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 Submissions using forms that are more than 30 calendar days out of date will not be accepted.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. 

  • 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). Full Board studies approved after November of 2018 will receive stamped IRB Approved Documents, which must submited for all future amendments in order to maintain a single, active application that incorporates all IRB-approved amendments.

  • 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.

Form

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

Application for Exemption

For all human subjects research that meets the criteria of an Exempt review category, as determined by the federal regulations (45 CFR 46.104).

June 2020

Application for Expedited / Full Board IRB Review

For all research requiring review by the full IRB Board at a convened meeting 
OR
Meeting the criteria of an Expedited review category, as determined by the federal regulations (45 CFR 46.110).

June 2020

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.

* An IAA Attestation signed by the Brown PI is required when Brown has ceded review to another institution’s IRB. Investigators affirm that they will follow the IRB of Record’s procedures for protections against COVID 19.

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.  

Download

When to use

Updated

Appendix A: Children as Subjects  

When children will be included as subjects

January 2019

Appendix B: Prisoners As Subjects  

When prisoners are included as participants; or prisoners' identifiable private information/identifiable biospecimens are obtained, used, studied, or analyzed.

October 2021

Appendix C: Use of Drugs  

When research includes the use of approved or unapproved drugs

May 2016

Appendix D: Use of Devices

When research includes the use of approved or unapproved devices

May 2016

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

Complete this appendix 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.

* An International Research Attestation is required when investigators/collaborators are currently located at an international study site and are able to resume in-person procedures and when investigators are initiating a new study abroad.

March 2020

 Appendix I: Advisor

When a graduate or medical student is the Principal Investigator.

 

June 2020

 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

Use this form 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.

Form

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)

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

September 2021

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

 

 NIH Data Repository Consent Addendum Template

For studies with federal grants that require PIs to ask their participants to share anonymized human subject data with a federal repository. If an award has this requirement, participants must consent before their research data can be shared. Use this document to supplement the informed consent process and explain the requirement to participants.

December 2020

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 Informed Consent 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.  

Download

When to use

Updated

Administrative Acceptance Form

Examples of changes that are administrative in nature include: 

  • Addition of new external funding that does NOT support changes to study population/procedures.

  • Updated graphics on a recruitment flyer

  • Changes to correct typographical or grammatical errors (NO content changes allowed with this form)

Additional guidance may be found here

Feb 2020

 

 

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

Download

When to use

Updated

*REVISED*

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. Do not submit these guides to the HRPP.

Form

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