Templates, Forms & SOPs

Is my study human subject research?

If you are not certain whether your activity is Human Research or you would like for the IRB Office to make that determination for you and provide you with documentation of that determination, complete the Human Research Determination Form (HRP-503).

  • Human Research Determination Form (HRP-503) This document is intended for use for those studies that do not meet the definition of human subjects research.  Upload this document in the protocol section of the eIRB+ study application. 

Public Use Data: Researchers using specified "public use" data sets for secondary analysis may not need to submit to the IRB for review since publicly available data does not constitute research with human subjects (as defined under 45CFR46:102). (See Guidance on the Use of Public Use Data)

Which protocol template do I use?

The IRB Office has developed protocol templates for use by the Northwestern University research community to describe research/human research activities:

  • Social Behavioral Protocol Template (HRP-583): This document is intended for use primarily by those conducting social, behavioral, or educational research. If your research involves physical procedures or devices, you may need to include sections that are contained in the biomedical template protocol.
  • Biomedical Protocol Template (HRP-593): This document is intended for use primarily by those conducting biomedical research. [Track Changes]
  • Local Protocol Addendum Template (HRP-508): This document contains local information not represented in the main protocol document received from a study sponsor or non-Northwestern University research collaborator. The Local Protocol Addendum should be uploaded along with the main protocol document in eIRB+ and modified as necessary throughout the duration of the study to account for local changes to the research. [Track Changes]
  • Data and Specimen Analysis Protocol (HRP-1704): This document is intended for use primarily by those involved in analysis of data and/or specimens.
  • Registry (subject pool) Best Practices (HRP-1103)A registry or subject pool is a list or database of participants that multiple investigators will use for recruitment in the future. A registry requires IRB approval as an independent project. 

Please consult this Protocol Conversion Guide 11-9-2014 for important information about using templates with new submissions or converting templates for previously approved research.  See also Recruitment Materials and Guidelines when developing the recruitment sections of your protocols.

Social Behavioral Studies

Consent Document Template

NOTE: If you are planning to obtain online or verbal consent, there are instructions at the end of the consent template (HRP-582) on how to alter the template for use with online or verbal consent.

Additional Consent Document Templates

Protocol Templates 

 Biomedical Studies

Consent Document Templates 

Protocol Templates 


HRP-001 - SOP Definitions

HRP-012 - SOP Observation of Consent Process

HRP-013 - SOP Legally Authorized Representatives, Children, and Guardians

HRP-020 - SOP Incoming Items

HRP-021 - SOP Pre-Review

HRP-023 - SOP Emergency Use

HRP-024 - SOP Reportable New Information

HRP-025 - SOP Directed Review Audits

HRP-026 - SOP Suspension or Termination Issued Outside of Convened IRB

HRP-027 - SOP All Emergency Use, Compassionate Use (Device Only), and IRB Waiver for Individual Patient Expanded Access (Drug Only) Post-Review

HRP-028 - SOP Post-Approval Monitoring

HRP-029 - SOP Suspension or Termination of IRB Approval by Convened Panel

HRP-030 - SOP Designated Reviewers

HRP-031 - SOP Non-Committee Review Preparation

HRP-032 - SOP Non-Committee Review Conduct

HRP-033 - SOP Determining and Processing 'No Continuing Review'

HRP-040 - SOP IRB Meeting Preparation

HRP-041 - SOP IRB Meeting Conduct

HRP-042 - SOP IRB Meeting Attendance Monitoring

HRP-043 - SOP IRB Meeting Minutes

HRP-044 - SOP Not Otherwise Approvable Research

HRP-050 - SOP Conflicting Interests of IRB Members

HRP-051 - SOP Consultation

HRP-052 - SOP Post-Review

HRP-053 - POLICY Conflict of Interest and Conflict of Commitment

HRP-054 - POLICY Institutional Conflict of Interest in Research

HRP-055 - POLICY Conflict of Interest in Research

HRP-056 - SOP IRB Review of Conflict of Interest

HRP-060 - SOP Annual HSPP Evaluations

HRP-061 - SOP Ongoing HSPP Evaluations

HRP-063 - SOP Expiration of IRB Approval

HRP-064 - SOP NIH GDS Institutional Certification

HRP-070 - SOP IRB Records

HRP-071 - SOP Standard Operating Procedures

HRP-072 - SOP IRB Records Retention

HRP-080 - SOP IRB Formation

HRP-081 - SOP IRB Removal

HRP-082 - SOP IRB Membership Addition (Appointment and Re-Appointment)

HRP-083 - SOP IRB Membership Removal

HRP-084 - SOP IRB Meeting Scheduling and Notification

HRP-090 - SOP Informed Consent Process for Research

HRP-091 - SOP Written Documentation of Consent

HRP-092 - SOP External IRBs

HRP-093 - SOP IRB of Record for Multi-Site Research

HRP-094 - SOP External Reporting Process

HRP-095 - SOP Handling Complaints & Allegations of Non-Compliance

HRP-096 - SOP Principal Investigator (PI) Permissions

HRP-097 - SOP Post Approval Monitoring - Recruitment Materials and Process

HRP-098 - SOP Corrective and Preventive Action (CAPA) Plan Assessments

HRP-801 - SOP Establishing Authorization Agreements

HRP-802 - SOP Institutional Profile Management


These worksheets are used for initial review, continuing review, and review of modifications to previously approved Human Research.  Investigators and their research teams are encouraged to use the worksheets to write their protocols in a way that addresses the criteria for approval (HRP-314).

HRP-301 WORKSHEET Review Materials

HRP-302 WORKSHEET Approval Intervals

HRP-303 WORKSHEET Communication of Review Results

HRP-304 WORKSHEET IRB Composition

HRP-305 WORKSHEET Quorum and Expertise

HRP-306 WORKSHEET Drugs and Biologics


HRP-308 WORKSHEET Pre-Review

HRP-310 WORKSHEET Human Research Determination

HRP-311 WORKSHEET Engagement Determination

HRP-312 WORKSHEET Exemption Determination

HRP-313 WORKSHEET Expedited Review

HRP-314 WORKSHEET Criteria for Approval

HRP-315 WORKSHEET Advertisements (Recruitment Materials)

HRP-316 WORKSHEET Payments

HRP-317 WORKSHEET Short Form Consent Documentation

HRP-318 WORKSHEET Additional Federal Agency Criteria

HRP-319 WORKSHEET Limited IRB Review

HRP-320 WORKSHEET Scientific or Scholarly Review

HRP-321 WORKSHEET Reportable New Information Items

HRP-322 WORKSHEET Emergency Use

HRP-323 WORKSHEET Criteria for Approval for HUD

HRP-325 WORKSHEET Compassionate Use of an Unapproved Medical Device

HRP-330 WORKSHEET HIPAA Authorization


HRP-332 WORKSHEET NIH-GDS Certification

HRP-333 WORKSHEET Certificate of Confidentiality

HRP-334 WORKSHEET Media Relations

HRP-335 WORKSHEET GDPR Data Protection

HRP-336 WORKSHEET Mobile Apps and Mobile Medical Apps

HRP-830 WORKSHEET Communication and Responsibilities

HRP-1301 WORKSHEET Industry Sponsored Agreement Guidelines

HRP-1801 WORKSHEET Authorization Agreement Review


HRP-401 - CHECKLIST Pre-Review

HRP-402 - CHECKLIST Non-Committee Review

HRP-410 - CHECKLIST Waiver or Alteration of Consent Process

HRP-411 - CHECKLIST Waiver of Written Documentation of Consent

HRP-412 - CHECKLIST Pregnant Women

HRP-413 - CHECKLIST Non-Viable Neonates

HRP-414 - CHECKLIST Neonates of Uncertain Viability

HRP-415 - CHECKLIST Prisoners

HRP-416 - CHECKLIST Children

HRP-417 - CHECKLIST Cognitively Impaired Adults

HRP-418 - CHECKLIST Non-Significant Risk Device

HRP-419 - CHECKLIST Waiver Consent Process - Emergency Research

HRP-427 - CHECKLIST Post Approval Monitoring: Drug or Device Clinical Trial

HRP-428 - CHECKLIST Post Approval Monitoring: Participant File

HRP-429 - CHECKLIST Post Approval Monitoring: Biomedical Research

HRP-430 - CHECKLIST Post Approval Monitoring: Social Behavioral Research

HRP-431 - CHECKLIST Minutes - Quality Improvement Assessment

HRP-432 - CHECKLIST Quality Assurance Assessment

HRP-441 - CHECKLIST HIPAA - Waiver Authorization

HRP-442 - CHECKLIST Genetic Biobanking Studies

HRP-443 - CHECKLIST Observation of the Consent Process

HRP-1403 - CHECKLIST IRB Member Appointment

HRP-1404 - CHECKLIST IRB Member Re-Appointment

HRP-1405 - CHECKLIST Post Approval Monitoring: Registry, Data Review, and/or Specimen Collection

HRP-1406 - CHECKLIST Post Approval Monitoring: Studies Under External IRB Review

HRP-1407 - CHECKLIST Post Approval Monitoring: Site File

Supporting Documents

HRP-216 - FORM Media Relations  [Example Permission Form]

HRP-1201- FORM Compassionate Use Request for Investigational Devices

HRP-1202 - FORM Radiation Dosimetry

HRP-1203 - FORM Emergency Use of Investigational Drug, Device, or Biologic

Certificate of Translation Template For Non-English Documents

HIPAA Revocation Template Letter

Change in Contact Information Template Letter

IRB Authorization Agreement  - Please see the Reliance Agreements Webpage

Short-Form Consents

Arabic * Gujurati Lao * Serbian
Chinese Hindi Oromo * Somali *
Croatian * Hmong * Polish * Spanish *
English Khmer * Portuguese Tagalog
French * Korean Russian * Ukrainian
Viatnemese *      

*Translation provided with permission from the University of Minnesota.

Certificates Of Translation:

For additional information, refer to OHRP's guidance on obtaining and documenting informed consent of participants with limited English proficiency.

See alsoConsent Translation and Short Form Guidance.