Compliance - Institutional Review Board for the Protection of Human Subjects (IRB)
Federalwide Assurance #: FWA00000479
Students, employees, and agents of the University who conduct research involving human subjects must comply with the University Policy and Procedures for the Protection of Human Subjects of Research. These procedures exist for the rights and welfare of the people who participate in UMaine research. No systematic investigation of information obtained by observing or interacting with people, or by collecting and examining any form of identifiable private information about people, may be conducted until the Protection of Human Subjects Review Board has approved the research protocol.
- Application Form for Approval of Research with Human Subjects: The application form for requesting approval from the IRB for research with human subjects. Cover Page (Word) (PDF) and Instructions (Word) (PDF) (Last update 8/2015).
- Continuing Review Instructions: For currently approved (non-exempt) studies.
- Data Encryption Requirement: To ensure confidentiality of identifiable, electronic data, the Institutional Review Board (IRB) is now requiring that the electronic key linking participants’ identities to their data be encrypted. See link for additional information.
- Deadlines: The deadline for submitting applications for approval is the first Friday of the month.
- Exemption Categories: Listing of research activities that may be exempt from further review.
- Expedited Review Categories: Categories of research that may be reviewed by the IRB through an expedited review procedure.
- Graduate School Policy: Graduate students and faculty advisors, please read section 10.2.3 (page 38) Human Subjects Approval (PDF), from the Graduate School’s Policies and Regulations.
- Guidelines for Class Projects: These guidelines are intended to assist instructors in determining when class projects meet the definition of research with human subjects and require review by the University of Maine’s Institutional Review Board for the Protection of Human Subjects (i.e., IRB). Please see flow chart to assist with the decision-making process. (Last update 11/2009.) Sample of a course syllabus addressing class projects (used with permission).
- Information about Oral History Activities: Information to assist individuals in determining when/if oral history activities require human subjects review.
- Informed Consent Information and Sample Document: Information about the informed consent process, requirements, and a sample document. (Last update 06/2015)
- Internal Institutional Data Collection Guidelines:
- Membership: Current membership listing.
- Policy Concerning the Protection of Human Subjects of Research: All persons involved with human subjects research should read this Policy. (Last update 10/2009.)
- Referral Handout Template: Use for studies on sensitive topics where referrals are required.
- Request for Student Data for Use in Research Project: If a researcher proposes a project using student records (non-directory information, e.g., email addresses, SAT scores, grades, majors, etc.) approval for use of such data must be obtained from the Office of Student Records. This form must be completed and submitted to the Office of Student Records.
- Required Training: All personnel named in an existing or new “Application for Approval of Research with Human Subjects” must complete a web-based tutorial on the protection of human subjects. The training is valid for four years from the date of completion.
- Useful websites: Links to federal policy, guidelines, resources, etc.
- What is HIPAA?: HIPAA is the Health Insurance Portability and Accountability Act. If investigators gather, generate, access, or share subjects’ personal health information, the research may be subject to the Privacy Rule (a Federal regulation under HIPAA).