Over 120 Clinical Research Professionals (CRPs) gathered to celebrate the 2nd annual CRP State of the Union event on March 12th, 2013. Sabin Auditorium was bustling with energy as CRPs from all over the institution gathered to network and meet their new Leadership Committee members. Unique to this year’s event was a poster presentation in which 18 colleagues showcased a research or quality improvement project which they had previously presented at a conference. The posters were well received and brought to life how CRPs are living their mission of supporting high quality clinical research by facilitating knowledge exchange. Rachel Baker, Chair of the CRP Leadership Committee, commenced the event by presenting some of the statistics from this year’s CRP Membership Profile Survey. As a fairly new group, we realized how important metrics were in stating how wide spread and diverse of a group we are. These results can help us to support the strategic goals of the institution by providing our status for where we are now, and develop goals for where we want to go.

One goal of the CRP group is to make sure that all constituents of CRPs are

The Results Are In!

Summer 2013

ePAS and IACUC: Updates

New Effort Reporting System

Professional Development

Progressive People

Consent Corner

CCTST Methods, Ethics Grants

Sample Size Workshop Announced

Magnet’s Impact on Research

Dates & Deadlines

Research Rocks! Recap

CRC Advancement

Press Points

Trivia Corner

Now Enrolling

Transitioning after Fellows

Accent Reduction Program

ClinicalTrials.Gov Registry

represented. This survey shows how diverse this group is and how it is growing. Recently this year the CRP Leadership Committee developed two new committees – the Regulatory Committee and the Data Management Committee. These two facets are integral to the research we conduct here at Cincinnati Children’s and we are pleased to see these groups represented. From this vibrant group of diverse professionals we also found that education is highly valued. Among all job family respondents, Data management, Project Management, and Clinical Research Coordinators (CRCs) were among the highest percentage of those currently enrolled in a Master’s program. 64% of CRCs have obtained a Bachelor’s degree – that’s more than any other job family who responded. While 42% of the research professional respondents have published material within the past year, we hope this percentage will increase even more over the next year. Perhaps the most promising finding from the survey is the surge in interest from CRP’s regarding membership in one of the committees. This is an exciting time for this group that is only beginning to realize the institution-wide impact they have on changing the outcome.

2

So, what is happening with the ePAS-IACUC module? Many of you may recall that the ePAS-IACUC module went live earlier this year; however, there has not been a lot of communication related to conversion and submission requirements and deadlines in ePAS versus the old paper-based system. This has been purposeful as we have been following a soft launch approach for the ePAS-IACUC module. This approach has allowed us to gain feedback from a smaller set of earlier adopters, to make some system enhancements and to ensure that IACUC support resources are in place and prepared to provide support as needed. This work is still ongoing and we are always interested in any suggestions for improving the system. With that said, we would like to update you on a few improvements that have occurred as well as to provide some timelines related to the IACUC and the ePAS module. First, ORCRA has recently hired a new compliance specialist assigned to the Animal Care and Use Program/IACUC. Rachel Murray comes to CCHMC from her prior position supporting the IACUC at the University of Cincinnati. She is an experienced IACUC administrator and animal researcher with both academic and industry experience. Rachel has a Master’s degree in biological sciences with a focus on translational research, and is also a Registered Laboratory Animal Technologist (RLATG), the highest level of certification for technicians in the laboratory animal science profession offered by the American Association for Laboratory Animal Science (AALAS). Rachel will be working exclusively with researchers on converting existing and submitting new protocols in the ePAS system. She will also be the primary content for providing ongoing support to the research community and the IACUC for protocols in the ePAS system. Second, after several years of service to CCHMC (even in retirement), Dr. Ann Akeson is stepping down as the chair of the IACUC. Over the last year Dr. Akeson has gone above and beyond in guiding much of the development for the ePAS-IACUC module as well as helping to lead the Animal Care and Use Program, the division of Veterinary Services and ORCRA through a significant period of transition. We thank Dr. Akeson for her commitment and services. With that said, we would also like to welcome Dr. Timothy Weaver as the next chair of the CCHMC IACUC. Dr. Weaver is an active researcher and well respected senior faculty member at CCHMC. Dr. Weaver is eager to pick up were Dr. Akeson has left off with a focus on continued improvement of CCHMC’s Animal Care and Use Program. Over the next couple of months, Dr. Weaver will be transitioning into this new role. Lastly, beginning in June, PI(s) and Primary Lab Contacts will begin to receive reminder emails from ePAS regarding upcoming 3-year renewal deadlines for their animal use protocols. If you receive one of these emails, you will be REQUIRED to complete your 3-year renewal in ePAS…paper submission will not accepted. You will receive multiple reminders from ePAS about this

ePAS & IACUC: Updates Abound

deadline as we want to ensure that we do everything possible to ensure that you have sufficient time to complete the renewal application. As mentioned above, these reminders will begin coming from ePAS during the second week in June and will be targeted at protocols that expire during the first week in October 2013. If you have questions once you receive one of these emails, you should contact Rachel Murray in the ORCRA-IACUC office (636-8039). Training/reference documents for the ePAS-IACUC module are being developed and will be available on the ORCRA website (http://orcra.researchlink.cchmc.org/ORCRA/lab-animal/ePAS%20for%20IACUC%20Resources/Forms/AllItems.aspx). Walk-in sessions/office hours are also available.

3

This fall, we hope you will be able to join us Friday, September 20, for our 15th annual human subject protections conference.

This year’s conference, entitled Human Subject Protection: We Can Work It Out, will once again take place at the Northern Kentucky Convention Center and will feature a diverse group of speakers discussing cutting edge topics such as: • The role of engaged and empowered

patients in medical research • Protecting research subjects in the

digital age • Improving communication between

IRBs and investigators • Human subjects protection issues in

translational research • Behavioral science and informed

consent

Additional details on speakers and registration information is coming soon.

Save the Date - Human Subject Protection Conference

Co-sponsored by Schulman Associates IRB, Cincinnati Children’s Hospital Medical Center, the University of Cincinnati and the University of Kentucky, our 2013 conference promises to be another engaging and informative event for members of the research community.

CCHMC to Deploy New Effort Reporting System The institution has recently signed an agreement with Huron Consulting to

deploy the eCRT Effort Reporting software. This solution will replace the current paper based Effort reporting process that CCHMC follows today. The project is currently in the testing phase, and the plan is to roll-out this application for the 1st quarter of FY14 certification in October. Huron created the eCRT project approximately ten years ago and it is now used at over seventy institutions. To get a preview of the application, you can watch the following demonstration: Huron eCRT Demo. The advantages of this project include migration to a more stable software platform, easier data entry and capture, better reporting capabilities, automated email notifications and reminders, and web based access. The Effort project team will be attending meetings in the near future to begin to communicate this product out and prepare everyone for this change. Training documentation will also be developed later this summer, and walk-in session will be available to support end users. If you have any questions about this project, including requesting a demonstration for your department, please send an email to effort@cchmc.org.

SPO Lunch-n-Learn: Review of Various NIH Mechanisms; June 12,11:30-12:30; S4.100 - - - - - - - - - - - - - - - - - - - - - - - - Shipping Training June 14, 9:00-11:00; Contact Dorothy Elsaesser to register 6-1843 - - - - - - - - - - - - - - - - - - - - - - - - SPO Lunch-n-Learn: Contracts & Foreign Subcontracts; June 18, 2:00-4:00; Res. Aud. - - - - - - - - - - - - - - - - - - - - - - - - June Webinar via UC: Effectively Using Social Media/Digital Marketing for Successful Subject Recruitment No CEUs available; Becomes available after June 18; contact Mina Busch for access - - - - - - - - - - - - - - - - - - - - - - - - Shipping Training July 1, 9:00-11:00; Contact Dorothy Elsaesser to register 6-1843 - - - - - - - - - - - - - - - - - - - - - - - - July Webinar via UC: Not Meeting Your Enrollment Goal – Do You Have a Recruitment Issue or a Feasibility Issue? No CEUs available; Becomes available after July 16; contact Mina Busch for access - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Orientation Monday, August 26th - Tuesday, August 27th; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Shipping Training Aug. 26, 9:00-11:00; Contact Dorothy Elsaesser to register 6-1843 - - - - - - - - - - - - - - - - - - - - - - - - ePAS – IRB Submissions Wednesday, August 28th; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Skills Training Thursday, August 29th; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Phlebotomy Training Thursday, August 29th; 1:00pm – 3:00pm; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - EPIC Research Registration Friday, August 30th; 8:00am – 2:00pm; ELM Registration

* * * * *

Don’t forget the ORCRA-created e-learning courses on the ELM: Good Clinical Practices and Informed Consent Scenarios.

Professional Development

4

As Director of the Office for Clinical and Translational Research (OCTR) and Sponsored Programs (SP) Contracts, Leslie Sullivan-Stacey has a full plate. Heaping, in fact! Leslie came to know Cincinnati Children’s and clinical and translational research through her work as CEO of The LAM Foundation (which partnered with Drs. Frank McCormack and Bruce Trapnell in the successful MILES trial). With a desire to continue work in the research arena, Leslie started at CCHMC as a consultant processing contracts for the Sponsored Programs Office (SPO). Not long after, she came on full time as a CCHMC employee and developed the SP Contracts division within the SPO. In late 2012, Leslie saw the vacancy in OCTR as an opportunity to expand her responsibilities and to move an already successful office forward. While assuming OCTR Director responsibilities, she retained responsibility for SP Contracts.. Because of the intertwined nature of contracts and budgets through what used to be the Clinical Trials Office (CTO), she felt that using her experience to merge these functions and

Progressive People: Leslie Sullivan-Stacey

Considering Informed Consent, there are three “steps”: receipt of information by the potential participant, followed by understanding of this information, followed still by their voluntary agreement to participate. While the signed consent form provides documentation of their consent to participate, it is of little value if there was incomplete understanding. In order to truly make an “informed” decision to participate, the potential participant must fully understand the information. A study cited in The Journal of Clinical Research Best Practices found that an analysis of over 200 participants from 44 clinical trials found over 60% had a therapeutic misconception about the trial in which they participated. Subjects with a therapeutic misconception may overestimate benefits or underestimate risks. This misunderstanding means the consent may not have been truly “informed”. This may not be due to error on the part of the consentor, but could be a matter of the consentee hearing what they want to hear and interpreting the shared information in a manner to support their pre-conceived beliefs. Asking open-ended questions where they explain their understanding can help highlight such situations. To help reduce therapeutic misconception, volunteers must understand that their participation in research may or may not produce benefits and that the physician investigators are not operating with the patients’ medical interests as their sole concern. To help separate their roles, Physician investigators should see themselves as scientists (and not as doctors) with regards to clinical research studies.

Consent Corner: Informed Consent & Therapeutic Misconception

Leslie Sullivan-Stacey, JD Pictured at her Oak building office in front of the quilt she received in recognition of her contributions as CEO for The LAM (lymphangioleiomyomatosis) Foundation

skillsets seemed like a great pathway to streamline the research process Some of Leslie’s (and the OCTR’s) goals include repositioning the OCTR forces to unify their service offerings (further blending the services of the former Translational Research Trials Office (TRTO) and CTO). Additionally, incorporating more upstream and downstream input into the budget and contracts process will aid in continuing to improving the caliber of our budgets and contracts. This will involve breaking down silos so that information flows freely and the best decisions can be made with the right people efficiently. Increased collaboration (across her team, across researchers at CCHMC, and across partner sites) was mentioned repeatedly as the means to both short- and long-term improvements. Leslie grew up in Cincinnati but was anxious to go away…first, to Colorado to study Anthropology, and then on to Law School in New Hampshire. She moved back to Cincinnati in 2005 to be near her family after working as a corporate attorney in the northeast. She and her husband, Terry, live in Norwood with their two Labrador Retrievers. Leslie finds the work here rewarding as she looks around and sees the children who benefit from what we do at Cincinnati Children’s. She points to the success and growth of research at CCHMC and says that with the tremendous support provided researchers through the Cincinnati Children’s Research Foundation (CCRF), the sky is the limit when it comes to success!

5

CCTST Methods, Ethics Grants Announced The Center for Clinical and Translational Science and Training (CCTST) has announced its 2013 grants in research methods and ethics. Two methodologic research projects are based in the Division of Biostatistics & Epidemiology. Bin Zhang, PhD will study Uterine Fibroids and Infants Hearing Loss Studies Using Interval Censored Data Analysis. Lili Ding, PhD and co-investigators Lisa Martin, PhD (Human Genetics) and Bin Huang, PhD (Biostatistics & Epidemiology) will study Modeling of Multivariate Longitudinal Phenotypes in Family Genetic Studies with Bayesian Multiplicity Adjustment. The program advances methodologic research in biostatistics, epidemiology, bioinformatics and related disciplines in order to enhance the capacity to conduct and analyze data from clinical and translational studies. One research ethics project was funded in 2013. John Lynch, PhD of the UC Department of Communication will lead the study Assessing the role of uncertainty in community and parent preferences for the return of biorepository-based research results with CCHMC co-investigators Michael Barnes, PhD (Rheumatology) and Monica Mitchell, PhD (Behavioral Medicine & Clinical Psychology). The Research Ethics Grant Program supports interdisciplinary empirical research that aims to develop, inform, or apply morally, socially and culturally acceptable frameworks which maximize the ethics of conducting clinical and translational research. One-year grants of up to $10,000 are offered annually by each program through the CCTST Biostatistics, Epidemiology & Research Design (BERD) core, with a January application deadline. Complete details are available here.

The UC Clinical & Translational Research Training Program will present Sample Size Calculation with R: A Two-Day Workshop, June 13-14 from 9 AM-5 PM in Kettering Laboratory, UC College of Medicine. Sample size calculations are basic in any planned study, whether retrospective or prospective. This workshop provides a thorough grounding in core ideas, formulas, and formula execution in a wide variety of design settings using the free computing software R. Participants are strongly encouraged to bring their laptops to work through each step alongside the instructor, MB Rao, PhD.

Sample Size Calculation Workshop June 13-14

MB Rao, PhD.

Dr. Rao has more than 30 years of experience in teaching, research, and consulting. His teaching and research experience ranges from highly theoretical fields of probability and statistics to applied statistics and biostatistics. His consulting experience includes agricultural, biomedical, engineering, business, and translational research. He has a joint appointment with the UC divisions of epidemiology & biostatistics and biomedical engineering, and is a biometrician with the CCTST. In biomedical engineering, he works with tissue engineers, medical imaging scientists, and neuroscience researchers. Examples will be culled from a variety of fields for illustrations in the workshop. Both graduate credit and non-credit registration options are offered. Non-

credit registrants may also participate online, via live streaming video. For complete details click here or contact Jackie Knapke.

6

Cincinnati Children’s is a Magnet® Facility! What does that mean to Researchers? According to Oxford Dictionaries (2013), a magnet is a person or thing that has a powerful attraction. Before I give a brief

history about the Magnet Recognition Program®, pause a few moments to consider what attracted you to Cincinnati Children’s and what keeps you here? Is it something tangible such as its location, the pay you receive, or being the # 3 Pediatric Hospital according to US News & World Reports? Is it intangible, e.g., being a part of an organization whose vision is to be the leader in improving child health or your role in achieving medical and quality of life outcomes for our patients and families? Whatever YOUR reason is, some personal criteria attracted you to Cincinnati Children’s and keeps you here.

A brief history of the Magnet Recognition Program®……..

In 1983, the American Academy of Nursing Task Force on Nursing Practice in Hospitals wanted to explore what kept nurses at their chosen hospital, during a period of nursing shortage. The Task Force conducted a study to identify work environments that attract and retain well-qualified nurses who promote quality patient, resident and client care. Forty-one of 163 institutions possessed qualities that enabled greater capacity to attract and retain nurses, and were therefore described as “magnet” hospitals.

Building on the study results, the American Nurses Association Board of Directors in 1990 approved a proposal for the Magnet Hospital Recognition Program for Excellence in Nursing Services. The American Nurses Credentialing Center (ANCC) (2013) explains: The Magnet Recognition Program® recognizes healthcare organizations for quality patient care, nursing excellence and innovations in professional nursing practice. Consumers rely on Magnet designation as the ultimate credential for high quality nursing.

In 2009, Cincinnati Children’s received recognition as a Magnet facility. In February 2013 we submitted our redesignation application to continue that recognition. Approximately 6.61% of all registered hospitals achieved ANCC Magnet Recognition® status, according to American Hospital Association Fast Facts on US Hospitals, 2011. In February 2013, only 32 pediatric hospitals were designated as Magnet facilities.

Pretty cool to be in such an elite group, huh? What does all this mean to Cincinnati Children’s research community? You do have research nurses, but not everyone involved in research here is a nurse.

Yes, the ANCC is a nursing organization that oversees the Magnet Recognition Program®, but the criteria to demonstrate that Cincinnati Children’s deserves this recognition are not solely about nursing. The criterion applies to all clinical research professionals involved in clinical research at our institution. The current criteria fall into one of five Magnet Model Components (evidence needed to demonstrate in parenthesis). As you review these, reflect on how YOU or YOUR leadership demonstrate any of these:

Transformational Leadership (evidence of: strategic planning; advocacy and influence; visibility, accessibility and communication);

Structural Empowerment (evidence of: professional engagement; commitment to professional development; commitment to community involvement; and recognition of nursing);

Exemplary Professional Practice (evidence of: application of professional practice model and care delivery systems; staffing and scheduling processes; interdisciplinary care; accountability, competency and autonomy; ethics, privacy, security and confidentiality; diversity and workplace advocacy; culture of safety; quality care monitoring and improvement);

New Knowledge, Innovations & Improvements (evidence of: research; evidence-based practice; innovation); Empirical Outcomes (evidence of: quality outcomes relating to nursing leadership and clinical practice).

In addition, what does this mean to YOU as a healthcare consumer? When I describe my work and my role at Cincinnati

(article concluded next page)

7

Dates & Deadlines NIH Grant Deadlines through December 13, 2013 ( CYCLE III )

ELECTRONIC submissions using the SF424 APPLICATION FORMS

Activity Code Program

Description SPO

Due Date CYCLE III Due Date

R18/U18

R25 New, renewal, resubmission, revision

Research Demonstration

Education Projects

Sep 18

Sep 25

C06/UC6 New, renewal, resubmission, revision

Construction Grants Sep 18

Sep 25

G07, G08, G11, G13, G20, S11, S21, S22, SC1, SC2, SC3

New, renewal, resubmission, revision

Other Activity Codes Sep 18

Sep 25

T Series

D Series New, renewal, resubmission, revision

Institutional National Research Service Awards

Other Training Grants

Sep 18

Sep 25

R01 New

Research Grants Sep 30

Oct 5***

U01** New

Research Grants – Cooperative Agreements

Sep 30

Oct 5***

K Series New

Research Career Development Oct 7

Oct 12***

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

Other Research Grants Oct 9

Oct 16

R15 New, renewal, resubmission, revision

Academic Research Enhancement Award (AREA)

Oct 18

Oct 25

R01 renewal, resubmission, revision

Research Grants Oct 29

Nov 5

U01** renewal, resubmission, revision

Research Grants – Cooperative Agreements

Oct 29

Nov 5

K Series renewal, resubmission, revision

Research Career Development Nov 5

Nov 12

R03, R21, R33, R21/R33, R34, R36 renewal, resubmission, revision

Other Research Grants Nov 11

Nov 16***

R41, R42

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

Small Business Technology Transfer (STTR)

Small Business Innovation Research (SBIR)

Nov 28

Dec 5

F Series Fellowships New, renewal, resubmission

Individual National Research Service Awards (Standard)

Dec 2

Dec 8***

R13, U13

New, renewal, resubmission, revision Conference Grants and Conference Cooperative

Agreements

Dec 5

Dec 12

F31 Diversity Fellowships New, renewal, resubmission

Individual Predoctoral (F31) Fellowships to Promote Diversity

in Health-Related Research

Dec 6

Dec 13

PAPER Submissions Using the PHS 398 APPLICATION FORMS

Activity Code Program

Description SPO

Due Date CYCLE II Due Date

P Series

New, renewal, resubmission, revision

Program Project Grants and

Center Grants

Sep 18

Sep 25

M01, R10/U10, R24, R24/U24, S06, U19, U45, U54, U56

New, renewal, resubmission, revision

Other Activity Codes Sep 18

Sep 25

UM1 New

Research Grants Multi-Component Cooperative

Agreements

Sep 30

Oct 5***

UM1 Renewal, resubmission, revision

Research Grants Multi-Component Cooperative

Agreements

Oct 29

Nov 5

** Effective May 25, 2011, the U01 Activity Code will be used for SINGLE RESEARCH PROJECT Cooperative Agreements ONLY *** Deadlines Falling on weekends or holidays move to the next business day

Children’s to my family members, I tell them when they have a choice in where they receive their healthcare, they should explore which of their choices are Magnet-recognized facilities, and chose one that is Magnet, because all staff are more engaged and patients have better outcomes at Magnet-recognized facilities (The Advisory Board, 2013). Our site visit by ANCC Magnet Recognition Program® Appraisers is expected later in calendar year 2013. Members of Cincinnati Children’s research community may be included in meetings with the Appraisers through your involvement in point of care research, interdisciplinary team work taking place, or open forum meetings provided for anyone connected with Cincinnati Children’s. Please use the opportunity to share your Magnet story! Carol Tierney, PhD, RN Magnet Program Director Center for Professional Excellence

Magnet (cont.)

8

If you passed the Albert Sabin Education Center: Fifth Third Auditorium on Monday, April 29, and thought that you heard strains of Elvis and Katy Perry songs, you weren’t imagining things. This year’s annual research symposium was themed, “Research Rocks!” Rock music and videos were played between research presentations about Good Clinical Practices to a rock concert atmosphere to entertain the crowd. This year’s symposium once again drew a capacity crowd of research personnel from Cincinnati Children’s filling available registration within hours. Online streaming access of the day’s symposium presentations was provided to staff on the waiting list, as well as UC and CCTST members.

Dr. Strauss participated in the relaxed, free-spirit of the rock-themed symposium by donning a lavender colored wig and delivering his opening remarks to the very amused audience. Dr. Strauss expressed his gratitude and thanks for the enormous contribution all the investigators, study coordinators and research personnel make through their daily responsibilities to move the science and research forward for the benefit of children and adults.

The Research Rocks! program, delivered by Cincinnati Children’s faculty and staff, covered an array of research topics from conflict of interest, genetics based research and human subjects’ protection to the use of social media. Clinical research “rock star” Kenneth Getz delivered this year’s keynote address, “Rockin’ Drug Development through Collaborative Innovation.” Getz is chairman of the Center for Information and Study on Clinical Research Participation (CISCRP), the nonprofit organization he founded to educate and raise public and patient awareness of the clinical research enterprise. He is also the director of Sponsored Research and an associate professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts research programs on drug development management strategies and tactics, outsourcing, global investigative site and patient recruitment practices, trends and policies. Mr. Getz is also the founder and owner of CenterWatch, a leading publisher in the clinical trials industry. “There are so many things we can do to infuse more progressive and more innovative and youthful approaches so that we can ultimately improve performance and bring treatments to the people who most need them, sooner and so that we can satisfy all of our missions in research,” said Getz. Getz discussed the trends in the clinical research environment that are impacting the performance, efficiency and quality of work, including poor study design, opportunities for collaboration among research sponsors and investigative sites, and patient retention and recruitment. “Every single element of complexity that we add hurts performance,” said Getz. “It’s the downstream effect of a really difficult protocol and really tough eligibility criteria that make it difficult for us to keep our patients and our studies,” said Getz. CISCRP estimates that the industry spends $2 billion per year on amendments to improve research study designs. Another $6 billion per year is estimated to support non-core procedures or procedures that support tertiary objectives. This is on top of difficulty in reaching prospective volunteers and combating a high level of mistrust among the public toward clinical research. “A very small percentage of patients learn about clinical research from their primary or specialty care doctor. In general, patients have to self-advocate,” said Getz, who encouraged researchers to become ambassadors for clinical research. “Give them a sense of the value we place on the relationship and that their participation mattered,” Getz added. He also urged researchers to foster the relationship with volunteers and create a greater sense of transparency by sharing trial results.

(continued next page)

2013 Annual Research Symposium Rocks!

9

Research Symposium (cont.) Morning Sessions – Investigator Focused

Conflict of Interest in Human Research – Don’t Get Caught Dancing to the ‘Jailhouse Rock’₁ Genetics-based Research and Human Subjects Protection – ‘The Times They Are A-Changin’ Michael Barnes, PhD, assistant professor in the Division of Rheumatology and director of the Cincinnati Biobank Core Facility at Cincinnati Children’s JP Clancy, MD, medical director of the Office for Clinical and Translational Research, research director for the Division of Pulmonary Medicine, and professor in the UC Department of Pediatrics Joan Gates, JD, counsel, Legal Department Achieving your study aims on time and on budget – Project management tools and techniques for clinical research professionals Sophia Thurmond, BS, senior project specialist in the Division of Pulmonary Medicine Afternoon Breakout Sessions – Coordinator Focused 1. Historical Mistrust: Building Trust Between Medical Researchers and Their Research Participants Melinda Butsch Kovacic, MPH, PhD, assistant professor, Asthma Research Charla Weiss, PhD, consultant in the Office of Diversity and Inclusion 2. Social Media and Clinical Studies Lorrie Duan, RN, BSN, clinical research manager in the Division of Pulmonary Medicine 3. Alternative IRB Models for Multi-site Research Jeremy Corsmo, MPH, CIP, CHRC, research compliance officer and senior director, Office of Research Compliance and Regulatory Affairs (ORCRA) 4. Social Media: What You Need to Know for Your Research Study Conduct Kate Setter, BA, media relations associate, Marketing and Communications Department Jackie Barnes, MA, CRP, clinical research coordinator IV, Behavioral Medicine and Clinical Psychology Kristen Safier, JD, deputy compliance officer, Integrity and Compliance Program Use of Micro-emotions in the Therapeutic Interaction with Children Dan Nelson, MD, associate professor of Psychiatry, University of Cincinnati, Department of Psychiatry and medical director of the Child and Adolescent Psychiatric Units at Cincinnati Children’s 2013 Annual Research Symposium Planning Committee Many thanks are extended to the 2013 Annual Research Symposium Planning Committee for making this year’s event both educational and fun - Marianne Brunner, RN, BSN; Mina Busch, MS, CCRP, CIP; John “JP” Clancy, MD; Anita Fritsch, RN; Leslie Korbee, BS; Scott Powers, PhD, ABPP, FAHS; Dana Raab, RN, BSN, MS; Mark Schuller, MA; Sheri Selk, MS, MBA; and Audrey Tramber. If you missed it… Research Rocks! morning presentations and those delivered in Sabin auditorium including the slides, video recordings and the symposium program are available online. Go to www.cincinnatichildrens.org/research-rocks

Last summer, with the rollout of new job descriptions and the updated advancement process, it was announced that certification will become a requirement of the CRC IV and Senior CRC positions as of March, 1, 2014. If you are currently in one of these roles and are not yet certified, please make plans to obtain your certification by then. This requirement began September, 2012, but a “grace” period was granted for those not yet certified. After March 1, 2014, lack of certification will be grounds for demotion. Additional details will be forthcoming to those potentially affected by this requirement. Please consider applying for certification. While other certification programs exist, the main ones for CRCs are offered by SoCRA (Society of Clinical Research Associates) and ACRP (Association of Clinical Research Professionals). Details of their certification offerings can be found here: http://centerlink.cchmc.org/WorkArea/linkit.aspx?LinkIdentifier=id&ItemID=106446&libID=106385 CCHMC will be hosting the SoCRA exam for their “Certified Clinical Research Professional” certification on the CCHMC campus on Saturday, October 19, 2013. Registration is required with SoCRA by September 6th at http://www.socra.org/html/certific.htm Study sessions will be available in September and will be announced through the CRP listserv in July/Aug. Look for further communications and/or announcements at CRP monthly meetings.

CRC Advancement

10

In the January issue of the journal Science, it was reported that a team of geneticists were able to determine the names of people who had donated DNA to research, even though test subjects’ identities were stripped from their genomic data. To make these connections, they used information posted to genealogy web sites and other Internet resources that are publicly available. Harvard geneticist George Church predicts this will continue to get easier to do as technologies improve. He recommends that medical researchers should “jump to the endgame” and admit that it’s increasingly difficult (impossible?) to promise anonymity. He said many proactive volunteers choose to self-identify. His recommendation is to “educate the population and recruit them in an honest and transparent way.”

* * * * * Seeking to replicate the success of the Human Genome Project, the Obama administration is planning a large-scale effort to map the human brain. The hope is that this will lead to technology necessary to understand Alzheimers and Parkinson’s as well as new therapies for mental illnesses. The Human Genome Project cost $3.8 billion and took 14 years, finishing ahead of schedule in 2003. A study estimates the investment has already returned $800 billion. The brain mapping initiative will be organized by the Office of Science and Technology Policy and is expected to be a much more significant challenge.

Press Points

Trivia Corner 1) This term used in clinical research is derived from the Greek word that means “drugs”and the Latin word meaning “to keep alert”. 2) The first blood glucose meter was introduced in which year? 1949, 1959, 1969, 1979 3) Cholesterol is the source of the following 5 crucial hormones: progesterone, testosterone, estradiol, aldosterone and ________. 4) Patient who, in 1951, died from cervical cancer from which an immortal cell line used in cancer research was born. 5) Research has shown that people are unlikely to read documents over __ pages.

Now Enrolling

* * * * * Drug companies are interested in nanomedicine…the ability to encapsulate drugs in tiny particles measuring billionths of a meter in diameter. This opens up new options for extremely precise drug delivery.

* * * * * We’ve all heard about superbugs. I’m not talking about cockroaches or even Cincinnati’s bedbugs, but rather E. coli and CRE. Coming into contact with these bugs is downright frightful. Equally scary is the fact that there are only seven new drugs in development for treatment of infections.

1)Pharmacovigilance 2)1969 3)Cortisol 4)Henrietta Lacks 5)Four

Send comments, story ideas or questions to: Mina Busch Office of Research Compliance and Regulatory Affairs Cincinnati Children’s Hospital Medical Center 3333 Burnet Ave. MLC 7040 Cincinnati, OH 45229-3039 Mina.busch@cchmc.org 513-636-3342 Contributors Editor – Mina Busch Writer – Jeremy Corsmo Writer – Vicki Davis Writer – Jim Flessa Writer – Sara Helbig Writer – Katie Hogan Writer – Katrina Purcell Writer – Mark Schuller Writer – Ellen Skalski Writer – Tori Spendel Writer – Carol Tierney Writer – John Zimmerly

Have a great summer!

CCHMC’s Division of Speech-Language Pathology is offering an Accent Reduction Program to help employees increase the clarity of their speech when using English. This program is designed to help those employees who are proficient ESL speakers, but have a strong “accent,” making their speech hard to understand at times. The goal of the program is to reduce the accent and improve English language usage to help the individual communicate more effectively with colleagues, patients and families. The participant will receive individual instruction with a speech-language pathologist. The program has been designed to be 12 sessions total. Cost: Free to current CCHMC employees Where: 3430 Burnet MOB in the Division of Speech-Language Pathology How: CCHMC employees may register for the Accent Reduction Program through ELM Contact: Connie Volker at (513) 803-3091 or via email at AccentReductionProgram@cchmc.org For more information, please go to the Division of Speech-Language Pathology site on CenterLink and click on “Accent Reduction Program Brochure.”

Accent Reduction Program

The FDA issued a rule that requires sponsors to inform research participants that trial data will be added to the national clinical trial registry at ClinicalTrials.gov. In addition to providing greater accountability of investigators for outcomes and adverse events, the FDA expects this to increase awareness of the existence of clinical trials and give participants an opportunity to review research progress. The deadline for compliance with this rule was March 7, 2012 (for trials initiated on or after 3/7/12).

According to a notice in the Federal Register, this wording should be used (verbatim): A description of this clinical trial will be available on http://www.Clinical Trials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

Are You Compliant with the ClinicalTrials.Gov Requirement?

The completion of a Fellowship at CCHMC brings with it numerous exit procedures and a lengthy “To Do Before Leaving” list. When a Fellow has been a Principal Investigator of one or more Human Subjects research studies, it is important for studies that are ongoing at the time you leave to have a CCHMC-based PI, your successor PI, both fully and formally on board. For ongoing research, IRB approval of the proposed successor PI is required. That approval is to be secured on or in advance of the take-over date, to accomplish PI succession in a fully compliant way. This means an ePAS filing done well before your last few weeks at CCHMC. Your ongoing study may be taken over by your Mentor although another qualified individual approved by the IRB may also succeed you. It is most convenient to add your successor to your study in another role well prior to study transfer, so your designated successor has access to the study before being named to lead it. It will be important for each study to change hands in a controlled manner. As much as there is to do when someone moves out or moves on in their career, completed hand-offs of all ongoing research deserves to be high on the “Must Do Before Leaving” list.

Fellows Departing? Move Studies into Successor PI’s Hands!