Chapter 1 - Before You Begin
...you might have some of the following questions about human subjects research.
- Why would my research require review?
- Where do the requirements come from and how do I know which apply?
- What is an IRB?
- What is (the) ORRP?
Why would my research require review?
The university has negotiated a Federalwide Assurance (FWA) with the federal Office for Human Research Protections (OHRP). According to the terms of this assurance, it is the university’s responsibility to ensure that the rights and welfare of research participants, or human subjects, are adequately protected in research conducted under its auspices. Federal laws require this protection, and in order for the university to fulfill its responsibility, all human subjects research must receive appropriate review and approval. For more information regarding OSU’s FWA, see Federalwide Assurance (FWA).
Where do the requirements come from and how do I know which apply?
All research conducted by OSU faculty, staff, or students that is determined to be human subjects research is subject to Department of Health and Human Services (DHHS) regulations and the terms of the university’s FWA. The Food and Drug Administration (FDA) regulations may also apply to human subjects research conducted by OSU 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) – including those performed in support of an OSU honors’ thesis, master’s thesis or doctoral dissertation – are subject to Institutional Review Board (IRB) review or exemption. However, faculty, students, and staff 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 Administrator in the Office of Responsible Research Practices (ORRP) is available to make project-specific determinations concerning the need for IRB approval for activities that may be human subjects research. An ORRP Administrator will review the proposed project, consult the applicable regulations and university policies, and notify the Principal Investigator (PI) about any study specific requirements.
What is an IRB?
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 participants’ rights as research subjects, in a manner they can understand. At OSU, human subjects research is reviewed by one of three university IRBs, depending on the nature of the research – Behavioral and Social Sciences, Biomedical Sciences, or Cancer – or an external IRB, Western IRB (WIRB).
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).
What is (the) ORRP?
The Office of Responsible Research Practices is an administrative unit of the Office of Research that provides a range of services supporting the university’s animal, human, and biosafety research programs and members of the university research community. 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.
The ORRP staff provides the following services for faculty, staff, and students involved in human subjects research:
- Assistance with general questions about human 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.
Although ORRP staff members work very 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 is committed to delivering excellent customer service. Consult the ORRP staff directory at Contact Us - ORRP for specific staff member contact information. The office is interested in suggestions for service improvements and is available to resolve customer service concerns.
For more information about ORRP or other units within the Office of Research at OSU, including links to other research resources, programs, and reports – see Office of Research.
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