Human Subjects Research Regulations
Protecting the welfare of human subject participants in research
The Ohio State University (OSU) Office of Responsible Research Practices (ORRP) exists to protect the welfare of human subject participants in research. This is accomplished by maintaining compliance with the federal and state regulations governing the protection of human subjects, and by facilitating the research efforts of OSU faculty, students and staff through education, training and monitoring
Human subjects research is either determined to be exempt or non-exempt from Institutional Review Board (IRB) review by the Office of Responsible Research Practices (ORRP). IRB approval is based upon a set of federal regulations; either the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA), or both depending on funding and research activities.
The links below contain detailed information regarding the federal regulations, ethical principles, and OSU HRRP policies regarding human subjects research.
OSU HRPP Resources
- OSU Human Research Protection Program Policies
- Collaborative Institutional Training Initiative (CITI) Basic Human Research online course (log in through Buck-IRB)
- Investigator Guide
- Human Participants in Research Videos
- OSU IRB Reviewer Reference Sheets
- Exempt Research
FDA Regulatory Resources
- FDA Regulations
- Protection of Human Subjects 21 CFR 50
- Institutional Review Boards 21 CFR 56
- Investigational New Drug Application 21 CFR 312
- Investigational Device Exemptions 21 CFR 812
- FDA Information Sheets
DHHS Regulatory Resources
Differences between DHHS and FDA Regulations
Good Clinical Practices/International Conference on Harmonization
Good Clinical Practice (GCP) is an international ethical and scientific quality standard that was developed by the International Conference on Harmonisation (ICH). The ICH is made up of regulatory authorities from the European Union, Japan and the United States. GCP guidelines include standards on how to design, conduct, record and report clinical trials to ensure protection of participants in trials, in addition to defining the roles and responsibilities of various clinical trial stakeholders.
Human Subjects Research Ethics
Health Information Portability and Accountability Act (HIPAA)
The HIPAA Privacy Rule permits researchers to access, use, or disclose protected health information (PHI) for research purposes when a subject provides formal written authorization. Such use is permissible in accordance with the requirements of the Rule at 45 CFR 164.508. However, there are certain types of research trials that are granted permission by the IRB to waive the requirement of written authorization. The links below contain detailed information regarding the federal regulations, ethical principles, and OSU HRRP policies regarding HIPAA.
- HIPAA Definitions and 18 Identifiers
- HIPAA Research Authorization
- The Privacy Rule
- US Department of Health and Human Services: Health Information Privacy
Responsible Conduct of Research (RCR)
Both OSU and CITI offer Responsible Conduct of Research (RCR) courses, however, review your specific training requirements to ensure that you are meeting all criteria. Additional RCR training is required for investigators on certain National Institutes of Health (NIH) grants and for those seeking National Science Foundation (NSF) funding. The links below contain detailed information regarding additional research training and OSU HRRP policies that may apply to your research trial.