UMass Boston

Kuali Protocols Log In

All IRB submission forms are online in Kuali. Create a new study application online in Kuali and select IRB Application (Basic Study Information) Form (HRP-211) as the submission type. The same form is used for exemption requests.

• Kuali UMass Boston IRB User Manual
• How to Navigate Legacy Studies
• How to Determine if Your Study has an Expiration Date and Requires Renewal

Kuali Instructional Videos (YouTube)

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

Kuali Quick Tips - Troubleshooting tips

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

All new studies require an Investigator protocol and any related study documents (e.g., informed consent form, data collection instrument, recruitment materials).

• HRP-503 Investigator Protocol Template
  • Use this Word template (or build your investigator protocol entirely in Kuali)
• Informed Consent Form Template
• Informed Consent Form for Recording Template
• Child Assent Form Sample
• HIPAA Waiver Request

• 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. All PIs and research personnel must follow these requirements.
• Investigator Manual - Appendices (HRP-103a)
  • Supplemental guidance 
• Human Research Protection Program (HRPP) Plan (HRP-101)
  • Mission overview
• IRB Guidance on GDPR
  • For investigators planning to conduct research involving “personal data” about individuals located in European Union member states plus Norway, Iceland, Liechtenstein, and Switzerland 
• IRB Guidance on SONA
  • For investigators using the SONA system for participant recruitment
• Guidance for unaffiliated researchers recruiting UMass Boston participants
  • For unaffiliated investigators without a UMass Boston research collaborator 

Checklists and worksheets are for reference only and do not need to be submitted to the IRB. 

Checklists

• Waiver of Alteration of Consent Process Checklist (HRP-410)
• Waiver of Written Documentation of Consent Checklist (HRP-411)
• Prisoners Checklist (HRP-415)
• Children Checklist (HRP-416)
• Adults With Impaired Decision-Making Capacity Checklist (HRP-417)
• HIPAA Waiver of Authorization Checklist (HRP-441)

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)
• Criteria for Consent Worksheet (HRP-314a)
• Advertisements Worksheet (HRP-315)
• Payments Worksheet (HRP-316)
• Additional Federal Agency Criteria Worksheet (HRP-318)
• Limited IRB Review and Broad Consent Worksheet (HRP-319)
  • Broad consent is not implemented at UMass Boston 
• Review of Information Items (HRP-321)
• FERPA Compliance Worksheet (HRP-331)
• Certificate of Confidentiality Worksheet (HRP-333)

Standard Operating Procedures (SOPs)

• Definitions SOP (HRP-001)
• LARs, Children, and Guardians SOP (HRP-013)
• Informed Consent Process SOP (HRP-090)
• Written Documentation of Consent SOP (HRP-091)

Additional Resources (External)

• Clinical Trial Definition (NIH)
• Clinical Trial Decision Tool (NIH)
• Clinical Trial Good Clinical Practice Training Requirement (NIH)
• Clinical Trial Informed Consent Form Posting Requirement (DHHS)
• Code of Federal Regulations (DHHS)
• FERPA Guidance (ED)
• HIPAA Guidance (DHHS)
• Human Subjects - Frequently Asked Questions (NIH)
• International Research Guidance (DHHS)

Additional Resources (UMass Boston)

• Campus Posting Policy
• Data Protection & Export Control/International Travel
• Data Security Services
• FERPA Guidance
• Gift Card Request Process
• Information Technology Services
• Information Technology Services - Data Security Guidelines
• OneDrive Online File Storage
• UMass Boston Research Home Page
• Zoom Video Conferencing

The IRB determines the type of review. Submissions are placed in a queue to accommodate all applicants.  

Exempt

Certain categories of human research are exempt from regulation but require initial IRB review. Exempt is different from "not human research."

Some exempt categories (i.e., category 2 iii) also require a type of expedited review called "limited IRB review" (see Limited IRB Review Worksheet (HRB-019)).

Ongoing IRB review and approval is not always needed after obtaining the initial exempt determination. 

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

Review Timeframe: Within about 2 to 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 2 to 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.

Most UMB IRB submissions do not require full board review. Therefore, PIs should submit as soon as applications are ready and not wait until the full board deadline date.

Review Timeframe: Results are communicated within about one week after the meeting date.

Upcoming IRB Full Board Deadline and Meeting Dates

IRB meetings are held from 12:30 pm to 2:30 pm (if needed). Dates/times are subject to change.

UMass Boston CITI SSO Log In

All UMass Boston research staff who are engaged in research involving human subjects must complete the Collaborative Institutional Training Initiative (CITI) online training prior to conducting human research and again every three (3) years.

UMass Boston provides the following two CITI training courses related to human research protections. Either course will be accepted. You may select the group appropriate to your research interests.

Social & Behavioral Research or Biomedical Research

Note: Other CITI courses (e.g., Responsible Conduct of Research (RCR); Conflict of Interest; Good Clinical Practice (GCP) – Social and Behavioral Research Best Practices for Clinical Research; Students-Class Projects; Export Controls) may be needed for other research activities but do not fulfill the required human research protections training.

Instructions

Use the UMass Boston CITI Single Sign-On (SSO) link above. Enter your campus-wide UMass Boston email and password.

Please be sure that your CITI profile has your first name, last name, and UMass Boston email address (XXXX.XXXX@umb.edu) as your primary email address. Your CITI profile must have your UMass Boston email as your primary email address. This allows your CITI trainings taken through UMass Boston to display in Kuali.

Under My Courses, select View Courses for University of Massachusetts Boston

Scroll down to Learner Tools for University of Massachusetts Boston

To add a new course, select Add Course. In Question 1: Select "Yes, I conduct research with live human beings, human samples or with data derived from human beings."

Choose either Social & Behavioral Research or Biomedical Research. (Do not select IRB Members.)

CITI training(s) from another organization

While the IRB will accept equivalent external CITI training certificates, we strongly encourage UMass Boston researchers to take our training. External training will not appear in the UMass Boston CITI database or display in Kuali unless you transfer those courses to your UMass Boston CITI account yourself. To transfer courses, log into the CITI SSO link above and follow the screen selection to "Add Affiliation" (add the external institution's name). Then, add the UMass Boston course equivalent. Only external CITI courses that match exactly (course and stage) will transfer, and you will need to complete the difference in modules in the UMass Boston course. Be sure to complete the Integrity Assurance Statement for the course.

External (non-UMass Boston) study staff

External research staff who do not have a CITI account and do not have a UMass Boston email will not be able to use the UMass Boston SSO link above. They can still register with CITI following the guide below to take our CITI courses at no cost to them.

• CITI guide: New Users Steps (for individuals without a UMass Boston email)

For CITI technical assistance, contact or visit CITI support. 

Amendment

Per federal regulations, once a non-exempt IRB protocol has received approval, any subsequent changes to the study must be submitted to the IRB via an amendment (modification) for review and approval by the IRB prior to implementation. If the proposed amendment changes any IRB approved documents (e.g., protocol, informed consent form), the investigator must also submit an updated version of each document for IRB review. 

For exempt research, amendments do not need to be submitted to the IRB unless the proposed changes could impact the exempt status (e.g., changes that add more than minimal risk to subjects, add a vulnerable population, impact privacy and confidentiality, affect design of research). 

Renewal

New studies initially approved via expedited review on or after January 21, 2019 under the Revised Common Rule will not have an expiration date and will not require any renewal submission (with some exceptions such as DOJ-funded research).

Expedited studies that were initially approved before January 21, 2019 (with few exceptions) will still have an expiration date and require a renewal submission at least annually. The investigator should submit for renewal at least 30 days before the expiration date.

Full board review studies are issued an expiration date and require a renewal submission at least annually (with some exceptions). The investigator should submit for renewal at least 30 days before the expiration date (or earlier depending on the available full board meeting dates).

Exempt studies do not have continuing IRB review and do not need renewal.

Reportable Event (Reportable New Information)

PIs and research staff are required to notify the IRB of any reportable new information within 5 business days of becoming aware of the event as stated in the Investigator Manual (HRP-103).

Closure Request

Submission of a closure request (final report) is required for all non-exempt research in order to formally close your IRB protocol. A protocol may be closed with the IRB once participant enrollment has permanently ended, all research-related interventions and interactions with participants are completed, no additional identifiable private information about the subjects is being obtained, and analysis of private identifiable data is completed.

Post-Approval Monitoring (PAM)

The Associate Director of Research Compliance and Integrity in conjunction with the IRB and/or research compliance staff will follow standard operating procedures for quarterly post-approval monitoring of selected active studies.

• SOP: Quarterly Evaluations of the HRPP (HRP-061)
• UMass Boston Post-Approval Monitoring (PAM) Program
• PAM Review Checklist (sample only)

Activities must meet the institutional definition of Human Research to fall under IRB oversight. Use the following worksheets to determine whether your project qualifies as human research.

• Human Research Determination Worksheet (HRP-310)
  • Detailed information and common examples of activities that are not human research
• Engagement Determination Worksheet (HRP-311)
  • Determining whether or not an organization is engaged in human research activities 

Related Links 

• NIH Definition of Human Subjects Research
• NIH Decision Tool: Am I Doing Human Subjects Research?
• NIH FAQs Human Subjects
• OHRP Quality Improvement FAQs

• Requests to rely on an external IRB for review of a study must be submitted online in Kuali. 
• The researcher should first confirm with the external IRB that they are willing to be the IRB of record (i.e., sIRB) before submitting the request to UMass Boston IRB.  
• Create a new study application online in Kuali and select Request for External Reliance (form HRP-811) as the submission type.  
• IRB staff will review the request (within about 2 weeks) and assist with documentation for the reliance agreement.  
• IRB reliance agreements are limited to non-exempt human research (with some exceptions such as for exemptions with limited IRB review conducted via expedited review). 

What is ResearchMatch.org?

ResearchMatch.org is a national recruitment registry that brings together researchers and people who are interested to learn more about health-related research studies via a secure website.

Only researchers (with a "umb.edu" domain) at the University of Massachusetts Boston conducting a health-related study may use this tool for:

• Feasibility Assessment
  • Researchers use ResearchMatch to assess the availability of volunteers that matches the requirements for study eligibility. Results of a feasibility assessment are provided in aggregate, without individually identifying information.
• Recruiting
  • Researchers invite volunteers who agree to be contacted.

Creating an Account

Create an account and follow the prompt to register. You MUST use your "umb.edu" email (Gmail or non-UMB emails are NOT allowed

Researcher Training is required in the system once you've registered and logged in. The PI and proxy (anyone on study team using ResearchMatch) must complete the Zoom training. Save copies of the Zoom training invitation as evidence of training.

Conducting a Feasibility Assessment

Using the ResearchMatch search-building tools, the researcher enters search criteria to assess availability of the study population of interest within the ResearchMatch database.

Criteria include (but are not limited to):

• Geographic factors (distance from institution and State)
• Age
• Gender
• Physical characteristics (height, weight, BMI)
• Race and Ethnicity
• Health status (diagnosed diseases and conditions)*
• Medication history
• Twin status
• English or Spanish language

*Absence of diagnoses is also captured for healthy volunteers

Upon completing a feasibility search, researchers can view how many ResearchMatch volunteers meet study-specific criteria.

IRB approval is NOT required for Feasibility access only.

Recruiting Research Subjects

ResearchMatch provides tools to assess how many individuals meet eligibility criteria, to view non-identifying descriptions of potential matches, to add an IRB-approved recruitment message to send to eligible individuals, and inviting permission to release identifying information for researcher initiation of enrollment procedures. Tools include mechanisms for tracking enrollment statistics.

IRB approval is REQUIRED for Recruitment access.

Securing IRB Approval

Every study requesting Recruitment Access must receive IRB approval to use ResearchMatch.

Specify use of RM in investigator protocol. To request approval to use this tool, researchers must include in the submission to the IRB an investigator Protocol specifying that ResearchMatch is requested to be used as a Recruitment Method.

If the study is NOT health-related, the IRB cannot approve the use of ResearchMatch, and you will be told to withdraw your request. Therefore, it is important that you clarify in the IRB submission how your study is health-related.

Studies must have a health-related outcome which means it must “reflect the effect of one or more interventions on human subjects' biomedical or behavioral status or quality of life.”

Examples include changes to physiological, biological or psychological factors or health-related behaviors.

Examples of study topics that do NOT have health related outcomes: Consumer spending/decision making, business, marketing, politics or religion; Ecological impact; Architectural features; Leadership styles; Work force issues, etc.

Evidence of Researcher Training must be provided to the IRB. The IRB will only approve the use of ResearchMatch for recruitment if the PI and proxy (if applicable) have completed the Researcher Training for ResearchMatch. Attach a copy of the Zoom Researcher Training invitation/email in the Project Personnel table in Kuali (same section where CITI training can be uploaded).

You must include in the IRB submission the “contact (recruitment) message” which will be sent to matched volunteers. Information identifying the study investigator(s) and how to contact recruitment coordinators must be omitted from this message, to retain communication pathways within ResearchMatch. The contact message must be text only and NOT include any hyperlinks/URLs or any contact information (study team names, emails, or telephone numbers). Pictures are not allowed. Be sure to label the document "RM contact message" or "ResearchMatch contact message" in your IRB submission.

• Tips for Creating an Effective Contact Message

Contact message you will send to potential volunteers

(The maximum character length is 2000. Note that spaces count towards character length.):

[The purpose of this study is…]

[Why it matters]

[Who is eligible?]

[Study activities]

[Compensation]

Your contact message will appear inside standardized language that is included on all emails from ResearchMatch.

ResearchMatch is available in Spanish! If you have IRB approval for recruitment of Spanish-speaking participants, you can message Spanish-speaking volunteers with your IRB approved Spanish contact message. Use the new language filter on ResearchMatch indicating that your message is in Spanish. 

Uploading Study-Specific Information 

Once IRB approval is provided, researchers enter study details and upload the IRB-approval document (PDF format). Following verification of IRB approval to use ResearchMatch for recruitment, the requesting researcher will receive notice that access has been granted. 

Identifying and Communicating with Potential Volunteers 

Researchers search the ResearchMatch database to assess how many individuals meet eligibility criteria, to view non-identifying descriptions of potential matches, and to add the IRB-approved recruitment message to send to eligible individuals. 

ResearchMatch sends the study recruitment message to matched volunteers to inform them about a new opportunity to participate. 

Once individuals respond with permission to be contacted for that study, personal contact information is made available to the researcher within the secure ResearchMatch system. After the match is made, the PI follows the IRB approved research protocol and contacts the volunteer per research protocol. Researchers must NEVER carbon copy (cc) the list of volunteers via email or any other method! This is a violation of the ResearchMatch agreement, and it is considered a reportable event to the IRB! 

Helpful Videos

Liaison Training: Researcher Registration

How To Perform a Search for Volunteers

How to Add a Study and Contact Volunteers

How to Add a Study to ResearchMatch (PDF)

Overview of Research Dashboard

Adding a New Study on ResearchMatch

How to Perform a Search for Volunteers

Selecting and Contacting Volunteers

Managing Volunteers in ResearchMatch

Extending a Study Expiration Date

Annual Renewal of ResearchMatch Use 

Approval for Recruitment use of ResearchMatch will expire after one year for all studies (regardless of the IRB approval period), and the researcher will need to submit a request in ResearchMatch to renew. 

Technical Assistance  

If you have general questions about ResearchMatch, contact the UMass Boston ResearchMatch Liaisons through our Research Request Dashboard.

Report technical difficulties with the ResearchMatch.org website or email ResearchMatch.org support: info@researchmatch.org