definition of a research program

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IRB FAQs – Basic Definitions

What is the definition of research?

Federal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46).” Activities that meet this definition constitute research, even if 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.

The regulations provide examples of activities which are deemed  not  to be research:

• 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 focuses 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, bio-specimens, 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 natural security missions.

As described in the Belmont Report, “…the term ‘research’ designates an activity designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.” So, a key aspect of research is that there will be a systematic design in advance, generally utilizing a scientific approach or protocol, for the defined purpose of contributing to generalizable knowledge.

A wide range of activities (e.g. experiments, observational studies, surveys, tests, and recording) may include or constitute research in circumstances where there is a clear advance intent to contribute to generalizable knowledge with a scientific protocol.

How is “generalizable knowledge” defined at ECU?

Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, assist in informing others about policy decisions or changes, or generalize findings beyond a single individual or an internal program (e.g., collaborations, publications or presentations.). However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to “generalizable (scholarly) knowledge,” – adding to a body of existing knowledge or creating a new body of knowledge – still falls under the definition of research. Research that is never published is still research. Participants in human research studies deserve protection whether or not the research is published.

Generalizable knowledge is not limited to quantitative studies designed to produce generalizations. Qualitative studies may also contribute to generalizable knowledge through the use of focus groups, case studies, ethnographies, interviews, or other means to identify general themes that others can choose to transfer to another situation

Examples of activities that typically are not generalizable include:

• Biographies;
• Oral histories that are designed solely to create a record of specific historical events;
• Service or course evaluations, unless they can be generalized to other individuals, departments, or institutions;
• Services, courses, or concepts where it is not the intention to share the results beyond the ECU community;
• Classroom exercises solely to fulfill course requirements or to train students in the use of particular methods or devices; and
• Quality assurance activities designed to continuously improve the quality or performance of a department or program where it is not the intention to share the results beyond the ECU community.

What is the definition of a principal investigator?

It is the scientist or scholar with primary responsibility for the design and conduct of a research project, including preparation of the proposal or research protocol.

Upon what are the regulations based for protecting humans participating in research?

In 1974, the National Research Act was signed into law. This law included the creation of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This commission was charged with developing guidelines that should be followed to assure that research involving humans met basic ethical principles. These principles of “respect for persons,” “beneficence,” and “justice” are the underlying principles of the regulations that now govern the use of humans in research. A full copy of the Belmont Report , which lists the charge the commission was given and the results of their efforts can be found online.

What is the definition of respect for persons?

Respect for persons is an ethical principal requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

What is the definition of beneficence?

Beneficence is an ethical principle that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules:

• Do no harm; and
• Protect from harm by maximizing anticipated benefits and minimizing possible risks of harm.

What is the definition of justice?

Justice is an ethical principle requiring fairness in the distribution of burdens and benefits. It is often expressed in terms of treating persons of similar circumstances or characteristics similarly.

Human Research Protection Program

IRBs, Quality, Compliance, and Reliance

Research vs. Quality Improvement and Program Evaluation

Determining whether a project constitutes human subjects research rather than quality improvement or program evaluation involves multiple factors. The federal definition of research is “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.” This is an important distinction to make because it determines whether IRB review and oversight of a project is needed because IRB oversight is limited to human subjects research.

The IRBs Office is frequently asked to make a formal determination that a project falls outside of the federal definition of research. Often, IRB review of these projects isn’t required; however, formal IRB determinations that the projects do not require IRB oversight are requested in anticipation of such documentation being required for journals, conferences, funding sources and others.

The materials below are intended to assist study teams in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. To address the issue of documentation, the IRBs Office also has developed a tool that can provide self-certification that the project does not require IRB review and oversight.

IRB QI/Program Evaluation Self-Certification Tool

This tool allows study teams to make the decision about whether their project constitutes the definition of research under the Common Rule (45 CFR 46) independent of the IRB. The tool is designed to help determine whether the project constitutes research or whether it is quality improvement or program evaluation, such that IRB review isn’t required.

NOTE: This tool is not designed to determine all of the cases when a project falls outside of the IRB’s purview. This tool is only for determining if a project is QI/Program Evaluation, rather than research. The tool should not be used for public health surveillance projects, as these projects require consultation with the IRBs Office Director. The IRBs Office has additional resources that can help determine the need for IRB review based on inclusion of human subjects, as well as qualification for exemption.

For assistance answering the questions in the IRB QI\Program Evaluation Self-Certification Tool, please review the following resources:

• QI\Program Evaluation Self-Certification Tool Guidance This guidance outlines how to complete the Self-Certification Tool with a breakdown of each question.
• IRB QI\Program Evaluation Decision Tree This Decision tree provides an additional resource for assistance in determining whether a project constitutes human subjects research (and subsequently requires IRB review) or quality improvement\program evaluation. The decision tree forms the basis for the questions in the IRB QI\Program Evaluation Self-Certification Tool (see above), but it does not provide a certification upon completion.
• Characteristics of Research, Quality Improvement and Program Evaluation Activities This table is intended to help in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected. Please contact the IRBs Office with any questions or for assistance in making a determination.

Please note, HIPAA Privacy and Security Rule Regulations may still apply to your project even though IRB review isn’t required. If you have questions or concerns about IRB review requirements after reviewing the above materials, please contact the IRBs Office for additional assistance.

Definitions

ORI  Introduction  to RCR: Chapter 3. The Protection of Human Subjects

Researchers are responsible for obtaining appropriate approval before conducting research involving human subjects. The need for approval rests on three seemingly obvious but not always easy-to-interpret considerations: 1) whether the work qualifies as research, 2) whether it involves human subjects, and 3) whether it is exempt. All three considerations are discussed in the Common Rule and guide decision making about the use of human subjects in research. The authority to make decisions about the need for approval rests with the Institutional Review Board (IRB, discussed below) or other appropriate institutional officials.

Research. The Common Rule defines research as “systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§ 46.102(d), see box, next page, for full definition). This means that a project or study is research if it:

• is conducted with the intention of drawing conclusions that have some general applicability and
• uses a commonly accepted scientific method.

The random collection of information about individuals that has no general applicability is not research. Scientific investigation that leads to generalizable knowledge is.

Human subjects. Human subjects are “living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information” (§ 46.102(f), see box, next page, for full definition). Humans are considered subjects and covered by Federal regulations if the researcher:

• interacts or intervenes directly with them, or
• collects identifiable private information.

If one of these two conditions applies and if the project or study qualifies as research, then institutional approval is needed before any work is undertaken.

Exempt research. Some studies that involve humans may be exempt from the requirements in the Federal regulations. Studies that fall into the following categories could qualify for exemptions, including:

• research conducted in established or commonly accepted educational settings;
• research involving the use of educational tests;
• research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if unidentifiable or publicly available;
• research and demonstration projects which are conducted by or subject to the approval of department or agency heads; or
• taste and food quality evaluation and consumer acceptance studies.

It is critically important to note, however, that decisions about whether studies are exempt from the requirements of the Common Rule must be made by an IRB or an appropriate institutional official and not by the investigator.

45 CFR 46.102

Email Updates

Human Subjects Division

• [email protected]
• 206.543.0098

Step 1. Is Your Project Considered Research?

If your research involves institutions or researchers other than, or in addition to UW, please consider steps 1-4 before making a decision about whether to submit an application.

Why this matters

• If your activity doesn’t fit one of the definitions of research (below), you do not need to obtain Institutional Review Board (IRB) approval or a determination of exempt status.
• The specific definition (if any) that applies to your activity determines which regulations and requirements govern your research. Use the worksheet, Human Subjects Research Determination to make your own determination about whether your activity meets either of the two definitions described here.

Two definitions of “research”

Definition 1: fda-regulated research.

Applies to: Activities that are regulated by the Food and Drug Administration (FDA) and that involve the use of a drug, device, or other item regulated by the FDA.

The activity is research if both of the following conditions are met:

• The intent of the activity is to develop information about a drug, medical device (including diagnostic tests), or biologic substance for submission to the federal Food and Drug Administration (FDA), and
• The activity involves the prospective physical use of drug, medical device (including diagnostic tests), or biologic substance, in a way that is not completely up to the discretion of a clinical practitioner.

Definition 2: Research that is not regulated by the FDA

Applies to: All activities that are not described in Definition 1.

Research is a systematic investigation , including research development, testing, and/or evaluation, designed to develop or contribute to generalizable knowledge .

Systematic investigation : A detailed or careful examination that has or involves a prospectively identified approach to the activity based on a system, method, or plan.

Generalizable knowledge : The information is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

• Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied
• Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.

Special cases

Activities can be considered research even if they are also considered to be program evaluation, quality improvement, public health surveillance, preliminary work, or pilot studies. For more information about these and other special situations, consult the HSD guidance, Is It Research ?

Request a determination (optional)

Follow these directions if you’d like to have a formal determination about whether your activity is research. Example situations for which a determination might be appropriate: (1) you need a determination in order to obtain or access data from a source; (2) you think you might need a determination later when you publish results; (3) you have a complicated project.

• Complete the questions marked “Determination” on the standard IRB Protocol form or on the No Contact version of the form.
• In Zipline , create a new application by clicking on the Create a New Study button and following the instructions. Attach your completed IRB Protocol form at the indicated place. Do not attach any consent materials.
• HSD will assess your application and issue a formal determination.

Next step, if you think your activity is research

Determine whether your activity involves human subjects.

More information

• Contact your HSD Team or send an email to [email protected] if you have questions or want guidance. Identify your department in your email.
• WORKSHEET Human Subjects Research Determination
• GUIDANCE Is It Research?
• GUIDANCE Case Reports, IRB Review and HIPAA

University of Washington Office of Research

Or support offices.

• Human Subjects Division (HSD)
• Office of Animal Welfare (OAW)
• Office of Research (OR)
• Office of Research Information Services (ORIS)
• Office of Sponsored Programs (OSP)

OR Research Units

• Applied Physics Laboratory (APL-UW)
• WA National Primate Research Center (WaNPRC)

Research Partner Offices

• Corporate and Foundation Relations (CFR)
• Enivronmental Health and Safety (EH&S)
• Grant and Contract Accounting (GCA)
• Institute of Translational Health Sciences (ITHS)
• Management Accounting and Analysis (MAA)
• Post Award Fiscal Compliance (PAFC)

Collaboration

• Centers and Institutes
• Collaborative Proposal Development Resources
• Research Fact Sheet
• Stats and Rankings
• Honors and Awards
• Office of Research

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Example sentences research programme

That was the beginning of a major research programme examining the impact of chemicals on wildlife.

A poor performance can mean funding cuts, even an end to a faculty's research programme .

Any sharks he boats will be tagged and released as part of a research programme into the fearsome predators.

However, many trusts have freezes on staff recruitment, and existing staff cannot be spared for the research programme .

The applied research programme provides grants of up to 500,000, which you would have to match yourself.

Definition of 'programme' programme

Definition of 'research' research

Cobuild collocations research programme.

Browse alphabetically research programme

• research participants
• research priorities
• research program
• research programme
• research project
• research publication
• research quantum
• All ENGLISH words that begin with 'R'

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“A systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”

Let's break this down....

A systematic investigation involves a methodical procedure and plan, is theoretically grounded, and specifies a focused and well-defined research problem or question, is informed by the empirical findings of others, is analytically robust, and provides a detailed and complete description of data collection methods.

Generalizable knowledge is information that is expected to expand the knowledge base of a scientific discipline or other scholarly field of study and yield one or both of the following:

• Results that are applicable to a larger population beyond the site of data collection or the specific subjects studied.
• Results that are intended to be used to develop, test, or support theories, principles, and statements of relationships, or to inform policy beyond the study.
• Note that publication or other dissemination of findings does not in and of itself make the activity “research”. It has been a long-standing myth that if you publish, IRB review is required.

What isn't generalizable?

• A quality assurance/quality improvement/organizational effectiveness study where the intent is to assess, improve, or develop programs or services for an organization. Outcomes will remain specific to the organization, programs or services, although other organizations may use the results for their own programs.
• An oral history or journalistic piece . These are published materials that are limited to only documenting or reporting on events, situations, policies, institutions, or systems without the intent to form hypotheses, draw conclusions, or generalize findings. It will not involve stories that will or may draw broad conclusions about the population, cultures, norms, and practices.
• A note about class/educational “research” activities – Class projects and research methods classes may involve data collection activities for training purposes that do not require IRB review and oversight because the intent is to teach methods, not to contribute to generalizable knowledge. The intent of other class projects may be to provide the student with real world experiences, information gathering techniques, and report writing. However, when the primary focus and initial intent of the class activities are to collect data to be used by students or other researchers beyond the classroom thereby contributing to “generalizable knowledge,” IRB review may be needed.
• A note about student internships – Students within many departments or schools of the University are involved in internships or practica. Some student practica/internships may include research activities that are designed to contribute to generalizable knowledge and, thus, involve research that requires IRB review.
• It should be noted that even though a research activity may not qualify as "regulated research" now, this does not mean that you may not use these data for future "regulated research" activities. The use of data that was initially collected for non-research purposes is known as “secondary use of data not initially collected for research”.