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.