review category.
  5. How do I know if I need to submit my protocol for full review? All studies that pose greater than minimal risk to subjects and/or involve vulnerable populations such as children, prisoners, people with impaired decision-making capacity, or pregnant women must be submitted for full review. If you have any questions regarding what kind of review your protocol requires, contact the IRB office for more information. There is no penalty if you request an expedited review and your study ultimately requires full review.
  6. If my study is exempt, does this mean it doesn’t need IRB review? No. Only the IRB can award an exemption for a research proposal. This means that any research you conduct, even if it falls under one of the exempt categories, must undergo IRB review. When an IRB determines that a protocol is exempt from further IRB review, any modification requires that the protocol again be reviewed by the IRB.
  7. Can I submit my proposal to the IRB without having completed the CITI training? No. All PIs and co-investigators must complete the CITI training program in order to submit to the IRB. The program is free of charge for all researchers.
  8. If I completed another training program at a different institution, do I still need to complete the CITI course? Yes. The University is committed to upholding the highest standards of research ethics and compliance and believes that the training that CITI provides will ensure that these standards are maintained.
  9. What do I need to submit to the IRB for my application to be considered complete? You should complete pages 15-18 of the new protocol application, and should be sure that you submit all informed consent documents, recruitment materials, and any other relevant information along with your protocol. Applications that do not have all of the appropriate signatures will not be accepted.
  10. Do you have samples of consent or assent forms for investigators’ reference? There is a consent form template included in the new protocol application instructions. For an example of an IRB-approved consent form and assent form (for children under age 18), click here.
  11. How long will it take for me to obtain IRB approval for my research? The length of time it takes to obtain IRB approval depends on the type of review your study requires, typically ranges from 1-5 weeks. If your protocol is being reviewed by the full board, you can expect to receive communication from the IRB no more than three business days following the meeting. Be sure to leave enough time for the IRB to review your project before your intended start date. The IRB works with investigators to review research as quickly as possible, but cannot guarantee reviews within a specified amount of time. You will be notified via a formal IRB approval memo when your project receives IRB approval.
  12. If my project has been reviewed and approved by the IRB at another institution, do I still need to obtain IRB approval from UMass Boston’s IRB? Yes. All researchers affiliated with UMass Boston must have all human subjects research reviewed and approved by the IRB before beginning recruitment and data collection.
  13. Do I need to send the IRB any updates on the status of my research? Yes. If your protocol was approved by the full board or on an expedited basis, you must submit a progress report (or continuation) on at least an annual basis. This progress report must be reviewed and approved before the IRB approval expiration date (typically one year after the date of approval) or the study falls out of compliance and risks being shut down.
  14. What do I do if I want to make changes to my approved protocol? Before you make any changes to your approved documents, you must submit a modification to the IRB. The modification must be reviewed and approved before you may implement any of the proposed changes.