Human Research Protection
Education and Training of HRPP Personnel
Adopted By: Associate Dean for Research Policy, UW-Madison Graduate School
Adoption Date: December 8, 2005
Revised By: Human Research Protection Program Advisory
Revised: October 18, 2006
Revised: December 6, 2007
Revised: January 11, 2008
Revised: April 10, 2008
Revised: May 6, 2010
Revised: March 1, 2012
This document describes how UW-Madison
ensures that its research investigators, IRB members and staff, and other
personnel, when appropriate, maintain continuing knowledge of, and comply with,
their legal and ethical obligations to protect human subjects when conducting
I. At the UW-Madison, the responsibility for the protection of human research
participants is shared by the Institutional Official (IO), the Research Policy
Office (RPO), the Institutional Review Boards (IRBs), and the investigators.
Each has a crucial, yet distinct, role to play.
II. Ethical Obligations.
A. In all research involving
human participants, UW-Madison is guided by the ethical principles as set forth
in the “Belmont Report” by the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research [Ethical
Principles and Guidelines for the Protection of Human Subjects of Research],
regardless of whether the research is federally-funded or non-federally funded
III. Federalwide Assurance
A. Through its Federalwide
Assurance (FWA) with the Department of Health and Human Services (DHHS),
UW-Madison guarantees that all UW-Madison investigators working on all
federally-funded human subjects projects will comply with the terms of
assurance for protection of human subjects for institutions within the United States. The FWA places shared responsibility for protecting the rights of human research
participants on research investigators and on the UW-Madison as an
IV. Federal Common Rule
A. With respect to all
federally-supported human subject research, UW-Madison complies with the
Federal Policy for the Protection of Human Subjects, known as the Common Rule,
45 CFR Part 46, as well as any additional human subject regulations and
policies of the sponsoring Department or Agency.
V. Other Applicable Rules and Guidelines
A. Where applicable,
UW-Madison also complies with the Food and Drug Administration’s
(FDA’s) regulations and guidance on protection of human research
participants in research studies involving drugs, medical devices and
biologics, 21 CFR Parts 50 and 56; the Veteran’s Administration (VA) regulations
pertaining to the protection of human research participants, 38 CFR Part 16; and
the privacy requirements of the Health Insurance Portability and Accountability
Act of 1996 (HIPAA) implemented by 45 CFR Parts 160 and 164 (Privacy Rule).
VI. Communication of ethical standards and legal obligations
A. The UW-Madison’s
Human Research Protection Program (HRPP), the HRPP Advisory Committee, and the
four UW-Madison IRBs are responsible for ensuring constructive communication
among the research administrators, department heads, research investigators,
clinical care staff, research participants, and institutional officials as a
means of maintaining a high level of awareness regarding the safeguarding of
the rights and welfare of research participants.
VII. Training in ethical standards and legal obligations
A. IRB Members and Staff
1. New UW-Madison IRB
members and IRB staff participate in orientation and training programs provided
by the University covering research review and human research protection.
See, ED IRB & SBS IRB
Member Training SOP
HS IRB & MR IRB
Member Training and Orientation SOP.
2. UW-Madison IRB members
and IRB staff receive training manuals, IRB Member Handbooks, and have access
to reference books and copies of the Belmont Report.
3. IRB members and IRB staff
also participate in ongoing education and training through continuing education
provided by the IRB chairs and staff, as well as during discussion of protocols
at IRB meetings, CITI IRB member training, and attendance at meetings and
workshops relating to human research protection ethics, including the
UW-Madison Graduate School Seminar Series and Public Responsibility in Medicine
and Research (PRIM&R) sessions.
a. Education Research and
Social & Behavioral Science IRBs (ED/SBS IRBs) Staff are also provided
copies of all of the same materials that are provided to IRB members and access
to all UW-Madison policies and guidance through the web based document storage
and management system. IRB staff are required to take CITI training and to attend/participate in any ongoing programs offered by the ED/SBS IRBs Office
and the Graduate School Seminar Series and may attend professional conferences.
b. In addition to what is
described above, HS IRBs staff involved in the triage and review of submissions
are required to complete and pass campus human subjects protection training and
HIPAA Privacy Rule training for researchers. New staff reviewers undergo a
two-month training period by an experienced staff member and work under the
mentorship and oversight of an experienced staff member for at least six
months. Ongoing education occurs at the weekly meetings held for all staff,
which include review of existing and new policies and discussion of review and
B. Investigators and Research
1. Training and educational
a. UW-Madison’s HRPP
website and the websites of the four campus IRBs provide educational and
instructional material, including online tutorials, for investigators and
b. UW-Madison requires that
all personnel engaged in human subjects research, as defined in Sec. VII.B.5 of this policy, to complete human subjects training. The required UW-Madison training
consists of certain CITI human subjects protection
training modules [https://my.gradsch.wisc.edu/citi/index.php] designated
by the UW-Madison. CITI training is provided by the Collaborative Institutional
c. Personnel engaged in
human subjects research who have dual appointments with the William S.
Middleton Veteran’s Affairs Hospital and the UW-Madison (“dual
appointees”) and are required to take the VA human subjects training are
not required to take the UW-Madison CITI human subjects protection training.
Completing the VA human subjects training will satisfy the UW-Madison human
subjects training requirements stated in Section VII.B.2.
d. University of Wisconsin
Hospital and Clinics Authority (UWHCA) employees are required to take
UW-Madison CITI human subjects training, even if they have no UW-Madison
appointment and are not UW-Madison students.
e. All personnel engaged in
human subjects research, as defined in Sec. VII.B.5 of this policy, must retake
the required UW-Madison human subjects training every three years.
Outside collaborators from institutions that do not have an FWA
must also satisfy UW-Madison’s three year retraining requirement.
Dual appointees, as defined in Sec. VII.B.3 of this policy, who
take the VA human subjects training to satisfy the UW-Madison human subjects
training requirements are subject to the VA’s annual retraining
f. All personnel engaged in
human subjects research, as defined in Sec. VII.B.5 of this policy, must achieve
an 85% pass rate averaged across all modules each time they take the UW-Madison
CITI human subjects protection training course.
g. Personnel engaged in human
subjects research, for purposes of this policy, means, individuals who:
direct research or serve as the principal investigator,
enroll research subjects (including obtaining subjects’
informed consent or screening potential subjects) or make decisions related to
eligibility to participate in research,
conduct study procedures,
analyze or report research data,
analyze or report adverse events, or
author manuscripts concerning the research for publication.
subcontractors, and consultants who act in any of the roles listed above are personnel
engaged in research, as defined in Sec. VII.B.5 of this policy, and required to
take human subjects training. Any new research personnel, including
investigators or other research staff, added during the course of a project
must also complete human subjects training.
h. For personnel at other
institutions collaborating with UW-Madison researchers, UW-Madison IRBs may
accept certification of the completion of a comparable human research training
program as a substitute for completion of UW-Madison’s required training.
UW-Madison IRBs accept the following substitutes:
the Veterans Affairs Good Clinical Practice & Human Subjects
training taken at another institution that uses the CITI Course
in The Protection of Human Research Subjects,
the National Institutes of Health training, and
training from other institutions holding a Federalwide Assurance.
Investigators can also
apply to the IRB Offices for approval to substitute other training programs for
personnel engaged in human subjects research, as defined in Sec. VII.B.5 of
this policy, who are not otherwise affiliated with the UW-Madison, if
circumstances warrant. For example, a different substitute training program
might be approved, if other personnel would have difficulty accessing one of
the training programs listed above because they are not located in the U.S.
i. When relevant,
UW-Madison investigators and research personnel must also take HIPAA research
training before being permitted to conduct research involving humans.
j. Individuals having an
interest in translational and clinical research may also participate in the UW-Madison Medical School’s Clinical Investigator Preparatory Program (CIPP), a
training program funded by the National Institutes of Health. The program
provides two years of coursework linked to research and mentoring.
k. Investigators and
research staff are required to review the principles of the Belmont Report when
completing the UW-Madison CITI training modules.
2. Monitoring and Verifying
a. ED/SBS IRBs
Verification of training for researchers and other personnel
listed on an Initial Review, Continuing Review and Change of Protocol
application is ensured by an automated process built into the ED/SBS
IRBs’ electronic protocol submission system. Unless all personnel listed
on an electronic application have a current human subjects training date in the
training date field, the system will not allow the Principal Investigator to electronically
submit the application to the IRB office. Instead, when the PI attempts to
submit the application, an automated response identifies who on the research
team has not completed human subjects training.
b. HS IRBs
During IRB administrative review of an initial application IRB staff
verify that all members of the study team have completed required human
subjects protection training and, if applicable, HIPAA Privacy Rule training
for researchers via the campus training database. Additionally, the HS IRB and
MR IRB confirm human subjects protection training requirements via the campus
training database when personnel changes are submitted for review.
C. Institutional Official
and IRB Chairs
designated Institutional Official and IRB chairs complete the online Assurance
Training offered by the OHRP. [See, http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp]
VIII. Written Policies and Procedures
A. UW-Madison HRPP has and
follows written policies and procedures to assure human research is conducted
in compliance with applicable ethical and legal obligations, including policies
and procedures for (i) conducting initial and continuing review of research,
(ii) handling amendments to protocols, (iii) ensuring IRB approval before
research and changes in approved research are initiated, and (iv) reporting and
processing unanticipated problems involving risks to participants or others,
instances of serious or continuing non-compliance, and the suspension and termination
of research approval. These policies and procedures are made available to all
individuals involved in the research review process, including investigators
and research staff, IRB members and staff, and institutional officials. The
UW-Madison IRBs also provide investigators and research staff with written
guidance documents and forms and instructions relating to the research review
and reporting processes.
A. Before any sponsored
research study may begin, the study must be reviewed and approved by a
UW-Madison IRB to assure compliance with applicable federal regulations, state
laws and ethical requirements for human research.
B. UW-Madison’s FWA
requires all human research, including industry-sponsored research, to be
conducted in accordance with the Belmont Rule.
C. The standard research
agreement used as a model for agreements between UW-Madison and sponsors
specifically identifies the UW-Madison’s responsibility to comply with
rules and regulations for human research including adherence to applicable ethical
principles, state, local and federal laws, federal guidance and all
requirements of the approved research protocol. See, UW-Madison Standard
Clinical Trials Agreement
D. Sponsor protocols contain
terms and conditions requiring studies to be conducted in compliance with
federal regulations governing protection of human subjects and the
UW-Madison’s ethical obligations. See, UW-Madison Policy on Sponsored
Research Agreements; Standard Clinical Trials Agreement