The following is a non-

comprehensive list of the most

common issues the IRB staff

come across that we wished

every person working in ePAS

knew needed to be done. This list

is in no specific order:

1. Stacking – ePAS has a function to allow updates to documents to be “stacked” on top of the previous version. This is done by clicking “upload revision” instead of “add”. The importance of this is to keep all versions of the same document together. Any time you make a revision to a document that has already been uploaded into ePAS please click “upload revision” instead of “add”. Failing to do this may require you to withdraw an amendment and start over. 2. Tracked Changes – Any time you revise a document a tracked changes version of the document is required. This is why there is a spot to upload a “tracked changes” document in the amendment application. Giving the IRB a description of changes will not “cut it” anymore. The IRB reviewers use the tracked changes document to aide in their review. If you are working on the initial approval of a study, to submit a “tracked changes” version, you will need to upload the tracked change document first and then click “upload revision” and “stack” the clean revised copy next. This will put

the clean revised version “on

top” and be the document that

opens when you click the

document link.

3. Description of

submission/changes – When

submitting an amendment,

please give a complete

description of the submission

and justification for the changes

to the study. You must give

justification for why revisions to

an approved study are being

mad. For instance, if you

uploaded “performance sites”

into the ePAS smartform, do not

just tell the IRB that performance

sites were added. Please outline

which performance sites were

uploaded. If you made changes

to the actual ePAS smartform,

tell the IRB which sections of the

ePAS smartform were updated

and what. If revisions to the

protocol were made, like adding

or deleting a study aim, justify

why this revision is being made.

This allows the IRB to know what

exactly has changed and why. If

not, the IRB will send it back and

ask for this information. We

won’t “just guess” or “go

hunting” to figure it out.

4. Updating Staff when people

leave – It is important to keep

your staff list current. The

“Update Study Staff” tab is

available to update (continued Page 6)

The Top 10 Things the IRB

Wished You Knew!

This Issue Contains:

Acute Care Research Symposium

New Informatics Tools

Precision Genomics Midwest

Educational Opportunities

Animal User Education Launches

New IACUC Chair

Redcap Revisited

Now Enrolling

Health Visit Transportation

Residents Informatics/QI Project

CCH Innovation Fund Winners

KL2/CT2 Career Development

Scholars Named

Trivia Corner

Magnet Update

Dates and Deadlines

CpG Project Funding

Edition 39 – Spring 2018

Driving the Future- Integrity & Innovation in Acute Care Research is the theme of the first annual

Acute Care Research (ACR) Symposium, Monday April 9 from 8 am-12 noon in Cincinnati Children’s

Location S1.203.

Keynote speaker is Neal Dickert, Jr, MD, PhD of the Division of Cardiology and Center for Ethics at

Emory University, who will discuss Informed Consent for Acute Care Research: Patient-Centered or

Pointless?

The program is presented by the CCTST’s Acute Care Research Council (ACRC) as part of UC

Research & Innovation Week 2018, with grant support from the UC College of Medicine.

• Symposium agenda

Poster abstracts and award nominations are now being accepted:

• Call for Abstracts (deadline March 9)

• Call for Nominations: Leadership & Innovation Awards (deadline March 23)

Registration is free of charge. For more information, contact

Amy Ewing. Read more

Three new informatics tools were recently launched at Cincinnati Children’s:

- A novel real-time computerized system automatically increases medication administration accuracy and rapidly alerts providers to correct any errors. The new patient safety enhancement system collects and processes information from several electronic health record (EHR) sources simultaneously to monitor medication administration with a high degree of sensitivity. It is currently being tested in clinical practice in Cincinnati Children’s neonatal intensive care unit. Read more.

- A new regional, geocoded perinatal data repository called the Maternal and Infant Data Hub integrates maternal, neonatal and pediatric patient records across the greater Cincinnati region to support research and improve care. The repository ties together information on more than 110,000 infants born at 14 regional delivery hospitals from 2013 to 2017. It securely links patient data from institutional silos in order to make it easier for researchers to study care that one patient receives at different institutions, and to link a baby’s care to the prenatal care its mother received. Read more.

- Researchers have described the first integrative analysis of disparate single-cell datasets applied to a single developmental system. They used a single-cell computational approach called ICGS in the software AltAnalyze (Olsson et al. 2016, Nature) to directly process and simultaneously analyze data from three separate technologies. This computational innovation allows researchers to compare their single-cell experimental results to others or between different single-cell technologies, which has not been previously reported. Read more.

Acute Care Research Symposium April 9

Page 2

New Informatics Tools Link Patient Records,

Improve Medication Safety, Integrate Genomic Data

EPIC Research Training Wednesday, March 14; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - - Core Clinical Research Training Tuesday, March 20 – Thursday, March 22;

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

- - - - - - - - - - - - - - - - - - - - - - - -

ePAS New Submissions

Friday, April 13; 8:30am – 10:30;

- - - - - - - - - - - - - - - - - - - - - - - -

Regulatory Documents Workshop (tentative)

Wednesday, April 18 9:00-11:30

- - - - - - - - - - - - - - - - - - - - - - - -

ePAS Post Submissions

Thursday, April 19; 1:00-2:30

- - - - - - - - - - - - - - - - - - - - - - - -

EPIC Research Training

Wednesday, April 25; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - -

Informed Consent Role-Play

Thursday, May 3; 9:00am – 11:30

- - - - - - - - - - - - - - - - - - - - - - - -

Core Clinical Research Training

Tuesday, May 15 – Thursday, May 17; 8:00am –

12:00pm (plus e-learning pre-work)

- - - - - - - - - - - - - - - - - - - - - - - -

Clinical Research Orientation

Monday – Tuesday May 21-22; 8:00am – Noon

- - - - - - - - - - - - - - - - - - - - - - - -

EPIC Research Training

Wednesday, May 23; 8:00am – 4:00pm;

- - - - - - - - - - - - - - - - - - - - - - - -

ePAS New and Post Submissions

Friday, May 25; 8:00am – 10:00 and 10:30-12:00

Registration for each is via the ELM.

Register NOW for Precision Genomics Midwest, May 11,

2018 at the Kingsgate Marriott. The conference is free, but

space is filling up fast, since the conference draws from

nearby states.

The day includes Keynotes from Dan Kastner, scientific

director at the National Human Genome Research Institute

and Mike Murray, director of clinical genomics at Geisinger

Health. It also includes breakout sessions in Epigenetics,

Pharmacogenomics, Clinical Informatics, Clinical

Genomics, Informatics, and the Ethical, Legal, and Social

Implications of Genomics. It also features one of the

largest vendor fairs for a regional conference.

To see a full agenda, speaker information, exhibitors, and

to register, go to: www.cincinnatichildrens.org/pgm

Page 3

Precision Genomics

Midwest: May 11

Educational

Opportunities

In late January, a new training program for animal users

was launched as a mechanism to provide better animal

user training, increase employee safety, and streamline

the onboarding training process for new animal

users. New research personnel who work with animals

will now be granted “authorized animal user” status after

completing a defined set of training and occupational

health requirements. This status will be current for three

years and each researcher will be assigned an expiration

date for their active status. New animal users must

complete the requirements

and be granted

“authorized animal user”

status prior to an amend-

ment being submitted to

add them as protocol staff.

Animal facility training will

be delivered by Vet

Services once the IACUC amendment is approved.

Current animal users are also required to maintain their

“AAU” status by completing a defined set of continuing

education requirements. A detailed help guide about the

new program for both new animal users as well as current

animal users is available on Centerlink on the “Animal Use

Training” homepage. If you have any questions, please

e-mail animal.lab.training@cchmc.org.

New 2018 Animal User

Training Program Launches

Researchers at Cincinnati Children’s can now access expanded support services for REDCap research data capture

software from the Division of Biomedical Informatics (BMI) and Center for Clinical & Translation Science & Training

(CCTST), which share a mission to support our research communities in capturing research data.

Use of REDCap has climbed steadily. Over the past year, the average number of weekday users has grown from 93 to 160

and monthly total projects have increased from 2694 to 3440.

Users often describe REDCap as something that is easy to learn, but difficult to master. REDCap project designs can range

REDCap Support Team Expanding, Offering

Additional Features, Training

Page 4

from very basic data entry forms to multi-site longitudinal

projects using tools like automated invitations, text messaging

and modules to extend functionality. The flexibly and

customization REDCap provides makes it both accessible to new

users and powerful enough to keep experienced users utilizing

REDCap in new and different ways.

“We are working to continually improve our model,” says Maxx

Somers, the REDCap program manager. “We want to build a

cohesive and dynamic community of users where everyone is

welcome and people share knowledge and ideas.”

(continued next page)

IACUC Welcomes New Chair As of July, 2017, Edith Janssen, PhD, is the new IACUC Chair for Cincinnati Children’s Hospital. Edith currently works in

the Division of Immunobiology, studying immune responses to dying cells and self-antigens in the context of

autoimmune disease and cancer. She has been employed at Cincinnati Children’s Hospital since 2008 and has experience

with a variety of laboratory animal species.

Edith attended Utrecht University in The Netherlands where she

studied Biology and graduated with a Master’s degree. She then did

a one-year exchange program in Madrid, Spain, before returning to

Utrecht University to complete her PhD with the Division of

Veterinary Immunology and the Division of Pharmacology. After

receiving her PhD, Edith moved to San Diego, La Jolla Institute for

Allergy and Immunology for her postdoc. It was there in 2004 that

she joined their IACUC.

After moving to Cincinnati Children’s, Edith joined the IACUC here in

late 2009. In 2014 she became Vice Chair of the IACUC, and in July

2017 she assumed her current role as IACUC Chair.

Edith is passionate about maintaining the highest standards of animal welfare and creating a culture of compliance. She

believes in transparency between the IACUC and the research community and welcomes constructive dialogue with all

researchers.

REDCap is available to

anyone at Cincinnati

Children’s or UC and to

CCTST members. If you are

tackling a research study,

quality improvement study

or project that could be

defined as operational

support, attend a training

session and see if REDCap

might work for you.

REDCap can help you with

contacting study

participants, automating

survey invitations,

organizing research data,

facilitating research data

entry, and much more.

Redcap (continued)

Page 5

Here are some immediate changes you may see:

• Timely Updates: REDCap is now running LTS 8.1.2 which adds new features including REDCap Messenger, allowing your survey participants to download a PDF of their own responses, improved accessibility for surveys, new action tags, the option to allow respondents to return to their survey without having to provide a return code and more.

• REDCap Workshop: If you need one-on-one or small group time to ask questions about your project, attend one of our REDCap workshops. The schedule can be found at (https://cctst.uc.edu/events).

• More REDCap Training Classes: The full year training schedule is available at https://cctst.uc.edu/events The REDCap Introduction and REDCap Project Management classes are now each given approximately twice a month in order to decrease class size and allow more time for specific questions. The class trainings have also been updated.

• REDCap Knowledge Base: Visit the new Cincinnati REDCap Resource Center for information about basic and advanced REDCap functions, training guides, log-In information, and other basic information. We hope the REDCap Knowledge base will grow beyond just a ‘how to’ and include a guidance on several different issues that researchers encounter. https://confluence.research.cchmc.org/display/CCTSTRED/Cincinnati+REDCap+Resource+Center

• REDCap Extensions: We are working to make more external modules available to extend the use of REDCap. New external modules will be documented in our REDCap Knowledge Base and can be found via the external module menu under the applications side bar menu in your REDCap project.

• REDCap Help: Help-REDCap@bmi.cchmc.org or the “Contact a REDCap Administrator” function within REDCap is still a great resource for getting REDCap Help.

REDCap is freely available to CCTST members.

Signing up is easy at https://cctst.uc.edu. CCTST

members and external users associated with

CCTST REDCap projects are eligible for REDCap

accounts. We appreciate your continued

involvement in our shared research community.

The REDCap program staff (from left):

Maxx Somers, REDCap Program Manager;

Warren Welch, REDCap Application Specialist;

Theresa Baker, REDCap Training Specialist;

Michael Wagner, Associate Professor

Now Enrolling

Imagine being able to have your research participants picked up, brought to the hospital for their study visit,

and then returned home. That day is here (or at least coming soon to this area !)

Transportation service provider Uber has recently announced Health-specific transportation services. Uber

Health enables healthcare providers to assign rides from a centralized dashboard. The rider doesn’t even

need to have the Uber app (or a smartphone). Uber claims to be following HIPAA standards compliance as

identified by the Healthcare Industry Professionals Group.

Lyft states that it’s been working in the healthcare space for years through their Concierge offering, which

provides transportation services for non-emergency medical transportation.

Both of these programs should help reduce the number of patients who miss important appointments as

well as to allow those without transportation to participate in optional/voluntary clinical research.

(add/delete) study staff without having to submit an amendment. The only change requiring an amendment is a change

in Principle Investigator (PI). The IRB recommends that you check your study staff list for updates PRIOR to opening a

new amendment, as study staff updates cannot be done during an amendment. The IRB staff will have to intervene if

one is required or you withdraw the amendment. This is especially important for staff deletions as ePAS will not allow

you to submit an amendment if someone has left the institution and are still noted on the study.

5. Enrollment Log – If you find an error on the previous year’s continuing review enrollment log, please correct in the

current continuing review and upload a document to explain the error. This explanation may also be noted in question

#6 on the summary page. Additionally, if you are the lead site, please breakdown enrollment by site. If you have multiple

enrollment groups (control vs disease) breakdown your enrollment by group.

6. “Current State” – Where is my study? – If the “Current State” says “Changes Requested” this means your submission

is currently with YOU the study team. So, if you have made your changes, as requested by the IRB or DSR, but notice the

state says “Changes Requested”, you have NOT submitted your changes. Please click the “submit changes” tab under My

Activities. The table in Appendix A shows the comment states and who it is with:.

7. Multi-site study closures – To close a study that is a multi-site, the IRB is going to require either documentation from

the lead site/industry sponsor that it is okay for CCH to close the study or if CCH is the lead site, documentation that

each site has closed the study or communication that the site is aware that no more data may come to CCH as it relates

to this study.

8. Justification for waivers – Please make sure you have provided a justification for any consent waivers you request.

The main component people do not address is the impracticability requirement of the regulations. Tell the IRB why it is

impracticable, not inconvenient, for you to obtain consent from all subjects.

9. Updating versions upon document change – The IRB and the compliance team expects that you will update the

version of any document you have revised. It may be a simple formatting change. If it required an amendment to the IRB

for the document change, the version needs to be updated.

10. Page numbers & versions – All documents to the IRB must have page numbers, if more than one page AND must

have a version.

Each division has a point person in the IRB to assist you in your research. Please reach out to your division’s HPA (Human

Protections Analyst) for assistance with any of these items. We are here to help! But, following these guidance’s will

minimize the delays in your submission.

Health Visit Transportation

IRB (continued)

Page 6

Jesse Hansen, MD, now a clinical cardiology fellow in the Heart Institute at Cincinnati Children’s Hospital Medical Center,

participated last year in the first-ever clinical informatics research rotation for residents offered by the Division of

Biomedical Informatics. He just published the first research paper from that experience focused on improving

interdisciplinary communication in the hospital environment with secure text messaging.

“We were looking to improve communication channels between medical residents and nurses,” he says. “The two groups

previously relied on unidirectional pager systems, but those pagers could be a source of frequent interruptions, constant

handoff of messages, and avoidable confusion between team members.”

The team of Jesse Hansen, Philip Hagedorn, MD and Margot Lazow, MD used quality improvement methodology to both

implement a secure text messaging system (Voalte) and to evaluate its impact on communication patterns. They

succeeded in creating a unified communication platform for nurses and residents. Read more about the project in this

recent blog post.

“Dr. Hansen’s work on this project is a great example why, as an informatics community, we should be engaging

residents in our work,” says Dr. Hagedorn, who manages the

informatics rotation program for residents. “Physician trainees

here are not only bright and hardworking, but they’re

stakeholders highly invested and engaged in clinical

information systems. Residents frequently have a wealth of

ideas but lack the mentorship or institutional knowledge to

make headway. We’re trying to remove those barriers and

rope more physicians into our informatics community!”

Want to help reach out to residents or clinical fellows

through educational talks, rotations and other hands-on

experiences? Contact Philip.hagedorn@cchmc.org to

volunteer or for more information.

Resident’s Informatics/QI Project Leads to Better

Nurse-Resident Communications

Page 7

How NOT to be a “Once and Done” Investigator

Per the ACRP Monitor magazine in October 2017, the Clinical Trials Transformation Initiative recently shared the

results from a survey of principal investigators who conducted a single study (and no more) to see if they can find

some resources and advice to assist PIs to stay involved in research. Here are some easily implementable

recommendations that might help to keep an investigator from going the route of “once and done”:

• First of all, hire and retain experienced and well-trained research coordinators. This holds true too for other essential staff, such as regulatory and project managers. Specifically, look for expertise with budgets and contracts, patient recruitment/retention, and regulatory affairs.

• Also, ensure training is provided (ongoing) to all staff involved in clinical research activities. Universal participation in the training is key.

• Finally, develop and utilize standard operating procedures (SOPs) to assist with consistency and organization. This spans throughout pre-study, start-up, execution, and closeout.

(From left) Jesse Hansen, MD, Philip Hagedorn, MD and

Margot Lazow, MD successfully implemented secure text

messaging to improve resident-nurse communications.

Congratulations to the recent awardees of the

Cincinnati Children’s Innovation Fund

The Center for Technology Commercialization (CTC) leverages various funding sources to cultivate discoveries toward

their full potential – products that will change the outcome for our patients. The CTC is pleased to announce these

recent awardees of the Cincinnati Children’s Innovation Fund*:

• Jose Cancelas and Yi Zheng -- Refrigerated preservation of platelets for human transfusion A proprietary chemical additive shown to prevent platelet lesions in the cold, enabling safe, long-term preservation of platelet function under refrigeration which would dramatically change the current practice of blood transfusion.

• Alexander Vinks -- Electronic health record embedded decision support platform for precision drug treatment in neonates Development and validation of a precision dosing system for morphine in critically ill neonates, that can be leveraged to other populations and drugs that require precision dosing.

• John Perentesis -- Electronic cancer care navigation Development of a mobile app to provide integrated, remote, medical and psycho-social care navigation for cancer patients and their families.

• Jing Xiang -- MEG Processor A software package for processing magnetoencephalography (MEG) signals, with many applications including pre-surgical localization of epileptic foci and functional brain mapping.

• Takanori Takebe -- Validation human liver organoid based toxicity (LoT) screen in a dish Validation of a high-throughput screen system to predict drug-induced liver injury, a major reason for market withdrawal of drugs.

• Assem Ziady -- Blood protein marker algorithms that predict lung function decline in CF and other pulmonary diseases Validation of biomarker based algorithms to predict lung function decline. Translating the technology to guide therapeutic decisions for patients with cystic fibrosis (CF) and other pulmonary diseases.

*Fifty percent funding provided by the State of Ohio, Ohio Development Services Agency, Ohio Third Frontier, Grant

Control # TECG20170361 matched with 50% funding from Innovation Fund.

The CTC is also pleased to share the following new hires and promotions in FY18:

Guillermina Gomez (Marketing and Outreach Manager), Danielle Gray (promoted to Acceleration Consultant),

Joe Messina (Innovation Specialist), Matthew Moscato (Contracts Specialist), Aniruddha Puntambekar (Sr.

Asset Acceleration Manager), Justin Rosenacker (Financial Manager), Laurie Shirk (Patent Coordinator), Matt

Wortman (Portfolio Manager) and Eileen Yeoh (Project Manager).

To meet with a member of the CTC team and begin a discussion about your innovation, visit

http://centerlink.cchmc.org/research/administrative-information/ctc.

The CTC engages with faculty and clinicians to identify ideas with commercial potential, and nurtures these discoveries

through the difficult preclinical stages of product development. To begin a discussion about your innovation, visit

http://centerlink.cchmc.org/research/administrative-information/ctc.

Page 8

KL2/CT2 Research Career Development Scholars Named

The Center for Clinical and Translational Science and Training (CCTST) KL2/CT2 career development award

program has named four new scholars who begin April 1.

Funded by a NIH Clinical & Translational Science Award (CTSA) and institutional support, the program is

designed to provide a two year mentored research and career development experience in clinical and

translational research for junior faculty, leading toward an independent interdisciplinary scientific career.

The program is directed by Jessica Kahn, MD, MPH, associate chair, Academic Affairs and Career

Development, Cincinnati Children’s and co-directed by Jason Blackard, PhD, associate professor, Department

of Internal Medicine, Division of Digestive Diseases, UC College of Medicine.

The Scholars are:

Moises Huaman, MD, MSc, Department of Internal Medicine, Division of Infectious Diseases, UC College of

Medicine. His project is entitled Coronary atherosclerosis and immune activation in latent and active

tuberculosis, mentored by Carl Fichtenbaum, MD, Department of Internal Medicine, Division of Infectious

Diseases, UC College of Medicine.

Yoonjee Park, PhD, Department of Chemical and Environmental Engineering, UC College of Engineering and

Applied Science. Her project is entitled “On-demand” Long-Term Drug Delivery for Chronic Posterior Eye

Disease Treatment, mentored by Winston Kao, PhD, Department of Ophthalmology, UC College of Medicine.

Senu Apewokin, MD, Department of Internal Medicine, Division of Infectious Diseases, UC College of

Medicine. His project is entitled iHIOs & Metagenomics to unravel host immune-microbiota interactions in C.

diff, mentored by Alison Weiss, PhD, Department of Molecular Genetics, Biochemistry and Microbiology, UC

College of Medicine.

Carley Riley, MD, MPP, MHS, Division of Critical Care Medicine, Cincinnati Children's. Her project is entitled

Mapping Families' Social Networks to Improve the Health and Well-being of Children, mentored by Peter

Margolis, MD, PhD, James M. Anderson Center for Health Systems Excellence, Cincinnati Children's.

Read more

Save the Date!

The fall Human Subject Protection

conference will once again be held

at the Northern Kentucky

Convention Center. The event will

be held Thursday, October 4, 2018.

This will be the 20th year running

for this conference, although the

format has changed somewhat

over the years.

Registration will begin this

summer!

Page 9

Trivia Corner

1. In what would you find this phrase: “No experiment

should be conducted where there is a priori reason to

believe that death or disabling injury will occur; except,

perhaps, in those experiments where the experimental

physicians also serve as subjects.”?

2. What is the conventional value of statistical significance?

3. Who was the investigator of the famous study on

obedience involving electric shocks?

4. What is the name of the film starring Danny DeVito about

a genetic experiment gone bad?

Answers:

1. Nuremberg Code

2. p<.05

3. Stanley Milgram

4. Twins

You are involved in research at Cincinnati Children’s. You keep hearing about Magnet® and everybody seems to think it

is a big deal but to be honest, you don’t really know what it means or how it impacts you. Isn’t this solely for nurses in

the clinical setting?

What is Magnet®?

The American Nurses Credentialing Center (ANCC) created the

Magnet Recognition Program® in 1990 to recognize nursing

excellence and healthcare organizations that provide the very

best in patient care. Organizations must demonstrate evidence

of Transformational leadership, Exemplary professional

practice, New knowledge, and Structural empowerment

(TENS) both in documentation and a site visit.

Those words sound impressive, but what do they mean,

how are they related to research, and more importantly,

how do they impact me?

How Does Magnet® Impact Research?

Embedded in Cincinnati Children’s vision and strategic plan is our commitment to innovation, discovery, and translation

of research into practice. This vision has propelled Cincinnati Children’s to be one of the top recipients among pediatric

institutions in National Institute of Health grant funding. Magnet® status heightens our visibility both in the community

and state for being a leader in health care – recognition by federal funding agencies equates to increased research

funding (which equates to increased research positions and opportunities). This spirit of inquiry throughout Children’s

culture has led to the review of more than 1,300 research protocols by Children’s own Institutional Review Board (IRB)

over the past 12 months.

The new knowledge, innovation, and improvements component of Magnet® focuses on research and evidenced based

practice that supports expectations for research. Innovation and research is one of the tenets of our Interprofessional

Practice Model. This tenet addresses the generation of new discoveries, the creative use of technology and the

transformation of evidence-based knowledge and learning into practice and policy here at Children’s. Magnet®

designated hospitals must have an infrastructure and resources that support the advancement of research. Hospitals

applying for re-designation must demonstrate clear evidence of continued growth and expansion of research.

Infrastructure includes support for research related resources such as education, compliance policies and procedures,

data management, grants management, IRB, opportunities to propose and conduct research projects, publications in

peer-reviewed journals, and podium and poster presentations at national professional conferences. Collaboration with

researchers who incorporate compliance with applicable research policies and regulations in the protection of human

subjects’ standards is imperative. Policies include but are not limited to:

-Informed consent process and documentation

-ICP Form -Short Form Consenting -Obtaining Consent when the Individual is not Physically Present -Obtaining Consent from Individuals Unable to Read

-Research Involving Pregnant Women Human Fetuses and Neonates -Research Involving Children -Registration of an Institutional Review Board (IRB)

(Continued next page)

What does Magnet® Have to do With Research?

Page 10

Magnet (Continued)

How Does Magnet® Impact You?

In addition to the advancement and impact on research, Magnet® designated hospitals also provide the infrastructure to

support structural empowerment. The structural empowerment component ensures that all employees (clinical and

research including allied health professionals) are part of an organizational structure that encourages professional

development and personnel policies. Examples at Children’s includes tuition reimbursement, nurses and allied health

professionals working together on Shared Governance councils, research nurses included as voting members of the IRB

responsible for reviewing all nursing protocols, participation in standardized advancement criteria, leadership

opportunities, certification support, and opportunities to collaborate with our peers to maintain and improve

professional development (i.e. RNF, CRPLC, participation in other councils and committees) and are all expectations of a

Magnet® designated hospital.

Magnet® Site Visit

Cincinnati Children’s has been granted a site visit from the Magnet Recognition Program®! This is a big deal — only 10%

of organizations are awarded site visit following initial document review. The Magnet® appraisers have determined that

our scores are within the range of excellence for Magnet® and will now seek to verify, amplify and clarify content in the

written documentation. Three appraisers will tour inpatient and outpatient units, as well as neighborhood locations,

April 23-25. This site visit is an exciting opportunity to highlight what we do every day in caring for our patients and the

research that is being conducted.

What to Expect

Magnet appraisers will visit multiple units and departments (including research), conduct interviews with leaders, staff,

and open forums during their 3 day visit. The visit will focus mostly on clinical staff but appraisers can ask anyone

questions about research or other topics such as advancement, performance appraisal process, levels of professional

practice, the hospital’s mission, professional practice, organizational structure, etc. A mock appraisal for research nurses

will be scheduled prior to the visit. Everyone is welcome to attend.

This is a really exciting and noteworthy time at Cincinnati Children’s. Magnet® should remind us all to take responsibility

for continued improvement in the research being conducted here. Quality research results in improved quality clinical

care which will ultimately accelerate

our impact on child health. We will

improve child health and transform

delivery of care through fully

integrated, globally recognized

research, education, and innovation.

(Centerlink, 2018) It is all related.

Magnet® - we are all TENS!

Reference

Centerlink, 2020 Strategic Plan:

Changing the Outcome Together,

2018.

Page 11

Page 12

Dates and Deadlines NIH Grant Deadlines May 25, 2018 through August 12, 2018 ( CYCLE II )

Activity Code

Program Description

SPO Due Date

CYCLE I Due Date

P Series New, renewal, resubmission, revision

Program Project Grants and Center Grants May 18 May 25

R18/U18

R25 New, renewal, resubmission, revision

Research Demonstration

Education Projects

May 18

May 25

C06/UC6

New, renewal, resubmission, revision

Construction Grants

May 18

May 25

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

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

Other Activity Codes

May 18

May 25

T Series

D Series

New, renewal, resubmission, revision

Institutional National Research

Service Awards Other Training Grants

May 18

May 25

R01 New

Research Grants

May 28

June 5

U01 New

Research Grants –

Cooperative Agreements

May 28

June 5

K Series

New

Research Career Development

June 5

June 12

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

New

Other Research Grants

June 11

June 16

R01

renewal, resubmission, revision

Research Grants

June 27

July 5

U01

renewal, resubmission, revision

Research Grants –

Cooperative Agreements

June 27

July 5

K Series

renewal, resubmission, revision

Research Career Development

July 5

July 12

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

renewal, resubmission, revision

Other Research Grants

July 9

July 16

R41, R42

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

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

December 27

January 5

F Series Fellowships (including F31

Diversity) NOT-17-029) New, renewal, resubmission

Individual National Research Service Awards

(Standard)

August 1

August 8

R13, U13

New, renewal, resubmission, revision

Conference Grants and Conference Cooperative

Agreements

August 6

August 12

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

The Center for Pediatric Genomics (CpG) will be awarding $1 million in funding for Pilot and/or Accelerator

projects that focus on genomic discovery and clinical translation to improve child health. Pilot projects will

receive $100,000 and Accelerator projects can receive up to $300,000 to accelerate the progress of more

developed research.

This is the fifth year for CpG’s grant initiative. It is an integral part of CpG’s mission to advance research and

knowledge through innovative scientific and translational genomics projects. CpG has funded 40 projects

with $4 million since 2015. Those projects can be viewed here:

https://www.cincinnatichildrens.org/research/divisions/c/genomics/clinicians-researchers/projects

To receive funding, CpG encourages multidisiciplinary collaboration between clinicians, basic scientists,

genetics experts, and informaticists. Projects can range from scientific discovery – such as investigating

gene expression, metagenomics, or examining variants responsible for a disease characteristic – to

translational genomics, including creating therapeutics or diagnostic tools to improve children’s health. Other

potential areas for funding include clinical implementation, education, evidence-based outcomes, and ethical,

legal & social implications of genomics.

Applications must have a Cincinnati Children’s faculty member as the PI, although collaborators are allowed

from other institutions. In order to apply, the PI cannot have an active CpG grant on July 1, 2018.

Faculty with early-stage ideas or incomplete plans can submit an optional Letter of Intent (up to three pages)

by March 6 to Mike Furgason: john.furgason@cchmc.org.

Submissions should be no longer than five pages for a Pilot grant or six pages for an Accelerator grant. They

are due via the CCAPS system on April 3.

For more information, go to CpG Funding on Centerlink and download the CpG Funding Application

Guidelines, or contact Mike Furgason at John.Furgason@cchmc.org or (513) 803-5509.

Center for Pediatric Genomics (CpG) Announces

Project Funding: Submissions due April 6

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:

Heide Aungst

Rocky Byington

Jim Flessa

Kathy Goodin

Jane Howie

Julie Kramer

Rachel Murray

Dana Raab

Jill Williams

Eileen Yeoh

Appendix A