APRIL, 2009
QUARTERLY NEWS
New Guidelines for Quality Improvement Research
There is often confusion in determining whether Quality Improvement (QI) or
Quality Assurance (QA) activities fall under the jurisdiction of the IRB. There is
often overlap between QI and research activities and encourage local IRB
clarification or guidance in these instances. A guidance document has been
developed to assist the research community deciphers the difference
between these activities and if IRB review is warranted. If the IRB determines
that the activity is strictly QI then the research can either be categorized as
exempt or not human subject research.
Utilizing characteristics of a study can help differentiate between QI and
research through evaluation of certain criteria (i.e., intent/purpose, degree of
generabilizability and associated risks). For instance, QI intends to increase
efficacy of processes as part of routine care within the organization versus
research intends to generate knowledge independent of routine care.
Typically, research is aimed to benefit a large population, while QI studies
intend to satisfy local/internal population consisting of a smaller population
(i.e., staff, patients, caregivers and the study participants themselves).
A characteristic of research is the potential of having greater than minimal risk
and QI projects have minimal risk. QI tends to use benchmarks from previously
established best practices eliminating concerns for additional risks. Lastly,
“intent to publish” may be a red herring and not used as a means to
differentiate between research and QI along. Intrinsic components of QI,
educational infinitives and competency assessment are shared learning. It is
entirely appropriate to disseminate and replicate QI successes, including
through channels that are external to an organization. This may include
presentations at meetings and publications in professional journals. Therefore,
the mere intent to publish the findings of a QI project does not obligate IRB
review. As long as the publication does not refer to the activity as research
and makes it clear the publication is the result of a quality improvement or
educational/competency assessment as defined above, there is no need for
any action on behalf of the IRB. If a journal questions this determination, the
Offices of Research Compliance and the IRB will be happy to provide them
with the guidelines referenced above.
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Inside This Issue
PAGE
Human Subjects:
Guidelines for QI Research
1
New Genetics Law
2
Responsible Conduct of
Research:
Mentoring Plans for Postdocs
2
RCR Training Sessions
2
Transport/Travel Research Materials?
3
Animal Care and Use
IACUC News
4
Preparation: IACUC Spring Inspections 4
Conflict of Interest
Disclosure in Informed Consent
Contact us at:
Office of Research Compliance
CSAB 128
251-460-6625 (Office)
dlayton@usouthal.edu
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New Genetics Law: Genetic Information Nondiscrimination Act (GINA)
The DHHS, Office of Human Research Protections has issued guidance for investigators and IRBs on
how to comply with relevant portions of GINA, a Federal law that prohibits discrimination in health
coverage and employment based on genetic information. GINA defines a genetic test as an analysis
of human DNA, RNA, chromosomes, proteins, or metabolites that detect genotypes, mutations, or
chromosomal changes. Routine tests that do not detect genotypes, mutations, or chromosomal
changes, such as complete blood counts, cholesterol tests, and liver enzyme tests, are not considered
genetic tests under GINA. The Office of Human Research Protections state that given GINA has
implications regarding the actual or perceived risks of genetic research and an individual's
willingness to participate in such research, investigators and IRBs should be aware of the
protections provided by GINA as well as the limitations in the law's scope and effect. In
particular, criteria for IRB approval of research and requirements for obtaining informed consent
will need to be satisfied under the new law. When investigators develop, and IRBs review
consent processes and documents for genetic research, they should consider whether and how
the protections provided by GINA should be reflected in the consent document's description of
risks and provisions for assuring the confidentiality of the data.
For those interested in additional information a document entitled, "What Does GINA Mean: A Guide
to the Genetics Information Nondiscrimination Act" written by the Coalition for Genetic Fairness,
provides guidance for individuals, employers, health care providers, and health insurers on the new
federal law. The document is at:
http://www.oregon.gov/DHS/ph/genetics/docs/GINAsummaryGeneticsAlliance.pdf
Academicians can better assure clinical trial participants that their genetic data will not be used to
make insurance or employment decisions and that they have recourse under the law if their genetic
information is abused in such a manner. Additional guidance on this law will be forthcoming for the
research community for educating both physicians and patients regarding their rights and that of the
IRB to assess risks and additional protections provided by GINA.
Resources for Addressing NSF Postdoctoral Mentoring Requirement
The NSF has published a revised version of the NSF Proposal & Award Policies & Procedures Guide, NSF
09-29, which applies to proposal received beginning April 6, 2009. The revised guide addresses NSF
implementation of the mentoring requirement in the America COMPETES Act to include a
supplementary document describing the mentoring plan/activities for proposals when funding will
support postdoctoral fellows on the project. The Office of Research Compliance issued a
memorandum to College Deans, Chairs and Grants Administrators providing information about how to
meet this requirement. Guidelines for Mentoring Plans in Research, Career Development and Training
Proposals are posted at: http://www.southalabama.edu/researchcompliance/responsible.html
SAVE THE DATE! The Office of VP for Research will present the second series of
training in Responsible Conduct of Research:
WHAT:
WHEN:
WHERE:
Collaborations and Team Science
June 8th, 10:00am or June 17th, 3:00pm
College of Education Conference Room, UCOM 3901
Training objectives and request for registration will be distributed at a later date.
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Do You Transport or Travel With Research-Related Materials?
There are various laws and institutional procedures that impact the transportation and travel of University
property, and research-related materials, including data, biological materials and equipment, regardless if the
information or material is hand-carried during travel or packaged and shipped. Employees, as well as
international visitors, should be aware of several key factors:
USE OF MATERIAL TRANSFER AGREEMENT (MTA):
An MTA protects the University and the USA providing scientist against claims that may arise through the
recipient’s use of the USA material. An MTA also allows the use of the materials to be limited to specific projects
and precludes the further transfer of the materials to non-approved recipients.
• The MTA permits review of intellectual property rights to protect the interests of the University and the USA
scientist
• When the University is the recipient of materials, the MTA triggers appropriate compliance review for
specified regulated research activities
• MTA should be used when transferring materials (i.e. research materials, software, biological materials,
etc.) from the University to outside parties
• MTA should be used when University materials are received from an outside party
• MTA forms are available on the Office of Technology Transfer website at:
http://www.southalabama.edu/ott/
***********
EXPORT CONTROL AND TRADE SANCTIONS:
Export Controls refers to regulations used by the federal government to control the export of information or items
for reasons related to national or economic security and foreign policy. These laws regulate the export of
sensitive equipment, software, technologies and biological materials. The use of controlled items by foreign
nationals requires a license from the respective governing agency unless an exemption exists. Furthermore, trade
sanctions, imposed by the Office of Foreign Assets Control may restrict travel, payment or providing anything of
value to sanctioned entities, regardless of exemptions.
•
Information and guidance materials is available on the Office of Research Compliance and Assurance
website at: http://www.southalabama.edu/researchcompliance/exportcontrol.html
***********
AIR TRANSPORTATION:
The Transportation Security Administration has rules what regarding what passengers can place into their
checked and carry-on luggage. Be aware that these rules may prohibit research materials and equipment from
being brought on the airplane.
•
List of permitted and prohibited items are posted on the TSA website at: http://www.tsa.gov The list is
subject to periodic updates.
***********
BIOLOGICAL MATERIALS:
Be aware that federal law and regulations by the USDA, FDA or EPA can significantly limit the interstate shipment
of certain biological, recombinant or toxic materials. Commercial shipment of hazardous materials must comply
with US Department of Transportation regulations.
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Spring 2009 IACUC Inspections
Bite Wounds –
Do You Know What to Do?
During the last week of May, the IACUC will
begin semiannual inspections of all animal
facilities and research laboratories in which
surgery or euthanasia procedures are
performed or animals are kept for greater than
twelve hours as defined by USDA. Note the
following steps to a successful inspection:
See the Standard Operating Procedures
for Laboratory Animal Bites and Scratches
at:
http://www.southalabama.edu/research
compliance/pdf/sopBitescr.pdf
•
•
•
IACUC News
•
•
•
The IACUC voted to expand the
acceptance of multiple species on a
single animal protocol (up to three
species per protocol), provided that
submitted experimental procedures are
identical among the submitted species.
Any minimal species-specific
differences in treatment, dosages,
response, and measurement of
husbandry must be clearly delineated
by the investigator.
Led by Chair Dr. Gard and a subcommittee, the IACUC is developing
“IACUC Policy for reporting animal
welfare concerns” to better identify,
handle and process incidents.
•
•
Follow appropriate drug storage,
control and expiration date monitoring
Keep drug/controlled substance logs
Separate, mark and/or dispose
properly of expired supplies
See that APPROVED protocols are
available in lab animal areas, including
IACUC Approval letter
o Know your animal protocol
o Refer to the protocol often
o Make training documentation
available for all who work with
animals on your protocol
o Be certain that training
documentation is up-to-date
(within last three calendar
years)
o Has everyone in your lab read
the protocol and know where it
is located?
o Deviations from the protocol
are not allowed
o There is no such thing as a pilot
study that does not need
IACUC approval
o Protocol(s) must match your
grant application
Demonstrate that approved
euthanasia technique(s) are used
properly
Have separate surgery areas for prep,
procedure and recovery
All individuals involved in animal research
activities at USA are applauded for your
diligent efforts in maintaining high standards of
compliance and for the safety and welfare of
animals. Your cooperation in guiding IACUC
reviewers through your facilities and labs during
this process is appreciated.
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Conflict of Interest Disclosure and Informed Consent:
What’s Important to IRBs, Human Subjects and Research Coordinators
Clinical research investigators should utilize
model language to help enable informed
decision making for subjects, reduce risk of
legal liability and promote transparency.
Ultimately, disclosure has become a staple of
conflict of interest management by institutions
and academic medical centers as
recommended in the 2008 AAMC-AAU joint
report available at:
http://research.unm.edu/coi/private/Guideline
s/AAMC-AAUCOIHuSubRprt_2008.02.pdf
relationships. However, the IRB encourages the
use of its template to be used in constructing
disclosure statements for the informed consent
document available at:
http://www.southalabama.edu/researchcomp
liance/pdf/conflictguidance.doc
Additionally, if a COI is indicated, the party for
whom the conflict exists must complete the
management plan form documenting how the
individual plans to manage, reduce, or
eliminate the potential conflict(s). This form is
available at:
http://www.southalabama.edu/researchcomp
liance/forms.html
Clinical research coordinators are often at the
forefront in communicating conflict of interest
(COI) disclosures to prospective research
participants and are in the “need to know” to
help facilitate questions received on COIs from
participants. In particular, financial conflicts of
interest involving academic physicians has
been a hot topic and expectations are that
this pattern will continue due to a number of
congressional investigations ensued to
evaluate physician-industry financial
relationships. Thus, this issue in particular has
been in the limelight for those that receive NIH
funding whereby members of the Senate
Finance Committee led investigations of two
publicized cases occurring at Emory and
Stanford Universities. As a result of such
investigations a draft bill called the “Physicians
Payments Sunshine Act”, if passed will require
manufactures of pharmaceutical drugs,
devices and biologics to report to the federal
government dollars greater than $500 that give
to physicians via payments, travel, gifts,
honoraria, etc. Several companies to include
Eli Lilly and Merck & Company are expected
this year to begin public electronic disclosures
of physician’s income.
It is hoped that using these tools will help
facilitate the understanding with prospective
participants by promoting transparency during
the process of consent, as well to recognize the
importance of the need to manage any
potential conflicts.
Departmental Presentations
The Office of Research Compliance is
available for providing education on a
variety of compliance topics in a variety
of venues such as brown-bag lunch
meetings, workshops, or student classes.
Please contact Dusty Layton at 460-6625
or dlayton@usouthal.edu if you are
interested in scheduling a training session
for your department or student class.
yyyy
Due to the possible complex and varying
interests investigators may have in sponsors, it is
difficult to create a boilerplate informed
consent form statement that will universally
adhere to informing subjects of such
Questions or Suggestions?
We welcome your input and suggestions
for future issues. Let us know what you
think and how you use the newsletter.
Newsletter archives are available through the Office of Research Compliance website at:
http://www.southalabama.edu/researchcompliance/index.html
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