From: Strasser, Jane (strassje) <strassje@UCMAIL.UC.EDU>
Sent: Thursday, September 21, 2017 7:39 AM
To: UC-COMP-MATTERS@LISTSERV.UC.EDU
Subject: [UC-COMP-MATTERS] Compliance Matters
Flag Status: Flagged
|
|
Fall
2017
Resilience
There
have been a lot of natural disasters in the news lately. The only ‘good’ thing
about hurricanes is that impacted communities have advance warning; other
disasters (from tornados to cyber-attacks) can arise unexpectedly. Your
research is valuable and some of it may be unique and irreplaceable. If
your laboratory, office, and/or computer were destroyed, would you be able to
resurrect your research? There are things that you can do to protect your data
and reagents. The National Academies of Sciences, Engineering, and Medicine has
complied a report on the topic. You can access it here:
https://www.nap.edu/resource/24827/081017_Academic_%20Resilience_%20highlights.pdf
The Open Science Framework (OSF) is an
open-source workflow management tool developed by the Center for Open Science.
Appropriate for any discipline, OSF enables researchers to manage workflows,
share files, view project analytics, and more. Osf.uc.edu
is the free portal for UC students, faculty, staff and others to manage project
files and documents; you can sign in using your UC (6+2) login.
The
Center for Health Informatics (CHI)
has highly trained data analysts to mine clinical research data effectively,
efficiently and compliantly. CHI provides services to UC, UC Health and CCHMC.
The CHI is the designated “Honest Broker” for UC Health research data. To
ensure its sustainability CHI is now a designated Service Core. Cost for data
services is $72 per hour but often fees are waived based on the criteria published here. The new structure will
allow the Department of Biomedical Informatics (BMI) and the CHI to continue to
collaborate with investigators on grant development, submission and execution
where needs include data services. The CHI is expanding capabilities to
application development, ‘big data’, analysis and the evolving discipline of
data science. If you have any questions please contact the CHI Director Brett Harnett.
We
look forward to continuing to service the research community. If you have any
questions, please feel free to reach out to me directly. Thank you.
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
IT’S
ALMOST HERE: The new online system for animal orders, services requests,
non-traditional procurement and invoicing goes live on Thursday October 26th.
IACUC protocol functions follows shortly thereafter, going live on Wednesday
January 3rd. Animal
care and use functions are moving to an integrated online system, “Research
Activities Portal” (RAP). The new system is designed to streamline
your interface with LAMS and the IACUC. During the month of October,
web-based training materials will be available to all researchers who utilize
Animal Operations (LAMS) functions. Similar training materials will be
released in December to assist with IACUC protocol development and
submissions. Details of the RAP and educational materials can be found on
the Office of Research How 2 Animal Care and Use Program website: http://researchhow2.uc.edu/home/browse-by-offices/animal-care-and-use-program
Reproducibility
in Animal Research
”Planning
Research and Experimental Procedures on Animals: Recommendations for
Excellence” (aka “PREPARE”
includes tools to reduce waste and increase reproducibility in animal research.
A few minutes spent reviewing PREPARE could save you many hours later.
Household
and Pet Store Rodents/Rabbits – Risky Business
Did
you know that you could be contaminating your research animals with pathogens?
Exposure to household rodents, rabbits, or pet stores that sell animals (e.g.
mice, rats, gerbils, hamsters, guinea pigs, rabbits, etc.) is a known risk
factor for the introduction of disease to research animals. The impact a
pathogen outbreak has on the research enterprise is HUGE. Here are steps
you can take to prevent cross contamination:
·
Follow
all required PPE and proper barrier practices
·
Avoid
bringing unnecessary items into animal housing areas
·
Avoid
any direct exposure with rodents (mice, rats, etc.) and rabbits within 12 hours
of entering UC animal areas
·
If
you are in contact with rodents and/or rabbits outside of the animal facility
take a shower (or bath) and change your clothes before you enter a UC animal
facility
If you have questions
about how to keep your research animals from getting contaminated, you can
always contact LAMS (lams@uc.edu or 558-5171) for
assistance.
Transporting
Animals Outside of LAMS Facilities
Researchers
must follow IACUC Policy #3 when transporting
rodents from animal housing facilities to IACUC-approved procedural
laboratories. Please remember the following:
·
Use
service elevators where available
·
A
maximum of two cages/carriers may be hand carried; larger numbers of cages or
carriers must be transported using a cart. Do not stack cages more than 2 high
·
Cages
must have micro-isolator lids on them, the lids must be secured, and cages
covered using a clean, breathable drape or similar material to prevent public
viewing and contain allergens
·
Appropriate
species-specific ambient temperatures must be maintained during transportation
·
Non-rodent
USDA covered species must be transported by LAMS unless otherwise approved by
the IACUC
For
animals used in biological, chemical, or radiological studies, additional
safety requirements may apply (consult with applicable safety office).
Please contact LAMS if you have questions (lams@uc.edu
or 558-5171).
Safe Use of Needles
Needle
stick injuries are common and readily avoided. These incidents typically occur
because the user did not appropriately dispose of used needles or tried to
recap the needle. Needles should not be bent, sheared, broken, recapped,
removed from disposable syringes, or manipulated by hand before disposal.
Needles are available with safety features that retract or shield
the needle. If recapping needles is absolutely necessary, use a device to recap needles or the one-handed scoop technique. If needles
need to be reused, do not leave them unprotected on bench tops or loose in
drawers. To protect an uncapped needle insert it into a Styrofoam block, cork,
or place and seal in a tube, or dispose of in an approved sharps container.
If a needle stick occurs, promptly wash the
puncture area with soap and water and contact University
Health Services for medical assistance. Needle sticks must be
reported to EHS as described in Advisory
12.2. If the needle stick
involves infectious or potentially infectious materials and/or recombinant
nucleic acid, it must be also reported to the Biosafety
Office.
International
Travel & Shipments
When
travelling abroad the Export Controls Office can assist you with the proper
identification of export control classification of items and information, as
well as end-user and destination screening to facilitate compliance. If you are
hand-carrying or shipping any UC owned equipment, samples, prototypes, etc. and
you travel internationally you may need an export license. If you are traveling
to Iran or Cuba there are additional licensing requirements, please notify the Export
Controls Office as soon as possible as it may take several months to obtain a
license. More information on shipping and traveling internationally can be
found on our website.
Purchases
Whenever
you purchase items please request the export classification of the product(s)
from the vendor or manufacturer. The export classification remains with the
product at all times regardless of its use and could still have restrictions
even if you can buy it from eBay or Amazon. If you have questions, please
contact us at exportco@uc.edu or 556-1426.
Certificates of Confidentiality
The NIH has updated their Certificate of Confidentiality (CoC)
Policy.
Effective October 1, 2017 all biomedical, behavioral, clinical or
other research, in which identifiable, sensitive information is collected, on
or after December 13, 2016, will be deemed to have a CoC and must protect the privacy
of individuals who are subjects of such research. Certificates issued in this
manner will not be issued as a separate document. Please review your ePAS
submission and make any applicable updates to your protocol and/or informed
consent forms(s). NIH will continue to consider CoC requests for
non-federally funded research that collects or uses sensitive
information.
Students
and the Outside Activity Report (OAR)
If
a student is working on an unfunded research project, (s)he does not need to
complete an OAR. The only time an OAR is needed from a student is when
they are the PI or Co-PI on a funded research project. This is typically
seen for dissertation fellowships. Students should still mark “yes” on the
OAR ePAS question when submitting unfunded research projects. This will allow
them to move forward with the protocol submission.
Tips
for Using Social Media or Texts to Recruit & Communicate with Participants
Study
specific social media and text messaging accounts may be used to recruit
potential study participants and/or follow up with current research participants.
It is important to understand privacy policies and features of the selected
medium. Plans for use must be approved by the IRB. To prevent confidentiality
breeches and the release of sensitive information do not invite prospective or
active study participants to communicate using personal email or social
messaging.
Submissions
for WIRB
WCG
(WIRB-Copernicus Group) has implemented significant revisions to the initial
review submission form (IRSF) and the process for
consent and assent instructions. Some of the
key changes include:
·
In the IRSF, when a response requires an additional/supplemental
document, a warning symbol and instructions will appear in that line item and
at the end of the form
·
Financial disclosure form is embedded in the IRSF form
·
Translation Request form is no longer embedded in the IRSF form
·
Consent and Assent Instructions will no longer be included on the
Certificate of Approval but will be located on the informed consent form.
Re-consenting requirements will still be included on the Certificate of
Approval for the modification review.
·
The Consent and Assent Instructions to be used when children are
participating in research will no longer be specific to age groups, but rather
have reference to the capacity of the child.
For further information, please refer the WCG
website: http://wirb.com/Pages/DownloadForms.aspx
Payments
to Participants
Ensure
that the informed consent form clearly states what visits will, or will not, be
paid. Please clearly state whether you will or will not pay for repeated visits
(e.g., re-performing lab tests).
UCHealth
Research Locations
Whenever
a UCHealth facility (e.g. UC Medical Center, West Chester Hospital, Drake
Center, etc.) is being used, the informed consent must list the name of each
facility where research will occur (see UCH-OCR-REV-SOP-002-02).
The Radiation Safety Office will be
closed for the winter break beginning December 23, 2017 through January 1,
2018. Any users of radioactive materials (RAM) should plan RAM shipments
to arrive prior to December 22, 2017 as radiation safety staff will not be on
site to receive and deliver your order during the break. If there are any
plans to order and receive RAM during the winter break, please contact the
Radiation Safety Office at (513) 558-4110 to make special arrangements.
As usual there will be a Radiation Safety Technician on call (513) 249-6812
during the closure to assist in any emergency.
As we wrap up the calendar year, we
would like to remind all individuals (and their staff) who use/possess
radioactive materials to ensure completion of the required annual radiation
safety refresher training. Instructions for completing the required
training can be found at http://researchcompliance.uc.edu/RadSafety/Training.aspx
TRAINING OPPORTUNITIES
UC Libraries and the Graduate School are sponsoring a Workshop for Increasing Openness and Reproducibility in Quantitative Research. October 25, 2017. The workshops will take place from 9:00AM-12:00PM in MSB and from 1:30-4:30PM in Langsam Library. Topics covered include project documentation, version control, pre-analysis plans and open source tools. Register at https://goo.gl/Hf5neh; contact Amy Koshoffer at ASKDATA@uc.edu for more information.
The Office of Research has partnered with the regional smart
cities initiative, to sponsor the upcoming the Smart Regions Conference
being held on October 24-25 at the BB&T Arena in Northern
Kentucky. The conference will be attended by public
officials, academic and industry experts and leaders, and community leaders
committed to technology as a tool to improve outcomes for people. For more information go to: https://www.smartregions.org/conference-details/goals-and-impact.
Anyone interested in participating and/or
attending should contact hello@smartcincy.org by September 25. Make sure that
you identify yourself as being part of UC.