507. New Projects that May or May Not Be Human Research

Updated January 26, 2023

Determinations about whether a project requires Research Integrity or IRB oversight are not always straightforward. The following explanations and examples for types of projects that commonly raise questions about the type of oversight required may be useful in making such determinations. Because investigators sometimes require a formal determination from the IRB that their project is either, not research, or does not involve human participants (e.g., dissertation committee requirements), investigators may submit a Human Research Determination form. Regardless of the form submitted by the investigator, the IRB reviewer may make the determination that a project does not involve human participants. The IRB will not provide a formal written determination after the project has been initiated.

FDA Regulations

The IRB reviewer refers to 21 CFR 50.1 (a) for a definition of the scope of clinical investigations regulated by the U.S. Food and Drug Administration. Activities that meet any of the following criteria do not qualify for the "Not Human Research” designation."

• Any use of a drug or medical device not approved by the FDA, regardless of the presence of an IND or IDE.
• Any use of a drug in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved drug in the course of medical practice.
• Any use of a medical device in any manner (even if approved and even if used in an activity which does not meet the DHHS definition of research) other than the use of an FDA approved medical device in the course of medical practice.
• Any use of an FDA regulated item in which the data will be submitted to or held for inspection by FDA.

Department of Justice

When conducting research within the Bureau of Prisons, Department of Justice, implementation of Bureau programmatic or operational initiatives made through pilot projects is not considered to be research.

Research Practicums and Research Methods Classes and Human Research Protection Requirements

University colleges and departments may offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these courses is to train students, and provide them with experiences in social, educational, or psychological processes and research methods.

Examples of Student Projects that Do Not Constitute Human Research

• Projects involving public information obtained from newspapers or magazines, or websites that are open to the public (e.g., US Census data).
• Projects involving contact with individuals and the collection of identifiable information (e.g., names, addresses) but the findings will ONLY be used for the class.

Examples of Student Projects that May Constitute Human Research

• Information is obtained from venues participants may consider private (e.g., chat rooms, list-serves, password-protected websites) and the student initiating the project records identifiers or interacts with participants (e.g., asks questions and records responses; posts a survey).
• The student initiating the project interacts with individuals (including via survey or interview), may or may not collect private information, and plans to use the findings outside of the class (e.g., presentations at conferences, publication in newsletters or professional journals).

Humanities Projects and Human Research Protection Requirements

Humanities projects (e.g., ethnographic research) that meet the federal definitions for research AND involve human participants require exempt or IRB review. Not all humanities projects meet both definitions. Humanities projects may be considered human research and require exempt or IRB review when the purpose is to create a broader understanding of a particular environment, population group, or personal characteristic; or these receive Federal funding and the agency plans to generalize findings across sites (e.g., US Department of Health and Human Services, National Science Foundation, US Department of Education including the Fulbright program).

Examples of Humanities Projects that Do Not Constitute Human Research

• A project to collect and compare and contrast policies and procedures to identify commonalities among private businesses when the questions do not relate to respondents' involvement, opinions, or compliance with the policies/procedures.
• Leaders of an organization conduct audiotaped interviews with employees to identify how operational procedures could be changed to improve productivity for the sole purpose of internal review and improvements.

Examples of Humanities Projects that May Constitute Human Research

• A study of a single event involving interviews of affected parties when participants' responses are analyzed to draw conclusions about a population's general reactions.
• Researchers collect information from records kept by a private gym that include income, timeliness of payments, history of injuries; and clients' names, telephone numbers, home addresses to describe the population of gym members.

Scholarly and Journalistic Activities and Human Research Protection Requirements

Scholarly and journalistic activities is the collection and use of information that focus directly on the specific individuals about whom the information is collected, e.g. oral history, journalism, biography, literary criticism, legal research and historical scholarship. Oral history is a technique in which the researcher conducts a series of interviews with individuals or groups of people about a particular historical event or period. Often, the intention is to convey historical insight rather than to present conclusions about the event or confirm a hypothesis.

Oral History Projects that Do Not Constitute Human Research

Oral history video recording of interviews with Holocaust survivors is created for viewing in the Holocaust Museum. The creation of the videotape is not intended to prove a hypothesis, inform policy, or draw conclusions. The sole purpose is to create an historical record of specific personal events and experiences related to the Holocaust and provide a venue for Holocaust survivors to tell their stories.

Oral History Projects that May Constitute Human Research

• Open-ended interviews are conducted with surviving Gulf War veterans to document their experiences and to draw conclusions about those experiences, inform policy, and generalize findings.
• Open-ended interviews are conducted with surviving Negro Baseball League players to create an archive for others to analyze and generalize findings in the future. Since the intent of the archive is to create a repository of information for others to use in research, the creation of such an archive would constitute research.

Case Reports and Human Research Protection Requirements

University or affiliate faculty or staff may, in the course of their professional activities, summarize clinical data (i.e., prepare a case report) to be used for medical or instructional purposes.

• A "case report" is a detailed description of a one (or more) cases of a disease, usually with an unexpected presentation, which generally include the findings, clinical course, and prognosis of each case.
• If the report includes three or more cases in the analysis, the practitioner is advised to contact RI to determine if oversight or IRB review is required.
• If in addition to the presentation of factual content, general conclusions are drawn, the activity may constitute "research."
• The use of protected health information to prepare a case report may not require IRB review, but the author of a case report must comply with HIPAA.

Case Reports that Do Not Constitute Human Research

Information about a single individual is collected to describe or document her/his/their situation, experience, or condition. If no conclusions are drawn, the activity is not research.

Case Reports that May Constitute Human Research

• Information is compiled from multiple case reports to formulate a hypothesis or arrive at general conclusions about a condition or outcomes.
• Information that would not ordinarily be collected is obtained for the purpose of reporting or publishing the case.

Innovative Practice and Human Research Protection Requirements

University and affiliate faculty or staff may employ innovative or newly-introduced clinical procedures or therapies to enhance the well-being of an individual patient or client. Whether or not IRB review is required depends on the reasons the new practice is implemented. Experiments involving one or more human participants and a test article that is regulated by the FDA or that requires marketing approval by the FDA require IRB review and approval.

Innovative Practice that Does Not Constitute Human Research

Innovative clinical practice with a reasonable expectation of success is used solely for diagnosis, preventative treatment, or therapy for a particular individual.

Innovative Practice that May Constitute Human Research

A project that involves testing an innovative procedure for the purpose of generating and disseminating knowledge about the effectiveness of the procedure.

Standard Diagnostic, Therapeutic, and Instructional Procedures and Human Research Protection Requirements

University and affiliate faculty or staff may employ standard, accepted diagnostic, therapeutic, and instructional procedures for the benefit of individual patients, clients, or students as long as information about individual responses is not collected for dissemination outside of clinical or educational settings.

Standard Practice that Does Not Constitute Human Research

• Standard treatment is provided for a particular individual and the individual's response to the treatment is noted in the clinical record.
• Standard educational practices are used in a classroom setting. The teacher records and uses outcome information to revise the curriculum.

Standard Practice that May Constitute Human Research

Participants are assigned to receive either standard or experimental treatment and information about participant outcomes is collected.

Program Evaluations and Needs Assessments and Human Research Protection Requirements

Program evaluations and needs assessments involve the systematic collection and analysis of information about the effectiveness of an existing program or the needs of a community or population, respectively. Information may be obtained through interactions among researchers or consultants, and program staff or participants (e.g., pre-post-tests, interviews, and collection and analysis of background information).

Program evaluations involve the assessment of the processes and outcomes of a program with the intent of furthering the program's development and improvement.  The process is collaborative and client-focused in that evaluators work closely with program staff to create and implement an evaluation design that is responsive to the needs of the program.

Needs assessments involve the collection of information about a community or population to identify gaps between current and desired conditions (i.e., difference between "what is" and "what should be").

Both processes are as rigorous and systematic as traditional social science research, and may involve qualitative and quantitative data collection methods used by researchers.  However, the primary purpose of program evaluations and needs assessments is to provide timely and constructive information for decision-making about a particular program or community, not to advance more wide-ranging knowledge or theory.

Program Evaluations or Needs Assessments that Do Not Constitute Human Research

• Program evaluations that are designed solely for internal assessment of a program to improve program effectiveness or inform decisions about future programs.
• Program evaluations that are designed to provide information about program effectiveness for program providers or sponsoring agency.
• Needs assessments that are used solely by the entity collecting the information to guide program development.

Program Evaluations or Needs Assessments that May Constitute Human Research

• Program evaluations that involve the collection of data about program effectiveness to make general recommendations for providing similar programs or to confirm a hypothesis may be considered human research, if these involve interaction with participants or the collection of identifiable information.
• The collection of information that may be used to describe the needs of populations or communities in general may constitute human research if these involve interaction with participants or the collection of identifiable information.

Quality Assurance and Quality Improvement (QA/QI) Projects and Human Research Protection Requirements

Precise definitions to permit the distinction between research studies and QA/QI projects have not been established. The purpose of QA/QI projects is to improve patient care within a given patient care environment (e.g., hospital or health care organization) and project outcomes are not likely to be generalizable to other patient care environments. Publication of a quality assurance project does not, per se, categorize that project as research.

QA/QI Projects that Do Not Constitute Human Research

• A radiology clinic collects patient information from medical records to monitor and forecast radiation dosimetry, a practice that has been shown to reduce over-exposure incidents in patients having multiple procedures, 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 will audit patient charts 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.

QA/QI Projects that May Constitute Human Research

A project that involves an untested clinical intervention to improve the quality of care but includes the collection of patient outcome data to establish scientific evidence about the efficacy of intervention.

Public Health Surveillance or Investigative Purposes that Does Not Constitute Human Research

• 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.
• 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.
• Collection and analysis of information, biospecimens or records in support of intelligence, homeland security, defense or other national security missions.

Pilot Projects

The regulations for the protection of human research participants do not make a distinction on whether a research project is a pilot or a more advanced project. If a project meets the definition of research, regardless of whether it is referred as pilot or otherwise, the project is considered research. Generally, if the project has a question (or a hypothesis), a systematic way to answer the question, and ultimately leads to generalizable knowledge, then this project is research. A pilot project that serves to inform how a subsequent more developed research project needs to proceed is contributing to generalizable knowledge.

To determine whether or not a project meets the definition of human research (and therefore requires prior IRB approval or an exempt determination), the following questions should be asked in the order presented:

1. Is the activity Research?
2. Is the research Human Subjects Research?

Projects that meet the definition of research and involve human subjects must be approved or determined exempt by the IRB prior to implementation.

Determination that an activity IS NOT Human Research

After reviewing the protocol submission, the IRB reviewer documents his/her/their determination in the IRB application.

The Principal Investigator of the activity is notified of IRB designation of "not human research" in the IRB application. The determination letter specifies at a minimum:

• concurrence that the project does not meet either the definition of "research" as defined at 45 CFR 46.102(l) or 21 CFR 56.102(c); or the definition of "human subject" at 45 CFR 46.102(e)(1) or 21 CFR 56.102(e); and
• that the IRB should be notified in advance of any proposed substantive modifications of the activity.

Determination that an activity IS Human Research

The IRB Reviewer may determine that the proposed activity is human research because it meets the DHHS definition of research (45 CFR 46.102(l)) and involves individuals who meet the definition of human subject (45 CFR 46.102(e)(1)); or meets the FDA definition of clinical investigation as described above.

For activities determined by the IRB Reviewer to meet either the DHHS or FDA definition of human research, the Principal Investigator is advised to resubmit the research for exempt, expedited or full-board IRB review, as appropriate.