When we rolled out the current

Greater Cincinnati Academic &

Regional Health Centers entity

in CITI in 2008, we planned it

as a nine-year comprehensive

program (initial training,

Refresher 1 taken at year

three, and Refresher 2 taken

at year six, with overall

program lasting nine years).

As such, we are approaching

the end of this program’s use.

Beginning July 1, an updated

curriculum will be

implemented.

We will not be requiring

everyone to go through it at

once, rather the new training

requirement will be deployed

in 3 phases over the next 2

years. The timing of required

retraining is based upon the

date that the current program’s

“Academic and Regional Core

Curriculum” (hereafter referred

to as the “core”) was initially

completed. Beginning July 1,

notifications will go out to

those who will need to

complete re-training before the

end of 2017 (those due for

refresher/retraining this year).

New employees and existing

employees who were assigned

but have not completed the

“Core” yet will also transition to

this new program at this time.

Those due to complete

retraining in 2018 will be

notified in January 2018, while

those due to complete

retraining in 2019 will be

notified in January 2019.

Those who completed new

CITI training in the first half of

2017 will transition to the new

program in January 2020.

The new program is still under

the “Greater Cincinnati

Academic & Regional Health

Centers” entity that was

established in CITI in 2008.

This is used by Cincinnati

Children’s, University of

Cincinnati, and UC Health for

the “academic” programs and

by Tri-Health and Christ for the

“regional” programs.

While there are fewer Human

Subjects Research (HSR)

curriculums overall, the new

program also offers training on

Biosafety, Laboratory Safety,

and Animal Research.

Additionally, the program

allows for completion of

optional courses of potential

interest on Clinical Research

Conduct and vulnerable

populations.

The new comprehensive

“core” program is required of

all those involved with Human

Subjects Research and is

titled “HSR CORE for 2017

Program”. Also, due to

continued next page

CITI Program Updates -

Going Live July 1

This Issue Contains:

Human Subject Protection Event

BMI Event Series

SPIN Extramural Funding Database

CPR for Research Coordinators

CCTST Community Engagement

Speaker Series

Informatics Graduate Certificate

New BMI Mobile App

Professional Development

Dates and Deadlines

Research Horizons Headlines

Trivia Corner

Consent Corner

CTC Seminars with Industry Series

Now Enrolling

Protocol Complexity

Edition 36 – Summer 2017

broader NIH requirements for training on Good Clinical Practices (GCP), more researchers will be required

to complete GCP training than in the past.

While we (Cincinnati Children’s) are satisfied with the completion of just the required elements in the GCP

course, you may need to also complete the few remaining modules (marked as “optional”) to satisfy the

industry standard GCP requirements. This is the industry standard for pharma studies.

How it will work: Prior to being notified that you are due for re-training, all of your currently-assigned

HSR courses (shown on your Main Menu) will be inactivated. Please note that CITI maintains course

completion history for all completed courses (and modules) and your history will be retained

despite a course being inactivated. When you are notified that re-training is required, you will need to

log in to CITI. Your main menu will likely be empty (or at least all Human Subjects Research courses

should be removed).

Instructions have been prepared to guide you through the re-training setup process. A link to the

instructions will be included in the notification of retraining requirements. The Instructions on how to get

the new program assignments will permanently reside on the Research WaterCooler site. Follow the

instructions titled “CITI Affiliation Guide for Existing Users”. There will be related instructions for

altogether-new users as well as those transferring to CCHMC from another CITI-using institution. These

instructional documents will be posted on the WaterCooler site by the end of June. It will be important to

read and follow these instructions as CITI has made some changes to the process needed to add

and remove course assignments.

Research policies and SOPs have been updated to reflect these changes and will be put into effect July 1.

If any of this presents immediate questions, please contact ORCRA Education.

Registration is now Open

Cincinnati Childrens has partnered

with the Office for Human Research

Protections (OHRP) and regioinal

hosts to bring a Research

Community Forum to Cincinnati.

The event will include talks from

several national speakers and will

include considerable focus on the

new Common Rule regulations.

There are one- two-day attendance

options with OHRP talks both days.

Day two includes three sessions

where talks are broken out by the

following topic tracks:

• Ethics/Regulatory

• Community Based Research

• Novel / Technology Based

Register today!

CITI Updates (continued)

Page 2

Visit the conference website (www.cincinnatichildrens.org/OHRP2017)

for the agenda and session specifics, speaker information, education

credits, and a link to register. Early registration ends June 25!

OHRP Research Community Forum:

Human Subject Protection and All That Regulatory Jazz!

The UC Office of Research now offers

InfoEd Global's SPIN extramural funding

opportunities database to the research

community! Through a browser-based

portal system, SPIN provides details on

over 40,000 opportunities from more than

12,000 unique sponsors. Users can

quickly and easily find the most relevant

and up-to-date grants and awards

currently available and set up ongoing,

automated alerts for future opportunities.

For anyone on the UC network, login is

not required for basic searches. However,

for those outside UC or who would like to

create and save customized searches, a

username and password can be

requested which will allow access to

SPIN from any location.

Read more

BMI Event Series Updates

Consolidating on Fridays; Offering *.ics Files

The Biomedical Informatics team offers several event

series for the academic research community. Next year,

BMI’s three research-focused series will all be offered on

Fridays at 11. Topics will rotate between:

• Hutton Lectures – formal presentations on current research in biomedical and clinical informatics.

• Clinical Informatics Focus Group – networking forum for clinical informatics researchers to discuss current research projects.

• Biomolecular Informatics Focus Group – networking forum gathers researchers and students to focus on topics in molecular biology, molecular modeling, proteins, and protein-protein interactions.

Event notices will be emailed with *.ics attachments,

downloadable files which allow you to add events to your

calendar. (Note, once an item is downloaded it does not

maintain a live link and will not reflect event updates or

cancelations).

Fall schedules for BMI events will be posted later this

summer at http://cincinnatichildrens.org/bmi-events. To

subscribe to event notifications, email bmi-seminar-

join@mailman.cchmc.org.

Page 3

SPIN Database of

Extramural Funding

Now Available

Have a Great Summer!

Safety is CCHMC’s highest responsibility - one that each of us shares - and it begins with a

commitment to ourselves and our colleagues. Keeping ourselves safe means we are equipped to

provide the best possible care for our research participants. Our commitment to safety defines who

we are and how we approach our business of healthcare. It leads to improved performance, and

enables us to fulfill our calling - better outcomes for our patients. And it's just the right thing to do.

Cardiopulmonary resuscitation (CPR) is a procedure performed in an emergency when the heart

stops, with the goal of prolonging circulatory and lung function. The earlier you give CPR to a person

in cardiopulmonary arrest (no breathing, no heartbeat), the greater the chance of a successful

resuscitation. By performing CPR, the affected individual receives oxygenated blood flowing to the

heart and brain until a defibrillator becomes available. When a victim suffers from cardiac arrest, they

have but a few short minutes before brain damage, organ damage, or even death occurs. Rescue

breathing coupled with chest compressions buys the victim the time that may be required to save

their life.

CCHMC requires that direct patient care staff such as RNs, RTs, and PCAs are CPR certified and

they must renew this certification every two years. Non-nurse research coordinators are not required

by the hospital to be CPR certified. However, if you interact with research participants you may want

to talk with your manager about becoming CPR certified if you haven’t done so already. The biggest

benefit of CPR certification is the ability to save lives if and when the situation arises.

Cincinnati Children's Hospital Medical Center offers American Heart Association (AHA) Basic Life

Support (BSL) courses. These review courses are a condensed version of the BLS full course and

are open to all employees for

biennial CPR recertification

and new employee orientation.

They can also be taken by an

employee who wants to be

prepared for an emergency

in any setting. You can enroll

in AHA Biennial BLS for

Healthcare Providers Review

through My Hub.

Cardiopulmonary Resuscitation (CPR) for

Research Coordinators

Now Enrolling

Page 4

Reference: http://cpr.heart.org/AHAECC/CPRAndE

CC/UCM_473161_CPR-and-ECC.jsp

The big data revolution and advances in data science

are reshaping both medical research and the delivery

of healthcare. Researchers in biomedical informatics

are breaking new ground in bioinformatics, genomics,

and clinical informatics, including precision medicine

and precision genomics.

Want to learn more? Consider a Graduate Certificate

in Biomedical Informatics, offered as a joint program

between the University of Cincinnati’s College of

Medicine and College of Engineering & Applied

Science, in partnership with Cincinnati Children’s.

The curriculum consists of seven courses (five core

courses and two electives). It is designed to combine

foundations in computer science and engineering

with state-of-the-art clinical and biomedical

applications.

Open to graduate students, clinicians, and health

professionals, the program seeks to train participants

to develop and apply computational methods

addressing current problems in biomedicine, as well

as design and implement clinical informatics systems.

The integration of the electronic health record (EHR)

and related systems within clinical practice and

research are also addressed.

Applicants must hold a Baccalaureate degree or higher with a minimum 3.0 GPA. Official transcripts, two letters of recommendation, and TOEFL/IELTS scores (international applicants only) are required for admission. For more information, please visit http://med.uc.edu/bmigrad.

CCTST Community

Engagement Speaker

Series June 15-16 The CCTST welcomes Camara Jones, MD, MPH,

PhD for the Community Engagement Spring Speaker

Series June 15-16, 2017. The Series' 3 events will

focus on Achieving Health Equity: Tools for a

National Campaign Against Racism.

Dr. Jones is a family physician and epidemiologist with

the Morehouse School of Medicine. Her work focuses

on the impacts of racism on the health and well-being

of the nation. She seeks to broaden the national health

debate to include not only universal access to high

quality health care, but also attention to the social

determinants of health (including poverty) and the

social determinants of equity (including racism).

The Series includes:

Award Reception and Dinner June 15, 5:30pm,

Bell Event Centre (444 Reading Road)

Dr. Jones will present her work in the area of health

disparities and social determinants of health. The 23

graduates of the 2017 Community Leaders Institute

and 10 academic-community partnerships receiving

this year’s Community Health Grants and Partnership

Development Grants will also be recognized.

Community Forum / Coffee Hour June 16, 9:00 -

11:00am at Interact for Health (Rookwood Tower,

3805 Edwards Road)

A discussion-based approach to highlight the local

research and resources in Cincinnati that address

health equity. Dr. Jones will moderate a panel

discussion featuring local community organizations and

individuals working to address social determinants of

health and provide services for under-resourced areas

in Greater Cincinnati.

Community Grand Rounds June 16, 12:00 -

1:00pm at Cincinnati Children's MERC Auditorium

(Oak Campus, 620 Oak Street)

All events are free and open to the community. Please

register online for any/all of these opportunities by

June 9. For more information, email Stacey Gomes

or call 513-803-0917. Click for More information

Interested in

Informatics? Explore a

Graduate Certificate

Page 5

Parents of children newly diagnosed with cancer carry a heavy burden. While still reeling from news of a

diagnosis, they must quickly learn complex medical terms and procedures, meet sprawling care teams,

manage frequent appointments and track test results. Now, a new collaboration between Behavioral Health

and Biomedical Informatics aims to lighten their load by creating a one-stop shop for information on a child’s

entire course of treatment.

Ahna Pai, PhD and Keith Marsolo, PhD are the lead Cincinnati Children’s researchers teaming up to develop

a new mobile app as part of Pai’s Illness Management and Parent Adjustment to Cancer Treatment (IMPACT)

study. Together, they are working to transform the 4-inch-thick binder of documents that parents typically

receive upon diagnosis into a mobile app that also connects to the electronic health record in real time.

Pai and her team, including registered nurse Caroline Morrison, came up with the idea of a new application

after reflecting on the negative impact uncertainty can have on a child’s care. Past research shows that

uncertainty raises a parent’s stress levels, affecting parental psychological functioning. Understanding that

health technologies are becoming a popular mode of intervention delivery, Pai and Morrison contacted

Marsolo and his Biomedical Informatics team to see what could be developed.

They were looking for a mobile platform to deliver a new

behavioral health intervention they were testing and wanted to

add in features that would be useful to parents. While Pai’s

team interviewed parents, caregivers and providers to

determine what would be helpful to include in a new app,

Marsolo’s team began exploring possible technology

platforms.

The development team, which included Billy Shuman and

Jeremy Nix, had to break new ground in designing a way to

import real-time data from the patient’s medical record. They

succeeded in blending study data and EHR data in real time,

making IMPACT the first mobile application to do so. They

leveraged authentication and authorization protocols so

parents could sign on with their current MyChart username

and password, simplifying the log-in process.

In response to parent requests that the technology work

across all platforms, they decided to use the Java Enterprise

(continued next page)

Need help with data and related

tools? Contact BMI

The Data Services team within the

Division of Biomedical Informatics aims

to improve child health by helping

researchers interact with high-quality

data to gain new, actionable

knowledge. They can help you with:

• Development of data collection/transfer tools

• Complex extraction of clinical data for research purposes

• Integration of data and transformation into standard/common models

• Implementation of reporting, visualization and discovery tools

• Data-in-once solutions.

Do you need a web or mobile data

collection app developed?

Help developing interactive datasets

and reports? A research registry? Help

integrating solutions with the electronic

health record? They can provide these

services and more.

To learn more, contact Ron Bryson

at ron.bryson@cchmc.org.

New Mobile App Aims to Lighten the Load for

Parents of Cancer Patients

Page 6

Professional

Development

EPIC Research Training Wednesday, June 21; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - ePAS New Submissions Class Wednesday, July 12; 8:00am – 10:30am;

- - - - - - - - - - - - - - - - - - - - - - - - EPIC Research Training Wednesday, July 26; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - Informed Consent Role-Play Friday, July 28; 9:00am – 11:30

- - - - - - - - - - - - - - - - - - - - - - - - ePAS Post Submissions Class Friday, July 28; 8:30 - 10:30am;

- - - - - - - - - - - - - - - - - - - - - - - - ePAS New Submissions Class Friday, August 11; 8:00am – 10:30am;

- - - - - - - - - - - - - - - - - - - - - - - - ePAS Post Submissions Class Friday, August 18; 8:30 - 10:30am;

- - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Orientation Monday – Tuesday August 28-29; 8:00am – Noon

- - - - - - - - - - - - - - - - - - - - - - - - EPIC Research Training Wednesday, August 30; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Skills Training Thursday, August 31; 8:00am – 12:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Phlebotomy Training Thursday, August 31; 1:00pm – 3:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - ePAS New Submissions Class Friday, September 1; 8:00am – 10:30am;

- - - - - - - - - - - - - - - - - - - - - - - - ePAS Post Submissions Class Friday, September 1; 10:30am - Noon;

- - - - - - - - - - - - - - - - - - - - - - - - Core Clinical Research Training Tuesday, September 12 – Thursday, September 14;

8:00am – 12:30pm (plus e-learning pre-work)

Edition (EE) version 7 stack for the application

development. This technology, though not typically

used for mobile applications, was chosen to allow for

full-text searching and to maintain a responsive user

interface, thereby allowing a traditional website to

function more like a native application. Their IMPACT

app is accessible on iOS, Android operating systems

and a desktop or laptop.

University of Cincinnati design students working

through the Livewell Collaborative helped Marsolo’s

team by creating the user interface and user

experience for the app.

The IMPACT app serves as a delivery platform for the

behavioral health intervention being tested by Pai and

her team. It also incorporates current lab results,

medications, and care team information, as well as

background materials, definitions of medical terms,

and explanations of common procedures and

treatments. It offers a calendar function to keep track

of upcoming appointments for the child by pulling

appointments directly from the child’s MyChart

account. Parents can also note questions within the

app for future discussion.

Pai’s team, along with co-investigator Larry L. Mullins,

PhD at Oklahoma State University, is currently testing

the efficacy of IMPACT

through a National Institutes

of Health-funded study.

Participants are being recruited

from Cincinnati Children’s

Hospital and the University of

Oklahoma Health Sciences

Center.

Technical details on the

creation of the app will appear

in an upcoming paper,

currently in press. The

biomedical informatics team

hopes to apply this technology

and the lessons learned to

other projects.

To inquire about similar collaborations, contact

ron.bryson@cchmc.org.

New Mobile App (cont.)

Page 7

NIH Grant Deadlines SEPTEMBER 25, 2017 through DECEMBER 13, 2017( CYCLE III )

Activity Code

Program Description

SPO Due Date

CYCLE III Due Date

P Series New, renewal, resubmission, revision

Program Project Grants and Center Grants September 19 September 25

R18/U18

R25 New, renewal, resubmission, revision

Research Demonstration

Education Projects

September 19

September 25

C06/UC6

New, renewal, resubmission, revision

Construction Grants

September 19

September 25

G07, G08, G11, G13, G20, S11, S21,

S22, SC1, SC2, SC3 New, renewal, resubmission, revision

Other Activity Codes

September 19

September 25

T Series

D Series

New, renewal, resubmission, revision

Institutional National Research

Service Awards Other Training Grants

September 19

September 25

R01 New

Research Grants

September 28

October 5

U01 New

Research Grants –

Cooperative Agreements

September 28

October 5

K Series

New

Research Career Development

October 5

October 12

R03, R21, R33, R21/R33, R34, R36

New

Other Research Grants

October 10

October 16

R01

renewal, resubmission, revision

Research Grants

October 31

November 5

U01

renewal, resubmission, revision

Research Grants –

Cooperative Agreements

October 31

November 5

K Series

renewal, resubmission, revision

Research Career Development

November 7

November 12

R03, R21, R33, R21/R33, R34, R36

renewal, resubmission, revision

Other Research Grants

November 9

November 16

R41, R42

R43, R44, U43, U44 New, renewal, resubmission, revision

Small Business Technology Transfer (STTR) Small Business Innovation Research (SBIR)

March 29

April 5

F Series Fellowships

New, renewal, resubmission

Individual National Research Service Awards

(Standard)

December 1

December 8

R13, U13

New, renewal, resubmission, revision

Conference Grants and Conference Cooperative

Agreements

December 5

December 12

F31 Diversity Fellowships New, renewal, resubmission

Individual Predoctoral (F31) Fellowships to

Promote Diversity in Health-Related Research

December1

December 8

**Standard due date falls on weekend or federal holiday. Deadline extended to next business day.

Dates & Deadlines

Page 8

Research Horizons magazine delves into

Infectious Diseases, Immunobiology

Scientists at Cincinnati Children’s are breaking ground in understanding how the body produces high-affinity B cells,

how antibiotics can affect a newborn’s developing immune system, how mathematical models may become a formula

for improving treatments for autoimmune diseases, and more. Here are highlights of the Spring 2017 issue:

INFECTIOUS DISEASES:

Systems Vaccinology

Infectious Diseases and Immunobiology forge a partnership to apply systems biology concepts to vaccine development.

Their goal: to further integrate expertise in genomics, transcriptomics, lipidomics, metabolomics and other emerging

fields into the established vaccine world of virologists, immunologists and infectious disease specialists.

New Vaccine Surveillance Network

CDC-funded New Vaccine Surveillance Network and the PREVAIL cohort study track vaccine effectiveness and babies’

health.

Immunity and Pregnancy

New research reveals that influenza vaccine follows a consistent direction, but

an uneven path, as it affects the immune systems of pregnant women and their

developing babies. For flu shots during pregnancy, earlier appears to be better.

IMMUNOBIOLOGY:

Attacking Infection by the Numbers

Emily Miraldi, PhD, is a computational and systems biologist who focuses on

immuno-engineering: altering the behavior of specific immune cell populations

during disease without compromising the body’s normal immune function.

B Cell Factories

A team of experimental and computational biologists at Cincinnati Children’s

has managed to probe far deeper into the inner workings of infection-fighting B cell factories.

Blood Cell Study Stirs Debate

A groundbreaking paper in Nature shows that blood cells in mice appear to reach their final states following

competitions between opposing gene regulatory networks. The study infers that within these genetic tugs of war that

determine the fates of blood cells there are still other yet-to-be-discovered multi-lineage intermediates.

THE MICROBIOME

Battling the Dark Side of Antibiotics for Newborns

Doctors have long understood that antibiotics that protect infants from infection also can disrupt the normal

growth of their gut bacteria. However, a new study reveals that the consequences of routine antibiotic use

may be deeper and longer lasting than expected.

(continued next page)

Page 9

Trivia Corner

1. Tips for ease of comprehending informed consent include all of the following EXCEPT:

a. Use upper case throughout document. b. Break content into short sentences. c. Use font size no smaller than 12 point. d. Arrange content with subheadings.

2. All of the following are common examples of endpoints used in drug development research EXCEPT:

a. Time to progression b. Best clinical response c. Percentage of patients who withdraw

from study d. Quality of Life measures

3. For what purpose does the IRB review the informed consent?

a. Protect the Institution b. Protect the subject c. Provide the Institution with information

about proposed research trials d. Protect the Sponsor

4. Which of the following is NOT an ESSENTIAL element of ethical research?

a. Valuable scientific question b. Balance of risks and benefits c. Subject selection based on locality d. Independent review

5. Who is ultimately responsible for ensuring protocol integrity?

a. Principal Investigator b. Study Coordinator c. Study Monitor d. The study research team

Research Horizons (cont.) Fecal Metagenomics and Blood

Many hospital infection control programs share a

common problem: current blood tests generally do

a poor job of detecting multidrug-resistant bacteria.

But Cincinnati Children’s is developing—and is

close to clinically testing—a new early detection

system.

Welcome to the Microbiome World

Although research into immune system response is

not new, the science of analyzing the good or

“commensal” microbes in mice devoid of microbes

is a relatively new arena that has taken off over the

last decade.

Page 10

Consent Corner An article in February’s Journal of Empirical

Research on Human Research Ethics included

some updates on Amy Corneli’s research on

Informed Consent Simplification. They polled

potential research participants and their findings

are such that they can be implemented with

relative ease:

• The majority (91%) of respondents agreed on the grouping of study procedures by their frequency of occurrence.

• The majority (again, 91%) liked the idea of supplemental information being placed into appendices.

• Most (93%) liked seeing duplicate side effects only listed once.

These changes can contribute to reducing the

overall length of Informed Consent forms, which

is a goal of the updated Common Rule

regulation.

The updated regulation also touches on the

consent form itself, including a new requirement

to move key information to the beginning of the

consent document.

Additional communication on revisions to the

consent forms will be forthcoming in the coming

editions as well as communicated through

several CRP channels.

Answers:

1) A; 2) C; 3) B; 4) C; 5) A

Protocol Complexity is on the RISE!

CenterWatch newsletter recently shared some intersting statistics that were published by Tufts University’s

Center for the Study of Drug Development. Increased complexity results in more difficulty with recruitment

and retention, not to mention increased costs to execute the study.

Send comments, story ideas, or questions to:

Mina Busch, Editor

Program Manager, Education & Outreach

Office of Research Compliance and Regulatory Affairs

Mina.Busch@cchmc.org

513-636-3342

Cincinnati Children’s Hospital Medical Center

3333 Burnet Ave.; MLC 7040

Cincinnati, OH 45229-3026

Contributing Authors:

Heidi Aungst

Tim Bonfield

Jim Flessa

Kathy Goodin

Jane Howie

Dana Raab

Ginny Van Horne

Jill Williams

Seminars with Industry

Series

The Center for Technology Commercial-

ization (CTC) hosts the "Seminars with

Industry" Series.

On June 26 at

noon, please join

Jan Rosenbaum,

PhD, Airway

Therapeutics, in the

Research Auditorium

to learn about

"Understanding

the Value in Drug

Development.

Jan Rosenbaum, PhD Airway Therapeutics