Guidance & Policy for Human Subjects Research

Policy

• Graduate School Policies and Regulations: Graduate students and faculty advisors, please read section 10.2.3 Human Subjects Approval, from the Graduate School’s Policies and Regulations.
• Policy Concerning the Protection of Human Subjects of Research (PDF): All persons involved with human subjects research should read this policy.
• Revised Common Rule Changes (Word)

Guidance

• Anonymous vs Confidential
• 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.
• Depression and Suicidality in Human Research – Guidance for Researchers (Word). These guidelines are intended to assist researchers who use measures that screen for depression and/or suicidality.
• Does My Study Require IRB Review? Flowchart – Diagram (PDF); Does My Study Require IRB Review? Flowchart – Plain Text (Word)
• Event Reporting: Unanticipated Problems, Adverse Events and Other Problems
• Expedited Review Categories (external link): Categories of research that may be reviewed by the IRB through an expedited review procedure.
• Exemption Categories: Listing of research activities that may be exempt from further review.
• FERPA (Family Educational Rights and Privacy Act) Guidance: Consideration when collecting student records
• 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 (IRB).
  • Please see Flow Chart for Guidance on Whether a Class Project Requires IRB Review (PDF) to assist with the decision-making process.
  • Sample of a course syllabus (PDF) addressing class projects (used with permission)
• Human Subject Payment Guidelines
• Information about Oral History Activities: Information to assist individuals in determining when/if oral history activities require human subjects review.
• Informed Consent Guidance: Information about the informed consent process.
• Internal Institutional Data Collection Guidelines
• International Human Subjects Research
• Online Survey Guidance (Word): Tips and guidance for writing an IRB application using online surveys and examples of common survey platforms.
• Recruitment Flyer Guidance
• Referral Handout Template (Word): Use for studies on sensitive topics where referrals are required.
• Research vs. Program Evaluation (Word)
• Sex, gender, and sexual orientation guidance on demographic questionnaires
• Social Media Guidance: Guidance for using social media for research purposes.
• Tips for SONA users: Guidance for researchers using SONA/Psychology Subject Pool & obtaining IRB approval.
• What is General Data Protection Regulation (GDPR)?
• Zoom Guidance for IRB Studies