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Human Subjects

Policies & Guidance

Defining Research vs. Quality Improvement / Quality Assurance (QI/QA)

This information is intended as guidance in making a preliminary determination regarding the need for IRB oversight. Whenever there is uncertainty as to whether a project is considered research or QI/QA, the investigator should request guidance from the Human Subjects Office (HSO).

Purpose:

To establish the definition of Research versus Quality Improvement (QI) or Quality Assurance (QA) –
referred to collectively in this guidance as ‘QI/QA.’

Research projects must comply with specific policies and regulations designed to protect human subjects and privacy rights. QI/QA projects are not required to be carried out in accordance with research policies and regulations. However, it may be difficult for an investigator to determine if his or her project is research or QI/QA. Since this determination may have a significant impact on the project design, procedures, and regulatory compliance, the investigator should not hesitate to ask the HSO for guidance. There are serious consequences for not following Indiana University policies and Federal regulations when conducting research.

The first section provides definitions for Research and QI/QA. The second section provides certain characteristics typically associated with research and QI/QA projects. Once you review the definitions and characteristics, you should be able to determine the appropriate category for your project. If you determine that the project is similar to both definitions, then the project is research.


Section 1: Definitions

What is Research?  The Common Rule defines research as “a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge”. [Source: Code of Federal Regulations 45CFR46.102]

Please be aware the intent to publish is an insufficient criterion for determining whether a project involves research. Planning to publish an account of a quality improvement project does not necessarily mean that the project fits the definition of research; people seek to publish descriptions of nonresearch activities for a variety of reasons, if they believe others may be interested in learning about those activities. Conversely, a quality improvement project may involve research even if there is no intent to publish the results. [Source: OHRP FAQs]

What is Quality Improvement / Quality Assurance (QI/QA)?  The human subjects regulations offer no formal definition of Quality Improvement or Quality Assurance. The IU Human Research Protection Program considers QI/QA to involve:

  1. Data collection and analysis for an institution’s own internal operation monitoring and program improvement purposes, that is, only if:
    • the data collection and analysis is limited to the use of data originally collected for any purpose other than the currently proposed activity, or
    • is obtained through oral or written communications with individuals
  2. Implementation of an accepted practice to improve the delivery or quality of care or services (including but not limited to education, training, procedures related to care or services) provided by a specific institution, that is, only if the purposes are limited to:
    • altering the utilization of the accepted practice; and
    • collecting data to evaluate the effects on the utilization of the practice

NOTE: QI/QA activities are not designed to contribute to generalizable knowledge.

VA researchers should refer to additional definitions and guidance in VHA Handbook 1058.05 – VHA Operations Activities that may Constitute Research.


Section 2: Distinction between Human Subjects Research and Quality Improvement

Section 3: Similarities and Differences between Human Subjects Research and QI/QA

Examples of implementing a practice and collecting patient or provider data for non-research clinical or administrative purposes [purposes are limited to (a) implementing a practice to improve the quality of patient care, and (b) collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes] include:

  • A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
  • A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.
  • A clinic increasingly utilized by geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient charts in order to see if the assessments are performed with appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the capacity assessment in geriatric patients if it finds that the assessments are not being administered routinely.

Section 4: IRB Oversight

Retroactive approval: The IRB cannot retroactively approve research. If a project commenced without IRB approval and was later determined to constitute research with human subjects, please review the Guidance on Reporting Unanticipated Problems and Noncompliance.

Publication considerations: Some academic journals require documentation of IRB oversight, or in lieu of IRB oversight, a determination that IRB oversight is not required of a project that does not represent human subjects research. In these cases, the HSO recommends investigators complete and submit an Application for Non-Human Subjects Research prior to commencing the project.

Funding considerations: If a project is funded as ‘human subjects research’, please submit the appropriate human subjects research application for IRB review. If a funder requires documentation of IRB oversight or determination that oversight is not required for a project which does not represent human subjects research, please follow the instructions in ‘Publication considerations’ above.

Projects utilizing data collected for a QI/QA project: Some projects propose to utilize data that are already in existence and that were collected as part of a QI/QA endeavor. Depending on the design of the project, this may represent research with human subjects. Please contact the HSO for assistance in making this determination.


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