Submitting an Application | New Applications | Appendices and Supporting Documents | Consent/Assent Forms & HIPAA Authorizations  | Revision Forms | Progress Reports, Study Closures & Reportable Events | Self-Determination Tools & Checklists

Submitting an Application to the Brown IRB

Principal Investigators must submit an application and required supplemental materials for research activities that meet the definition of human subjects research. Download a submission form from this page each time you submit. Forms are periodically updated to meet any changes in federal regulations and Brown policy. Submissions using forms that are more than 30 calendar days out of date will not be accepted. All IRB/HRPP submission forms and templates are provided below.  

Submission instructions

  • Ensure that you have completed all required CITI training and Conflict of Interest reporting before you submit any new application materials.

  • Abide by the "Single Submission Policy." For an accurate sequential review of your study submissions, HRPP will only accept one submission per study at a time. For example, if you have a progress report under review, you may not submit an amendment for the same study until the first submission is approved.

  • E-mail all submissions to: [email protected].  (Please do NOT submit to an individual HRPP staff member. Please do not copy individual HRPP staff members on your submissions.)

  • Include all submission materials in ONE single PDF file attachment.  Please do NOT attach multiple files, Word docs, or zip files. 

  • PIs should not embed any associated documents into the application. Required documents (i.e. recruitment material, consent document, surveys) should be included in the single PDF, but not in the associated sections of the application.

  • Certain components of human subjects research may require Ancillary Review by a department outside of the IRB. These reviews are independent of IRB approval and will not delay approval to conduct your research. However, compliance with the determinations of an ancillary review are required before you can begin research activities. 

  •  *REVISED* HRPP has a One Application Policy in accordance with Title 45 CFR 46.115 (Health and Human Services, IRB Records) and Title 21 CFR 56.115 (Food and Drug Administration, IRB Records).  All new initial studies (Exempt/Expedited/Full Board) reviewed by the IRB/HRPP after May 1, 2022 will receive stamped IRB/HRPP Approved Materials upon approval. The stamped document must be retained in your study records.Future submissions must include updates to all applicable documents to maintain a single, active application that incorporates all IRB/HRPP approved revisions.

  • If the PI is a graduate or medical student, the student’s academic advisor (as listed on the application) must be copied on e-mailed submissions.

  • Expect a holistic review of your active study. The HRPP conducts a holistic review of your active study with each submission as part of normal review procedures to ensure it remains in compliance with current federal regulations, Brown policies, and IRB position statements. For example, if modifying compensation on a flyer, HRPP will review the entire flyer to confirm that it meets Brown's current recruitment policy.

  • Need help? Please contact HRPP staff at 401-863-3050 or [email protected]

New Applications

New applications must be reviewed and approved by the IRB prior to conducting research with human participants. Depending on the details of the proposed research, supplemental forms and approvals may be required.  Please ensure that you have completed required CITI training and your Conflict of Interest disclosure BEFORE you submit your study application.

Before you submit a new application, the Brown HRPP strongly encourages you to review its web page, Does My Project Need IRB ReviewSubmission instructions are found above.


When to use

Last Updated

Undergraduate Research

For Undergraduate Work Involving Human Subjects.  If the project meets the criteria for undergraduate research, please provide The Letter of Introduction for Undergraduate Work Involving Human Subjects to all participants.

November 2020


Human Subjects Research Application

For all human subjects research that meets the criteria of an Exempt review category, the criteria of an Expedited review category, or requires review by the IRB at a convened meeting.

October 2022

IAA Application

When requesting to implement a reliance agreement to relinquish IRB oversight to another institution or for Brown to become the IRB of record for the human subjects work being done at a collaborating institution. Please visit Collaborative Research for more information.

Use the IAA Investigator Checklist to ensure all procedural requirements are met.

July 2020

Appendices and Supporting Documents

Appendices must be submitted with a New Application as applicable and may also be required if details of the research change after approval is granted.  


When to use


Appendix A: Children as Subjects  

Effective November 14, 2022, this form is no longer necessary.

November 2022

Appendix B: Prisoners As Subjects  

Effective November 14, 2022, this form is no longer necessary.

November 2022

Appendix C: Use of Drugs  

When research includes the use of investigational drugs

Guidance: Studies Involving Drugs or Devices

May 2016

Appendix D: Use of Medical Devices

When research includes the use of investigational medical devices

Guidance: Studies Involving Drugs or Devices

November 2022

Appendix E: Prescription Drug/Medication Management

When study procedures include administering prescription medications to study participants.  Guidance for Investigators: Management of Human Research Studies Involving Drugs and Medications

January 2019

Appendix F: Mental Health Safety Plan

When participants may experience significant emotional distress, or be at risk of harming themselves or others

January 2020

Appendix G: Use of Protected Health Information (PHI) in Research

When the proposed research involves the access, use or disclosure of PHI.  This appendix will document how authorization/permission related to PHI will be obtained, or if a waiver of authorization is being requested

April 2020

Appendix H: International Research

When research activities will occur in a non-US location

March 2020

 Appendix I: Human Subjects Research Advisor

When a graduate or medical student is the Principal Investigator


January 2023

 Additional Investigators' COI


When additional Investigators' Conflict of Interest (COI) disclosures need to be added to any of the above applications or to an amendment (form seen below)

June 2019

DSMB Charter Template

The DSMB charter defines the responsibilities for the study principal investigator and DSMB members and sets guidelines for the conduct of DSMB meetings

September 2019

Data Security Assessment

When revising an approved study or as requested by the HRPP. This form should reflect the confidentiality measures for all human subjects data collected in your study, not just new data

April 2020

Request to Serve as a PI

Individuals who are not automatically eligible for PI status by virtue of their appointment or employment type must submit this form to the appropriate institutional officials and be approved for PI eligibility

June 2020

Consent/Assent Forms and HIPAA Authorizations

Every consent form must include essential elements of informed consent as described in federal regulations. The Brown HRPP provides to below templates and guidance to support researchers in developing consent forms for different study populations and study procedures.


Guidance and Instructions

Last Updated

Standard Consent Template for Adults (18+)

For studies that are greater than minimal risk, more complex, or are more than 3 pages in length. 

February 2020

Bulleted Consent Template for Adults (18+) 

For studies that are minimal risk, less complex and are less than 3 pages in length. 

February 2020

Child Assent Template (Ages 7-12)

Child Assent Template (Ages 13-17)

Standard Parent Permission Template

Bulleted Parent Permission Template

For studies including children as participants (ages 7 - 17).

December 2022

Consent Addendum

For studies adding new activities or procedures that require an additional consent process for enrolled participants - either currently active or completed with permission to be re-contacted for future procedures in the same study.

June 2020

Data Repository Consent Template (15+)

Data Repository Parent Permission Template

Data Repository Assent Template (7-14)

Researchers who intend to deposit human subjects data into data repositories should use these templates as an addendum to the informed consent process.

November 2022

GUID Data Repository Consent Template (15+)

GUID Data Repository Parent Permission Template

GUID Data Repository Assent Template (7-14)

Researchers who are funded by specific NIH Institutes are now required to deposit de-identified human subjects data into federal repositories using special codes called Global Unique Identifiers (GUIDs). If an award has this requirement, use these templates as an addendum to your informed consent process.

November 2022

The Letter of Introduction for Undergraduate Work Involving Human Subjects

For Undergraduate Work Involving Human Subjects that meets the criteria for undergraduate research.

June 2019

Brown University MRI Research Facility Addendum

For Brown University research studies that involve the use of the MRI Research Facility, use this consent addendum to provide important information to participants about MRI scans and safety procedures. The text of this addendum should not be modified. PIs using this document should only add their study title, version and date indicated by the shaded brackets of the header.

This document can be used for participants aged 15 and over.

March 2021

HIPAA Authorization

When seeking a participant's authorization to use PHI for the purpose of your research

August 2019

Revision Forms 

Changes to approved research must be requested and approved before implementation.  


When to use


Administrative Acceptance Form

As we reduce our forms, this process is no longer needed. All revisions should be submitted for review and approval using the Revision Request Form.

November 14, 2022



Revision Request Form: Full Board/Expedited Amendments and Exempt Modifications


Submit when:

  • making changes to an Exempt, Expedited, or Full Board study

  • adding or modifying study design, eligibility criteria, recruitment process, study materials, measures, and/or consent documents, etc.

Oct 2020

IAA Application (Amendment)

This form should be used to add an IAA to an existing approved protocol. The IAA request should be the only modification listed on this application.

July 2020

Progress Reports, Study Closures & Reportable Events


When to use



Progress Report Form 

Use for submission of annual continuing reviews if your study has not been released from continuing review

Click here for instructions on completing the progress report form.

**Attention Apple users: Word 2016 is required for MACs**

Microsoft Office 2016 download is available for free to all Brown staff and Brown-paid faculty on the CIS Software webpage.

October 2021

Study Closure Form

Investigators should use this form to request the closure of any Brown research study outside of Continuing Review.

  •  Research Data Management Offboarding Checklists

  • The purpose of these checklists is to serve as a guide for Brown researchers closing out a project (checklist 1) or leaving Brown (checklist 2) with regard to research data by orienting them to existing policies, guidance, and tools available at Brown.

June 2020

Reportable Events Form

Investigators must use this form to report to HRPP any Reportable Events as defined in the Institutional Review Board Policy on Reportable Events and Noncompliance.  All qualifying events must be reported consistent with reporting time frames, also noted in the policy.

July 2021

Self-Determination Tools & Checklists

Self-determination tools and checklists are guides to assist Brown researchers in complying with federal regulations and Institutional policy. These guides are not applications and do not require submission to the HRPP unless eligible for an exception as outlined within the document.


When to use

Last Updated

Human Subjects Research Self-Determination Tool

Use this tool to determine if your project meets the definition of human subjects research.

July 2021

Human Subjects Self-Determination Decision Tree

Use this decision tree to help you determine if your study involves human subjects.

July 2021

IAA Investigator Checklist

Use this checklist to ensure all procedural requirements are met before submitting an IAA Application reliance request for collaborative research.

July 2021

Research Data Management Offboarding Checklists

  • Study Closure 

  • Leaving Brown

Use these checklists when closing out studies or before leaving Brown to ensure compliance with research data management, sharing, storage, transfer, and retention.

July 2021