Submitting an ApplicationNew Applications | Appendices and Supporting Documents | Consent Forms & HIPAA Authorizations  | Revision Forms | Progress Reports, Study Closures & Reportable Events 

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 Submissions using forms that are more than 30 calendar days out of date will not be accepted.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

  • 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 and Brown policies. 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

Human Subjects Determination Form

For determining if your research study meets the federal definition of human subject research

May 2020

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.

December 2016

** UPDATED**

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

**UPDATED**

Application for Expedited / Full Board IRB Review

For all research requiring full committee or expedited review

June 2020

**UPDATED**

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 IRB Authorization Agreements (IAAs) for more information.

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 in the subject population, either by design or incidentally

January 2019

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 in-person research activities will occur in a foreign location.

March 2020

**NEW**

 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

Excerpted from our FB/Expedited Application for independent use to capture data storage and collection procedures.

April 2020

**NEW**
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 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 / Assent Template 

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

February 2020

**NEW**

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

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

Please use the document in the link below for all new and continuing review submissions that involve the use of the Brown MRI Research Facility with human subjects. 

Please note: For external human subjects research projects where Brown University's only involvement is the use of the MRI Facility (e.g. no Brown-employed faculty are engaged as co-investigators on the project), Brown University is not considered to be engaged in human research activities, and no Brown IRB review or reliance agreement (IAA) is required.  

March 2015

HIPAA Authorization

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

August 2019

Administrative Acceptance & Amendments 

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

 

Amendment Request Form 

Submit when:

  • making changes to study procedures or amending an expedited or full board protocol

  • changing recruitment strategy, inclusion/exclusion criteria or modifying IRB approved recruitment materials

  • updating consent form

Feb 2018

*NEW*

Exempt Modification Request Form 

Submit when: 

  • making changes to study procedures or modifying an exempt protocol

  • changing recruitment strategy, inclusion/exclusion criteria or modifying HRPP accepted recruitment materials

  • updating consent form

Feb 2020

**UPDATED**

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

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.

June 2020

**NEW**

Study Closure Form

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

June 2020

Reportable Events Form

Investigators must use this form to report to HRPP any Reportable Events as defined in the Brown University Reportable Events Policy.  All qualifying events must be reported consistent with reporting time frames, also noted in the policy.

November 2018