Chapter 1 – Before You Begin
The mission of The Ohio State University Human Research Protection Program (HRPP) is to protect the rights, dignity, welfare, and privacy of all participants, or human subjects, in research conducted on behalf of the university (regardless of funding) by adhering to the principles outlined in the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research report entitled, Ethical Principles & Guidelines for the Protection of Human Subjects of Research (“Belmont Report”). The university has policies describing the requirements for its HRPP, including that all human subjects research must receive appropriate review and approval before it is initiated. For federally-sponsored research Ohio State maintains a Federalwide Assurance of Compliance (FWA) with the Office for Human Research Protections (OHRP), in which the university pledges to comply with federal human subjects protection regulations. The ethical and regulatory requirements of the HRPP apply to all research involving human subjects conducted on behalf of the university.
All research conducted by Ohio State faculty, staff, or students that is determined to be human subjects research is subject to the university’s HRPP policies. Department of Health and Human Services (DHHS) regulations, Food and Drug Administration (FDA) regulations, and the terms of the university’s FWA may also apply to human subjects research conducted by Ohio State investigators. When research involves the use of protected health information, Health Insurance Portability and Accountability Act (HIPAA) requirements must be followed. Depending on the type of research conducted, the requirements of one or more of the applicable regulations may apply.
Many faculty, students, and staff throughout the university conduct research involving human subjects. All activities that involve research with human subjects (as defined by the federal regulations and HRPP policy) – including those performed in support of an Ohio State University honors’ thesis, master’s thesis or doctoral dissertation – are subject to Institutional Review Board (IRB) review or exemption. However, faculty, students, and staff may also conduct other types of scholarly or scientific inquiry involving interactions with people that do not require IRB review. To comply with federal regulations, state laws, and university policies, investigators must be aware when their work requires IRB review or exemption. A designated Senior IRB Protocol Analyst in the Office of Responsible Research Practices (ORRP) is available to make project-specific determinations concerning the need for IRB approval (or exemption) for activities that may be human subjects research. The ORRP Protocol Analyst will review the proposed project, consult the applicable regulations and University policies, and notify the Principal Investigator (PI) about any study- specific requirements.
Institutional Review Boards were established by the federal government to protect the rights and welfare of human subjects participating in research. IRBs are responsible for ensuring that physical, psychological, legal, economic, and social risks to research participants are minimized and that the risks associated with the research are in line with the importance of the research and/or the knowledge to be gained. IRBs also ensure that research participants receive complete information about the nature of the research and any associated risks, as well as their rights as research subjects, in a manner participants can understand. Depending on the nature of the research at Ohio State human subjects research is reviewed by one of three university IRBs – Behavioral and Social Sciences, Biomedical Sciences, or Cancer – or an external IRB.
IRBs review human research activities to ensure that the university, affiliate institutions, and investigators are compliant with the ethical standards and regulations governing human subjects research. The primary regulations are codified in the Code of Federal Regulations (CFR) from the US Department of Health and Human Services (45 CFR 46) and the Food and Drug Administration (21 CFR 50; 56).
The Office of Responsible Research Practices is an administrative unit of the Office of Research that provides a range of services supporting members of the University research community and the University’s animal, human, and biosafety research programs. Staff members assist faculty, staff, and students seeking committee approvals to conduct human subjects and animal research; provide educational programming in support of the responsible conduct of research; and support the operations of the University’s Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and IRBs. Although ORRP staff members work closely with the various review boards, they are not IRB members and cannot act on behalf of the Boards. Only the IRB has the authority to review and approve non-exempt research.
The ORRP staff are committed to delivering excellent customer service. The staff provide the following services for faculty, staff, and students involved in human subjects research:
- Assistance with general questions about research review procedures
- Assistance with study-specific questions
- Pre-screening of Board submissions for completeness to facilitate the review process
- Determinations about whether human subjects research meets the criteria for IRB review or exemption
- Attendance at meetings to provide support to IRB members
- Preparation and distribution of IRB correspondence to investigators
- Coordination and delivery of educational programs
- Responses to researcher, community, and research participant questions and concerns.
Consult the ORRP staff directory for specific staff member contact information. For more information about ORRP or other units within the Office of Research at Ohio State, including links to other research resources, programs, and reports – see Office of Research.