Ohio Administrative Code
Title 3341 - Bowling Green State University
Chapter 3341-7 - Research
Section 3341-7-07 - Protection of human subjects

Bowling Green state university (BGSU) has given assurance via a federalwide assurance (FWA00003853) that it will comply with the department of health and human services regulations for the protection of human research participants ( 45 CFR part 46). BGSU requires that all research projects involving human subjects, as defined by the federal regulations (45 CFR 46.102(d)(f)), regardless of the source of support or location of the performance site, be reviewed and approved by the human subjects review board (HSRB) prior to the initiation of the research project. The HSRB is under the authority of the vice president for research and economic development.

The purpose of the HSRB is to protect the rights and welfare of human subjects participating in research. The HSRB reviews and oversees research with human subjects to assure that the ethical principles described in the "Belmont Report", a publication of the "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" are being followed, and that the research complies with federal regulations that pertain to human subject protections ( 45 CFR 46) and other pertinent regulations, guidance, state, and local laws.

The HSRB is guided by the ethical principles in the belmont report. The following principles are defined in the belmont report:

The HSRB has the authority to review research with human subjects when, but not limited to:

Research covered by this policy may be subject to additional review and approval or disapproval by officials of BGSU. However, those officials may not approve research with human subjects if it has not been approved by the HSRB.

Inappropriate attempts to influence the HSRB process, individual HSRB members, or office of research compliance staff will be reported to the vice president for research and economic development. The vice president for research and economic development will investigate and appropriately respond to these concerns, and has the authority to limit or remove an investigator's privilege to conduct research after due process.

If research with human subjects is being internally or externally funded, the protocol must be reviewed and approved by the HSRB prior to expenditure of any grant funds. The funded grant proposal must substantially correspond to the HSRB approved protocol.

The HSRB must maintain and follow written procedures consistent with applicable laws and regulations such as the "Belmont Report'. J 45 CFR 46. and the university's federal-wide assurance. These procecmres will be available to all researchers through a link at the office of research compliance website.

The HSRB can serve as the IRB of record for other institutions and can rely on another IRB for review and continuing oversight when there is an IRB authorization agreement in place as an effort to avoid duplication of effort. This is at the discretion of the BGSU HSRB and will only be done in cases where the other institution has a valid federal-wide assurance.

All university personnel and students shall cooperate fully with the procedures implemented by the university HSRB to provide protections to human subjects.

Violations of law, regulation, or university policies respecting human subject protections will be considered serious matters, which may warrant sanctions or more serious action, such as suspension of research protocols, termination of research protocols, and loss of research privileges, as the situation may warrant, including investigation for scientific misconduct in accord with established policies.

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge ( 45 CFR 46A02(d) ).

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) /Data through intervention or interaction with the individual, or (b) identifiable private information (45 CFR 46.102 ('f))

The office of research compliance is responsible for the oversight and implementation of this policy.