Research Using Human Subjects

The Florida State University is committed to the ethical principles for the protection of human subjects in research as set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979). The ethical principles are:

• Respect for persons – which includes the requirement of a voluntary informed consent process
• Beneficence – which entails an obligation to protect persons from harm by minimizing risks and maximizing benefits
• Justice – which requires that selection of subjects be fair and equitable, and that particular care be taken when working with vulnerable populations (e.g., children, economically or educationally disadvantaged).

Human Subjects Research—Identifying Intent

Federal law applicable to the protection of human subjects (45 CFR 46) requires Institutional Review Board (IRB) review and on-going oversight of research involving human subjects.

As defined by §46.102 of the Common Rule (45 CFR 46), "Research" means a systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge. When evaluating a specific project, it is helpful to focus on two key elements:

1. The project involves a systematic investigation, and
2. The design – meaning the goal, purpose, or intent – of the investigation is to develop or contribute to generalizable knowledge.

A "Human Subject" is living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (even in the absence of intervention or interaction). Some examples include:

• Assessing students' academic performance or instructors' use of instructional techniques or content
• Surveying or interviewing persons about their lives, conditions, activities, status, habits or understanding
• Measuring individuals' human physical, physiological, behavioral or cognitive performance
• Evaluating service, program or treatment outcomes upon clients, beneficiaries, recipients or patients

Institutional Review Board

An IRB is a committee composed of scientists, non-scientists (e.g., professionals as well as laypersons) as well as unaffiliated (non-FSU) members that review proposed research involving human subjects to ensure the protection of their rights and welfare. Pursuant to federal law and FSU policy, the IRB has authority to approve, require modifications in (to secure approval), or disapprove all research activities covered federal law and FSU policy. Research that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by FSU officials; however, these officials may not approve the research if it has not been approved by the IRB.

Assurance and Jurisdiction of the IRB

FSU’s Assurance with the federal government, an agreement under which as a condition of receiving federal funds and support for human research FSU agrees to abide by the terms of the Assurance, with all applicable laws (federal, state, local and international) and The Belmont Report, requires that all research activities involving human subjects be reviewed by the IRB, regardless of funding source or sponsorship. This includes:

• Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent in connection with his or her institutional responsibilities
• Research conducted by or under the direction of any FSU employee (faculty, staff, student) or agent using any property or facility of this institution
• Research involves the use of FSU’s non-public information to identify or contact human research subjects or prospective subjects, or to conduct or support human subjects research

The Office for Human Subjects Protection (OHSP)

The FSU Office of Research, through the Office for Human Subjects Protection, or OHSP, provides the requisite reviews and on-going oversight of all exempt research involving human subjects; provides the research community with consultation on and regulatory determinations for activities that may involve research or research involving human subjects but that may not require OHSP or IRB reviews under applicable law or FSU policy; performs pre-IRB review of non-exempt research involving human subjects; provides post-approval monitoring to ensure compliance with applicable laws; provides professional, technical and administrative support to the IRB, its business, meetings and documentation; maintains the electronic protocol management systems that serve to document and archive OHSP and IRB reviews and determinations; provides FSU leadership, the research community,  and the IRB with applicable law and policy information and resources; and provides or makes available initial, renewing and continuing training regarding human research regulatory requirements and related guidance. The OHSP staff also serve as a resource for investigators, IRB members and the research community, and has delegated authority to determine the initial appropriate level of review required for each research proposal submitted for IRB review.

For an explanation of the process at FSU for review of human subjects research, click on the Human Research Review tab on the left or click this link.