New Study Requirements

Before submitting a new application

1. Determine the Principal Investigator:

Every research study requires a Principal Investigator (PI). This person takes full responsibility for the conduct of the study.  Below is a comprehensive list of who may and may not serve as PI.  Click here to find out if your PI is eligible to serve as PI at NU.

If based on University status/title you fall into the “case-by-case” category, please contact Dr. Richard D'Aquila, Associate Vice President for Research, via email to request permission for such faculty.  Please include your CV, a copy of your protocol, and a letter of support from your Department Chair/Division Chief.  If approval is granted, upload the confirmation email into the "Supporting Documents" section of your eIRB+ submission.

2. Identify the Study Team:

Study team members are all individuals, both internal and external, who have a significant role in the research design, conduct or reporting of the research.  Determine whether any member of the team has a financial interest related to the research. 

Click the link to determine where these individuals are listed in the application.

3.  Register in eIRB+:

To add study team members to a study in eIRB+, they must be registered.  If you are unable to find an individual in the Study Team Member List, confirm he or she has registered in the eIRB+ system.

4.  Complete Human Subjects Protection Training:

All study team members on active IRB studies must have completed human subjects protection training within the past 3 years. See the Training section for the types of training accepted by NU and instructions for completing training.

5.  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 four protocol templates for use by the Northwestern University research community to describe human research activities:

Tip:  You are encouraged to use Worksheet HRP-314 to compose your Investigator Protocol in a way that addresses the criteria for approval.

6.  International Research:

Research conducted by Northwestern University investigators in foreign countries remains under University purview and guidelines.  While we do not impose our standards for written documentation on other cultures, we do not relax our standards for ethical conduct of research or a meaningful consent and assent process. If you are conducting international research, please refer to the guidance at this link: International Research

7.  Gather Support Documents:

Be prepared to attach several files to your submission.  When attaching each file, name it as you want it to appear in the IRB determination letter. 

PI Eligibility

For a summary of who is eligible to serve as the Principal Investigator (PI) on IRB and IACUC protocols, as well as Sponsored Research Projects, see the Northwestern Research page on IRB/IACUC/Sponsored Research PI Eligibility.

If based on University status/title you fall into the “case-by-case” category, please contact Dr. Richard D'Aquila, Associate Vice President for Research, via email to request permission for such faculty.  Please include your CV, a copy of your protocol, and a letter of support from your Department Chair/Division Chief.  If approval is granted, upload the confirmation email into the "Supporting Documents" section of your eIRB+ submission.

 Investigator Eligibility

A Principal Investigator (PI) or Co-Investigator (Co-I) is defined as the project director or principal or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research, or proposed for such funding, which may include, for example, collaborators or consultant.

PIs and Co-Is should never be designated as ‘study team member’ in the eIRB+ application. Students should not be listed as PI or Co-I. Please see PI eligibility for further information: IRB/IACUC/Sponsored Research PI Eligibility

Study Team Members

Role Location in eIRB+ Application Responsibility Study Team Member?
Principal Investigator Listed only in the Basic Information Section of study application Ultimately responsible for all aspects of the research study Yes
Primary Contact My Current Actions - Assign Primary Contact
  • Creates the new study application
  • Assigns the PI to the study, and
  • Receives all communications from the IRB on behalf of the study team
May or May Not Be
Study Team Members Study Team Member Section of study application All individuals, internal and external, who have a significant role in the research design, conduct or reporting of the research Yes
Study Access List Members My Current Actions - Manage Study Access List Individuals who have been granted "edit" access to the eIRB+ submission. May or May Not Be
Submitters (PI Proxy) My Current Actions - Manage Submission Rights Individuals who have been granted "edit/submit" access to the eIRB+ submission (submitters) May or May Not Be

 

Documents

Attach the information listed below (if relevant to your study) in the Section identified.


Protocol: (Basic Information Section)

  • Protocol templates for Northwestern are located on the Templates, Forms, & SOPs page
  • Complete Sponsor Protocol (to include Lead Site for federally funded studies)

Funding Information: (Sources of Funding and Other Support Section)

  • Grant applications
  • Sub-contracts

Drug Details: (Drugs Section with each drug listed) 

  • Package Insert/Investigator Brochure
  • Verification of each IND number (one of these):
    • Sponsor protocol with the IND number
    • Communication from the FDA or sponsor with the IND number

Device Details: (Devices Section with each device listed)

  • Product labeling/Investigator Brochure
  • Device instructions
  • Verification of each IDE or HDE number (one of these):
    • Sponsor protocol with the IDE / HDE number
    • Communication from the FDA or sponsor with the IDE /HDE number

Consent Documents: (Consent Forms and Recruitment Materials Section)

  • NU consent form(s)
  • Sponsor or lead site-approved consent form(s)
  • Verbal script of the information provided orally to participants
  • Templates for Northwestern consent documents are located on the Templates, Forms, & SOPs page

Recruitment Materials: (Consent Forms and Recruitment Materials Section)

  • Advertisements (including printed, audio and video)
  • Recruitment materials and scripts
  • Press Releases (when the study is open to accrual)

All Other Relevant Documents: (Supporting Documents Section)

  • Approval/Authorization Letters
  • Audio/Video/Image Files
  • Certificates
    • Certificate of Confidentiality - new guidance issued 10/1/2017
    • Certificate of Translations
  • Confirmation Email to serve as PI (see PI eligibility above)
  • Debriefing Scripts
  • Data Safety Monitoring Board Report
  • Interview Scripts/Data Collection Tools
  • Executed Agreements
    • Letters of support from sites where research will be conducted
    • Institutional Authorization Agreements (IAAs)
    • IRB approval letters or the equivalent from International Sites
  • Other
    • Radiation Dosimetry Form
    • IRB-approved consent forms from prior studies
    • Non-English versions of materials for participants
    • A copy of the most recent IRB approval letter, the most recently approved protocol and consent form(s) from the IRB of record for CIRB submissions.

File: