Human Subject Research Information and Guidance
Below, you will find applications, guidelines, forms, and more for new and existing research submissions.
For additional information, please see our FAQ.
New Submission Guidance and Applications
Research Determination Requests
Review of PHI Preparatory to Research
Decedent Research (deceased individuals only)
Student Classroom Project Exclusions
- Student Classroom Project Guidelines (PDF)
- Application for Student Classroom Project Exclusion
- CITI Training (PDF)
Clinical Case Studies
- Application for Case Study Registration
- Consent Form Template for Case Study
- HIPAA Authorization Template for Case Study
- Verbal Consent Script Template for Case Study
Research Approved or Exempted by an External IRB
- Notification Form: Participation in a Research Study Approved or Exempted by an External IRB
- CITI Training (PDF)
Exempt Research Projects
- Application for Exempt Research Projects
- Research Proposal Guidance for Exempt Projects Involving Interviews and Surveys (PDF)
- Research Proposal Guidance for Exempt Projects Involving Retrospective Chart Review (PDF)
- Guidance for Using a Master List in a Research Project
- Guidance for Recruiting Students as Research Participants (PDF)
- Guidance for Building, Managing, and Closing REDCap Projects (PDF)
- Principal Investigator Certification (PDF)
- Participant Information Sheet Template (Exempt Projects Only)
- HIPAA Forms:
- CITI Training (PDF)
Non-Exempt Research Projects
- Application for Non-Exempt Research Project
- Guidance for Using a Master list in a Research Project
- Guidance for Recruiting Students as Research Participants (PDF)
- Guidance for Building, Managing, and Closing REDCap Projects (PDF)
- Principal Investigator Certification (PDF)
- Assent and Consent form templates for non-exempt research projects:
- HIPAA Forms:
- Investigational Device Information Form
- CITI Training (PDF)
Existing Submissions
Amendments, Renewals, Closures, and Reporting
- Submission Attestation Form (PDF)
- Application for Amendment (for exempt and non-exempt research projects)
- Application for Renewal (for non-exempt research projects only)
- Study Closure Report Form (for non-exempt research projects only)
- New Reportable Event Form (for non-exempt research projects only)
Additional Guidance
Responsible Conduct of Research (RCR) Training
HHS Office of Human Research Protections (OHRP)
HIPAA Privacy Rule
UNE Policies and Procedures
- UNE Policies, Procedures and Guidance on Research with Human Subjects (PDF)
- Pre-2018 IRB Policies, Procedures, and Guidance on Research with Human Subjects (PDF)
Contact
Board email
Professor of Psychology
Chair, Institutional Review Board
Affiliated Faculty, Women's, Gender, and Sexuality Studies
