Division of Research

HRPP Toolkit Library

Investigators preparing their human subjects research materials for review by the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) may find it useful to review HRPP/IRB standard operating procedures, worksheets and other documents used to evaluate studies at Brown.

The HRPP Toolkit Library is a set of documents for the Human Research Protection Program (HRPP), IRB staff, IRB members, and members of the research community. Researchers may find documents, like the standard operating procedures for consent processes and documentation (HRP-090, HRP-091), particularly helpful. If you have a question and need further guidance please email irb@brown.edu.

These general documents include manuals that lay out the expectations of and requirements for the review and/or conduct of research by IRB staff and members, and investigators and research personnel, participant brochures, and decision flowcharts.

Number Title Updated
101 Human Research Protection Program Plan February 2024
102 Flowcharts February 2024
103 Investigator Manual February 2024
103p Site Investigator Manual February 2024
104 Should I Take Part in Research Brochure February 2024
105 HHS-FDA Written Procedure Crosswalk February 2024
108 Study-Specific Emergency-Disaster Risk Mitigation Planning Decision Guide February 2024

Brown-specific documents are tools to support all individuals involved in the conduct of human subjects research under the auspices of Brown University. 

Title Updated
Children in Research January 2019
Use of Sexual Orientation and Gender Inclusive Language October 2021

Standard operating procedures (SOPs) describe policies and procedures related to the HRPP/IRB review, management, or function of human subjects research.

Number Title Updated
001 Definitions February 2024
012 Observation of Consent Process February 2024
013 Legally Authorized Representatives, Children and Guardians February 2024
020 Incoming Items February 2024
021 Pre-Review February 2024
023 Emergency Use, Compassionate Use, Individual Patient Expanded Access February 2024
024 New Information February 2024
025 Investigations February 2024
026 Suspension or Termination Issued Outside of Convened IRB February 2024
027 Emergency Use, Compassionate Use, Individual Patient Expanded Access Post-Review February 2024
030 Designated Reviewers February 2024
031 Non-Committee Review Preparation February 2024
032 Non-Committee Review Conduct February 2024
040 IRB Meeting Preparation February 2024
041 IRB Meeting Conduct February 2024
042 IRB Meeting Attendance Monitoring February 2024
043 IRB Meeting Minutes February 2024
044 Not Otherwise Approvable Research February 2024
050 Conflicting Interests of IRB Members February 2024
051 Consultation February 2024
052 Post-Review February 2024
054 Institutional Conflicts of Interest February 2024
055 Financial Conflicts of Interest February 2024
060 Annual Evaluations of the HRPP February 2024
061 Quarterly Evaluations of the HRPP February 2024
062 Daily Tasks February 2024
063 Expiration of IRB Approval February 2024
064 NIH GDS Institutional Certification February 2024
065 Response Plan for Emergencies - Disasters Impacting the HRPP February 2024
070 IRB Records February 2024
071 Toolkit Management February 2024
072 IRB Records Retention February 2024
080 IRB Formation February 2024
081 IRB Removal February 2024
082 IRB Membership Addition February 2024
083 IRB Membership Removal February 2024
084 IRB Meeting Scheduling and Notification        February 2024
090 Informed Consent Process for Research February 2024
091 Written Documentation of Consent February 2024
801 Establishing Authorization Agreements February 2024
802 Institutional Profile Management February 2024
804 External IRB Post-Review February 2024
805 External IRB Updates February 2024
806 Review Request to Rely on External IRB February 2024
  Use of Sexual Orientation and Gender Inclusive Language October 2021
  Children in Research  

IRB staff and members refer to these downloadable worksheets when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.

Number Title Updated
301 Review Materials February 2024
302 Approval Intervals February 2024
303 Communications of Review Results February 2024
304 IRB Composition February 2024
305 Quorum and Expertise February 2024
306 Drugs and Biologics February 2024
307 Devices February 2024
308 Pre-Review February 2024
309 Ancillary Review Matrix February 2024
310 Human Research Determination February 2024
311 Engagement Determination February 2024
312 Exemption Determination February 2024
313 Expedited Review February 2024
314 Criteria for Approval February 2024
315 Advertisements February 2024
316 Payments February 2024
317 Short Form of Consent Documentation February 2024
318 Additional Federal Agency Criteria February 2024
319 Limited IRB Review and Broad Consent February 2024
320 Scientific or Scholarly Review February 2024
321 Review of Information Items February 2024
322 Emergency Use February 2024
323 Criteria for Approval for HUD February 2024
324 Contracts February 2024
325 Device Compassionate Use February 2024
326 Performance Evaluation for IRB Chairs February 2024
327 Annual Performance Evaluation Criteria for IRB Members February 2024
328 Annual Performance Evaluation for IRB Staff February 2024
330 HIPAA Authorization February 2024
331 FERPA Compliance February 2024
332 NIH GDS Institutional Certification February 2024
333 Certificate of Confidentiality February 2024
351 Protocol-Specific Emergency/Disaster Risk Mitigation Planning February 2024
352 Additional Emergency-Disaster Review Considerations February 2024
830 Communication and Responsibilities  February 2024
832 Considerations for Relying on an External IRB February 2024
833 Considerations for Serving as the sIRB February 2024

IRB members and staff use these downloadable checklists to assess and document regulatory items and enhance compliance with federal, state and local requirements.

Number Title Updated
401 Pre-Review February 2024
402 Non-Committee Review February 2024
410 Waiver or Alteration of Consent Process February 2024
411 Waiver of Written Documentation of Consent February 2024
412 Pregnant Women February 2024
413 Non-Viable Neonates February 2024
414 Neonates of Uncertain Viability February 2024
415 Prisoners February 2024
416 Children February 2024
417 Cognitively Impaired Adults February 2024
418 Non-Significant Risk Device February 2024
419 Waiver of Consent Process for Emergency Research February 2024
430 Investigator Quality Improvement Assessment February 2024
431 Minutes Quality Improvement Assessment February 2024
441 HIPAA Waiver of Authorization February 2024

IRB staff and members, and investigators and research staff use forms as resources for IRB submissions. Investigators and research staff preparing IRB submissions use templates for protocols and consent documents.

Forms

Number Title Updated
202 IRB Member Information February 2024
211 Basic Study Information February 2024
212 Continuing Review February 2024
213 Modification February 2024
214 Reportable New Information February 2024
811 Basic Site Information February 2024
812 Site Continuing Review February 2024
813 Site Modification February 2024
814 Site Reportable New Information February 2024
815 Institutional Profile February 2024
816 External IRB Study Update February 2024

Templates

Number Title Updated
500 Template Broad Consent Not in use at this time
501 Template Minutes February 2024
502 Template Consent Document February 2024
503 Template Protocol February 2024
503a Template SBS Protocol February 2024
504 School Permission to Conduct Research February 2024
505 Template SOP February 2024
506 Template Consent Document – Expanded Access February 2024
507 Template Consent Document – Short Form February 2024
508 Template Site Supplement February 2024
509 Template VA Minutes Supplement Not in use at this time