Ohio Administrative Code
Title 3359 - University of Akron
Chapter 3359-47 - Policies and Statements on Alcohol, Property and Diseases on University Property
Section 3359-47-11 - Protection of human subjects
Universal Citation: OH Admin Code 3359-47-11
Current through all regulations passed and filed through September 16, 2024
(A) University institutional review board.
(1)
A university "Institutional Review Board for the
Protection of Human Subjects" (IRB) shall be appointed by the vice president
for research and dean of the graduate school. All protocols, projects or
proposals prepared by university personnel or university students that involve
human subjects shall be reviewed by the IRB.
(2)
The IRB shall be
composed of at least five members. IRB members shall have varied backgrounds
and expertise. Membership shall be diverse, including consideration of race,
gender and cultural backgrounds. At least one member shall have nonscientific
areas as a primary concern. At least one member will be non-affiliated with the
university. Members of the IRB shall be appointed for terms of three
years.
(3)
The IRB shall develop policies, procedures and programs
related to human subject protections at the university of Akron consistent with
applicable laws and regulations such as the "Belmont Report," a publication of
"The National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research;" 45 C.F.R. 46 ; and the university's federal-wide
assurance. Unless otherwise required by law or applicable regulations, the IRB
shall review such policies and procedures annually and implement changes that
are appropriate and necessary.
(4)
The IRB
represents the interests of the subjects, thus has the ultimate authority over
human subjects study at the university of Akron. No other university office or
official may approve research involving human subjects that has not been
approved by the IRB. Research that has been approved by the IRB may be subject
to further appropriate review and approval or disapproval by the vice president
for research and dean of the graduate school. However, the vice president for
research and dean of the graduate school shall not be authorized to approve
research if it has not been approved by the IRB.
(B) IRB chair.
(1)
An IRB chair
shall be appointed by the vice president for research and dean of the graduate
school to implement the human subject protections program at the university of
Akron. The chair shall ensure that human subject protection activities are
performed at the university of Akron in accordance with approved policies and
regulatory requirements.
(2)
Duties of the chair.
(a)
Establish and
implement, in conjunction with the university IRB, written policies and
procedures for the protection of human subjects.
(b)
Establish and
implement, in conjunction with the university IRB, training and educational
experiences for university personnel and students on the protection of human
subjects.
(c)
Investigate deviations from human subject protections
policies and procedures and implement corrective actions as
necessary.
(d)
Approve or disapprove changes in human subject
protections policies and procedures with the advice and consent of the
university IRB.
(e)
Provide a written briefing on the human subject
protections program at the university of Akron to the vice president for
research and dean of the graduate school on an annual basis. In addition the
chair, or designee, shall make monthly reports of activities to the
IRB.
(C) Compliance with human subject protection laws, regulations and policies.
(1)
All university
personnel and students shall cooperate fully with the policies and procedures
implemented by the university IRB to provide protections to human
subjects.
(2)
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.
(D) An IRB policies and procedures manual as required by federal regulation shall be available to all researchers in print as well as through a link at the office of research administration website.
Replaces: 3359-47-11
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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