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Not Human Subjects Research (NHSR)

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The Research Compliance Office and Institutional Review Board (IRB) are responsible for oversight of all research activities involving human subjects. 

Activities that do Not Constitute 'Research'

Under the federal Common Rule, “research”, "means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

In addition, the FDA has separate definitions for what constitutes research and therefore, if your project includes use of a drug, device or biologic, it may be subject to FDA regulations and require IRB review.

While some activities are typically outside the realm of research (e.g. operational activities such as defined practice activities in public health and medicine, or internal management activities such as quality improvement, quality assessment and program evaluation), some of these activities may constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge. Often, determining whether a project constitutes research under federal and institutional regulations can be a complex process that involves assessing the project intent, design, mandates, expected outcomes, and dissemination of results.

If you believe your project does not constitute human subjects research, but are required by policy or a publisher to obtain a determination, this application type is appropriate. If the project includes a research question/hypothesis, an intent to publish, present or contribute to generalizable knowledge, or the project would not be conducted in the same way or at all if there was no potential for publication/presentation, the project is most likely considered research and another application type required.

According to the new 2018 Common Rule Regulations, the following have been deemed to NOT be research and thus not requiring IRB review:

  • Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
  • Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
  • Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
  • Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Activities That do not Constitute 'Human Subjects'

Some projects may be "research" but do not involve human subjects as defined by the Common Rule.

  • A 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.
  • Intervention includes both physical procedures by which information or biospecimens are gathered (e.g.,venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
  • Interaction includes communication or interpersonal contact between investigator and subject.
  • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g.,a medical record).
  • Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen."

It is the institutions role is to oversee "research" involving "human subjects". As a result, studies that do not involve human subjects do not require oversight. Some examples of this type of research are straightforward and easy to determine, e.g. analyzing de-identified tissue samples obtained from a commercial source, or analyzing data from deceased individuals. However, it is often difficult to determine whether a study involves human subjects or not. For assistance with this, please see the NIH decision tree.

If you are required by policy, a funding agency, or a publisher to obtain an Institutional determination, please submit an application for this type of research.

QA/QI vs. Human Subjects Research

What is QA/QI?

There is no regulatory definition but often QA/QI is described as “systematic, data-guided activities designed to bring about immediate (or nearly immediate) improvements in health care delivery”, and the combined efforts of everyone to make changes that will potentially lead to better patient outcomes, better system performance, and better professional development. In medical institutions, QA/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.

Screening Checklist for QI Projects

QA/QI vs Research
Points to Consider Research QA/QI
Purpose To test a hypothesis or establish clinical practice standards where none are accepted To assess or promptly improve a process program or system; or improve performance as judged by accepted/established standards
Focus/Aims Aims to explore a hypothesis or theory in order to draw general conclusions beyond the scope of the institution The focus is local and specific, aiming to improve a particular institutional practice
Participants Results or data from participants may be generalized as being representative of the population at large Does not use participants as a representative sample of a broader population
Starting Point To answer a question or test a hypothesis To improve performance
Benefits Designed to contribute to generalizable knowledge and may or may not benefit subjects Designed to promptly benefit a process, program, or system and may or may not benefit patients
Risks/ Burdens May place subjects at risk and stated as such By design, does not increase patient’s risk, with exception of possible privacy/confidentiality concerns
Data Collection Systematic data collection Systematic data collection
End Point Answer a research question Promptly improve a program/process/system
Conclusions Conclusions are meant to be disseminated and applicable to people and institutions beyond the site where the project took place Conclusions are intended to only be directly applicable to the particular institution; no claim that the results apply outside the institution
Testing/ Analysis Statistically prove or disprove a hypothesis Compare a program/process/system to an established set of standards
Publication Publications and presentations aim to be applicable to the field more broadly.  For example, if a particular intervention in the research study led to better outcomes, a publication would generalize those findings and suggest that they are applicable to other institutions as well. Any publication or presentation on the project would still focus on the specific practice and improvement at the particular institution; it is only relevant to external institutions to the extent that they can draw their own conclusions about applicability at their institution

Activities conducted by one or more institutions whose primary 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

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.

QA/QI generally refers to a range of activities conducted to assess, analyze, critique, and improve current processes of health care delivery in an institutional setting. QA/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, nor do they impose more than minimal additional risks or burdens on patients.

  • ensuring new evidence-based interventions are incorporated into practice
  • improvement of over-all quality of life
  • reduction of morbidity and mortality
  • ensuring that patients receive evidence-based interventions for their particular 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
  • evaluating procedures no greater than minimal risk to patients
  • usual care practices, and interventions offered to all patients.

Quality Assessment and Improvement consist of systematic, data-guided activities to bring about prompt positive changes in the delivery of health care and involve deliberate actions to improve care. Depending on the activity, QA/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 QA/QI methods often means encouraging people in the clinical care setting 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.

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.

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 you are comparing the safety and/or effectiveness of a drug, or comparing a regulated device to another, you are engaged in a clinical investigation and must follow FDA regulations.

Yes. The following characteristics make it more likely that a project involves both QA/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.
  • 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.

No. An example of a QA/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).

The intent to publish is an ‘insufficient criterion’ for determining whether a quality improvement activity involves research, according to OHRP.

When QA/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.

Outside external funding may make a difference in distinguishing between QA/QI and research. An NIH research grant to support a project would often be considered research. Internal funding to improve a program may not.

Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes.  Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.  Ideally, the author of the article will obtain the signed authorization of the subject, or the subject’s legally authorized representative if the subject is deceased, to use the subject’s information in the article.  If it is not possible to obtain authorization, the author should be aware that one of the identifiers described by HIPAA as requiring written authorization is, “Any other unique identifying number, characteristic, or code….”  Moreover, HIPAA requires that, at the time of publication, “[t]he covered entity does not have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information.” 

  • Authors who remove HIPAA identifiers (including unique patient characteristics) from the data prior to submission and publication of the article do not need to obtain a signed privacy authorization. 
  • Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization.  This authorization does not need to be submitted to the IRB for review. 
  • If the author strips off all HIPAA identifiers, but the information associated with the subject of the article includes a “unique characteristic” which would make it identifiable to the subject, or the author has actual knowledge that the information about the subject could be used alone or in combination with other information to identify the subject, the author must contact the HIPAA Privacy Officer to discuss the required steps to take prior to publication.

Submit an application for Determination of Human Subjects Research and/or contact umkcirb@umkc.edu if you are still uncertain how to proceed.

Program Evaluation vs Research

Program evaluations are defined as:

Systematic collection of information about the activities, characteristics and outcomes of programs to make judgments about the program (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development.

Below are elements that are common to evaluation and research projects.  This list is not intended to be comprehensive and not all elements are required in order for a project to be considered research or evaluation.  Rather, this list of elements can be used to assist faculty in determining whether an activity involves research requiring IRB review.

Common Elements

Program Evaluation

Research

Assessment of how well a process, product, or program is working in a specific context

Aims to produce new knowledge to contribute to a broader societal endeavor

Focus on process, product, or program

Focus on population (human subjects)

Designed to improve a process, product, or program via:

  • needs assessment
  • process, outcome, or impact evaluation
  • cost-benefit or cost-effectiveness analyses

Same as at left, but adds procedures, component(s) or analyses aimed to generalize (e.g. combining data with other projects, randomization, expanded sites, literature review)

Assessment of program or product as it would exist regardless of the evaluation

May include an experimental or non-standard intervention

If publication results, has no impact on how the project is designed or analyzed

The desire to disseminate impacts the choice of procedures or analyses, in order to strengthen generalizability

Activity will rarely alter the timing or frequency of standard procedures

Standard procedures or normal activities may be altered by an experimental intervention

Directed and usually funded by the entity doing the program

May have external funding (note: some external funding is explicitly limited to non-research projects, which will in turn place limitations on scope of project and publications)