From: Strasser, Jane (strassje) <strassje@UCMAIL.UC.EDU>
Sent: Tuesday, July 25, 2017 6:57 AM
To: UC-COMP-MATTERS@LISTSERV.UC.EDU
Subject: [UC-COMP-MATTERS] Compliance Matters
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Summer
2017
Reproducible Research
We have all heard the concerns voiced over the quality of
research produced and the inability to reproduce much of it. Reproducible
research is more than transparency and data sharing. You can find some useful
tools to promote quality and transparency here and
for replication here. If there are other
tools that you find useful please share them.
Single IRB Mandate
NIH has delayed implementation of the single IRB (sIRB) mandate
to January 25, 2018. If you missed the CCTST Forum on sIRBs you can review the
information here.
New Website
All units within the Office of Research are migrating to a new integrated web
portal. You have the opportunity to provide input that will make the websites
more useful to you. Please visit Research How2 and take the
Application Tour.
As always, if you have
a suggestion that will help us to help you, please contact us at research.compliance@uc.edu.
Jane Strasser, PhD
Associate Vice President for Research
IN THIS ISSUE:
Animal
Care and Use Program Update
Human Research Protection Program News
Radiation
Safety News
Training
Opportunities
ANIMAL CARE AND USE PROGRAM
UPDATE
We
need your input
The
new IACUC protocol submission application is nearing completion. The next
step will involve thorough user testing to ensure that the system is functional
and meets your needs. Volunteers are needed to submit their current IACUC
protocols in the new system.
Transport
and Disinfection of Supplies and Equipment
All supplies and
materials within any LAMS facility must be in a closed, nonporous, leak proof
container (styrofoam and cardboard are not acceptable) and items must be
secured during transport. All carts and containers must be sprayed with Clidox
when entering animal facilities. Items being placed in the laminar flow hood or
biosafety cabinet must be sanitized.
Expand
Your Skill Set
Did
you know LAMS offers free training on surgical and non-surgical procedures?
Topics include blood collection techniques, genotyping, perfusion methods,
anesthesia administration and monitoring, aseptic technique, renal capsule
implant and many more. To register for free LAMS training, please submit
a Veterinary Service Request at: http://researchcompliance.uc.edu/LAMS/ServiceRequests/ServiceRequestVet.aspx
Lab Hazard Awareness Training: Non-Lab
Personnel
Online
training
is available to familiarize non-lab personnel with possible lab hazards (e.g.
biological, chemical, radiological hazards), safety warning signs, and
labels. This training also discusses the procedures for visiting a lab
and how to respond to an accidental exposure.
Accidents
Happen
Accident
prevention is the most important part of our job, but we can’t do it
alone. If you are aware of a spill or potential exposure that involves
recombinant nucleic acids, infectious or potentially infectious materials,
please let us know. Were you involved in an accident? Click
here to learn how to respond
and report.
International
Travel Review
When
traveling abroad export controls regulations apply to what you are taking, who
you are visiting (institution/person), and where you are going. A license or
exception/exemption may be necessary prior to your trip. When travelling
internationally the Export Controls Office requests that travelers complete a
brief form and submit it via email prior to travel, the form helps us protect
you while you travel. Please let the Export Controls Office know if you have any
questions or concerns.
CITI Training
As of July 1st we have new CITI training
for human subjects’ researchers (“Core Human Subjects Research Curriculum”
which is comprised of 9 required and 2 optional modules). You will start to see
expiration notices if your training expires this year and new trainees will
only see the new training. Remember, to facilitate cross-institutional research
our training is under the “Greater Cincinnati Academic and Regional Health
Centers” (not under UC).
If
you have previously completed training in CITI and you need to retrain click
the “Add a Course” link inside of the My Learner Tools box. Guidance on
answering the questions is on the website; if you have not
previously completed CITI training information for registration is available here.
Note that if your training does not expire this year you will not
yet be able to access the training.
Collecting
Pregnancy Information from or about Female Partners and Newborn Infants
In some research studies, investigators may be
required to obtain information about the progress of a pregnancy if the partner
of a research subject becomes pregnant. Collection of information about the
pregnant partner and newborn infant constitutes human subjects research.
In such cases, the IRB-approved protocol must include provisions
for collecting information from the pregnant partner and newborn infant. The
IRB must approve the study to include pregnant women and minors. Informed
consent must be obtained from the partner prior to the collection of any data
from her or the newborn infant. Written authorization for use and disclosure of
protected health information must also be obtained.
Clinicaltrials.gov
There is increasing scrutiny of reporting in clinicaltrials.gov.
Reports of noncompliance do not take into account the amount of time issues
reside at PRS, or the number of times researchers send queries. Protect
yourself and document your interactions.
EPIC
Care Everywhere
UC Health does not permit the use the Epic Care
Everywhere feature for research purposes. This includes screening for patients,
validating inclusion and exclusion criteria, chart review, or follow ups.
SAE
Reporting to UC Health
UC Health must be notified whenever there is an
unexpected and related serious adverse event that occurs for a study patient
while at a UC Health facility. Use the MIDAS system to report these events. For
more details please
review the SOP.
Agree
to Participate in ePas for New Study Personnel
The
notification to key personnel to agree to participate on amendments in ePas is
still broken. Please direct new study personnel to log into ePas, search the
study number and complete the
‘agree to participate’ form using the activity
button to the left. If study personnel are not able to see the study after
logging into the system contact
your HPA
for assistance.
Student,
Fellow, and Resident Research
Per
UC HRPP
Policy IV.01,
human subjects research conducted by a student, fellow, or resident must have a
faculty member as the PI or Co-PI.
Billing
changes
As
of July 1st 2017, all invoices related to IRB review (including
initial review) will go directly from UC’s Office of Research to the
departments. If you have questions about fees for UC IRB services, please
visit our
website
or contact Amy
Bryant.
For questions regarding the Office of Clinical Research and their billing
process, please contact UCP-ClinicalTrials@UCHealth.com.
NIH
e-Protocol Writing Tool and NIH-FDA Clinical Trial template
NIH has released the Final
NIH-FDA Clinical Trial Template for Phase 2 and 3 IND/IDE Studies. The template aims to assist NIH-funded investigators in preparing clinical
trial documents efficiently. NIH has also released a web-based platform where
investigators can utilize the protocol template in an interactive
fashion. The Electronic Protocol Writing Tool allows for a collaborative approach to writing and reviewing
protocols. Investigators will be able to use the tool to form a “protocol
writing team” and assign different individuals with writing and reviewing
roles. All of the above resources can be found on the Office of Science
Policy’s website.
New Radiation Safety Officer
Please welcome our new Radiation Safety Officer, Terry Lindley, MRHP, CHP, CNMT. Terry has an impressive health physics background
working with radiopharmaceuticals and most recently working for the Illinois
Emergency Management Agency. Terry assumed leadership of our Radiation Control
and Safety Program on May 30. Special thanks to Beth Boston for
outstanding leadership as the interim Radiation Safety Officer while we
completed the search.
TRAINING OPPORTUNITIES
Human Research Protection Forum
September 6-7, 2017 at the
Northern Kentucky Convention Center
Space is limited--register today!
Representatives from the Office
for Human Research Protection (OHRP) and other federal agencies as well as
research experts will provide perspectives and resources for interpreting and
applying human subject protections in an evolving regulatory landscape. Attend
one or both days. OHRP presentations included both days.
Visit the conference
website to view the full conference schedule.