Confirm if your project is considered Human Subject Research

A project that meets the definition of Human Subject Research is subject to IRB review. If you are not sure if your project meets the definition, we recommend that you submit a Human Subject Research Determination (HSRD) Form.

The HSRD Form may be used by faculty, staff, and students who are not sure if their activity requires IRB review. The HSRD Form will isolate elements of your project so the IRB Office can make a quick and accurate determination.

If you are confident that your project meets the definition of Human Subjects Research, do not fill out and submit an HSRD form.

Submit the HSRD Form

1. Go to irbnet.org and log in. If you do not already have an account, see Step 2.
2. Go to Create a New Project on the left-hand side and fill in the requested information.
3. Go to the Designer and Click Attach a New Document. Upload the completed HSRD Form.
4. Click SIGN THIS PACKAGE under the Project Administration menu and follow the instructions.
5. Next, if you are the PI listed in IRBNet, click SUBMIT THIS PACKAGE.  If you are not the PI, share the project and direct them to sign.
6. Select “University of Maryland College Park IRB” in the “Search for Organization” dropdown menu and click Continue. Be careful not to select the IACUC, which reviews animal research.
7. Be sure all documents are attached and in final form.  Once you “SUBMIT,” the package cannot be edited unless you contact the IRB Office.
8. Finally, select New Project as the Submission Type and click “SUBMIT.”
9. To confirm you have submitted, click PROJECT OVERVIEW to review what has been sent.
10. Project Status will reflect “Pending Review” status until the review has been completed.  If status reads “Work in Progress” you have not submitted the project.

The IRB Office staff will review and make a determination as to whether an IRB Application is required due to the protocol meeting the definition of human subject research or if the protocol does not meet the definition of human subject research.

If the IRB Office determines that your protocol meets the definition of human subject research and requires IRB review, you will be notified via email to submit an Initial Application. If your project is determined to not require further IRB review, a determination letter will be published in IRBNet.

 The purpose of the HSRD form is to establish whether your study meets the definition of human subjects research and therefore, requires IRB review. It is not meant as a preliminary review or to determine whether CITI Training is required. Once the form and all accompanying documents are attached, share the package with your IRB liaison for sign-off.

Please consider what data you plan to collect!

The IRB cannot establish for certain whether questions/interactions/data collected do not ask anything that would be considered private or identifiable data without clarification of the proposed study. As such, providing documentation of interviews, survey questions, or any other methods of data collection should be included along with the HSRD form. Unfortunately, it is difficult to determine risk and whether definitions are or are not fulfilled without a bit more information. Unless it is obvious that no human subjects or their data are involved or the study is not for research purposes, the IRB will usually need additional detail for IRB/ human subjects research determinations.