Research Compliance Information & Resources

Project Determination Form/Certificate

• Determination Form/Certificate
• Amendment Form for QI/PE Projects

Guidance materials:

• The IRB Submission and Approval Process
• To IRB or Not to IRB?- guidance for students/faculty/staff
• Research or Evaluation ?- presentation by Julie Aultman, Ph.D.
• Evaluation vs. Research- chart of contrasting characteristics
• Human Subject Research, Quality Improvement, or Program Evaluation- determination checklist

Video Presentations

Presented by NEOMED Faculty:

• Mentorship and Navigating the Research Review Process- Information for Student Researchers and their Mentors
• Research, Quality Improvement and Program Evaluation.  What’s the Difference (and Who Cares)?
• Location, Location, Location: Conducting International Human Subjects Research
• The Issue with Tissue: Using Human Tissue Specimens in Research
• Time and Effort Reporting, IRB and IACUC Compliance, Financial COI

Presented by the Office of Human Research Protections (OHRP):

• What is Research and What it Isn’t? And Who is a Human Subject Anyway?
• Institutional Engagement in Human Subject Research
• How Do I Know if a Research Study is Human Subject Research and What Does that Really Mean?

Decision Charts from the Office of Human Research Protections

• Human Subject Regulations Decision Charts

News

National Institutes of Health Proposal Requirement Update

The NIH will implement a new Data Management and Sharing Policy for all grant applications submitted on or after January 25, 2023.