UNR Office of Human Research
Protection
Submit all applications to
the UNR OHRP at 205 Ross Hall / 331,
(775) 327-2368
(775) 327-2369 FAX
Note: A complete mailing address and
department/program affiliation are required for institutional certification.
Training /
Ongoing Education of Principal Investigator and Key Research Personnel
One
component of a comprehensive human research protection program is an education
program for all individuals involved with research subjects. The University of Nevada, Reno is committed to providing
training and an on-going educational process for investigators and members of
their research team, as well as IRB members and the staff of the
UNR Office of Human Research Protection (UNR OHRP),
related to ethical concerns and regulatory and institutional requirements for
the protection of human subjects.
Research Conducted at the VA
Sierra Nevada Health Care System
All
Principal Investigators and members of their research team, as well as
IRB members and the staff of the
UNR Office of Human Research Protection (UNR OHRP), must review
core training documentation including the UNR
Policies and Procedures for Human
Research Protection, and the Belmont Report: Ethical
Principles and Guidelines for the Protection of Human Subjects of Research
(see the Belmont Report).
The UNR OHRP maintains a
subscription to the web-based “CITI
Course in the Protection of Human Research Subjects” sponsored by the
Collaborative IRB Training Initiative (CITI) and the
To
satisfy the initial education requirement, complete one of the following with
an overall competency level of 75%:
·
Group
1
Social Behavioral Research Investigators and Key Personnel Group.
·
Group
2
Social Behavioral Research Investigators and Key Personnel Group. [For
research conducted at the VA Sierra Nevada Health Care System in
·
Group
3
Biomedical Research Investigators and
Key Personnel Group.
·
Group
4
Biomedical Research Investigators and Key Personnel Group. [For research
conducted at the VA Sierra Nevada Health Care System in
Effective
August 1, 2004, new research protocols and applications for continuing review will not be accepted from principal investigators who have not
completed the initial education requirement [or the continuing education requirement once the
initial education requirement has been satisfied].
Research
protocols and applications for continuing review will be accepted and reviewed,
but final
approval will not be granted until all co-investigators and members
of the research team have completed the initial education requirement [or
the continuing education
requirement once the initial education requirement has been
satisfied].
If
investigators or members of their
research team can verify that they have successfully completed
equivalent human subjects research training, they may request a waiver to the
requirement for Initial Education. For
example, certification of attendance at one of PRIM&R’s IRB 101 pograms
or
completion of the Department of Veterans Affairs training, Overview of Good Clinical Practice and Human Subjects
Protection, will qualify as equivalent
training and will satisfy the requirement for Initial Education. However, all investigators
or members of their research team must complete the requirements of Continuing Education.
All investigators and members of their research team
must meet the UNR continuing education requirement every two (2) years after certification
of Initial Education for as long as they are involved in human subject research. There is no exception to this requirement. Once
every two years, all investigators are required to complete the Refresher Course (see https://www.citiprogram.org/default.asp) with an overall
competency level of 75%.
NOTE: Biomedical researchers must complete the Refresher
Course and the Optional Modules
Initial Education must be completed every (6)
years.
Research
Conducted at the VA
All
researchers, regardless of institutional affiliation, who propose to conduct
research at the VA Sierra Nevada Health System (VASNHCS) must have completed an
approved human research protection training within 365 days of submitting a
protocol application for human subjects review. There is no exception to this requirement.
On-line
IRB policies and procedures:
·
UNR Policies
and Procedures for the Protection of Human Subjects is maintained and routinely updated on-line by UNR OHRP, and
is available for reference and downloading: http://www.unr.edu/ohrp.
·
Department of Health and Human Services, Office for Human
Research Protections: http://www.hhs.gov/ohrp/
·
U.S. Food and Drug Administration Information Sheets:
http://www.fda.gov/oc/ohrt/irbs/default.htm
·
Department of Veterans Affairs, Office of Research
Oversight: http://www1.va.gov/oro/
·
Human research protection information will be made
available at http://www.unr.edu/ohrp on an
ongoing basis by the UNR OHRP staff to keep the University research community
apprised of current events.
Consultation:
The IRB Chair, members, and staff
stay current on local laws and federal and institutional regulations, and are
available for consultation.
Workshops:
UNR OHRP staff is
available for training seminars or presentations upon request.
If you have any questions regarding these
requirements contact the UNR OHRP office by phone at 775-327-2368.
University of Nevada, Reno
Maintained by: ohrp@unr.edu
Last Modified: August 24, 2005