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Research Involving Human Subjects

Is My Project Human Subjects Research?

For a project to be deemed human subjects research, it must meet the federal definition for both ‘research’ and ‘human subject’ per 45 CFR 46.102.

Research

A systematic investigation1, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge2.

Human Subject

A living individual about whom an investigator (whether faculty, student, or staff) conducting research obtains:

  • Data through intervention3 or interaction4 with an individual; and/or
  • Identifiable private information or biospecimens5.
  1. A predetermined system, method, or plan for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory. It includes the collection of information and/or biospecimens, and quantitative or qualitative analysis.
  2. Activities designed to draw broad conclusions, inform policy, or generalize outcomes beyond the specific group/population, entity, or institution being studied.
  3. Includes both physical procedures (e.g., blood draws) and manipulations of the subject (e.g., altering perception, cognition, emotion) or the subject’s environment (e.g., altering lighting or noise conditions) that are performed for research purposes.
  4. Includes communication or interpersonal contact between investigator and subjects.
  5. Private information or biospecimens for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information or biospecimens.

What are Some Examples of Activities That Are/Are Not Human Subjects Research?

Human Subjects Research6

  • Interviews
  • Surveys/questionnaires
  • Focus groups
  • Educational research
  • Benign behavioral interventions
  • Use of identifiable data or biospecimens
  • Retrospective chart reviews
  • Observational research
  • Biomedical research
  • Clinical trials involving drugs and medical devices

Not Human Subjects Research

  • Oral history, journalism, biography, literary criticism, legal research
  • Activities not designed to produce generalizable knowledge (e.g., student classroom projects7, internal quality improvement projects)
  • Medical case studies (n ≤ 3 patients)8
  • Research involving only de-identified data (e.g., data contains no direct or indirectly linked personally identifiable information or protected health information)
  • Information about things, products, or policies
  • Cadavers or information about deceased individuals
  1. This assumes the activity is a systematic investigation and there is an intent to generalize findings beyond MU.
  2. Faculty teaching a course involving research methods or systematic investigations (e.g., activities involving both data collection and quantitative/qualitative data analysis) via interaction with individuals outside the course are encouraged to submit a 'Student Classroom Project Exclusion’ to Cayuse Human Ethics using the Not Human Subject Research Application  for review.
  3. Individuals pursuing a case study involving 3 or fewer patients may submit a 'Case Study Registration’ to Cayuse Human Ethics using the Not Human Subject Research Application  for review.

If you are in doubt about whether your proposed project constitutes human subjects research, please submit a ‘Not Human Subject Research Application’ in Cayuse Human Ethics for evaluation before the project is initiated. The Office of Research Integrity will issue you a determination letter indicating whether the proposed work is or is not human subjects research. Please note that if the project has already started or has been completed, the Office of Research Integrity cannot issue a determination letter retrospectively.

Who is Responsible for Overseeing Human Subjects Research at Miami?

The Institutional Review Board (IRB) and the Office of Research Integrity (ORI) review research proposals involving human subjects at MU to ensure compliance with federal regulations and institutional policies. However, the IRB and the ORI review different types of submissions.

Non-Exempt Research Projects

The IRB reviews all projects that do not qualify for exempt review, and any project that is deemed greater than minimal risk.

Exempt Research Projects

Exempt projects are low risk and reviewed by the ORI. Most social, behavioral, and educational research qualifies for exempt review.
  • Common examples include research involving interviews, focus groups, surveys, and retrospective chart reviews

Administrative Submissions

Reviewed by the ORI.
  • Common examples include submission of research determination requests, case studies, notification forms, and requests for student classroom project exclusion

What Resources are Available to Me?

Details

Access to IRB application submissions for initial review, modifications, incidents, renewals & closure

Answers to commonly asked questions about MU research support resources

Access to RCR guidance, upcoming RCR training events, and access to online training & toolkit

What if I Have a Question or Need Help?

Please contact the Office of Research Integrity at humansubjects@MiamiOH.edu to submit a question or request a consultation to discuss your proposed human subjects research project.