Getting Started

Welcome to the Northwestern University IRB Office! Our mission is to protect the rights and welfare of human research participants. The IRB Office provides resources, training, oversight, and consultation to the Human Research community. Below are some common questions and topics that come up when individuals new to the NU IRB Office are starting or joining research studies:

How do I login to eIRB+?

eIRB+ is Northwestern University's electronic submission and review system for human research. See our eIRB+ webpage for more information.

How do I know if I have a biomedical or social and behavioral study?

The chart below should be used as general guidance and provides the category that certain types of projects typically fall under. FDA projects must be submitted to Bio-Medical.

The category you submit to should be based on the procedures involved in the research project, not your NU department affiliation.

Biomedical vs Social-Behavioral Studies Table
BioMedical	Social-Behavioral
All studies that either test or use drugs and/or devices FDA regulated studies (drugs, devices, biologics) Collection of biospecimens Medical record chart-reviews Involving medical procedures either invasive or non-invasive procedures, including EKGs, muscular strength testing, etc. Research that carries physical risk Changes to medical standard of practice Randomized medical care	Research employing survey, interview, oral history, focus groups Education-based research Research on individual or group characteristics or behavior Behavior-change research Research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior

Does my research meet the definition of Human Research?

At Northwestern, individuals seeking to conduct research who are unsure whether their research meets the definition of Human Research should review the Human Research Determination Form (HRP-503). If an individual is unclear whether their research meets the definition after reviewing the form, they may submit the form for review by the IRB Office through the electronic submission system, eIRB+. The IRB Office will review the individual’s responses in the form and provide an official determination. If the IRB Office determines that a project is human research, the reviewer will assist the individual with the next steps in the formal review. Next steps may include preparing a research protocol.

The IRB Office encourages investigators to err on the side of caution in determining whether to submit a Human Research Determination request because the Office will not review already conducted research if the investigator later learns that IRB review was required.

I'm new to submitting to the Northwestern IRB - where do I get started?

The Initial Studies webpage is a great step-by-step resource for preparing new studies. The Investigator Manual (HRP-103) is also a great resource and it describes responsibilities and processes that Northwestern researchers must follow.

Can I serve as the Principal Investigator for my study?

Human research studies require an appropriately qualified individual to serve as the Principal Investigator. This individual must be identified before the IRB will review a project. More information can be found on our PI Eligibility webpage.

What should I do if a problem with my study is discovered?

If, during the conduct of the study, the Investigator or designee discovers an unanticipated problem or non-compliance, the Investigator may need to notify the IRB through a Reportable New Information (RNI) submission in the eIRB+ system. The Investigator must subit information that falls within the defined criteria on the dedicated RNI webpage.

What is the difference between checklists, worksheets, and SOPs?

Checklists provide support for the IRB office (IRB members, Designated Reviewers, and Compliance Analysts). They contain important elements from pertinent regulations. Examples of checklists include subpart determination for special populations, waivers, PI transfer responsibilities, as well as post-approval monitoring. The IRB member / Designated Reviewer / Compliance Analyst is required to complete these checklists as they review the research study. Study teams are not required to complete these checklists to submit with their study application in eIRB+. However, study teams may use these checklists to anticipate any information they need to include in their protocols to be eligible for the aforementioned criteria, or use post-approval monitoring checklists to regularly monitor their research compliance. Of note, study teams may be required to complete post-approval monitoring checklists upon request, but they are not submitted in eIRB+.
Study teams are encouraged to review the worksheets as they write their protocols in a way that addresses the criteria for approval. Worksheets are guidance materials used by the IRB Office for human subjects research in initial reviews, continuing reviews, and modification reviews, to enhance compliance with federal, state, and local requirements.
SOPs, or standard operating procedures, are documents that outline the relevant policy and the IRB Office practices in accordance with Human Research Protections (HRP). If you have questions about the IRB Office policies and practices, please review our SOPs.

Who is the IRB?

The Northwestern Institutional Review Board (IRB) Office is primarily responsible for developing and directing the University’s Human Participant Protection Program (HRPP), which also involves other offices at Northwestern University. The Office also supports 6 IRB panels comprised of over 80 members from within the University, our affiliates, and the community.

The Northwestern IRB panels are groups of people who review and approve human research. The IRB includes professors, doctors, scientists, and people from the local community. They review human research to protect participant rights and welfare before and during research studies.

Where can I find more helpful resources?

Check out our Researcher Resource Library for more resources that includes everything from archived Brown Bag presentations to information on federal regulations.

Check out our Regulatory Agencies webpage for more information on regulatory agencies (such as the FDA, NIH, OHRP, etc).

Check out our Research Ethics webpage to learn more about the history of research ethics and the guiding principals we use today.