Quality Improvement Projects and HPRB Review

Overview

Quality Improvement (QI) consists of activities that are undertaken to measure the effectiveness of standard accepted processes, programs, or services, the results of which are generally intended to benefit the specific process, program, or service being evaluated. QI projects cannot expose individuals to any additional risks.

In contrast, research consists of a systematic investigation that is designed to develop or contribute to generalizable knowledge, the results of which are to be shared with both individuals associated with and individuals unassociated with the investigation.

It is important to note that language matters. Terms such as ‘research’ and ‘human subject’ or ‘participant’ have distinct definitions in the federal regulations, and use of such terms may invoke a set of requirements that perhaps do not apply. When referring to QI projects, it is best to avoid use of the terms ‘research’ ‘study’ and even ‘study intervention’. More appropriate terms might include ‘project’ or ‘proposal’. Similarly, for research, the people participating are referred to as ‘subjects’ or ‘participants’. For QI projects, the participants are generally ‘patients’ or ‘clinicians.’ Likewise, ‘researchers’ generally conduct ‘research’, but ‘clinicians’ more commonly undertake QI.

Do QI Projects Require IRB Review?

Protecting human participants during research activities is critical and has been at the forefront of Health and Human Services (HHS) activities for decades. In addition, HHS is committed to taking every appropriate opportunity to measure and improve the quality of care for patients. These two important goals typically do not intersect, since most quality improvement efforts are not research that is subject to the HHS regulations regarding protection of human research participants. However, in some cases quality improvement activities are designed to accomplish a research purpose as well as the purpose of improving the quality of care, and in these cases the regulations for the protection of participants in research (45 CFR §46) may apply.

While the majority of quality improvement projects do not require expedited or full review by the IRB, similar to exempt research, quality improvement projects may be submitted and registered with the IRB. There are, however, cases where the project would fall under the purview of the IRB. Projects which qualify as “research” and which involve “human participants,” as defined in the federal regulations at 45CFR46.102(e) and (f) and further explained below, would require IRB review under Edgewood policy. The most common reason for QI projects to require IRB review is that they are projects involving systematic investigations intended to develop generalizable knowledge. Additionally, IRB oversight may be required in some NON-research projects, for the protection of participants and/or personal information.

Thus, the IRB will review QI projects to make a determination as to whether or not the project meets all the requirements for a QI project. At present, the standard IRB proposal form, along with the QI Checklist, should be submitted to IRB to assist in making this determination.

What Constitutes "Quality Improvement"?

Quality Improvement (QI) projects involve systematic, data-guided initiatives or processes designed to improve clinical care, patient safety, health care operations, services and programs or for developing new programs or services (e.g. teaching evaluations, patient/employee service surveys). QI is intended to use experience to identify effective methods, implement the methods broadly, and evaluate the immediate impact or effect of the implemented changes. As such, QI is an intrinsic part of good clinical practice where lessons learned are used to enhance future healthcare delivery for patients, healthcare operations and services or programs at the institution in which the QI activity is implemented. A QI project may involve implementing a practice, for example, to improve the quality of patient care, and collecting and immediately assessing data regarding the degree to which implementation of the practice was successful for clinical, practical, or administrative purposes. Process-based QI activities strive to overcome barriers to dissemination and implementation of best practices. Note that these “best practices” represent accepted, evidence-based approaches to caring for patients (such as hand-washing, ordering mammograms for eligible women, or improving glucose control in diabetic patients), enhancing the work environment for more efficient practices by the employee rather than experimental/unproven interventions (see “Research” below). Results of a QI project could and should be shared with others, either via presentation or publication.

In general, QI activities would not be considered human participants research if the following applies:

1. The project goal is to implement existing/known knowledge to improve or enhance health/clinical care
   
2. The project does not test a hypothesis testing, involve randomization, or utilize comparison or control groups.
   
3. The project is based on data collection that is immediately evaluated, and if appropriate, leads to modification of practices or behaviors.

What Constitutes "Research"?

Federal regulations under the oversight of the Office of Human Research Protections (OHRP) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Under this definition, the project must intend at the outset to generate conclusions which can be applied in or be predictive of similar circumstances.

What Constitutes a "Human Participant"?

Federal regulations under the oversight of the Office of Human Research Protections (OHRP) define human subject as a “living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) obtains identifiable private information” (45 CFR §46.102(f)).

Key to this definition is that the information collected is about an identified person and is intended for research. A QI project certainly may involve ‘human patients’, but may not involve ‘human participants’ as described above.

Another consideration is that there may be different populations that are involved in the project. For example, a project might involve both patients and staff in a new activity. Depending on the nature of the activity, A determination should be made whether one or both groups could be considered ‘human participants.’

When are QI Projects Considered to be Human Participants Research Requiring IRB Review?

In certain cases a quality improvement project may constitute non-exempt human participants research. For example, if a project involves introducing a clinical intervention for purposes which include not only improving the quality of care but also collecting information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results, that quality improvement project may also constitute nonexempt human participants research under the HHS regulations. Similarly, if the proposed project will involve collecting identifiable information about a living individual AND will be used to inform broad policy or generalize findings, then the project must be submitted to the IRB for review.

For example, the following may be indicators that the project would need IRB review as research:

• The study is funded by an agency or sponsor which seeks to support projects designed to create generalizeable knowledge.
  
• The study involves multiple individuals’ perspectives on the issue of interest AND these perspectives are analyzed to reach generalized conclusions.
  
• The goal of the project is to document a specific issue or event, or the experience of individuals, e.g., conducting a root-cause analysis of a medical error.
  
• The project compares and contrasts policies, procedures or events to identify general commonalities or inform policy decisions without the collection of information about identified individuals.

What if I Intend to Publish the Results of the Project

The intent to publish (or present) is an insufficient criterion for determining whether or not a quality improvement activity involves research. In publication, however, the project must be clearly identified as quality improvement, and not referenced as 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 non-research 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.

If a Quality Improvement Project is Human Participants Research Requiring IRB Review, Do I Need to Obtain Separate IRB Approval From Every Institution Engaged in the Project?

No, not if certain conditions are met. The HHS protection of human participants regulations allow one IRB to review and approve research that will be conducted at multiple institutions. An institution has the option of relying upon IRB review from another institution by designating that IRB and having an IRB Authorization Agreement with the other institution.

What About Informed Consent? Is it Required?

QI is an integral part of the normal operations of the organization. Someone seeking care from a health care organization cannot insist on the freedom to opt out completely from efforts to improve the quality of care in that organization, as that is contrary to the mission of the organization and moreover might jeopardize the quality of care delivered to him or herself. Conversely, informed consent is required for research, unless stringent requirements are met for allowing waiver of consent (see below)

If a Quality Improvement Project Involves Non-Exempt Research with Human Participants, Do I Always Need to Obtain Informed Consent From All Participants (Patients and/or Providers) Involved in the Research?

No, the HHS regulations protecting human participants allow an IRB to waive the requirements for obtaining informed consent of the participants of the research when:

1. the risk to the participants is minimal,
   
2. participants’ rights and welfare will not be adversely affected by the waiver,
   
3. conducting the research without the waiver is not practicable, and
   
4. if appropriate, participants are provided with additional pertinent information after their participation (45 CFR 46.116(d)).
   

Other applicable regulations or laws may require the informed consent of individuals in such projects independent of the HHS regulations for the protection of human participants in research.

What Must be Submitted to the IRB?

At present, the standard IRB proposal form, along with the QI Checklist, should be submitted to IRB. Detailed information is available on the Human Participant Review Board (IRB) website at hprb.edgewood.edu, including an application form and consent form templates. In general, applications include a description of the project including the goals of the project, the type of information to be collected, who will be involved in the project , and if applicable, what information will be provided to the participants to obtain their agreement to participate.