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).

Which protocol template do I use?

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

  • 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.
  • 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 Template Protocol (HRP-593): This document is intended for use primarily by those conducting biomedical research.

Please consult this Protocol Conversion Guide 11-9-2014 for important information about using those templates with new submissions or converting to those 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 and Examples

Social Behavioral Consent Document (HRP-582)

Protocol Templates

Social Behavioral Protocol Template (HRP-583)

Local Protocol Addendum (HRP-508)

Human Research Determination Form (HRP-503)

Biomedical Studies

Consent Document Templates

Biomedical Consent Document (HRP-592)

Emergency Use Consent Document (HRP-506)

Short Form Consent Document (HRP-507)

Protocol Templates

Biomedical Protocol Template (HRP-593)

Local Protocol Addendum Template (HRP-508)

Human Research Determination Form (HRP-503)

SOPs

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 Review

HRP-024 - SOP New Information

HRP-025 - SOP Investigations

HRP-026 - SOP Suspension or Termination

HRP-027 - SOP Emergency Use Post-Review

HRP-030 - SOP Designated Reviewers

HRP-031 - SOP Non-Committee Review

HRP-032 - SOP Non-Committee Review Conduct

HRP-040 - SOP IRB Meeting Preparation

HRP-041 - SOP IRB Meeting Conduct

HRP-042 - SOP IRB Meeting Attendence 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-054 - SOP Institutional Conflicts of Interests

HRP-055 - SOP Financial Conflicts

HRP-060 - SOP Annual Evaluations of the HSPP

HRP-061 - SOP Monthly Evaluations of the HSPP

HRP-062 - SOP Daily Tasks

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

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 Commerical IRBs

HRP-092 - Commercial IRB Screenshots

Worksheets

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

HRP-307 WORKSHEET Devices

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 of Approval

HRP-315 WORKSHEET Advertisements

HRP-316 WORKSHEET Payments

HRP-317 WORKSHEET Short Form Consent Documentation

HRP-318 WORKSHEET Additional Federal-agency critaria

HRP-320 WORKSHEET Scientific or Scholary Review

HRP-321 WORKSHEET Review Information Items

HRP-322 WORKSHEET Emergency Use

HRP-323 WORKSHEET Criteria Approval HUD

HRP-324 WORKSHEET Contracts

HRP-330 WORKSHEET HIPAA-Authorization

HRP-331 WORKSHEET FERPA Compliance

HRP-332 WORKSHEET NIH-GDS Certification

Checklists

HRP-401 - CHECKLIST Pre-Review

HRP-402 - CHECKLIST Non-Committee Review

HRP-410 - CHECKLIST Waiver or Alteration-Consent Process

HRP-411 - CHECKLIST Waiver-Written Documentation - Consent

HRP-412 - CHECKLIST Pregnant Women

HRP-413 - CHECKLIST Non-viable Neonates

HRP-414 - CHECKLIST Neonates- 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-430 - CHECKLIST Investigator Quality Improvement Assessment

HRP-431 - CHECKLIST Minutes - Quality Improvement Assessment

HRP-432 - CHECKLIST Quality Assurance Assessment

HRP-441 - CHECKLIST HIPAA - Waiver Authorization

HRP-442 - CHECKLIST Biobanking

HRP-443 - AUDIT TOOL CHECKLIST - Consent Process

Supporting Documentation

Certificate of Translation Template For Non-English Documents

Compassionate Use Request Form for Investigational Devices

Emergency Use Form

Letter for Subjects to Revoke HIPAA Authorization

Letter to Notify Subjects of Change in Contact Information

Media Relations Form

Radiation Dosimetry Form - eIRB+

IRB Authorization Agreement 

Short-Form Consents

The following are posted with permission from the University of Minnesota. See OHRP's Guidance on obtaining and documenting informed consent of subjects who do not speak English.

See also: Consent Translation and Short Form Guidance.

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