Forms, Policies & Procedures

Research vs. Quality Assurance / Improvement Guidance

The Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP), federal regulations that govern human subjects research (45 CFR 46) requires research with human subjects to be reviewed and approved by an Institutional Review Board (IRB) prior to initiation.

To determine whether a project constitutes research or QA/QI can be challenging. The IRB does not have the authority to retrospectively review a protocol or provide retroactive approval. It is therefore important to determine whether an activity meets the criteria for human subjects research or a QA/QI initiative BEFORE the activity is initiated.

Use this resource for additional guidance.

The complete policy and more can be found on the UD Research Office’s web site.

Schematic Representations of a Study Examples

Schematic representations of a study are a quick ‘snapshot’ aimed to depict the involvement of research subjects from recruitment to end of study. This document presents examples of different schematics that show the level of detail needed to convey an overview of the study design. The examples included are intended to guide the development of a schematic that is appropriate to the planned study design and will need to be customized for each protocol. Depending on the nature of the study, one example may be more appropriate than another. Study-specific information should be use to modify the example chosen as needed (e.g., changing method of assignment to study group, adding visits, study arms, etc.)