Forms and Templates | Research at Brown

New Applications	Appendices & Supporting Docs	Consents & Authorizations
	Additional Forms	Tools & Checklists

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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.

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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 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 Review? Submission 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. Human Subjects Research Application Guidance	May 2023
Collaborative Research 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 Collaborative Research for more information. Use the IAA Investigator Checklist to ensure all procedural requirements are met.	May 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	April 2020
Appendix I: Human Subjects Research Advisor	When a graduate or medical student is the Principal Investigator	January 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

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. Standard Consent Template Guidance Standard Consent Template Example Additional Standard Consent Language	February 2020
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 Additional Bulleted Consent Language	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). Child Assent Template Guidance Child Assent Template Ages 7-12 Example Child Assent Template Ages 13-17 Example Additional Parent Permission Language	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. Consent Addendum Example: Active Participants Consent Addendum Example: Completed Participants	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. GUID Data Repository Consent Addendum Guidance NIH Policy for Data Management and Sharing	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
Brown University MRI Research Facility Addendum	For Brown University research studies that involve the use of the MRI Research Facility, use this consent addendum to provide important information to participants about MRI scans and safety procedures. The text of this addendum should not be modified. PIs using this document should only add their study title, version and date indicated by the shaded brackets of the header. This document can be used for participants aged 15 and over.	March 2021
HIPAA Authorization	When seeking a participant's authorization to use PHI for the purpose of your research	August 2019

Continuing Reviews, Study Closures & Reportable New Information

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

Study Closure Form

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

Research Data Management Offboarding Checklists
The purpose of these checklists is to serve as a guide for Brown researchers closing out a project (checklist 1) or leaving Brown (checklist 2) with regard to research data by orienting them to existing policies, guidance, and tools available at Brown.

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

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New Applications

Form

When to use

Last Updated

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

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.

May 2023

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 Collaborative Research for more information.

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

May 2023

Appendices and Supporting Documents

Download

When to use

Updated

When participants may experience significant emotional distress, or be at risk of harming themselves or others

January 2020

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

When a graduate or medical student is the Principal Investigator

January 2023

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

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/Assent Forms and HIPAA Authorizations

Form

Guidance and Instructions

Last Updated

For studies that are greater than minimal risk, more complex, or are more than 3 pages in length.

February 2020

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

February 2020

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

December 2022

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

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

May 2023

For Undergraduate Work Involving Human Subjects that meets the criteria for undergraduate research.

June 2019

This document can be used for participants aged 15 and over.

March 2021

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

August 2019

Continuing Reviews, Study Closures & Reportable New Information

Download

When to use

Updated

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

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

The purpose of these checklists is to serve as a guide for Brown researchers closing out a project (checklist 1) or leaving Brown (checklist 2) with regard to research data by orienting them to existing policies, guidance, and tools available at Brown.

May 2023

Self-Determination Tools & Checklists

Form

When to use

Last Updated

Use this tool to determine if your project meets the definition of human subjects research.

July 2021

Use this decision tree to help you determine if your study involves human subjects.

July 2021

Use this checklist to ensure all procedural requirements are met before submitting an IAA Application reliance request for collaborative research.

July 2021

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

Attention Apple users: Word 2016 is required for MACs