Other Administrative Determinations or Registrations

Sometimes proposed activities in projects do not constitute human subjects research or UCSD/RCHSD may not be engaged in human subjects research activities. OIA/IRB review is not required for such activities. However, researchers still have the option of submitting an application (abbreviated application) to the OIA for initial review to receive confirmation that their project does not fall under IRB oversight. We understand that publishers, financial sponsors or others entities may require documentation of OIA’s determination of Not Human Subjects Research (NHSR) or Non-Engagement.

Additionally, faculty and staff conducting Quality Improvement, Quality Assurance, and Evidence Based Practice activities/initiatives at UC San Diego Health and Rady Children’s Hospital San Diego have the option to apply for formal NHSR determinations through ACQUIRE (pulse) or E-QUAL, respectively.

Not Human Subjects Research (NHSR)

Research projects that do not meet the definition of human subjects research as stated by the Common Rule or the definition of a clinical investigation as stated by the FDA are excluded from IRB review.

Evidence-Based Practice (EBP)

EBP translates existing generalizable knowledge to implement local practice changes and/or answer a local practice question. EBP activities may include implementing practice changes on a pilot unit, evaluating process & outcomes.

Quality Assurance/Quality Improvement (QA/QI)

If the project is collecting data with the intent of evaluating and improving existing services and programs or for developing new services or programs (e.g., teaching evaluations or customer service surveys) and the intent is limited to evaluating the course or program (i.e. there is no intent to generalize the findings outside of UCSD/RCHSD).

Clinical QI/QA: Systematic, data-guided activities designed to implement promising ways to improve clinical care, patient safety, and health care operations. The activity is designed to bring about immediate positive changes in the delivery of health care, programs, or business practices in the local setting. Intent is limited to the local population and improving care, operations, etc.

Non-clinical QI/QA: Data collected with the limited intent of evaluating and improving existing services and programs or for developing new services or programs at an institution. Examples include teaching evaluations or customer service surveys. Intent is limited to evaluating services or programs and does not extend to developing or contributing to generalizable knowledge.

Case Studies

A Case Study is understood to mean the collection and presentation of detailed information about a particular participant or small group, frequently including the accounts of subjects themselves. A form of qualitative descriptive research, the case study looks at an individual or small participant pool, drawing conclusions only about that participant or group and only in that specific context.

A case report or case series does NOT meet the federal definition of “Human Subjects Research” if all of the following conditions are met:

The activities are limited to only reporting the facts. There is no intention to form a hypothesis, draw conclusions or generalize findings to a population outside of the sample case(s); AND
Identifiable information is NOT obtained from a State of California Agency (such as CA Dept. of Public Health, county registrar, etc.); AND
There is no plan to collect information that would not normally be placed in the records.

NOTE: The intent to publish the results of such projects does not make the project research.

Non-Engagement

An institution is considered engaged in a particular non-exempt human subjects research project when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention (including manipulation of their environment) or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research. An institution may also be considered engaged if it is the prime recipient of a federal grant that supports human subjects research activities.