Your research may be classified as human subjects research, if your research
- meets the definition of research and
- involves the testing and evaluation of living individuals and gathers data through intervention or interaction with that individual or
- uses identifiable private data from those individuals.
See also:
Do I need IRB Approval for My Research?
NIH Definition of Human Subjects Research and Decision Tool
NIH Definition of Clinical Trials and Decision Tool
Start Here
HRPO Research Guide
Guide to human subjects research and to IRB approval policies and procedures by the WU Human Research Protections Office (HRPO).
Human Subjects Research Resources – OVCR
Links to offices, policies, how-to’s, and other tools.
Do I need IRB approval for my research?
From the 2021 HRPO Research Guide (p. 9)
“The Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) define human subject research differently.
– The DHHS defines research as a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge involving a living individual about whom an investigator conducting research obtains: (I) data through intervention or interaction with the individual; or (2) identifiable private information.
– The DHHS also defines research in terms of a clinical trial. A clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
– The FDA speaks in terms of a clinical investigation. A clinical investigation means any experiment that involves a test article and one or more human subjects. If your study is human subject research, a clinical trial or a clinical investigation IRB approval is required.
If your study is human subject research, a clinical trial or a clinical investigation IRB approval is required.“
Resource List
Decision Tool: Am I Doing Human Subjects Research? (NIH)
Complete this questionnaire to determine whether your reserach classifies as human subjects research
HIPAA Policies & Procedures
WU policies and procedures for compliance with the Health Information Portability and Accountability Act
HIPAA Privacy Office
Resources for compliance with the Health Information Portability and Accountability Act
Human Research Protection Office
Protects the rights and welfare of participants in human research and clinical investigations.
Human Research Quality Assurance Program (HRQA)
Monitors active research protocols to ensure protection of human subjects and confirm that research is conducted in compliance with federal regulations and university policies.
Human Subjects Education Policy
Applicable to individuals responsible for the design, conduct and reporting of research involving human participants
Human Subjects Protection (IRB)
Resources, policies, and guidelines relating to all human subjects research, including, but not limited to, clinical and social/behavioral research
Human Subjects Research Resources – OVCR
Links to offices, policies & procedures, how-to’s, and other tools.
Office of Research Integrity & Ethics (ORIE)
Provides programmatic resources for: Individual and Institutional Conflicts of Interest, Human Stem Cell Research, Research Integrity and Authorship Standards , Human Research Quality Assurance and Improvement, Institutional Animal Care and Use.
Resources – Clinical
Center for Clinical Studies
Provides WU researchers with administrative and clinical research services from the initial proposal phase through study close-out.
Clinical Research Coordinator Orientation Manual
Training manual for staff supporting human subjects research. Produced by the WU OVCR.
Clinical Research Training Center
Provides a cohesive and supportive infrastructure to foster clinical and translational research training and career development for predoctoral students, house-staff, postdoctoral fellows, staff, and faculty.
Clinical Trials Registration and Informed Consent Posting Guideline
WU Guidelines from the Office of the Vice Chancellor for Research
Education in Good Clinical Practices Policy
Applicable for faculty and staff involved in the conduct, oversight or management of clinical trials
Human Research Quality Assurance Program (HRQA)
Monitors active research protocols to ensure protection of human subjects and confirm that research is conducted in compliance with federal regulations and university policies.
Include Informed Consent Document Language for Registered Clinical Trials
Required languagefor all registered clinical trials on or after 3/7/2012
Register a Trial on Clinicaltrials.gov
WU tip sheet from the Office of the Vice Chancellor for Research
Other Clinical Trials Resources
- Protocol Templates for Clinical Trials
- NIH ASSIST Human Subjects and Clinical Trials Information Form – information, instructions, and annotated form
Training
Clinical Research Coordinator Orientation Manual
Training manual for staff supporting human subjects research. Produced by the WU OVCR.
Clinical Research Training Center
Provides a cohesive and supportive infrastructure to foster clinical and translational research training and career development for predoctoral students, house-staff, postdoctoral fellows, staff, and faculty.
Education in Good Clinical Practices Policy
Applicable for faculty and staff involved in the conduct, oversight or management of clinical trials
HRPO Education Programs
These programs provide a variety of ways to help investigators and research teams navigate the approval and conduct of human subjects research.
Human Subjects Education Policy
Applicable to individuals responsible for the design, conduct and reporting of research involving human participants
Other Training Resources
NIH Training & Resources for Human Subjects Research & Clinical Trials