Not Human Subject Research (NHSR) Self-Determination

The UCI IRB allows NHSR Self-Determination (i.e., IRB review not required) for activities that are not research, or for research that does not involve a human subjects.

Registration Process

When an activity is not human subject research, IRB approval is not required and will not be provided. Instead, the Principal Investigator (PI) must register a "Non-Human Subject Research Self-Determination" in ZOT IRB.

IMPORTANT! The registration process is different than the submission process for IRB review. Review the IRB Researchers Guide to learn how to "Create and Register a Self-Determination". A complete PROTOCOL NARRATIVE - Not Human Research Self-Determination must be uploaded the registration. No other supplemental documentation is required.

Ready to Register a NHSR Self-Determination?
Go to ZOT IRB

Activities that are Not Human Subject Research

  • Research

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

    Per federal regulations, the following activities 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 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.

  • Human Subject

    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.

    Examples of activities that do not involve human subjects:

    • Obtaining information about deceased individuals, except for obtaining California Death Records (see scenario below).
    • Obtaining information about a place or a thing (e.g., company or organization), not a person.  Note: Obtaining a person's opinion about a place or thing would involve a human subject.
    • Obtaining identifiable public information (e.g., census data) about a living individual. 
    • Obtaining de-identified private information or de-identified biospecimens. De-identified means the information / biospecimen does not include any of the 18 identifiers and the investigator cannot readily ascertain the identity of the individuals.
    • Obtaining a limited data set (LDS) when the source of information is provided by a third party (not study team) and a Data Use Agreement is executed.   

Is this Activity Human Subjects Research?

Educational Activities

Educational Research - Human Subjects Research

If an instructor determines that there is a possibility that a student's proposed research project may result in a formal presentation or publication, he/she should recommend that the student submit the project for IRB review before beginning the study.

There may be instances when a student or instructor wishes to use data for research that was previously collected for educational purposes. An application should be submitted to the IRB when a student or instructor wishes to analyze the data with the intent of contributing to generalizable knowledge.

Examples:

  • An instructor is surprised at some of the unique findings that appeared when students completed surveys as part of a classroom activity. The instructor would like to do additional analysis on the data and submit it for presentation or publication when the course ends. The instructor's intent has changed and an IRB application is necessary because the instructor will now be analyzing existing data that was collected for a non-research purpose.
  • An undergraduate junior psychology major wishes to conduct research in the hopes of having a publication to list on her application to graduate school. She plans to devise an experiment, enroll subjects, analyze the results and write a manuscript. This is human subjects research. Prior IRB review and approval is necessary.

IRB Approval: IRB approval is required for human subject research that is not eligible for exempt self-determination.

Publication: Publications describe "research" and cite evidence of IRB approval.

VS.

Educational Activities - NOT Human Subjects Research

Although all human subjects research requires prior institutional approval, not all data gathering by students constitutes human subjects research. To be research, an activity must be designed with the intent to develop or contribute to "generalizeable knowledge." Clearly, some classroom activities are designed to teach research techniques and have no such intent.

Simulations of human experimentation and course-assigned data collection do not constitute human subjects research if the activities are designed for educational purposes only; and

  • the data will not be generalized outside the classroom (reporting of data within the class is acceptable because the activities were performed solely for teaching purposes); and
  • the data will not result in a master's thesis, doctoral dissertation, poster session, abstract, or other publication or presentation; and
  • the student volunteers or other participants are clearly informed that the activities are an instructional exercise, and not actual research.

IRB Approval: IRB approval is not required. However, a Not Human Subject Research Self-Determination must be registered in ZOT IRB.

Exception: Any activity that is a clinical investigation or involves medical intervention or procedures, even when they are a part of a course curriculum, always constitutes human subjects research and requires prior IRB review and approval.

Publication: Publications describe "educational activities”, do not use the term "research", and cite evidence of the Not Human Subject Research Self-Determination.

Quality Improvement Activities

Want a more in-depth comparison?

HRP Guidance: Quality Improvement

QI Research - Human Subjects Research

Intent: An activity that is initiated with a goal of improving the performance of institutional practices in relationship to an established standard, with the intent to contribute to generalizable knowledge (“widely applicable”).

IRB Approval: IRB approval is required for human subject research that is not eligible for exempt self-determination.

HIPAA Rule:  Requirements for waiving informed consent and/or waiving the requirements for documentation of informed consent must be met.

Publication: Publications describe QI “research” and cite evidence of IRB approval.

VS.

QI Project - NOT Human Subjects Research

Intent: An activity that is specifically initiated with a goal of improving the performance of institutional practices in relationship to an established standard.

IMPORTANT! If a project was originally initiated as a local QI project but the findings are of interest and the project investigator chooses to expand the findings into a research study, IRB review would be required at that time.

IRB Approval: IRB approval is not required. However, a Not Human Subject Research Self-Determination must be registered in ZOT IRB.

HIPAA Rule: PHI may be used within the covered entity for the purpose of quality improvement without obtaining a HIPAA Authorization.

The following activities are considered “healthcare operations” (they are not considered “research”):

  • Conducting quality assessment and improvement activities, including outcomes evaluation and development of clinical guidelines, if the obtaining of generalizable knowledge is not the primary purpose of studies resulting from the activities
  • Population-based activities relating to improving health or reducing healthcare costs
  • [Clinical] protocol development, case management and care coordination

Publication: Publications describe a QI “project”, do not use the term "research", and cite evidence of the Not Human Subject Research Self-Determination.

 

Resources

Case Reports

Case Report Series - Human Subject Research

Per the HRP-101 Human Research Protection Program Plan: Case Report Series of four or more individuals is considered Human Subjects Research.

IRB Approval: IRB approval is required.

HIPAA Rule:  Requirements for waiving HIPAA Authorization must be met or a signed HIPAA Authorization Form is obtained from the patient.

Publication: Publications describe the activity as "research" and cite evidence of IRB approval.

VS.

Case Reports - NOT Human Subject Research

Case Reports typically involve retrospective medical record reviews of three or less patients and are not considered Human Subjects Research. In this scenario, the only interaction with the patient has been for purposes of treating the patient, and not for the purpose of gathering research data.

IRB Approval: IRB approval is not required. However, a Not Human Subject Research Self-Determination must be registered in ZOT IRB.

HIPAA Rule: PHI may be used within the covered entity for the purpose of preparing a case report without obtaining a HIPAA Authorization.

If PHI will be presented or published outside of the covered entity case report, then a HIPAA authorization would be required. Disclosure of photos, even if de-identified, would require a signed authorization form. The signed authorization form should be maintained in the patient's record and completed as follows:

    • Release Records To:  Indicate the UCI faculty/resident name, and include the caveat “to be further disclosed in a Case Report publication".
    • Purpose:  Indicate “Case Report publication”.

Often, case report activity involves sharing medical knowledge, improving quality, and providing education, and therefore will fall under healthcare operations (they are not considered “research”), this includes:

Reviewing the competence or qualifications of health care professionals, evaluating practitioner and provider performance, health plan performance, conducting training programs in which students, trainees, or practitioners in areas of health care learn under supervision to practice or improve their skills as health care providers, training of non-health care professionals, accreditation, certification, licensing, or credentialing activities.

Publication: Publications describe the activity as a "case report", do not use the term "research" and cite evidence of the Not Human Subject Research Self-Determination.

Death Records

California Death Records - Human Subject Research

California death data files containing personal identifying information may be released to persons expressing a valid scientific interest, as determined by the appropriate IRB. See the CA Health and Safety Code, Sections 102231-102232 for more information.

IRB Approval: UCI IRB approval is required. In addition, reach out to the California Department of Public Health (CDPH) to inquire if their IRB approval is required.

HIPAA Rule: A signed HIPAA Authorization Form from the legally authorized representative of the deceased patient is required if there is disclosure of PHI outside the covered/hybrid entity.

Publication: Publications describe "research" and cite evidence of IRB approval.

VS.

Medical Death Records - NOT Human Subject Research

A medical record review of deceased patients is not considered Human Subjects Research.

IRB Approval: IRB approval is not required. However, a Not Human Subject Research Self-Determination must be registered in ZOT IRB.

HIPAA Rule: Decedent PHI may be used within the covered entity without obtaining a HIPAA Authorization.

If PHI will be presented or published outside of the covered entity case report, then a HIPAA authorization from the legally authorized representative of the deceased patient would be required. Disclosure of photos, even if de-identified, would require a signed authorization form. The signed authorization form should be maintained in the patient's record and completed as follows:

    • Release Records To:  Indicate the UCI faculty/resident name, and include the caveat “to be further disclosed in a research publication".
    • Purpose:  Indicate “research publication”.

Research on decedent's information. The covered entity obtains from the researcher:

  • Representation that the use or disclosure sought is solely for research on the protected health information of decedents;
  • Documentation, at the request of the covered entity, of the death of such individuals; and
  • Representation that the protected health information for which use or disclosure is sought is necessary for the research purposes.

Publication: Publications describe the activity as "not human research" and cite evidence of the Not Human Subject Research Self-Determination.