So, you received an "IRB Might Be Needed" determination… 

If you have arrived at this webpage, the URTP Decision Form provided you with an “IRB Might Be Needed” determination. This page provides information on the “next steps” that you will take to submit your project to the IRB for a more in-depth review.

 

Ready?  Okay, let’s go for it!

 

All research projects meeting the regulatory definition of “research with human subjects” require submittal to, and approval by, an IRB. This includes the IRB determination that the research is exempt. However, not all activities that involve people, their data, or specimens are covered by the regulations governing human subjects research and may not require review by an IRB.

The question that must be considered when determining whether IRB review and approval is required is whether a project fits the regulatory definition of research (“regulated research”), and if so, whether it also involves human subjects.

We will need to determine if IRB review is needed, and you will start by submitted an abbreviated form to the IRB to help us determine for certain. Complete the following:

 

unoSTEP 1:  Using the electronic IRB submission system, ESTR, follow these steps to create a new study. Choose "Undergraduate Research Training Program (URTP)" for your Department.

 

dosSTEP 2:  Instead of completing a full IRB protocol template and uploading that to the Basic Information page, please complete URTP Application Form. Be sure to include any study related materials that you have already developed in your application in ESTR. It is also important for you to upload the email that you received as part of the URTP Decision Form as it provides the IRB Reviewer with additional information. You may upload these documents to the Local Site Documents page.

 

tresSTEP 3:  Once you have finished uploading these two documents, be sure to press the Submit button on the left side of the page in ESTR. Your submission will be assigned to an IRB Reviewer in the Harvard IRB office. Your reviewer may be in touch through ESTR with any questions or comments.

 

Through this process, you will receive one of three results:

 

no. 1A “Not Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work does not meet the threshold for regulated research and does not need IRB review;

 

no. 2A message posted in ESTR from your IRB reviewer indicating that your work seems to meet the threshold for human subjects research and further IRB review is necessary. In this case, you will receive more detailed instructions at that time on what documents to submit. You will continue to work within the same space in ESTR with the same study ID number; you will not need to create a second, separate application; OR

 

no. 3A “Not Human Subjects Research” determination: If you receive this determination, the ESTR submission is complete and you may commence your project. Your work meets the threshold for regulated research, but does not involve human subjects and does not need further review.