More than 20 Shared Facilities supported by the CCRF offer state-of-the-art services and technologies that otherwise would not be affordable or readily accessible to all of the researchers at the organization. We have recently begun to implement a centralized, automated system that streamlines the ordering, billing, and reporting processes for Shared Facilities in an effort to minimize administrative burden while enhancing functionality. The C.O.R.E.S. Billing system, developed by Vanderbilt University, provides business directors, investigators, lab managers and facility users customized access to all of the CCRF Shared Facilities. This includes the ability to easily identify available services, place and follow orders, create instrument reservations, and monitor usage of valuable research dollars. One of the key aspects of this system is that it reduces time to identify correct budget numbers -- a benefit to both the user and the Facility manager -- because each order and reservation requires a budget number at the time of request. Available budget numbers for a principal investigator and his/her lab members are stored and maintained with accuracy using a daily upload from the CCHMC PeopleSoft financial system to ensure charges are not placed on incorrect or expired funds.

CCRF Shared Facilities Implement a New Ordering and Billing System for Researchers

To date, three Shared Facilities (Confocal Imaging Core, Research Flow Cytometry Core, and Viral Vector Core) have been implemented into C.O.R.E.S Billing and are conducting all of their billing transactions through the new system. Over the next few months and into the summer of 2015, all of the other Shared Facilities will come on line. Information, FAQ’s, and Guides on how to use the C.O.R.E.S Billing system are available for reference on Centerlink (http://centerlink.cchmc.org/content1/110696/). Please feel free to visit this website or email help-cores@bmi.cchmc.org for any information, questions, suggestions, or comments about the new C.O.R.E.S Billing System.

Spring 2014

Progressive People

CCTST Awards Pilot Grants

CTC Receives Award

Now Enrolling

DMPC is Building Steam

Accent Reduction Program

Dates & Deadlines

Registration Open: OHRP RCF

Trivia Corner

Doing Battle with I.D.

Professional Development

Updates on the PEF

Research Tissue Collection

PCORI Update

Consent Corner: Re-Assenting

Investigator Certification

eConsents

In the News

The CORES Billing web-based ordering system for Shared Facilities integrates with CCHMC PeopleSoft to allow for accurate billing and usage reporting for researchers, Business Directors and Shared Facilities.

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You’ve seen the saying “Will work for food”? Well, based on a quick look around his office, an appropriate tagline for Ryan Varney, CCRF Web Content Coordinator, could be “Will Design for COFFEE”! Ryan started at CCHMC just over a year ago and immediately began offering his expertise and assistance to those needing help creating or maintaining Centerlink websites. He is the official webmaster for the Research Foundation websites and is the key figure in the redesigned Centerlink Research website (due out by Q4). (You can catch an image of a prototype site on the new environment behind him in the included photo.)

Progressive People: Ryan Varney, MS

The Center for Clinical and Translational Science and Training (CCTST) Pilot & Collaborative Translational & Clinical Studies (PCS) core has announced the awardees of FY 2015 “T1” pilot grants. The program is designed to foster T1 (translation one) research, which seeks to apply clinical or basic research knowledge in an identifiable pathway towards the development of trials and studies in humans. The T1 program attracted a total of 89 letters of intent (LOI) from investigators, 36 of whom were invited to submit complete proposals. Included in total funding of over $1 million are 9 T1 awards of up to $100,000, 3 “T1 Junior” awards of up to $25,000 for young faculty, and support of 2 innovative cores (up to $50,000 each). The one year awards begin July 1. A table listing (by type of award) project titles, investigators, co-investigators and their affiliations is available here. For more information on the T1 grant program, visit the PCS core home page or contact Bettie Durant. The next request for proposals will be announced in the fall. Congratulations to this year’s awardees!

Ryan Varney at his office on S10 with the new Centerlink design on display

CCTST Awards Over $1 Million in Pilot Grants

When asked about the new Centerlink site for Research, Ryan promises more organization with resources grouped by category and available from multiple paths. There will be more navigation options, all based upon user input (from lots of focus groups!) While Ryan hopes to get more people comfortable being their own content authors (with his support), he’s able to help anyone in research with getting their content onto Centerlink. His customer-service attitude and friendly, knowledgeable personality have gotten him a lot of “business” already. Ryan had a roundabout background leading to his current role. After growing up in Toledo, Ohio, he went to Bowling Green State University where he received a BS in Communications. For the next ten years, he lived in Chicago where he wrote copy for the Paul Harvey talk show. In 2009, he returned to Cincinnati where he soon received

a MS in Professional writing from the University of Cincinnati. Following graduate school, he got into web development and has been in that field for close to five years. This writing/technology combination enables him to create sound web sites with information that proves to be helpful for those using the sites. Ryan lives in Fort Thomas with his wife Jenn and their two cats. The cats are crazy enough…Ryan doesn’t share his coffee with them!

Goodbye, Winter… Hello, Spring!!!

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Nominations were submitted by hospitals, health systems, clinics, and public and private health organizations across the world for applying Microsoft technology to create transformative and highly-effective innovations. A panel of industry experts selected this year’s winners based on how their innovation represents a forward-thinking development or implementation of a solution that is delivering groundbreaking results and producing better health outcomes for more people. Recipients will be highlighted on the Microsoft website at http://www.microsoft.com/health/en-us/hug/pages/hug-index.aspx and on the Microsoft in Health blog at http://www.microsoft.com/health/ww/blog/Pages/index.aspx.

Now Enrolling

CTC Receives Microsoft Health Innovation Award The Center for Technology Commercialization (CTC) is a recipient of Microsoft Corp.’s 2014 Health Users Group Innovation Awards for innovation in the enhancement of quality in healthcare. The awards, announced at the 2014 HIMSS Annual Conference and Exhibition in Orlando, Fla., recognize health organizations and their technology solution partners for using Microsoft devices and services in innovative ways that help enhance the quality of patient care. This includes improvement of clinician productivity, electronic medical record (EMR) optimization, and streamlining clinical and business processes. “The healthcare industry is rapidly shifting. Despite these unprecedented changes, organizations and providers are being expected to transform how they operate, but in a way that maintains high quality care for patients,” said Steve Aylward, General Manager, Solutions & Strategy of U.S. Health & Life Sciences, Microsoft Corp. “The winners of this year’s Microsoft Health Users Group Innovation Awards all met this challenge with enthusiasm, advancing true innovation by using technology to achieve excellence.” Cincinnati Children’s portfolio of available technologies is large and diverse, with innovations ranging from therapeutics and diagnostics to medical devices and software. Identifying and connecting these innovations with a suitable industry partner capable of advancing these new technologies to the market is a constant challenge, according to Niki Robinson, PhD, assistant vice president for the CTC. The CTC saw this challenge as an opportunity to leverage an existing solution in Microsoft Dynamics CRM, but customize it for the center’s specific needs. What resulted was a tailored CRM (Customer Relationship Manager) solution for technology transfer – a two-way matching report based on shared areas of interest. The solution reveals companies that are suitable targets for a technology as well as all available technologies that a company would be interested in. “Having the ability to be very targeted and efficient in how we approach our industry partners has drastically improved how we collaborate,” said Robinson, PhD, “As the biotech and pharma industries evolve, we must also evolve – our CRM platform allows us to be nimble and constantly responsive to our collaborators needs.”

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2013 was a fantastic year for the Data Management Professionals Community (DMPC). We began the year by joining the CRP Leadership Committee. Next, we held a Data Management Plan (DMP) symposium to help researchers develop a DMP for their projects to better understand the data management tasks necessary for their research projects/studies. In July, we had a re-organization that created the DMPC-Leadership Committee. This committee consists of a chair, chair-elect, and Lead and lead-elect from the newly formed Communications and Education committees. This committee along with the help of our advisors (Rachel Akers, Eileen King, and Vadim Tantsyura) developed a strategy for the remainder of the year. In September we conducted a membership drive that resulted in an increase of our membership from 92 to 137. Who knew there were so many people that perform data management within our institution? As Dr. Strauss talked about during the CRP State of the Union, CCHMC has recognized the importance of Data Management and it is reflected in the number of data management staff throughout the institution and the growth of the Data Management Center (DMC) in the past 3 years. Furthermore, the DMPC was honored to plan the CRP meeting in November where we discussed the “Importance of Applying Project Management Principles in Data Management”. There were over 100 people who attended the discussion and the feedback from the program was extremely positive and we are excited to present again at the CRP meeting in June 2014. The discussion in June is still being finalized and will be announced in the upcoming DMPC newsletter. If you would like to help with this discussion please contact the education lead Jason Stock (Jason.Stock@cchmc.org). All are welcome. As we roll into 2014, the DMPC members have elected the following new officers: Chair-Elect: Justin Bates (DMC/Adolescent Medicine) Communications-elect: Kelly Olano (DMC), and Education-elect: Jennifer Hardy (GI) to support the current leads: Chair: Amita Mirani (DMC), Past Chair (Current CRP Leadership Committee Rep.): Cyndie Baker (DMC), Communications Lead: Jenney Nobbe (DMC), and Education Lead: Lynn Mullins (Emergency Medicine). Unfortunately, Lynn, left CCHMC to pursue other professional endeavors, but we are happy to report that Jason Stock (DMC) has volunteered to return for another term as Education Lead.

DMPC is Building Steam

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: Tania Tobar at (513) 803-3091 or via email: 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 Offered by Division of Speech-Language Pathology

Members of the DMPC Leadership Committee

5

Dates and Deadlines NIH Grant Deadlines May 25, 2014 through August 13, 2014 ( CYCLE II )

Activity Code Program

Description SPO

Due Date CYCLE II Due Date

R18/U18

R25 New, renewal, resubmission, revision

Research Demonstration

Education Projects

May 19

May 27**

C06/UC6 New, renewal, resubmission, revision

Construction Grants May 19

May 27**

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

New, renewal, resubmission, revision

Other Activity Codes May 19

May 27**

T Series

D Series New, renewal, resubmission, revision

Institutional National Research Service Awards

Other Training Grants

May 19

May 27**

R01 New

Research Grants May 29

Jun 5

U01 New

Research Grants – Cooperative Agreements

May 29

Jun 5

K Series New

Research Career Development Jun 5

Jun 12

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

Other Research Grants Jun 9

Jun 16

R01 renewal, resubmission, revision

Research Grants Jun 27

Jul 7**

U01 renewal, resubmission, revision

Research Grants – Cooperative Agreements

Jun 27

Jul 7**

K Series renewal, resubmission, revision

Research Career Development Jul 7

Jul 14**

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

Other Research Grants Jul 9

Jul 16

R41, R42 R43, R44, U43, U44

New, renewal, resubmission, revision

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

Jul 28

Aug 5 F Series Fellowships

New, renewal, resubmission Individual National Research Service Awards

(Standard)

Aug 1

Aug 8

R13, U13 New, renewal, resubmission, revision

Conference Grants and Conference Cooperative Agreements

Aug 5

Aug 12

F31 Diversity Fellowships New, renewal, resubmission

Individual Predoctoral (F31) Fellowships to Promote Diversity in Health-Related Research

Aug 6

Aug 13

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

NIH ACTIVITY CODES TRANSITIONING TO ELECTRONIC SUBMISSION OF

MULTI-PROJECT APPLICATIONS

6

Registration for “2014 OHRP Research Community Forum: Clinical Research and All That Regulatory Jazz!” is now open. Go to www.cincinnatichildrens. org/ohrp-rcf and click “Register Today!” then, under Event Registration, “Click here to register!” For the first time in this region, Cincinnati Children’s Hospital Medical Center/Office for Clinical and Translational Research, University of Cincinnati, Cincinnati Veterans Affairs Medical Center and the Center for Clinical & Translational Science & Training will partner to sponsor the 2014 Office for Human Research Protection (OHRP) Regional Community Forum (RCF): Clinical Research and All That Regulatory Jazz! The one-day Forum will be presented on Wednesday, May 21, 2014, at the Kingsgate Marriott Conference Center at the University of Cincinnati and will address topics pertaining to the protection of human subjects in research and research in general. The program features distinguished faculty members from academia, industry and the Federal Government. Marshall L. Summar, MD, Children’s National Medical Center, will deliver the keynote address – Multi-Center Longitudinal Research in Rare Disease: Why? What? And How? Also, Jerry Menikoff, MD, JD, MPP, director for the Office for Human Research Protections, is presenting “Improving Informed Consent.” In addition to keynote speakers, 5 curriculum tracks/15 breakout sessions for the Forum will include: regulatory, biobanking, technology and internet-based research, novel research and network-based research. Clinical research presentations, updates and panel discussions will be delivered by representatives from the national OHRP, as well as regional academic researchers and experts from the four partnering institutions. The registration fee for the Clinical Research and All That Regulatory Jazz! is $125 (early registration – before March 31, 2014), and $150 afterward. This activity has been approved for AMA PRA Category 1 Credit(s)™, as well as a variety of other types of credit. Don’t miss this educational and “jazzy”research event!

Registration Is Open… for “2014 OHRP Research Community Forum: Clinical Research and All That Regulatory Jazz!”

Trivia Corner Test your knowledge

of obscure phobias! 1) Pnigophobia 2) Agateophobia 3) Optophobia 4) Theophobia 5) Venustraphobia 6) Melissophobia 7) Neophobia 8) Levophobia 9) Zemmiphobia 10) Tonitrophobia

Now Enrolling

Fear of: 1) Choking 2) Insanity 3) Opening one's eyes 4) Gods or religion 5) Beautiful women 6) Bees 7) Anything New 8) Things to left side 9) The Great Mole Rat 10) Thunder

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P Particles Pave Way for New Vaccines explains how these man-made nanoparticles developed by Xi Jason Jiang, PhD, and Ming Tan, PhD, may soon serve as platforms for dual vaccines, targeted drug delivery and more. Outsmarting a Stealth Virus delves into work by Rhonda Cardin, PhD, Daniel Choo, MD, and other collaborators to reveal the mechanisms that can lead to deafness from cytomegalovirus infections. If you would like to have more stories like these delivered directly to your inbox, click here to subscribe to our quarterly Research Horizons publication and our monthly Pediatric Insights e-newsletter. If you have ideas for future news features, contact Mary Silva, Research Horizons editor; or Tim Bonfield, Pediatric Insights editor.

Doing Battle with Infectious Disease The winter 2014 edition of Research Horizons magazine focuses on the latest work happening in the labs of our Division of Infectious Diseases. This issue includes seven feature articles, 13 other research news updates, plus listings of large grant funding awards, appointments and other accomplishments. A New Look at Immunity in Newborns features new findings from Sing Sing Way, MD, PhD, and colleagues about how infants suppress their own immune systems to allow desired bacteria to colonize the gut. Taking Nature by Surprise recaps work by Joe Qualls, PhD, and collaborators who report that amino acid supplements could become an inexpensive way to boost immune system function. The Next Frontier in Herpes Simplex Research explores how Nancy Sawtell, PhD, and colleagues are using funding from NASA to study the risks of HSV reactivation posed by radiation exposure during space travel. Learning from Failures explores the valuable information David Bernstein, MD, MA, gained from the Herpevac Trial for Women even though the prospective vaccine against HSV-1 and HSV-2 was not found to be effective enough. Finding the Balance details the Antimicrobial Stewardship Program led by David Haslam, MD.

Core Clinical Research Training Tuesday, April 29th - Thursday, May 1st; 8:00am – 12:30pm; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - OHRP Research Community Forum: Clinical Research and All That Regulatory Jazz! Wednesday, May 21st (all day); Registration via www.cincinnatichildrens.org/ohrp-rcf - - - - - - - - - - - - - - - - - - - - - - - - Informed Consent Role-Play Thursday, May 29th; 9:00am – 11:30; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Orientation Monday, June 2nd - Tuesday, June 3rd; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - ePAS – IRB Submissions Wednesday, June 4th; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Skills Training Thursday, June 5th; 8:00am – Noon; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Clinical Research Phlebotomy Training Thursday, June 5th; 12:30pm – 5:00pm; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - EPIC Research Registration Friday, June 6th; 8:00am – 2:00pm; ELM Registration - - - - - - - - - - - - - - - - - - - - - - - - Informed Consent Role-Play Thursday, August 21st; 9:00am – 11:30; ELM Registration

Professional Development

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During your research study visits, will there be any procedures that will not be paid for by the research study? (i.e. a clinical procedure that is conducted during a research only study visit) If your answer to this question is yes, you should be registering the encounter as a mixed research visit in EPIC and completing a Protocol Encounter Form (PEF). The PEF should include all research procedures that will be done at the mixed research visit and e-mailed to the appropriate person. The EAP codes for the procedures can be found in the Research Fee Schedule FY14 located on Centerlink, under the Research tab. For outpatient mixed research visits, the appropriate person is the financial service representative (FSR) or other designee in your department. If you are not sure who this is, please ask your business director. For all inpatient encounters registered as a mixed research visit, the PEFs go to ResearchPFS@cchmc.org.You can find the PEF on Centerlink->Research Tab-> Epic Research Registration section->Research Registration Forms: http://centerlink.cchmc.org/content1/71961/ ALL MIXED VISITS NEED TO BE REGISTERED. It has been discovered that there is a lack of compliance regarding the registration of mixed research visits and providing PEFs. To achieve improved compliance, the process for mixed research visit registrations and PEFs will be clarified through the Epic Research Registration and Scheduling class, the Research Forward Newsletter, CRP emails, and at the CRP monthly meeting on March 19, 2014. Protocol Encounter Form (PEF) Instructions have also been created to help you through the process and will be available on Centerlink starting in March http://centerlink.cchmc.org/content1/71961/. To further improve compliance, the PEF has been revised and some additional information is required: NCT Number: National Clinical Trial Number Every study should be registered on clinicaltrials.gov if the data is to ever be published. When the study is registered, it is assigned a ClinicalTrials.gov registry number: “NCT” followed by an 8-digit number (e.g. NCT00000419). You can find the NCT code for all registered studies on clinicaltrials.gov. Due to new regulations from the Centers for Medicare & Medicaid Services (CMS), the NCT code is now required on specified patient accounts in order to ensure billing compliance for our CMS patients. Imaging Procedures Section Radiology has had to reconcile several charges associated with imaging procedures completed for research studies. Therefore, it is now required to send a PEF to a financial service representative (FSR) in radiology when you have an imaging procedure done for research. Imaging procedures include all x-rays, CT scans, ultrasounds and MRIs. Please submit these PEF forms that include imaging procedures to Shirita Hines at shirita.hines@cchmc.org IN ADDITION to the appropriate FSR depending on whether the visit is inpatient or outpatient Coming soon: ePAS Requirement and Language Clarification Currently, when submitting a study for approval in ePAS, Question 7 on the General Research Plan section intends to capture the need of a PEF for any of the study visits (required for all mixed research visits). We understand that this language in ePAS has been confusing, so we will be updating Question 7 on the General Research Plan section in the Smart Forms. In addition to the revised wording, completion will be making it a mandatory section starting July 1, 2014. To ensure that our families are not billed for research procedures, we appreciate your diligence in properly filling out Protocol Encounter Forms (PEFS) for all encounters that are registered as a mixed research visits. If you have questions regarding the PEF or this process, please come and attend the March CRP monthly meeting (March 19, 2014 from 3:00-3:20pm) or contact Kacey Appel at 636-3564/ Kacey.appel@cchmc.org.

Updates on the Protocol Encounter Form (PEF)

9

The FDA does not require certification. Neither do most CROs and pharmaceutical companies. So, should a physican seek this certification? Absolutely…YES! Recent data shows that certified investigators had significantly more “No Action Indicated” notices following an FDA audit. Certification is proving to be a predictor of a higher level of regulatory compliance. Another benefit to certification is that many pharmaceutical com-panies, including TransCelerate Biopharma (a nonprofit consortium of 17 biopharmaceutical com-panies), will now accept certifica-tion in lieu of required GCP training.

In an effort to improve patient safety and tracking of specimens released from the OR, a new process has recently been implemented. Researchers that have consent to receive tissue from surgical procedures will need to have a "Research Tissue Approval Form" signed by a pathologist prior to the procedure. This form is a joint effort between Pathology, the OR, and Pediatric Surgery, who are working together to improve both research compliance and maintain the integrity of specimens intended for clinical diagnosis. Forms are available in Pathology Administration (R2384) as well as the Pathology Manager's office (R2038a in the Pathology lab area). Researchers simply need to fill out the information regarding the procedure, including specific collection instructions in the comments area. They then bring the form to a pathologist who will review the form and deter- mine whether the tissue can be released as usual from the OR, or if it needs to be seen in Pathology prior to release. The pathologist will indicate this and sign the form. The form should be included on the patient's chart on the day of surgery. The researcher will keep the pink copy, the OR will retain the yellow copy, and the white copy will be sent to Pathology with the clinical specimen. Please contact the Pathology Manager, Meredith Taylor, at meredith.taylor@cchmc.org with any questions in regards to this process.

Investigator Certification?

New Procedure for Research Tissue Collection

In early February, the Patient-Centered Outcomes Research Institute (PCORI) announced eight funding opportunities (PFAs – PCORI Funding Announcements) for a total of up to $206M to support patient-centered comparative effectiveness research projects. Priority interest research topics are listed in the PFA and include a broad array of treatment strategies. PCORI is significantly increasing the amount of funding towards patient-dentered comparative effectiveness research. PCORI is an independent, nonprofit organization authorized by Congress in 2010. They have identified plans to commit around $1B over the next few years to support this research. Information about PCORI and these funding opportunities can be found on their website.

PCORI Update

The most current version of the Standard Operating Procedure for Research Involving Human Subjects 41-1.4: Informed Consent Process and Documentation (March 2014) has been revised. Specifically, the section regarding assenting research participants if they reach the age of assent (as determined by IRB) during the study was removed. The previously approved version of SOP 41-1.4 (June 2013) had added the section (2.8.1) which stated: “if a research participant reaches the age of assent as determined by the IRB during participation in research, the individual must be assented using the IRB-approved assent document.” Originally, the SOP was silent on assent so the section was added to clarify what should be done if the IRB has determined that assent is required and the subject is not at the age of assent when first enrolled in the study but turns 11 during the time in the study. However, after further discussion it was determined that the subject reaching the age of assent (11 years old) during the study is different from the minor reaching the age of majority (18 years old) in that the parental permission for study participation is no longer valid once the minor researches the age of majority. Engaging the minor in the "ongoing consenting process" over the life of the study in a manner that is appropriate to their level of maturity should be the practice. The investigator should be encouraged to document this activity in the record. However, having the minor sign an assent form once they turn 11 is not needed. This is because the regulations offer the IRB broad latitude in determining both whether and how a minor's assent is documented in all cases. In the currently approved version of SOP 41-1.4 (March 2014), the section has been removed since there is not a regulatory requirement to document assent once a minor reaches the assenting age over the course of a study.

Consent Corner: Re-Assenting SOP Revised

Send comments, story ideas or questions to: Mina Busch, MS, CCRP, CIP 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 – Kacey Appel Writer – Justin Bates Writer – Tim Bonfield Writer – Vicki Davis Writer – Jim Flessa Writer – Katie Hogan Writer – Amita Mirani Writer – Serena Phillips Writer – Mike Pistone Writer – Katrina Purcell Writer – Mark Schuller Writer – Jason Stock Writer – Meredith Taylor Writer – Nicole White

Congratulations to Bob Frenck, MD, IRB Chair

on his recent Service & Advocacy Award!

To learn more about how Clinical Research Professionals can utilize Electronic Consent (eConsent) in their studies, an interview was conducted with Tommie Grotjan, Clinical Research Coordinator IV, in the Division of Allergy and Immunology. Tommie has successfully implemented eConsent in one of her studies.

• Q: Is electronic consent available here at CCHMC? • A: Yes, the Biomedical Informatics (BMI) group at CCHMC developed and built

an eConsent Management System for studies here at CCHMC. • Q: Can eConsent be used on all types of studies here at CCHMC? • A: eConsent process can be used for registries, sample collection and

questionnaire studies at CCHMC. eConsent cannot be used with clinical drug studies.

• Q: What is involved with the eConsent process? • A: General steps to the eConsent process:

1) Coordinator contacts participant by phone. 2) If participant is interested in learning more about the research study, the

coordinator will collect their demographic information to register them on the eConsent Management website.

3) Once participant’s demographic information is entered on the eConsent Management website, coordinator emails potential participant the link to the specific study eConsent.

4) Participant will receive a notification email with link to login and complete online consent.

5) Once the consent has been completed a coordinator will be notified via email to review the document.

6) Coordinator will select view/approve pending consents (72 hours). 7) Coordinator will select the approve/reject button. If the coordinator

chooses approve then an email notification will be sent to the participant’s email.

• Q: Who is the contact for setting up a study with eConsent, and what is the cost?

• A: Dave Woodburn, Business System Analyst, is the BMI contact to set up an eConsent for a study. Fees vary $1,000 - $2,000 per study.

eConsents

Move over Martha Stewart!! According to recent articles in the Wall Street Journal and Forbes, a single doctor – who had inside clinical trial information – is very likely at the very heart of what is probably the largest insider trading scandal in U.S. history. The information was provided freely and without negative intentions (via an early release of a presentation).

The trader forged a friendship with the doctor and became privy to secret knowledge of an experimental drug, allowing him to invest accordiningly, netting over $250M, that he will likely lose! This highlights the incredible value of clinical trial data and the importance of maintaining strict confidentiality and licensing.

In the News