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.

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.....but in the meantime, please refer to our Determination of Human Subjects Research Chart

IRB Form #1

For all research requiring full committee or expedited review

August 2018

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

July 2018

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

Guidance and Instructions

Last Updated

Key Information Template (REQUIRED)

As of January 2018, a Key Information section is required at the beginning of all consent forms.  Key Information Examples

*This requirement does not apply to studies using the Bulleted Consent Template found below*

May 2018

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 as needed.

Additional Consent Document Language Guidance

August 2018

Standard Consent Template for Adults (18+)

When adults 18 years or older will be included as subjects.  Standard Consent Template Guidance.

October 2018

Bulleted Consent Template for Adults (18+)

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

Bulleted Consent Example

October 2018

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

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

October 2017

Appendix F: Mental Health Safety Plan

When participants may experience significant emotional distress, or be at risk of harming themselves or others.  Mental Health Safety Plan Checklist

May 2018

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

Feb 2018

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.

**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.

 May 2018

Submission instructions

Please note a change in procedure effective January 1, 2018: ALL submissions must be submitted via e-mail.  Paper delivery, by hand-delivery or campus mail, are no longer acceptable methods of submission.

  • E-mail all submissions to: IRB@Brown.edu.   (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.

  • 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.