Policy and Procedure

All applicants planning research at UMA that qualifies under the definition of “human subjects” must complete the required UMA IRB human subjects research application. The UMA IRB follows policies and procedures issued by the United States Health and Human Services Office of Human Research Protections, the University of Maine System Policy Section 601 Human Subject Research [linked below], and the University of Southern Maine Office of Research Integrity and Outreach [linked below] respectively.

UMS Section 601
Human Subject Research

USM ORIO
HRPP Policies

Informed Consent Checklist

OHRP Training:
Equitable Selection

OHRP Training:
Minimizing Risks

Maine Department of Corrections Policies

Principal Investigator and any co-investigator(s) must complete the Collaborative Institutional Training Initiative (CITI) Social & Behavioral Research–Basics/Refresher certification. The estimated time on task for the Social & Behavioral Research–Basics/Refresher is 4 to 6 hours. Find the link to the CITI suite of trainings in your UMA launch pad.

Investigator prepares the appropriate Informed Consent Form (ICF). Faculty must sign off on the ICF for student investigators. More information about constructing an Informed Consent Form is linked above and includes a full checklist with notes.

Investigator prepares the UMA IRB Application and submits it with ICF, CITI certificate, and other appropriate documents. The UMA IRB website offers many informational and training resources to assist investigators in preparing a complete and regulatorily compliant application. Please visit the U.S. Department of Health and Human Services Office for Human Research Protections website for further training, policy information, industry updates, and job aides.

If a sponsoring agency is involved, include a copy of the proposal and budget the investigator submitted for funding. If the the proposed research is with or in a Maine Department of Corrections facility, please view the MDOC polices linked above. The following policies have specific impact on research protocols proposed by UMA researchers; 1.24 Research, Evaluation, and Performance Measurement; and 24.10 Prisoner Use of Computers and/or Access to the Internet.

Student investigators must include a letter from the Faculty indicating that the Faculty approves the project, research, or thesis proposal. Student(s) and their Faculty will be co-investigators on the proposal.

The IRB chair reviews applications to determine

  • Is this research?
  • Is this excluded research?
  • Is this human subject research?
  • Is this exempt human subject research?
  • Does this require full board review?

View Human Subject Regulations Decision Charts: 2018 Requirements here.

If statute does not require full board review, the IRB Chair will contact the investigator(s) within two weeks of receipt to advise or ask clarifying questions. Approval timelines will vary from proposal to proposal.

If statute requires full board review, application materials will go to board members and the IRB will discuss the application as part of the next appropriate agenda. Please refer to the meeting dates and full board review deadlines on the IRB website.

If the board finds there are missing components, has concerns, or has questions, the IRB will return the material to the principal investigator and advisor if applicable. If the board recommends approval, the Chair will notify the Provost of a recommendation to approve.

Once approved by either the Chair or the board, the IRB Chair will forward the forms to the Provost who will review the final version and sign as the President’s designee.

The Provost’s Office will notify applicant of approval or disapproval. The Provost’s Office will return consent form(s) to the Principal Investigator with an IRB approval stamp which will indicate approval/expiration dates. Investigators may only use consent documents bearing a valid IRB approval for enrollment of research subjects. The Provost’s Office will keep copies of all approved forms.

Questions regarding research applications should be sent to the IRB Chair Chris Lage at clage@maine.edu, and cc’d to the Provost’s office at tlawson@maine.edu.