Is It Research?

This guidance is intended to provide researchers and staff at Fred Hutch examples of different types of projects that may or may not constitute research under the federal Common Rule.^[1] For help deciding whether your specific project is research, use this guidance and the Research Assessment Form. Research projects generally must be submitted for IRB review. Human Research Protection Regulations and the Fred Hutch Human Research Protection Program do not require that non-research activities receive IRB review and approval, or a determination of exempt status.

Investigators whose primary appointment is with another institution should contact their institution’s IRB for assistance regarding specific projects.

For questions about whether a project is research under FDA regulations, please visit Clinical Research Support's Regulatory Requirements page. 

The definition of research states that the activity is designed to develop or contribute to generalizable knowledge. This is different from whether or not the activity actually does produce generalizable knowledge.

There is no reference to size or scale in the definition. Non-research projects can be very large in size and scale; research projects may be very small in size and scale.

Federal regulatory guidance states that the intent to publish or present results is not an appropriate standard for determining whether an activity involves research. Projects that do not meet the definition of research often publish descriptions of non-research activities for a variety of reasons. For example, the authors may believe that others may be interested in learning about those non-research activities (such as a case report). Conversely, an activity may involve research even if there is no intent to publish the results.

Types of Activities

Case Reports

Case reports are usually considered to contribute to generalizable knowledge, and may therefore meet the Common Rule definition of research, if they involve more than three cases. A case report involving three or fewer patients is not considered research as long as it does not involve the use of a drug or device that is subject to FDA regulations.

Preliminary Activities (pilot, feasibility, exploratory, developmental work)

Preliminary activities are small-scale activities intended to assess and refine the study plan or aspects of the study plan (e.g., design, method, instrument) prior to performance of a larger study. These activities are generally considered research because they involve research development, testing, and evaluation activities that will affect a larger systematic investigation that is designed to develop or contribute to generalizable knowledge.

Occasionally, preliminary activities do not meet the definition of research because they are not part of a systematic investigation. For example:

• Going to a potential site to see if the research is possible
• Going through a consent process with friends to see if the information is comprehensible
• Sending your new survey to a few experts in the field for their feedback as to whether or not the questions are appropriate for the topic and/or study population
• Obtaining feedback from colleagues and peers about research design
• Consulting a community advisory board (for example, a tribal group) about what you propose to study and/or how best to conduct your study

Scholarly and Journalistic Activities

Scholarly and journalistic activities, including the collection and use of information, are not considered research when they focus directly on the specific individuals about whom the information is collected. This includes: oral history, journalism, biography, literary criticism, legal research, and historical scholarship. [45 CFR 46.102(l)(1)]

These types of activities as performed in anthropology or sociology are likely to be considered research as defined by the human subjects regulations if they focus more broadly than just the specific individuals about whom the information is collected. For example, it is considered to be research when studies use methods such as participant observation and ethnographic studies to gather information from individuals in order to understand their beliefs, customs, and practices, and the findings are applied to the studied community or group and not just the individuals from whom the information was collected.

Public Health Surveillance Activities

Public health surveillance activities, including the collection and testing of information or biospecimens, are not considered research when:

• They are conducted, supported, requested, ordered, required, or authorized by a public health authority, AND
• The 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 may 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). [45 CFR 46.201(l)(2)]

The following activities are considered to meet the definition of research:

• Subsequent research using information collected from public health surveillance activities
• Exploratory studies designed to better understand risk factors for chronic diseases (including genetic predisposition)
• Exploratory studies designed to elucidate the relationships between biomarkers of exposure and biomarkers of disease
• Exploratory studies of potential relationships between behavioral factors (e.g., diet) and indicators of environmental exposures

Criminal Justice and National Security Activities

Activities that exclusively involve the 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 are not considered research.

Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions are not considered research. [45 CFR 46.102(l)(3)-(4)]

Quality Assurance and Quality Improvement Activities

Quality assurance or quality improvement projects designed to measure, evaluate and/or improve performance or patient care in a clinical area or department that are not designed to contribute to generalizable knowledge.

These refer to projects usually designed to measure, evaluate and/or improve performance or patient care in a clinical area or department that are NOT designed to contribute to generalizable knowledge.

The question to consider: Is this QA/QI activity also research? Many activities are both research and something else (such as quality improvement).

Not Research Examples

• Quality improvement activities conducted by one or more institutions whose 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. Examples of such activities include:
  • A radiology clinic uses a database to help monitor and forecast radiation dosimetry. This practice has been demonstrated to reduce over-exposure incidents in patients having multiple procedures. Patient data are collected from medical records and entered into the database. The database is later analyzed to determine if over-exposures have decreased as expected.
  • A group of affiliated hospitals implements a procedure known to reduce pharmacy prescription error rates, and collects prescription information from medical charts to assess adherence to the procedure and determine whether medication error rates have decreased as expected.
  • A clinic increasingly utilized by geriatric patients implements a widely accepted capacity assessment as part of routine standard of care in order to identify patients requiring special services and staff expertise. The clinic expects to audit patient charts in order to see if the assessments are performed with appropriate patients, and will implement additional in-service training of clinic staff regarding the use of the capacity assessment in geriatric patients if it finds that the assessments are not being administered routinely.
• Activities related to (a) delivering healthcare, and (b) measuring and reporting provider performance data for clinical, practical, or administrative uses. Examples of such activities include:
  • Helping the public make more informed choices regarding health care providers by gathering and communicating data regarding physician-specific surgical recovery data or infection rates.
  • Practical or administrative uses of such data to enable insurance companies or health maintenance organizations to make higher performing sites preferred providers, or to allow other third parties to create incentives rewarding better performance.^[2]
• Activities that are not related to delivery of patient care, but rather evaluate the delivery or quality of other public benefit or social services. For example, institutions and other entities may provide social services, educational offerings, or other beneficial activities where there is empirical evidence of the value of those efforts, and they may wish to evaluate different ways of enhancing the delivery or quality of those existing services. The evaluation would be considered QA/QI and not research.^[3]
• A randomized study in which half the participating institutions would be assigned to have the staff undergo an educational intervention about the need to use an accepted practice, and the other half would not undergo that intervention, would not be research because it would only be intended to see if the intervention resulted in greater use of the accepted practice in the participating institutions. If the intent were to generalize about this intervention beyond this setting, it would be research.

Research Examples

• A project that introduces a clinical intervention for the purpose of improving the quality of care and also collects information about patient outcomes for the purpose of establishing scientific evidence to determine how well the intervention achieves its intended results.^[4]
• Quality improvement activities designed to assess the safety and efficacy of the accepted practice. Examples of such activities include:
  • Assigning patients to different versions of treatments that are within the standard of care in order to evaluate differences between those treatments in terms of effectiveness or risks
  • Assigning students to experimental and control groups to determine the effectiveness of experimental teaching methodologies^[5]
• Studies designed to determine whether a particular weight loss mobile application is or is not more effective than another.

Program Evaluation

This means data collection and analysis, including the use of biospecimens, for an institution’s own internal operational monitoring and program improvement purposes.^[6]

The question to consider: Is this program evaluation activity also research? Many activities are both research and something else (such as program evaluation).

Not Research Examples

• Activities designed for various administrative purposes related to using information only to improve the quality of services provided by a specific program.
• Focus groups, surveys or interviews with faculty or students intended only to evaluate and improve programs or services provided by the institution or to assess its needs.

^[1] The Federal Policy for the Protection of Human Subjects, known as the “Common Rule” because it is adopted into regulation by a large number of federal departments and agencies. See 45 CFR 46 subpart A for the HHS regulations. Note, the FDA has not adopted the Common Rule, so this guidance does not apply to FDA-regulated research.

^[2] OHRP Guidance: Quality Improvement Activities FAQs

^[3] Department of Health and Human Services, Notice of Proposed Rulemaking, “Federal Policy for the Protection of Human Subjects”. Federal Register volume 80, number 173; September 8, 2015; pp. 53948-49

^[4] OHRP Guidance: Quality Improvement Activities FAQs

^[5] Department of Health and Human Services, Notice of Proposed Rulemaking, “Federal Policy for the Protection of Human Subjects”. Federal Register volume 80, number 173; September 8, 2015; pp. 53948-49

^[6] Department of Health and Human Services, Notice of Proposed Rulemaking, “Federal Policy for the Protection of Human Subjects”. Federal Register volume 80, number 173; September 8, 2015; pp. 54045