New Applications

Appendices & Supporting Docs

Consents & Authorizations

 

Additional Forms

Tools & Checklists


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. 
 

Submission Instructions


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  BEFORE you submit your study application into the Huron e-IRB system and BEFORE you submit your Undergraduate Research form to [email protected]

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

 

Human Subjects Research Application

For all human subjects research that meets the criteria of an Exempt review category, the criteria of an Expedited review category, or requires review by the IRB at a convened meeting.

October 2023

Collaborative Research Application

When requesting to enact a reliance agreement with a collaborating institution. Please visit Collaborative Research for more information.

Use the IAA Investigator Checklist to ensure all procedural requirements are met.

November 2023

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 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

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

November 2023

 Appendix I: Human Subjects Research Advisor

When a graduate or medical student is the Principal Investigator

 

October 2023

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

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

Local Context Form

When Brown is serving as the IRB of Record, a Local Context Form must be signed by the Relying Site's Authorized Signatory and uploaded with the submission.

May 2023

External Investigator FCOI

When Brown is serving as the IRB under an Individual Investigator Agreement (IIA) or an Organizational Authorization Agreement (OAA) an External Investigator FCOI form must be submitted for each Principal Investigator and any Co-Investigators

May 2023

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)

Standard Parent Permission Template

Bulleted Parent Permission Template

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

December 2022

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

Data Repository Consent Template (15+)

Data Repository Parent Permission Template

Data Repository Assent Template (7-14)

Researchers who intend to deposit human subjects data into data repositories should use these templates as an addendum to the informed consent process.

November 2022

GUID Data Repository Consent Template (15+)

GUID Data Repository Parent Permission Template

GUID Data Repository Assent Template (7-14)

Researchers who are funded by specific NIH Institutes are now required to deposit de-identified human subjects data into federal repositories using special codes called Global Unique Identifiers (GUIDs). If an award has this requirement, use these templates as an addendum to your informed consent process.

May 2023

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

MRI Research Facility Consent (15+)

MRI Research Facility Parent Permission

MRI Research Facility Child Assent (7-14)

For Brown University research studies that involve the use of the MRI Research Facility, use these forms to provide important information to participants about MRI scans and safety procedures. The text of these forms should not be modified, with the exception of the shaded brackets that may be tailored for study specifics.

October 2023

HIPAA Authorization

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

August 2019

Continuing Reviews 

Download

When to use

Updated

 

Continuing Review 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 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 2023

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 and do not require submission to the HRPP unless eligible for an exception as outlined within the document.

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