Applying to the IRB

All PIs and research personnel must follow the requirements in the Investigator Manual (HRP-103).

Use the following tools and learn about the types of IRB review to guide you through the application process. After obtaining initial IRB approval, the PI is responsible for managing the IRB protocol.

All submission forms are online in Kuali. Any questions can be directed to our IRB team. Please provide your IRB ID number and PI name so that we can best assist you.

Kuali IRB Instructional Materials

Kuali UMass Boston IRB User Manual (pdf) - Detailed guides
How to Navigate Legacy Studies (pdf) Detailed

Kuali Instructional Videos (YouTube) - Basic guides

Creating a New IRB Protocol (HRP-211) (3:23) Basic
How to Submit an Amendment (HRP-213) (1:52) Basic
How to Submit a Renewal (HRP-212) (2:03) Basic
How to Close Your Protocol (HRP-212) (1:40) Basic
How to Respond to the IRB (2:51) Basic
How to Navigate Legacy Studies (3:03) Basic
Fall 2022 Protocol Update (2:51) Basic Option to build investigator protocol entirely online

Kuali Quick Tips - Troubleshooting tips

Kuali Research - Knowledge Base - General documentation related to the Protocols module in Kuali Research

Forms and Templates

Starting Monday, March 21, 2022, create a new study application online in Kuali by selecting IRB Application (Basic Study Information) Form (HRP-211) as the submission type. The same form is used for exemption requests, and there is no need to indicate a request for exemption or IRB review type.

All new studies submitted to the IRB will require the following documents: protocol (investigator study plan) and any related study documents (e.g., informed consent, survey instrument, recruitment materials). Submit related documents in Word format. Researchers should use the Protocol template HRP-503 (either in Word or build entirely in Kuali) to draft their investigator protocols. All study documents (consents, data collection instruments, recruitment materials, etc.) will continue to be attachments uploaded to Kuali by the researcher.

HRP-503 Protocol Template Use this Word template (or build entirely in Kuali)
Consent_Form_template_5.15.24 *new logo*
Consent_Form_recording_form_7.28.22.doc *new logo*
Assent_Form_sample_7.28.22.doc *new logo*
HIPAA Waiver request

After obtaining initial IRB approval, the PI is responsible for submissions to the IRB to amend, renew, request close, and report events for their study. For more information, visit our web page for Managing an IRB Protocol.

Reliance on External IRB Requests

Starting Monday, March 21, 2022, requests to rely on an external IRB for review of a study can be submitted to the UMass Boston IRB online in Kuali by creating a new study and selecting Request for External Reliance (form HRP-811) as the submission type. The researcher should confirm with the external IRB that they are willing to be the reviewing IRB before submitting the request to UMass Boston IRB. IRB staff will review the request and assist with executing a reliance agreement. Reliance agreements are generally restricted to non-exempt human research (with some exceptions such as for exempt categories with limited IRB review).

Investigator Manual and HRPP Plan

Investigator Manual (HRP-103) A "one-stop shop" to guide investigators through the policies and procedures related to the conduct of human research at UMass Boston.
Investigator Manual - Appendices (HRP-103a) Additional guidance and requirements to supplement the Investigator Manual.
Human Research Protection Program (HRPP) Plan (HRP-101) An overview of the mission and components of the HRPP at UMass Boston.
IRB Guidance on GDPR Investigators planning to conduct research involving “personal data” about individuals located in European Union member states plus Norway, Iceland, Liechtenstein, and Switzerland need to be aware of these additional EU General Data Protection Regulations. We thank Brown University IRB for sharing this resource with us.
IRB Guidance on SONA Investigators using the SONA system for participant recruitment need to be aware of these additional reviews and considerations. We thank UMass Lowell IRB for sharing SONA guidance with us.
UMass Boston COVID-19 policies If you have any questions, please reach out to the Office of Environmental Health and Safety (OEHS) at umbehs@umb.edu.

IRB Checklists, Worksheets, and SOPs

IRB checklists, worksheets, and standard operating procedures (SOPs) are used by the IRB in making regulatory decisions. These tools offer researchers insight into what the IRB is reviewing in protocols. Researchers do not need to fill out these documents. They are for reference only.

Checklists:

Worksheets:

SOPs:

What type of review does your study require?

Read below to learn the differences between exempt, expedited, and full Board review. Researchers themselves do not determine the type of IRB review -- only the IRB can make this determination. Formal IRB approval (or exempt determination) is required prior to conducting human research.

*Submissions received after 5 PM ET are considered received the next business day (excluding holidays/campus closures). The IRB operates year-round. Submissions are placed in queue to accommodate all applicants.

Exempt:

Certain categories of human research are exempt from regulation but require initial IRB review. Ongoing IRB review and approval is not always needed after obtaining the initial exempt determination.

Some new exempt categories (i.e., category 2 iii) also require a type of expedited review called "limited IRB review" (see Limited IRB Review Worksheet (HRP-319)."

Note: Exempt human research is NOT the same as activities which are "not human research."

Application deadline: None. Accepted and reviewed on a rolling basis.

Review timeframe: within about 3 weeks*

Expedited:

Certain categories of non-exempt human research may qualify for review using the expedited procedure, meaning that the study may be approved by a single designated IRB reviewer, rather than by the full Board.

Human research that poses minimal risk to human subjects and falls under one or more permissible expedited categories are eligible for expedited review.

Application deadline: None. Accepted and reviewed on a rolling basis.

Review timeframe: within about 3 weeks*

Full Board:

Non-exempt human research that does not qualify for review using the expedited procedure (e.g., research presenting greater than minimal risk to participants and/or research procedures not all within the expedited review categories) must be reviewed at a convened meeting of the full Board.

Application deadline: See Deadlines And Meetings

Review timeframe: within about one week after the meeting date

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