Initial Studies
Human research studies requiring IRB review and approval must be submitted through the electronic submission system, eIRB+. Before preparing your application, please read through the following points to assess requirements and considerations for new studies and whether any additional reviews are required.
There are also multiple subpages that detail various points to consider when submitting initial studies to the Northwestern IRB. Please see the left navigation menu for a list of subpages.
Determine the Principal Investigator
Every research study requires a Principal Investigator (PI). A PI is the individual who has the primary responsibility for ensuring the ethical conduct of the research study and assumes full responsibility for the conduct of the research.
Find a listing of PI responsibilities, who is eligible to serve as PI, and how to obtain PI permissions on the Principal Investigator Responsibilities, Eligibility, and Permissions page. If you are joining Northwestern University from another institution and you plan to continue an existing research study email irbreliance@northwestern.edu to discuss your ongoing research, determine whether the research requires review by the Northwestern IRB, and determine whether reliance agreements between Northwestern and another entity are required.
Individuals Not Qualified to Serve as PI
Individuals who are trainees or students, including undergraduate and graduate students, research assistants, residents, fellows, Masters or Doctoral Candidates, or Postdoctoral Researchers may not serve as the study’s PI. However, certain University statuses/titles may fall into a “case-by-case” category of individuals who may be eligible to serve as a study’s PI, as noted within the Office for Research PI Eligibility page.
Develop the Study Protocol
The study protocol should include a clear description of the study’s objectives, procedures, risks, benefits, recruitment, consent processes, and procedures to maintain confidentiality. The IRB Office has many protocol templates for use by the Northwestern University research community to describe human research activities.
- You are encouraged to reference the Investigator Manual when developing your protocol. This manual is a comprehensive document designed to guide you through policies and procedures related to the conduct of human research at Northwestern University. Study teams may use this when submitting a new study, and as a reference to maintain complaint research. You are also encouraged to use worksheet HRP-314 Criteria For Approval to compose your protocol in a way that addresses the criteria for approval.
- Please see our Study Support Resources and Templates webpage for a variety of tools and resources to help investigators conduct compliant human participant research.
- Whether your research will prospectively enroll participants, or will involve only chart review, find all of your informed consent, waiver, and HIPAA considerations on our Consent Templates & HIPAA Requirements webpage.
- Certificates of Confidentiality (CoC) are automatically granted to NIH-funded human research that meets a certain criteria. There may be required consent language for studies with a CoC. See our Certificates of Confidentiality webpage to see if your study meets this criteria.
- Studies that meet the definition of a clinical trial have additional aspects of submission, training, and reporting requirements. See our Clinical Trial Requirements webpage for more information.
- If your study includes institutions or individual collaborators whose activities will not be reviewed by their own IRB, or if Northwestern will cede IRB review to an external IRB, please visit the Reliance webpages for further information and resources.
- Visit our Recruitment Materials & Guidelines webpage for elements required by the IRB for materials used to recruit prospective participants including printed advertisements, email/telephone scripts, audio or video tapes, or websites.
- Please review FSM's Administrative Policy and Guidance regarding enrollment of students and trainees in research studies.
Note: Umbrella grants, training grants, or development-only grants are generally considered not to be human subject’s research in accordance with DHHS and FDA regulations.
Identify the Study Team
A study team is comprised of multiple appropriately qualified individuals with study-specific responsibilities. The below role definitions apply to studies submitted to the Northwestern University IRB.
- All study team members must complete human participant protection training and recertify every 3 years. More information can be found on our dedicated Human Participants Protections Training webpage.
- Study team members should also receive protocol-specific training before the study starts, when there are changes to study personnel or responsibilities, and whenever study expectations change.
- If you are seeking to add external or non-affiliated study personnel, please review our Reliance webpage. Requests for Northwestern to serve as the IRB of Record for external personnel or sites are reviewed on a per-study basis to ensure compliance with federal regulations.
- Minors, persons who are under age 18, cannot be engaged in human participant research, and they may not obtain:
- (1) data about the participants of the research through intervention or interaction with them;
- (2) identifiable private information about the participants of the research; or
- (3) the informed consent of human participants for the research.
- A minor may, however, subject to University requirements, serve as a research intern or volunteer, and in that capacity analyze de-identified data sets and/or perform other administrative tasks. Please see the IRB Office’s Human Research Policies & Guidance page to access the Minors Acting As Research Study Team Members policy.
| Role | Responsibility | Individuals Who Can Not Have This Role |
| Principal Investigator (PI) | The individual who has the primary responsibility for ensuring the ethical conduct of the research and assumes full responsibility for the conduct of the research study. | See Individuals Not Qualified to Serve as PI Above |
|
Co-Investigator / Sub-Investigator (Co-I, Sub-I) |
A study team member that makes significant contributions to the scientific development or execution of a study. Ensures the study is conducted in compliance with applicable laws, regulations and institutional policies. The Co-I should be qualified by training and experience and may perform some of the PI functions, but they do not have the ultimate responsibility for conducting the research study. | Trainees or students, including undergraduate and graduate students, research assistants, residents, fellows, Masters or Doctoral candidates, or Postdoctoral Researchers may not be qualified by training and expertise to serve as co-investigators. However, the PI may elect to make individual exemptions on a “case-by-case” basis. |
| Study Personnel / Key Personnel |
Study personnel are appropriately qualified research staff engaged in human participant research who may perform research related tasks as delegated by the PI. Individuals are considered engaged in human research if they will interact with participants or access their identifiable data. Examples of study personnel roles include: obtaining participants’ informed consent or screening potential participants, making decisions related to eligibility to participate in research, conducting study procedures, and collecting, reporting, or analyzing identifiable participant data. |
Individuals who fail to meet Northwestern University Human Research Protections Training Requirements are not qualified to serve as study personnel. Minors (persons under age 18) may not be listed as study personnel in eIRB+ nor be “engaged” in the research (interactions with participants or their identifiable data). |
Gather Documents and Support Information for eIRB+ Submission
Be prepared to attach several files to your submission. These may include your protocol, informed consent forms, recruitment materials, survey instruments, and more. All participant-facing materials require prior IRB review and approval. When attaching each file, name it as you want it to appear in the IRB determination letter. Please see our Filling out the eIRB+ Application webpage, for further information on aadding documents and information to eIRB+.
Ensure All Necessary Reviews and Approvals are in Place
Acquiring Northwestern IRB's review or determination is just one of many research administrative actions that must occur before human research activities can begin at Northwestern.
The Principal Investigator and all Co-Investigators on active IRB studies must have completed a conflict of interest disclosure within the past year, and training for conflict of interest within the past four years. Note that conflict of interest training is separate from the Human Participant Protection training requirement.
Studies that involve external funding and/or data sharing must have appropriate contracts and agreements in place with the Office for Sponsored Research (SR). SR is the IRB Office's counterpart for executing grants, contracts, and data sharing agreements. SR and the IRB Office are separate offices, but we do try to encourage and inform investigators of each others’ operations.
Depending on the particulars of your research study, you may need to secure additional reviews, approvals, or notifications from other units prior to initiating your research. For more information please reference our dedicated Additional Reviews webpage for examples where additional reviews, approvals, and notifications are relevant.