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