New Applications | Appendices | Consent Forms | Administrative Acceptance & Amendments | Progress Reports & Reportable Events | Submission Instructions

Submitting an Application to the Brown IRB

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 ensure you download application forms from this page EACH time you submit. All forms are periodically reviewed to meet changing regulatory or other requirements.  Submissions using forms that are outdated will not be accepted.

The Brown IRB has a "Single Submission Policy." To ensure an accurate sequential review of currently approved protocols, HRPP staff is only able to accept one submission (e.g. administrative acceptance, amendments, progress reports) per protocol at a time.

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 below.

Form

When to use

Last Updated

*NEW*
Human Subjects Determination Form

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

September 2019

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

Application for Exemption

For all research that meets Exempt criteria as set forth in our Exempt Determination Policy

 August 2019

Application for Expedited / Full Board IRB Review

For all research requiring full committee or expedited review

August 2019

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

August 2019

Additional Investigators' COI

Please attach to your submission 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

Appendices

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.  Mental Health Safety Plan Checklist

August 2019

*NEW* 
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

August 2019

Consent Forms

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+)

When adults 18 years or older will be included as subjects. 

Standard Consent Template Guidance

August 2019

Bulleted Consent / Assent Template 

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

Bulleted Consent Template Guidance

Bulleted Consent Example

August 2019

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

*NEW* 
HIPAA Authorization

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

August 2019

Investigator Self-Evaluation Checklist

This self-evaluation checklist will guide Investigators in determining if changes are needed to any currently approved informed consent documents in order to comply with the forthcoming changes to the Common Rule.

December 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

July 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

Administrative Acceptance & Amendments 

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

Download

When to use

Updated

Administrative Acceptance Form

This form should be used when submitting changes to an already approved expedited or full board study that are considered administrative in nature as they do not affect the research design, study procedures, populations enrolled into the study, study aims, or risk.  Additional guidance may be found here

June 2019

 

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

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.

August 2019

Amendment Key Information

This Amendment form is to only be used when revising formatting of currently approved consent forms to comply with the Common Rule requirement for Key Information.

December 2018

Progress Reports & 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.

 May 2019

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

Submission instructions

  • Ensure that you have completed all required CITI training before you submit any new application materials.

  • Ensure that you have completed any Conflict of Interest reporting requirements before you submit any new application materials.

  • 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.

  • 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 [email protected]