Defining Research v. Quality Improvement
Standard Operating Procedure
Institutional Review Board
Policy Number: #06
Effective Date: 10/8/2021
Owner: Vice President of Academic Affairs
Author: CSS IRB
Quality Improvement (QI)
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, the investigator should request guidance from The College of St. Scholastica (CSS) IRB.
What is QI
While there is no regulatory definition, QI is often described as ”systematic, data-guided activities designed to bring about immediate positive changes in the delivery of health care in particular settings... QI should be incorporated into the system of accountability for clinical care (Hastings Center Special Report, 2006),” potentially leading to better patient outcomes, better system performance, and better professional development.
In medical institutions, QI is a necessary, integral part of hospital operations and is not subject to review as research, as defined under federal regulation. Rather, it is governed by Joint Commission and hospital standards. Human Subject Research (HSR) is governed by federal regulation, under IRB oversight.
Quality improvement activities are an important component of hospital and non-hospital operations. Because QI activities are data-driven and involve human participants, overlap can occur with research methodologies common to human subjects research. Where overlap exists between QI and research methodologies, the federal regulations that protect human research participants may apply. Whether the QI activity is human subjects research or not, it must absolutely be executed in a manner that is ethical and respects the rights and welfare of human participants.
Definitions
Quality Improvement (QI):
A Hastings Center Special Report (2006) "...defined QI as systematic, data-guided activities designed to bring about immediate improvements in health delivery in particular settings." Improving the quality of care of patients is a fundamental obligation of health care providers. The QI process involves evaluating and learning from experience.
The CSS IRB considers QI to involve:
- Data collection and analysis for an institution’s own internal operation monitoring and program improvement purposes if:
- the data collection and analysis are 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.
- 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, 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.
Systematic Investigation
An activity that is planned in advance and that uses data collection and analysis to answer a question. Although research must include systematic investigation, many non-research activities also include systematic investigation. Systematic investigation does not, in and of itself, define research.
Human Subject Research (HSR)
The Office of Human Research Protections (OHRP) defines research as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge and 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) Identifiable private information (45 CFR 46.102(d)). For example, if a project using human subjects is designed to test a novel hypothesis, replicate another researcher’s original study, or withhold any aspect of conventional care shown to be beneficial in prior studies, OHRP’s definition of human subject research would apply.
Generalizable Knowledge
To be considered “generalizable knowledge” the activity would include the following concepts:
- The information gained is intended to contribute to a theoretical framework of an established body of knowledge.
- Results are expected to be generalized to a larger population beyond the site or population studied.
- Results are intended to be replicated in other settings.
- The primary beneficiaries of the study are other researchers, scholars, and practitioners in the field of study.
- Most academic institutions consider a thesis or dissertation to be generalizable knowledge (relevant only if it includes human research).
The FDA does not use the term research, but considers it to be synonymous with clinical investigations, meaning any experiment that involves a test article and one or more persons (21 CFR 56.102(23)(c)). For example, if the investigator is comparing the safety and/or effectiveness of a drug, or comparing a regulated device to another, the investigator is engaged in a clinical investigation and must follow FDA regulations.
What are some differences between research and QI?
Purpose
- Research tests a hypothesis OR establishes clinical practice standards where none are accepted. Designed to develop or contribute to generalizable knowledge.
- QI assesses or promptly improves a process program or system; OR improves performance as judged by accepted/established standards. Designed to implement knowledge, assess a process or program as judged by established/accepted standards.
Starting point
- Research answers a question or test a hypothesis. Knowledge-seeking is independent of routine care and intended to answer a question or test a hypothesis.
- QI improves performance. For example, knowledge-seeking is integral to the ongoing management system for delivering health care.
Design
- Research follows a rigid protocol that remains unchanged throughout the research.
- QI uses adaptive, iterative design (A process for arriving at a decision or a desired result by repeating rounds of analysis or a cycle of operations. The objective is to bring the desired decision or result closer to discovery with each repetition [iteration].)
Benefits
- Research is designed to contribute to generalizable knowledge and may or may not benefit subjects. Might or might not benefit current subjects; intended to benefit future patients.
- QI is designed to promptly benefit a process, program, or system and may or may not benefit patients. Directly benefits a process, system or program; might or might not benefit patients.
Risks and burdens
- Research may place subjects at risk and is stated as such.
- QI, by design, does not increase a patient's risk with exception of possible privacy/confidentiality concerns.
Data collection
- Both Research and QI use systematic data collection.
Participant obligation
- Research has no obligation for individuals to participate.
- QI has a responsibility to participate as a component of care.
End point
- Research answers a research question.
- QI promptly improves a program/process/system.
Testing or analysis
- Research statistically proves or disproves a hypothesis.
- QI compares a program/process/system to an established set of standards.
Adoption of results
- Research has little urgency to disseminate results quickly.
- QI results in findings that are rapidly adopted into local care delivery.
Publication/Presentation
- Research investigators are obliged to share results.
- QI practitioners are encouraged to share systematic reporting of insights.
Other activities that are considered QI
Activities conducted by one or more institutions whose primary purposes are limited to:
- implementing a practice to improve the quality of patient care, and
- collecting patient or provider data regarding the implementation of the practice for clinical, practical, or administrative purposes are considered to be quality improvement rather than research. However, if the project involves introducing an untested 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 human subjects research (HSR) under HHS regulations.
QI generally refers to a range of activities conducted to assess, analyze, critique, and improve current processes of health care or operational delivery in an institutional setting. QI activities are typically observational and unobtrusive and can involve the collection and analysis of data to which investigators have legitimate access through their institutional roles. These activities do not prevent or hinder the delivery of clinically indicated care to patients or others, nor do they impose more than minimal additional risks or burdens on patients or others.
What are some examples of QI?
- ensuring new evidence-based interventions are incorporated into practice
- improvement of overall quality of life
- reduction of morbidity and mortality
- ensuring that patients receive evidence-based interventions for their illness
- improvement in patient and family comprehension
- reduction in in-patient admissions and length of stay
- reduction of ER visits
- reduction in costs of service and operations
- evaluating procedures, no greater than minimal risk, in health care, business, legal and educational settings
- usual care /operational practices, and
- interventions offered to all patients / participants
Quality improvement consists of systematic, data-guided activities to bring about prompt positive changes in the delivery of healthcare and other services that involve deliberate actions to improve care and operations. Depending on the activity, QI can look like practical problem solving, an evidence-based management style or the application of a theory-driven science of how to bring about system change. Introducing QI methods often means encouraging people in the clinical care and other settings to use their daily experience to identify ways to improve care, implement changes on a small scale, collect data on the effects of those changes, and assess the results.
Can a project be both QI and Human Subjects Research (HSR)?
Yes. The following characteristics make it more likely that a project involves both QI and human subjects research and would fall under the jurisdiction of the IRB. Consult with the IRB if you are uncertain.
- Randomization of patients into different intervention groups in order to enhance confidence in differences that might be obscured by nonrandom selection (but not to achieve equitable allocation of a scarce resource).
- Testing issues that are beyond current science and experience, such as new treatments or new ways of operation.
- The involvement in key project roles of researchers who have no ongoing commitment to improvement of the local care situation.
- Delayed or ineffective feedback of data, especially if feedback is delayed or altered in order to avoid biasing the interpretation of results.
- Funding from an outside research organization with an interest in the use of the results.
If a study includes randomization, is it always considered Human Subject Research (HSR)?
No. An example of a QI study that involved medication compliance included the randomization of patients to one of three arms:
- In one arm patients were given a cell phone and a reminder call when it was time to take their medication.
- Patients in a second arm were given a reminder call but no cell phone.
- Patients in a third arm took their medication while being directly observed by staff (direct observation therapy--DOT).
Is it research if I intend to publish?
The intent to publish is an ‘insufficient criterion’ for determining whether a quality improvement activity involves research, according to OHRP.
When QI is published or presented, the intent is usually to discuss potentially effective models, strategies, assessment tools or to provide benchmarks, rather than to develop or contribute to ‘generalizable’ knowledge.
What if I am getting funding for my project?
Outside external funding may make a difference in distinguishing between QI and research. An NIH research grant to support a project would often be considered research. Internal funding to improve a program may not.
What if I need to access Protected Health Information (PHI)?
HIPAA makes an exception for QI activities, including outcomes evaluation and development of clinical guidelines or protocols. These activities fall under the category of ‘healthcare operations’ for which no HIPAA Authorization or Waiver of Authorization needs to be sought. The hospital’s Privacy Office can authorize the use of PHI for QA/QI projects.
IRB Oversight
The Code of Federal Regulations 45 Part 46 does not require review of quality improvement projects because they do not meet the definition of “research.” However, the CSS IRB believes that because of the potential for conflict of interest, limited review by the CSS IRB is necessary to determine whether a project is quality improvement or research.
The CSS IRB will review applications and make a determination about whether the project meets the definition of “research” provided by the DHHS. Faculty and students should follow the guidelines for submitting an application on the CSS IRB website and include the following:
- a completed application;
- relevant documents such as advertising flyers, consent form(s), letters of affiliation, and surveys/questionnaires.
If after a review, it is determined that the project meets the definition of research, it will be reviewed according to the IRB policies and procedures for the appropriate risk level. If the project is determined not to be “research” by the CSS IRB, the investigator will receive a letter reflecting this determination.
If a project has been reviewed by an IRB from another institution and determined to be quality improvement (not research), the applicant does not need to complete and submit a CSS IRB application form; they should, however, submit the following:
- a copy of the letter from the IRB that reviewed the project and determined it did not meet the definition of research;
- a copy of the application that was submitted to the external IRB.
The CSS IRB recommends investigators first do the following when making this determination: 1) consult the information in this standard operating procedure; 2) use the checklist provided in this SOP; and 3) consult an IRB member.
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 CSS IRB SOP #24 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 CSS IRB recommends investigators complete and submit an Application prior to commencing the project.
Clarifications for publishing QI work:
- Do not refer to QI projects as research in publications or presentations.
- If the project was not submitted to the IRB for determination, the following statement may be included in the manuscript:
“This project was undertaken as a Quality Improvement Initiative and as such does not constitute human subjects research.”
- If the project was reviewed by the IRB and was determined not to be human subjects research, the following statement can be included in the manuscript:
“This Quality Improvement Initiative was reviewed and determined to not meet the criteria for human subjects research by The College of St. Scholastica Institutional Review Board.”
Funding considerations
If a project is funded as ‘human subjects research’, 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 CSS IRB for assistance in making this determination.
PURPOSE
Is the primary aim or motive of the project either to:
- Improve care right now for the next patient seen? OR
- Improve operations or efficiency?
If yes, then the project is likely QI.
If no, then the project is likely research.
RATIONALE
Is there sufficient evidence for, or acceptance of, this mode or approach to support implementing this activity or to create practice change, based on:
- literature,
- consensus statements, or
- consensus among clinician teams?
If yes, then the project is likely QI.
If no, then the project is likely research.
METHODS 1
Are the proposed methods flexible and customizable, and do they incorporate rapid evaluation, feedback and incremental changes?
If yes, then the project is likely QI.
If no, then the project is likely research.
METHODS 2
Do the methods include any of the following?
- Control group
- Randomization
- Fixed protocol
If no, then the project is likely QI.
If yes, then the project is likely research.
RISK
Is the risk related to the project minimal and no more than usual care / operation (including the unavoidable minimal risk in implementing any changes made in processes of care /operation)?
If yes, then the project is likely QI.
If no, then the project is likely research.
PARTICIPANTS
Will the activity only involve participants (patients, students, parents, or CSS staff) who are ordinarily seen, cared for, study or work in the setting where the activity will take place?
If yes, then the project is likely QI.
If no, then the project is likely research.
FUNDING
Is the project funded by any of the following?
- An outside organization with an interest in the results
- A manufacturer with an interest in the outcome of the project relevant to its products
- A non-profit foundation that typically funds research, or by internal research accounts
If no, then the project is likely QI.
If yes, then the project is likely research.
It is the policy of the College that when QI is done at an external institution, the default is that the project will be reviewed as research.
For more guidance about whether the activity meets the definition of Human Subjects Research please contact irb@css.edu.
(Courtesy of Children’s Hospital of Philadelphia)
CSS IRB REVIEWER GUIDE
Quality Improvement Activities FAQs
(US Department of Health and Human Services- Office for Human Research Protection (OHRP)
Protecting human subjects during research activities is critical and has been at the forefront of 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 subject to the HHS protection of human subjects regulations. 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 subjects in research (45 CFR part 46) may apply.
To determine whether these regulations apply to a particular quality improvement activity, the following questions should be addressed in order:
Does the activity involve research (45 CFR 46.102(l));
(l) Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Does the research activity involve human subjects (45 CFR 46.102(e)910); (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Does the human subjects research qualify for an exemption (45 CFR 46.104(b)); and
Is the non-exempt human subjects research conducted or supported by HHS or otherwise covered by an applicable FWA approved by OHRP.
For those quality improvement activities that are subject to these regulations, the regulations provide great flexibility in how the regulated community can comply. Other laws or regulations may apply to quality improvement activities independent of whether the HHS regulations for the protection of human subjects in research apply.
IRB Guidance on Obtaining Letters of Permission
Investigators are responsible for ensuring that both research and quality improvement (QI) projects receive adequate permission from each institution in which research will occur, in accordance with that institution’s policies and procedures. Normally, this requires identifying the individual or entity with sufficient authority to grant permission for research to take place in the institution. Investigators should also be aware that IRB approval means that the research plans meet the requirements of federal regulations and St. Scholastica’s policies governing human subjects research. IRB approval in no way implies or guarantees that permission from other institutions will be granted.
What is a Letter of Permission?
A Letter of Permission is a letter of support or statement from the authorized official to act on behalf of that site which outlines their support of the research activities proposed in the IRB application. Letters of Permission are most typically required for sites where access would be considered “private” and not open for public use. Letters of Permission must be obtained from the site’s authorized official prior to IRB approval.
What is the purpose of a Letter of Permission?
The purpose of the Letter of Permission is to provide the IRB with documentation that the site is aware of the study activities and has agreed to the plan for carrying out those activities.
When is a Letter of Permission needed?
In the absence of documentation from another IRB or ethics committee at the site of recruitment or for data use, a Letter of Permission and/or other supplemental documentation may be needed from the site. The College of St. Scholastica IRB requires that investigators provide this documentation within their research application prior to approval to ensure that appropriate safeguards are in place, that the study is feasible, or the research plan is culturally appropriate.
Examples of external sites without IRBs where permission may be needed include, but are not limited to:
- Schools/educational departments
- Medical offices or clinics
- Private companies, Non-Profits, or Non-Government Organizations
- Religious institutions
- Federal, state, or local governance institutions or offices
- Closed/private social media groups
- Tribes - Tribal Council Resolutions may be issued for research involving Tribal populations
- Other universities
Is a Letter of Permission needed if my project is occurring at The College of St. Scholastica and not an external site?
Depending on the study recruitment or procedure methods, it is possible that permission from the specific department, college, or administration is needed. For example, researchers wishing to analyze specific institutional data will need permission from the Office of Institutional Effectiveness.
Who writes and signs Letters of Permission?
Letters of Permission should come from an individual in a position of authority to provide permission for using that site, or data, at the requested level of access. The Letter of Permission cannot come from a member of the study team, or from anyone who may have a conflict of interest relative to the study.
What is the format for a Letter of Permission?
A Letter of Permission can be documented in a hard copy letter or by electronic mail (email) and must contain the address site, professional title and contact information of the person providing permission.
What should be in a Letter of Permission?
The letter should contain enough information to enable the IRB to assess whether the site understands and supports the study plan. See Page 4 for an example template. As applicable, common elements include:
- Address the letter to The College of St. Scholastica Institutional Review Board
- Title of research project
- Research procedures or resources that will be facilitated by or occur at the site
- Sent from an authorized official (i.e., school principal, site manager, director, owner)
- Written on institutional/departmental letterhead or sent from the institutional email account
- Title and contact information (phone, address, and email) of person providing permission
Depending on the site and the study population, additional information may be required, such as:
- Any explicit restrictions to agreement/permission by the site
- Essentia Health requires that permission to conduct research at their institution must be authorized by Kate Dean, Executive Director of the Essentia Institute of Rural Health and/or Deneice Kramer
- St. Luke’s Hospital requires that CSS DNP students obtain a letter of support/permission from the department they wish to conduct their research. Research at St. Luke’s Hospital contacts are Marilyn Odean, Whiteside Institute for Clinical Research Program Director at - Marilyn.odean@slhduluth.com or Kelly Emmons, St. Luke’s IRB Specialist at
- irb@slhduluth.com
- Confirmation that the approach to recruitment, the method and timing for obtaining consent, and data collection activities are appropriate for the setting and the study participants
- Confirmation that additional local review is not required, and other local requirements have been met
- Confirmation that the research plan does not expose study participants to unnecessary risk
- Other stipulations as required by the site, such as requests to review research findings
CSS IRB Letter of Permission Template
See below template for a sample Letter of Permission; edit as appropriate for your project.
[INSTITUTIONAL/DEPARTMENTAL LETTERHEAD]
DATE
DEPARTMENT
SITE NAME
ADDRESS
To The College of St. Scholastica Institutional Review Board (IRB):
I am writing this letter at the request of [Research or Quality Improvement Investigator’s Name] to confirm that we support their research or quality improvement project, [“Title”].
I am aware that the project involves [list procedures, participants, and/or resources that will be facilitated by or occur at the site]. I am aware that the project involves [list benefits and risks]. I have
been provided with a summary of the proposed study and will support the project under the
proposed guidelines put forth in the College of St. Scholastica’s IRB application [for a specified time frame; etc.].
If any unanticipated problems or adverse events occur, it is up to [ Investigator’s name] to report these events to the College of St. Scholastica’s IRB as promptly as possible.
This project will be a valuable contribution to [area of study/goal of study] and we will be happy to support this endeavor.
Sincerely,
[Authorized official, school principal, site manager, department head,director, owner, etc.]
[Title]
[Email and or phone contact information]
Modified from Ferris State University IRB https://www.ferris.edu/administration/academicaffairs/vpoffice/IRB/IRBGuidanceObtainingSitePermissi on.pdf