How to submit an IRB Application, Amendment, or Progress Report

All IRB applications, appendices, post-approval submission forms and templates are provided below. Principal investigators must submit an application and required supplemental materials for research activities that meet the definition of human subjects research.

Please visit our Guidance for Human Subjects Protection in Research for additional information regarding preparing your application.

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.  See detailed submission instructions below.

Form

When to use

Last Updated

Human Subject Determination Form

When you are unsure if IRB review is required for your project, whether Brown is considered engaged in human subjects research, or if you need documentation that Brown IRB review is not required.

COMING SOON!

IRB Form #1

For all research requiring full committee or expedited review

August 2017

Undergraduate Research

For undergraduate students and their faculty advisors when research projects meet the federal definition of human subject research

Dec  2016

IRB Form #2  Exempt Application

Categories of EXEMPT REVIEW & Exempt Determinations Policy

Jan 2017

IRB Form #3 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

June 2017

Consent Forms

Every consent form must include essential elements of informed consent as described in federal regulations. 

Form

When to use

Last Updated

Additional Consent Language

Beyond the basic elements of informed consent, there may be additional elements that should be included based on the study design or research population. 

This list is not all inclusive and will be updated often.

October 2017

Consent Template for Adults (18+)

When adults 18 years or older will be included as subjects

June 2017

Appendices

Appendices should be submitted with a new application and may also be required if details of the research change after approval is granted.  The protocol checklist and submission procedures page in Form #1 highlight when appendices are required.

Download

When to use

Updated

Appendix A: Children as Subjects  

When children will be included as subjects

Mar 2015

Appendix B: Prisoners As Subjects  

When prisoners are included in the subject population, either by design or incidentally

2011

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

Amendments & Progress Reports

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

Download

When to use

Updated

Amendment Request Form 

Submit when:

  • making changes to study procedures or amending the protocol

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

  • updating consent form

  • adding a new funding source

Aug 2013

Progress Report Form 

Submit prior to deadline indicated in the notice for renewal that will be mailed to the PI (expedited and full committee review).  Click here for instructions on completing the continuing review report.

 Oct 2016

Submission instructions

Please note a change in procedure effective May 1, 2017: 
ALL submissions (including those to be reviewed by the Full Board) may be submitted via e-mail.  It is no longer required to submit additional paper copies along with the signed original document for Full Board protocols.  Paper delivery, by hand-delivery and campus mail, are still acceptable methods of submission.

1) E-mail to: IRB@Brown.edu.   When submitting via email, please ensure that your submission is included as one single PDF file
2) Via campus mail to: Box 1986; OR
3) Hand-delivery to: 2 Stimson Avenue, 3rd Floor

Full Board submissions that are ready for review and received by 5:00 p.m. the day of the deadline will go to the next scheduled committee meeting.

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.

Need help? Please contact HRPP staff at 401-863-3050 or irb@brown.edu.