N
Note from Director
July 2014 || Volume 6
Issue 2
INSIDE THIS ISSUE
Note from Director
1
Clinical Research News
1
Spotlight:
Investigator-Initiated Research
2
Do You Know About…
New IRB CITI Ethics Training
2
Research Certifications
3
Annual Conference
4
Upcoming Educational Opportunities 4
Thank you for your continued interest in our Newsletter, which aims to keep
you informed of pediatric research activities, research services and
educational opportunities that are available to you. In each issue, we highlight
some of our active research projects and include other announcements and
education that we think would be of interest to those across the Advocate
Children’s Hospital. You will see in this Newsletter that we feature studies that
were funded by internal and external grants awarded to our investigators.
Congratulations to these individuals and teams, and we look forward to
working with more of you to find ways to enhance and support your research
activities.
Denise B. Angst, PhD, RN
Director, Advocate Center for Pediatric Research
Clinical Research News
The Impact of Fortifiers on Breast Milk
Researchers at Advocate Children’s Hospital – Park Ridge (ACH-PR) are
leading a study to learn about the effects of human milk fortifiers on cellular
and nutrient components of breast milk. Human milk fortifiers are routinely
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the rapidly growing preterm infant.
The researchers are testing how the addition of commercial human milk
fortifiers may affect components of breast milk (e.g., lipase activity, fat
composition, immune supporting cells). The study will enroll approximately 80
mothers who will provide up to two samples of breast milk for milk testing
and analyses. In addition, the researchers will obtain samples from the
Illinois Donor Milk Bank. The milk testing will be performed by research
collaborators at Rosalind Franklin University of Medicine and Science
This research is being funded by a grant from the Gerber Foundation.
1
The Principal Investigator for this study is Ramona Donovan, MS, RD, CRCC.
If you would like further information about the study, please contact Ms.
Donovan at: 847-723-7157
. . . . . . . . . . . . . . . . . . . . . . . .
For more information on research with children at Advocate’s Children’s Hospitals, visit www.advocatehealth.com/pedsresearch
SPOTLIGHT ON
INVESTIGATORINITIATED RESEARCH
Physician-led Research
With collaborators on both campuses of the Advocate
Children’s Hospital, Keren Hasbani, MD (a pediatric
cardiologist and expert in MRI) is leading a study to
evaluate the feasibility, accuracy and clinical impact of
fetal cardiac magnetic resonance imaging (FCMRI).
Although cardiac MRI is commonly used to obtain
images of the heart in children and adults, researchers
around the world have just begun to perform FCMRI in
an effort to supplement fetal echocardiograms and
provide additional information for diagnosis and
treatment of fetuses with cardiac abnormalities. The
study, funded by the Russell Research Institute’s Small
Grants Program, will enroll approximately 80 women
over a 2-year period.
Did You Know…
NEW RESEARCH ETHICS
TRAINING
The Advocate IRB has changed the required research ethics
training for all who are involved in human subject research
to the CITI on-line training course: Collaborative Institutional
Training Initiative (CITI). As of October 6, 2014, all new IRB
applications and continuing reviews will be considered
incomplete if any member of the study team has not
completed CITI training. The CITI modules are available at
www.citiprogram.org/. Depending on the type of research,
investigators and research team members will select and
complete the modules in one of 4 user groups:
 Biomedical Researchers
 Social-Behavioral Education Researchers
 Biomedical Data or Specimen Only Research
 Remedial (specialized training that does not fall into the
other areas; e.g., research involving children, HUD
research)
For more information, please contact Dr. Hasbani at
847-723-9432.
All pediatric investigators and research team members will
need to complete the module on research involving
children, in addition to the other user group modules that fit
with the type of research to be performed.
Nurse-led Research
There is a detailed FAQ document on the IRB website that
provides step by step instructions on completing the CITI
Ethics Training (See
http://www.advocatehealth.com/formsinstructionspoliciesa
ndguidelines). If you have questions, please contact the IRB
at 630-929-6148.
Debra Skopec, BSN, RN, BC-NIC, from Advocate
Children’s Hospital- Oak Lawn (ACH-OL), is involved in
a study looking at pain response during a retractor eye
exam in children born 32 weeks or less and weighing
less than or equal to 1500 grams. Eye exams are
routinely performed on premature infants who have
been exposed to oxygen. Subjects in the study will be
randomized to receive the eye exam using either the
spring loaded eye retractor or the screw retractor. Both
retractors are safe and FDA approved. Investigators
hope to learn if one eye retractor causes less pain
than the other. It is expected that 10 babies from
Advocate Children’s Hospital will be enrolled in this
study. This study was funded by a nursing research
grant from ACMC/ACH-OL.
For more information, please contact Debra at 708684-4183.
2 2
Special Feature
RESEARCH CERTIFICATION
In nursing, medicine, and other clinical disciplines, certification is an accepted way to demonstrate specialized
expertise and training. The same is true for research. In fact, some would argue, that many of the research
noncompliance issues and research shutdowns of prestigious institutions have been in part related to a lack of
training of investigators and teams who may be clinical experts in their fields, but have little to no formal training in
the conduct of human subject research.
Certification of research professionals has been around for many years and allows individuals who have worked in
clinical research to demonstrate their knowledge and qualifications to perform and/or lead clinical research
activities. From an institutional perspective, having a core of certified research professionals speaks to a
commitment to excellence, best practices, and continuing research education. Research certification is also
recognized by the Magnet Recognition Program®, and many research sponsors will give preference to sites where
research staff are certified to better ensure regulatory and protocol compliance as well as human subject
protection.
There are a number of organizations that offer research certification. The most common are the Association of
Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA), and the Academy of
Physicians in Clinical Research (APCR). Candidates for certification must first meet eligibility requirements, such as
evidence of having met a minimum number of research experience hours, and each organization differs on such
things as cost, credentials, and years to re-certification. ACRP and APCR offer specific principal investigator (PI)
certification for physicians. SoCRA and ACRP offer certification of other research professionals who are working in
clinical research and who meet specific eligibility requirements.
A brief summary of ACRP and SoCRA certification information is outlined in the table below.
ACRP
SoCRA
Clinical Research Coordinators and
Associates and other roles in clinical
research
Certified Clinical Research Professional
(CCRP)
Recertification Cost
Clinical Research Coordinators, Clinical
Research Associates, and Physician
Investigators
Certified Clinical Research Coordinator
(CCRC); Certified Clinical Research
Associates (CCRA); Certified Physician
Investigator (CPI)
Must meet eligibility criteria; see website
for details
2 years
Offered every March and Sept.
$525 (test and application); early bird
prices available
$250 (recertification) + CE requirements
Annual Membership
$150
Intended for
Credential
Eligibility
Certification Valid For
Test Dates
Certification Cost
Must meet eligibility criteria; see website
for details
3 years
Offered throughout the year
$270 (test and membership)
$175 (recertification and membership) +
CE requirements
$75
Additional information can be found on each organization’s website:
 ACRP: http://www.acrpnet.org/MainMenuCategory/Certification.aspx
 SoCRA: http://www.socra.org/certification/certification-program-overview/introduction/
 APCR: http://apcrnet.org/
If you are working regularly in clinical research, consider certification. It is a great way to recognize your knowledge,
commitment, and expertise!
. . . . . . . . . . . . . . . . . . . . . . . .
For more information on research with children at Advocate’s Children’s Hospitals, visit www.advocatehealth.com/pedsresearch
3
3
ACHIEVING EXCELLENCE
IN CLINICAL RESEARCH
CONFERENCE
The 11th annual conference will be held September 19,
2014 in Oak Brook, IL. This year’s topics include:

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The SUPPORT Trial and Ethical Issues Raised by
Comparative Effectiveness Trials
Back to the Future: Redeveloping Clinical
Research in Resource Challenged Environments
Empowering the Public to Participate in Research
Including Cost Analysis in Research and QI
Projects: What You Need to Know
Investigator-Initiated Research: Navigating the
IND / IDE Process
Strategies to Become a Successful Author
Risk and Consent in Comparative Effectiveness
Research: Perspectives of Patients and the IRB
Community
Children as Research Subjects: What (if anything)
Makes This Ethical?
Research Mentors and Mentees: Enhancing the
Collaborative Relationship
Meeting Your Enrollment Targets: Effective
Strategies to Engage Research Participants
Registration is now open. To register, visit
http://www.advocatehealth.com/seminars#achieving
Be sure to register early as space is limited. The early,
discounted registration deadline is 8/24. Physician
CME (6.0 category 1 credit hours) and nursing contact
hours (6.0) will be available.
For more information or questions, call the Advocate
Center for Pediatric Research at 847.723.2164.
4 4
Educational Opportunties
UIC Clinical Research Boot Camp
October 10, 17, 24
UIC Student Center West (SCW) Room 206AB
828 S. Wolcott Ave., Chicago, IL
 Intensive, hands-on, interactive 3-day training program
 Topics include good clinical practice, the drug development
process, protocol assessment, recruitment and retention,
informed consent, medicare/medicaid billing, PAF and
contract review process, IRB submissions, human research
subject protections, investigational drug services, initiating
and managing studies, and data security.
 $250 for the 3 days, including breakfast and lunch
 Registration deadline Sept 15, 2014
 Additional information is available on the website:
http://www.ccts.uic.edu/content/clinical-research-boot-camp
Midwest Society for Pediatric Research (MWSPR)
October 30-31, 2014
Cleveland, OH
 The MWSPR provides a forum for pediatric scientists,
developmental biologists, and particularly junior faculty and
trainees at various levels to present their work in a supportive,
constructive setting
 Registration currently open
 Additional information is available on the website:
http://www.aps-spr.org/Regions/MWSPR/default.asp
Midwest Nursing Research Society (MNRS)
April 16-19, 2015
Indianapolis, IN
 39th Annual Research Conference
 2015 topic: Innovations for Person-Centered Care
 Additional information is available on the website:
http://www.mnrs.org/annual-conference/general-information
Pediatric Academic Society (PAS)
April 25-28, 2015
San Diego, CA
 The Pediatric Academic Societies (PAS) Annual Meeting is the
largest international meeting focused on research in child
health
 Includes independent society specific programming and joint
programming in areas of mutual interest between the
American Pediatric Society (APS), Society for Pediatric
Research (SPR), Academic Pediatric Association (APA),
American Academy of Pediatrics (AAP) and other affiliate
societies
 Additional information is available on the website:
http://www.pas-meeting.org/
.