Human Subjects

If your project involves you interacting with living people in any way, you may need IRB approval before you begin. The Institutional Review Board (IRB) of Northwestern University is a committee that reviews research involving human subjects in order to ensure that the rights and welfare of human subjects are protected. Federal law and NU policy mandates that all biomedical and social/behavioral research involving human subjects must receive IRB approval prior to the start of the research.

 

Human Subject Research Requiring IRB Approval

Grant Applicants

Research Involving Human Subjects That Does Not Require Approval

Help

 

HUMAN SUBJECT RESEARCH REQUIRING IRB APPROVAL

  • If you have received one of our grants, you must keep the Office of Undergraduate Research informed about your IRB status. This means that, even if you believe you do not need IRB approval, you have to contact us to tell us this!
  • If your proposed research involves human subjects (including interviews, surveys, clinical research on living people, etc.), you need to obtain approval from the Institutional Review Board before you may begin your project. You will need to complete an IRB application and include a protocol, recruitment material, consents and any data collection instruments (see the IRB web site for the Protocols, Templates and Forms that you may need.).
  • All Northwestern researchers, including undergraduates, who are involved in the conduct of human subjects research are required to complete CITI initial human subjects protection training and to recertify every 3 years. This training is separate from the application process to receive IRB approval for your research project.
  • While students will prepare the IRB application (as the Primary Contact), only faculty can serve as PI (Principal Investigator) and submit the application.
  • IRB applications are submitted electronically through the eIRB+ system.
  • Grant money cannot be released until final approval of the IRB application has been sent to the Office of Undergraduate Research

 

GRANT APPLICANTS

  • Summer URG applicants must complete CITI training and add the completion certificate to their application.  The formal IRB application process does not need to begin until you have been awarded the grant.
  • Academic Year URG applicants must complete the CITI training and submit their separate IRB application before they complete their URG application.

 

RESEARCH INVOLVING PEOPLE THAT DOES NOT REQUIRE IRB APPROVAL

  • Some projects will involve people as participants but do not require Institutional Review Board approval.  In these cases, you should submit a Human Research Determination Form (HRP-503) protocol outlining your project. . You will submit this protocol in eIRB+. You can list yourself as the PI and you do not need any other supporting documents although it is helpful to upload interview questions if you are completing interviews.
  • Examples of when the research is not human subjects research:
    • Journalism/Documentary/Artistic Activities:  Investigations and interviews that focus on specific events, views, etc., and that lead to publication in any medium (including electronic), documentary production, or are part of training that is explicitly linked to journalism; Writing a stage or screen play, poetry, musical, photo display, etc. based on the collected data.
    • Oral History or Case Study:  The project is limited to oral history activities or investigations into some event. Data collect can come from open ended or one-on one interviews, but the interviews only document that specific historical event or the experiences of individuals related to an event, without the intent to draw conclusions or generalize findings. These interviews can be with more than one person.
    • Existing Data:  Gathering or analyzing data that have been already collected by someone else, such as educational data, census data. The data are publically available and have no identifiers (names, addresses, emails, phone numbers, etc.; any information that could specifically identify a person) included.

IRB review of research projects that are not human subjects research is required if you want the IRB to document that the IRB has agreed that no IRB review is necessary. If the IRB does not agree with you that your project is not human subject research, you will be asked to submit a regular protocol.

DO NOT assume that your project is not human subjects research. You need to ask the IRB!

 

HELP

The staff at the Institutional Review Board is happy to answer your questions and assist you in preparing your application.

Visit the IRB website for more information, including drop-in hours and locations.