Current through all regulations passed and filed through December 16, 2024
(A)
Policy statement.
The university is committed to the protection of the rights, well-being, and
personal privacy of all human subjects in research in conformance with, but not
limited to, relevant federal and state regulations. All research projects
conducted under university auspices involving human subjects, samples or data
obtained from them, directly or indirectly, with or without consent must follow
university procedures and receive approval from the institutional review board
("IRB"), regardless of funding or funding source.
(B)
Purpose. To
promote research best practices that meet high ethical standards and adhere to
all applicable federal and state laws for research involving human
subjects.
(C)
Scope. This policy applies to all faculty, staff, and
students involved in human subjects research at the university.
(D)
Parameters.
(1)
The director of
research services annually forms an IRB committee composed of both university
and non-university personnel.
(2)
The IRB committee
provides oversight and monitors all research involving human subjects in
accordance with federal regulations ( 45 C.F.R. 46, 21 C.F.R. 50, and 21 C.F.R.
56), "The Belmont Report" of the national commission for the protection of
human subjects of biomedical and behavioral research, the food and drug
administration human research ethical codes, and university policy to protect
the rights and welfare of human subjects while participating in
research.
(3)
The IRB is charged with:
(a)
Maintaining
review procedures for research projects and programs that utilize human
subjects.
(b)
Reviewing all research involving human subjects. This
review process includes authority to approve, require modification, disapprove,
suspend or terminate activities that fall within its
jurisdiction.
(c)
Conducting continuing review of approved and ongoing
research, including requiring progress reports, observing the informed consent
process, auditing study conduct and progress.
(E)
Procedures.
(1)
The IRB has established procedures that are in
accordance with federal and state regulations. These procedures and other
information concerning human subjects issues and procedures are available in
the office of research services or online at
https://ysu.edu/office-research-services/human-subjects-research-irb.
(2)
All human subjects studies should be prepared and
submitted to the office of research services via the electronic submission
system for processing and reviewing.
Replaces: 3356-10-14
