Division of Research
HRPP/IRB Submission Forms and Templates
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 irb@brown.edu
Before you submit a new application, the Brown HRPP strongly encourages you to review Does My Project Need IRB Review?
| Form | When to use | Last Updated |
|---|---|---|
| Undergraduate Research (DOCX) | 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 (DOCX) to all participants. | November 2020 |
| Human Subjects Research Application | Please visit the HRPP Huron Toolkit Library for current documents. | This document was retired as part of the Huron Toolkit implementation |
| Collaborative Research Application | Please visit the HRPP Huron Toolkit Library for current documents. | This document was retired as part of the Huron Toolkit implementation |
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 | This document was retired as part of the Huron Toolkit implementation |
| Appendix G: Use of Protected Health Information (PHI) (DOCX) 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 (DOCX) | 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 | This document was retired as part of the Huron Toolkit implementation |
| Request to Serve as a PI (DOCX) | 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. | This document was retired as part of the Huron Toolkit implementation |
| External Investigator FCOI (DOCX) | 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 |
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+) (DOCX) | 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+) (DOCX) | 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 | |
| Consent Addendum (DOCX) | 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 | |
| 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 (DOCX) | For Undergraduate Work Involving Human Subjects (DOCX) that meets the criteria for undergraduate research. | June 2019 |
| 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 | |
| CADRE Repository Consent Template (DOCX) | Researchers who intend to deposit human subjects data into the CADRE Repository should use this template as an addendum to the informed consent process. CADRE is the Center for Addiction and Disease Risk Exacerbation, a federally funded NIH Center of Biomedical Research Excellence. The CADRE supports a number of research studies that are investigating ways that substance use may affect health. | August 2024 |
| HIPAA Authorization (DOCX) | When seeking a participant's authorization to use PHI for the purpose of your research | August 2019 |
| 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 | This document was retired as part of the Huron Toolkit implementation |
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 (DOCX) | Use this tool to determine if your project meets the definition of human subjects research. | July 2021 |
| Human Subjects Self-Determination Decision Tree (DOCX) | Use this decision tree to help you determine if your study involves human subjects. | July 2021 |
| IAA Investigator Checklist (DOCX) | 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
|
Use these checklists when closing out studies or before leaving Brown to ensure compliance with research data management, sharing, storage, transfer, and retention. | These documents are available on the Research Data Management website |