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

Kuali Protocols Log In

Kuali IRB Instructional Materials

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

Kuali Instructional Videos (mp4) - 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 / YouTube version w/ subtitles 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.

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 protocol and related documents in Word format. Researchers will continue to use the Protocol template HRP-503 (in Word) to draft their investigator protocols. All study documents (investigator protocol, consents, study instruments, etc.) will continue to be attachments uploaded to Kuali by the researcher.

HRP-503 Protocol Template Use this template to provide sufficient information for IRB review.
Consent_Form_12.20.22.doc *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. If the IRB staff determines the request is appropriate, then IRB staff will assist with execution of 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" fto 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 EU 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.
The University's current COVID-19 policies (subject to change) are available at https://www.umb.edu/coronavirus/covid_19_university_policy. If you have any questions, please reach out to the Office of Environmental Health and Safety – 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 may help provide researchers insight into what the IRB is looking for in protocols. Researchers do not need to fill out these documents. They are for reference only.

Checklists:

Worksheets:

Human Research Determination Worksheet (HRP-310)
Engagement Determination Worksheet (HRP-311)
Exemption Determination Worksheet (HRP-312)
Expedited Review Worksheet (HRP-313)
Criteria for Approval Worksheet (HRP-314)
Advertisements Worksheet (HRP-315)
Payments Worksheet (HRP-316)
Additional Federal Agency Criteria Worksheet (HRP-318)
Limited IRB Review Worksheet (HRP-319) Note: Broad consent is not implemented at this institution
Review of Information Items (HRP-321)
FERPA Compliance Worksheet (HRP-331)
Certificate of Confidentiality Worksheet (HRP-333)

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	Expedited	Full Board
Description	Certain categories of human research are exempt from regulation but require initial IRB review. Ongoing IRB review and approval is not usually needed after formally obtaining the initial exempt determination from the IRB. 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."	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.	Non-exempt human research that does not qualify for review using the expedited procedure (e.g., research presenting greater than minimal risk to participants; research procedures are not on the expedited review list) must be reviewed at a meeting of the full Board. The majority of UMass Boston IRB submissions will not require review by the full Board.
Application Deadline*	No deadline. Accepted and reviewed on a rolling basis.	No deadline. Accepted and reviewed on a rolling basis.	see Deadlines and Meetings
Review Timeframe	within about 3 weeks*	within about 3 weeks*	*within about one week after the meeting date*
Additional Guidance	Exemption Determination Worksheet (HRP-312)	Expedited Review Worksheet (HRP-313)	see Deadlines and Meetings

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