- About Us
Human Subjects in Research
OSU Center for Health Sciences is committed to and guided by the ethical principles regarding research involving human subjects as set forth in the report, Ethical Principles and Guidelines for the Protection of Human Subjects in Research, also known as the Belmont Report, published by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- What is an IRB?
- IRB Committee Meeting and Members
- Policies, Regulations and Guidelines
- Staff and Contact
In accordance with federal regulations and OSU-CHS Human Subject Research Policy and Procedures, the Institutional Review Board (IRB) is responsible for the oversight of all human subjects research.
An IRB is a committee whose primary responsibility is to protect the rights and welfare of human research subjects. In accordance with Department of Health and Human Services and Food and Drug Administration regulations, an IRB reviews research proposals to ensure risks have been minimized and the potential for benefit has been maximized before human subjects participate in the research.
The authority conveyed to the IRB includes decisions to approve, disapprove, require modifications, monitor, suspend and terminate research projects involving human subjects. The IRB also ensures, as required, that human subjects volunteer to participate in research only after providing legally effective informed consent. Investigators may not solicit subject participation or begin data collection until they have received approval from the IRB or written concurrence that the research has been determined to be exempt from IRB review.
OSU-CHS IRB committee meets at noon on the third Wednesday of each month.
Information must be submitted to the committee two weeks prior to the meeting date. Protocols must be submitted to the IRB administration and Office of Research. New protocol will need to be presented ot the IRB Board. Please schedule this time with the IRB Administrator.
IRB Committee Members
Effective April 2018
- Kath Curtis, Ph.D.
- Alicia Ford, Ph.D.
- Aaron Lane, D.O.
- Paul Rock, D.O., Ph.D.
- Caroline Abbott, J.D., community member/non-scientist
- Scott Gelfand, Ph.D., J.D., non-scientist/ethicist
- Amber Cornelius Howard, J.D., community member/non-scientist
Pre-Submission Tools and Templates
IRB Submission Forms
- Contact Information Form (doc)
- Application for Human Research Form (doc)
- Modification of Approved Human Research Form (doc)
- Continuing Review Progress Report or Notification of Study Completion Form (doc)
Exempt Research Forms
Federal Regulatory Agencies
- Department of Health and Human Services (DHHS), Office for Human Research Protections
- Food and Drug Administration
- DHHS Protection of Human Subjects: 45 CFR 46
- FDA Investigational New Drug Application: 21 CFR Part 312
- FDA Investigational Device Exemptions: 21 CFR Part 812
- FDA Human Subject Protection (Informed Consent): 21 CFR Part 50
- FDA IRB Regulations: 21 CFR 56
Policies and Principals
- Ethical Codes and Research Standards
- Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Declaration of Helsinki
- Nuremberg Code
- NIH IRBs and the HIPAA Privacy Rule
- NIH Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule
- NIH Research Repositories, Databases, and the Privacy Rule
Best Practices and Resources
- NIH Bioethics Interest Group
- Public Responsibility in Medicine and Research
- NIH Department of Bioethics
- FDA Clinical Trials and Human Subject Protection
- Office of Good Clinical Practice
- ICH E6: Good Clinical Practice: Consolidated Guidance
- FDA Device Advice: Comprehensive Regulatory Assistance
- Human Subjects Regulations Decision Charts
- Institutional Review Board Guidebook
- Information Sheets: Guidance for IRBs, Clinical Investigators, and Sponsors
All principal investigators/instructors, research faculty/staff and students involved in human subject research must complete prescribed training.
|Amber Hood, M.S., CPIA, CIP||Director, Regulatory Compliance and Research Facilities
|Rebecca Crandell, M.S.||Assistant Director, Research Compliance|| 918-561-1409