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Activities not considered Human Subjects Research

Background

The Revised Common Rule (2018) was implemented by the U.S. Department of Health and Human Services and other Federal Departments. The regulatory text includes a number of definitions (45 CFR Part 46.102) around what is and is not considered 'Human Subjects Research', as well as updated categories of review, and the role of the Institutional Review Board (IRB). 

 

Definitions

  • 46.102 - (e)(1) 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.

  • 46.102 - (l) Research - means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

Activities that are generally not considered Human Subjects Research

 Scholarly and journalistic activities (oral history, biography, legal research, 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 required or authorized by a public health authority.
 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.
 Cadaver research, biospecimens from deceased individuals, though genetic studies may lead to information about living relatives which should be reviewed in advance.
 Case studies – specifically clinical features/outcomes of a single patient/series of patients.
 De-identified/Anonymous Data or Biospecimens – where the data exists without ANY personal identifiers, or it has been provided by a research repository which takes responsibility for removing any identifiers (including any code link), or repository maintains firewall security preventing recipients from accessing identifiers. Researcher cannot be one of the parties responsible for collecting or maintaining the source material.
 Quality improvement/assessment activities for immediate internal use, rather than creating publications or presentations which aim to be applicable to the field more broadly.
 

Further Considerations

Determining the applicability of research regulations can be a complex issue, so please ask for help from CPHS as below.
 
Key aspects of the determination appear to be:
- How will the data be obtained? Is the data publicly available or will it be privately obtained?
- What are the research objectives? What data is being collected? How will the outcomes be used?
- Will the data analysis only ever be used for internal purposes, or disseminated externally?
- Is there a clear intent to contribute to generalizable knowledge?
- The source of funding does not determine alone whether the activity is considered human subjects research, but are there sponsor expectations and requirements?
 

What tools can help me decide?

Decision charts, produced by the Office for Human Research Protections (OHRP),  may help investigators and institutional officials follow whether activities should be considered Human Subjects Research, and whether they might meet certain categories which determine the type of review needed.

Presentation Slides (February 2022) - OHRP presentation material may also be useful on: 'What is Research and what it isn't? And Who is a Human Subject Anyway?' 


Who can I ask for help and what should I do next?

For further information please contact CPHS at [email protected]. 

If you are ready with a project idea and would like a determination from CPHS please submit a form for NHSR determination, available at the CPHS Forms Page. Submitting the form is an efficient way to explain the project and how data will be collected.

While you may be seeking a determination that the proposed project is not considered ‘Human Subjects Research’ it still likely touches on topics of handling data, understanding identifiers, and potential risks to participants and researchers. It is important to understand the definitions and what would become human subjects research should the project change. The CITI Program Human Subjects training is valid for three years and offers good insight, background, and research examples to help inform your research application.