Is My Project Human Subject Research?

Please review the following definition to determine whether your activity is human research. Note that publication/dissemination is not a determining factor for whether an activity is human research requiring review and approval by the Institutional Review Board (IRB).

“Human Research” (according to Department of Health and Human Services (DHHS)): The definition includes two components:

• “Research”: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
• “Human Subject”: A living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. For the purpose of this definition:
  • Intervention: Physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
  • Interaction: Communication or interpersonal contact between investigator and subject.
  • Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).
  • Identifiable Private Information: Private Information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
  • Identifiable Biospecimen: A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

If your activity does not meet both of these components, then it is not Human Research according to DHHS and does not need to be submitted to the IRB for review and approval.

A project is considered human research when there is a systematic investigation that intends to develop or contribute to generalizable knowledge about people or human behavior.

It’s human research when:

• Living individuals about whom information is obtained through intervention or interaction; OR
• Identifiable private information is collected

You may conduct a systematic investigation that involves collecting information from people, but it may not be generalizable about people or human behavior. i.e.: quality assurance, quality improvement, program evaluation, documentaries, case studies, etc.

Research that is about a program, process, course, a device, etc. is not typically about the people.
 

Examples of activities that are generally considered not to be Human Research

The following are examples of activities that are generally considered not to be Human Research according to the definitions above. If your activity is limited to one of the examples below, then it is likely not Human Research which would need to be reviewed by the IRB. Note that publication/dissemination is not a determining factor for whether an activity is Human Research.

1. Program Evaluation/Quality Assurance Review/Quality Improvement Project: The activity is limited to program evaluation, quality assurance, or quality improvement activities designed specifically to evaluate, assure, or improve performance within a department, classroom, or hospital setting.

Note: The purpose of a QA study is to assure known quality. The purpose of Program Evaluation (PE) is to assess that a program is doing what it is intended to do. Generally QI is designed for the purpose of improving the quality of a service, a program, a process, etc.. A QA, QI or PE study should present NO CHANGE in RISK to participants. These studies are mechanisms to assure that a service, a program, or a process functions optimally. Such projects are usually for internal auditing purposes only.

If you can answer "yes" to all of the following questions, the activity is most likely not human research:

1. Will you simply monitor an existing process (this may include evidence-based practice) for which there will be no manipulation of the existing process?
2. For QA or PE studies, will physicians or caregivers (parents, teachers, therapists, etc.) provide usual and customary care regardless of the conduct of the study?
3. Does the study involve collection of data to which the investigator routinely has access as part of his or her responsibilities within the institution to monitor data associated with, for example: treatment, cost containment, performance, or compliance?

Note that an evaluation, assurance review, or improvement project designed specifically for a particular setting may yield useful information for similar entities, and may still not the definition for Human Research.

2.Case Report: The project consists of a case report or series which describes an interesting treatment, presentation, or outcome. A critical component is that nothing was done to the patient(s) with prior “research” intent.

Note that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

3.Course-Related Activity: The project is limited to one or more course-related activities designed specifically for educational or teaching purposes where data are collected from and about students as part of routine class exercises or assignments and otherwise do not meet the definition of Human Research.
Note that some course-related activities, even those conducted by students, may yield information suggesting additional investigation or analysis. If an additional activity entails Human Research, then it must be submitted to the IRB Office for review.

 

4.Journalistic or Documentary Activity (including Oral History): The activity is limited to investigations or interviews (structured or open-ended) that focus on specific events (current or historical), views, etc. Such investigations or interviews may be reported or published in any medium, e.g, print newspaper, documentary video, online magazine.

 

5.Research Using Public or Non-Identifiable Private Information about Living Individuals: The activity is limited to analyzing data about living individuals (1) where the data have been retrieved by the investigator from public, non-restricted data sets or (2) where the private data have been provided to the investigator without any accompanying information by which the investigator could identify the individuals.
Note that “de-identified data” according to HIPAA may be identifiable according to the DHHS definition of “Human Subjects.” Please contact the IRB Office with any questions regarding research with data.

 

6.Research Using Health Information from Deceased Individuals: This activity is limited to analyzing data (identifiable or not) about deceased individuals.

Note that deceased individuals cannot be Human Subjects according to DHHS. Note also that HIPAA or other state or local laws may still apply to this activity. Please consult the entity from which you received or accessed the information contained in the report for further guidance.

7.Instrument/Questionnaire Development: This activity is limited to interacting with individuals in order to obtain feedback on the types of questions which could or should be used to develop an instrument or questionnaire. The focus is on the development and construction of a data collection tool and not on the individuals who are providing the feedback on the questions being developed. This will be true even when the feedback may be specifically sought from an identified group of people most likely to be affected by the topic of the instrument, survey or questionnaire. The instrument/questionnaire development process will apply to many aspects of reliability and validity testing of the instrument or questionnaire. Note that once the process gets to the level of testing discriminant, concurrent or predictive validity, the activity may need to be reclassified as human subject research.

Note: If the participant is asked to provide additional information unrelated to instrument/questionnaire construction, such as demographic information that will be analyzed as part of a research study, the project may need to be submitted to the IRB for review.

If, after reviewing the information above, (1) you are unclear as to whether your activity is Human Research and would like for the IRB Office to make a determination for you or (2) you believe that your activity is not Human Research but would like for the IRB Office to provide documentation that it agrees with your assessment, then please contact either the IRB Office at irb@misericordia.edu, or Jessica Kisenwether, IRB Administrator, jkisenwether@misericordia.edu.

2019: Adapted with permission from Northwestern University