Protection of Human Research Subjects UPPS No. 02.02.03
Issue No. 4
Effective Date: 08/23/00
Review: October 1 E3Y
01. POLICY STATEMENT
01.01 This
UPPS describes Texas State's commitment to full compliance with the U. S. Department of Health and Human Services (HHS)
regulations for the Protection of Human Research Subjects (45 CFR 46, June 18,
1991, as amended June 23, 2005 and thereafter) and describes and references
procedures that the University takes to fulfill this commitment.
02. ETHICAL PRINCIPLE
02.01 Texas State is guided by the ethical
principles regarding all research involving humans as subjects, as set forth in
the report of the National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research (entitled: Ethical Principles and Guidelines
for the Protection of Human Subjects of Research [the "Belmont Report"]),
regardless of whether the research is subject to Federal regulation or with
whom conducted or source of support (i. e., sponsorship).
03. REGULATIONS AND PROCEDURES
03.01 To
fulfill this commitment, Texas State has developed and submitted to the HHS Office of
Human Research Protections (OHRP) a Federalwide
Assurance (FWA) for the Protection of Human Subjects, following the Terms of
the Federalwide Assurance specified by HHS.
In addition, Texas State has registered with OHRP an Institutional
Review Board (IRB), established in accord with and
for the purposes expressed in 45 CFR 46.
03.02 This
FWA delineates the following concepts and procedures:
a.
Institutional
principles
b.
Applicability
of the terms of the FWA
c.
Compliance with the federal policy for the protection of human
subjects and other applicable federal, state, local, or institutional laws,
regulations, and policies
d.
Use of written procedures
e.
Scope of the IRB’s responsibilities
f.
Informed consent requirements
g.
Requirement for assurances for collaborating institutions
h.
Written agreements with independent investigators who are not
otherwise affiliated with the institution
i.
The role of the institutional official
j.
Institutional support for the IRB
k.
Compliance with the terms of the assurance
l.
A program of training in the protection of human research subjects
03.03 All research covered by this policy will be reviewed and
approved by the Texas State IRB except for those categories specifically
exempted or waived by Federal Regulation as outlined in 45 CFR, Section 46.101
(b)(1-6) and Section 46.101 (i). The involvement of human subjects in research
covered by this policy will not be permitted until the IRB has reviewed and
approved the research protocol and informed consent has been obtained from the
subject or the subject's legal representative as required by Federal
Regulations (45 CFR, Sections 46.111, 46.116 and 46.117).
Texas State assures that before human subjects are involved in
nonexempt research covered by this policy, the IRB will give proper
consideration to:
a.
The risks to the subjects;
b.
The anticipated benefits to the subjects and others;
c.
The importance of the knowledge that may reasonably be expected to
result; and
d. The informed consent process to be employed.
03.04 IRB approval for all federally-sponsored research involving
human subjects will be submitted to the OHRP or appropriate federal department
or agency. Compliance will occur within the time and in the manner prescribed
for forwarding certifications of the IRB review to DHHS or other Federal
departments or agencies for which this policy applies. As required by 45 CFR,
Section 46.119, in the event research is undertaken without the intention of
involving human subjects but it is later proposed to involve human subjects in
the research, the research shall just be reviewed by the IRB. Human research
involvement will not be permitted until IRB approval is received by the
appropriate federal department or agency.
03.05 As
the institutional official named in the FWA, the Associate Vice President for
Research is responsible for monitoring amendments to these regulations and
procedures and for proposing revisions to the FWA. Proposed amendments to the
FWA are subject to approval of the Provost and Vice President for Academic
Affairs.
03.06 These
regulations, procedures, concepts, and other relevant communications are
published on the IRB website.
Maintenance, revision and updates of this material are the responsibility of
the Associate Vice President for Research.
04. APPLICABILITY
04.01 This policy applies to all research involving
human subjects, and all other activities which even in part involve such
research, regardless of sponsorship, if one or more of the following apply:
a.
The research is sponsored by the University, or
b.
The research is conducted by or under the direction of any
employee or agent of the University in connection with his or her institutional
responsibilities, or
c.
The research is conducted using any property or facility of the
University, or
d.
The research involves the use of the University's non-public
information to identify or contact human research subjects or prospective
subjects.
04.02 All human subject research which is exempt
under 45 CFR, Section 46.101 (b) (1-6) or 46.101 (i) will be conducted in
accordance with:
a.
The Belmont
Report;
b.
The University's administrative procedures to ensure valid claims
of exemption; and
c.
IRB staff documentation of such activities.
05. REVIEWERS OF THIS UPPS
05.01 Reviewers
of this UPPS include the following:
Position Date
Associate Vice President for October 1 E3Y
Research
Director, Office of Sponsored October 1 E3Y
Programs
Chair or Co-Chairs, Institutional October 1 E3Y
Review Board
06. CERTIFICATION STATEMENT
This
UPPS has been approved by the following individuals in their official
capacities and represents Texas State policy and procedure from the date of
this document until superseded.
Associate Vice President for Research; senior
reviewer of this UPPS
Provost and Vice President for Academic
Affairs
President