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July 2013 | Newsletter IN THIS ISSUE A Talk With The CITI Program’s Animal Care and Use (ACU) Consultant, Kathy Wadsworth Learn more about what our ACU series has to offer and how she helps to maintain it. International Activities Review a brief history of the CITI Program’s international presence and updates from around the world. Newly Appointed Executive Advisory Board (EAB) The CITI Program is pleased to announce the distinguished members of its newly appointed EAB. CITI Program Establishes A Program Advisory Committee (PAC) Review the members of the CITI Program’s PAC who will be in charge of maintaining and developing content. CITI Program Welcomes Senior Research Analyst, Dr. Janice Adelman Meet our newest team member, Senior Research Analyst, Dr. Janice Adelman.
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Page 1: IN THIS ISSUE - Collaborative Institutional Training ...Chennai is located. Global Updates for 2013 In India, the CITI Program and our Center of Excellence based at Sri Ramachandra

July 2013 | Newsletter

IN THIS ISSUEA Talk With The CITI Program’s Animal Care and Use (ACU) Consultant, Kathy Wadsworth

Learn more about what our ACU series has to offer and how she helps to maintain it.

International Activities

Review a brief history of the CITI Program’s international presence and updates from around the world.

Newly Appointed Executive Advisory Board (EAB)

The CITI Program is pleased to announce the distinguished members of its newly appointed EAB.

CITI Program Establishes A Program Advisory Committee (PAC)

Review the members of the CITI Program’s PAC who will be in charge of maintaining and developing content.

CITI Program Welcomes Senior Research Analyst, Dr. Janice Adelman

Meet our newest team member, Senior Research Analyst, Dr. Janice Adelman.

Page 2: IN THIS ISSUE - Collaborative Institutional Training ...Chennai is located. Global Updates for 2013 In India, the CITI Program and our Center of Excellence based at Sri Ramachandra

Page 1

A TALK WITH THE CITI PROGRAM’S ANIMAL CARE AND USE (ACU) CONSULTANT, KATHY WADSWORTH

Why is it important for organizations to consider the ACU series?

In this time of ever-tightening budgets, it’s important for organizations to be able to provide high-quality training programs, while reducing overhead and staffing costs. With the CITI Program, organizations that require training in areas such as human subjects protection, may also utilize content offered in the ACU courses all for one subscription fee. Though no online program can replace hands-on training or web labs, the ACU courses provide a solid introduction to animal regulations, oversight, and the humane care and use of animals.

The CITI Program’s online platform allows organizations to customize the ACU course curriculum for multiple target audiences such as investigators, staff, IACUC members, vet techs, and students. Organizations may add modules from an animal or model specific course (for example, Working with Mice in Research Settings) to the modules offered in a basic course, which will help to further meet the needs of a researcher. Furthermore, learners are able to affiliate with several CITI Program participant organizations to simultaneously satisfy the training requirements of multiple organizations.

Are there plans to expand upon the ACU series?

The CITI Program is developing an Agricultural/Farm Animal course, which will include modules regarding working with horses, cattle, sheep, and poultry, with plans to include additional animals at a later date.

Other new courses we anticipate, include a Wildlife Research course, Postapproval Monitoring course, and the aforementioned Working with Zebrafish in a Research Setting course.

Kathy Wadsworth, CPIA, CIP,serves as the CITI Program’s

ACU Consultant. She is an author and works with the ACU Developers’ Group to

update content and develop new courses.

What type of content does the ACU series offer?

We have designed the ACU series to help organizations comply with the U.S. government principles, Health Research Extension Act of 1985, and the PHS Policy requirements for appropriately trained personnel, and availability of instruction and training for researchers working with animals. At this time, there are four basic ACU courses (Working with the IACUC, Essentials for IACUC Members, IACUC Community Member, and Post-Procedure Care of Mice and Rats in Research: Reducing Pain and Distress), as well as a refresher course (Working with the IACUC – Refresher). In addition to these courses, there are two additional modules of interest (Aseptic Surgery and Antibody Production in Animals). Animal-specific courses from “A” (amphibians) to “Z” (zebrafish [course will be available later this year]) are also available to help supplement the basic, refresher, and additional modules of interest.

The creation and maintenance of all ACU content is performed by the ACU Developers’ Group, which consists of veterinarians, IACUC members, IACUC chairs and coordinators, ethicists, and lab animal users.

We are also very excited about the refresher case studies for the IACUC member courses, which are in their final stage of development. These case studies consist of interactive scenarios that will test an IACUC member’s knowledge by taking them step-by-step through situations they may encounter in the course of their duties. Topics include a variety of issues such as investigating noncompliance, protocol deviation, disaster planning, and conducting semiannual program review.

How can an organization expand on their use of the ACU training?

As with other series offered by the CITI Program, the ACU curriculum may be modified to create site-specific content. For instance, organizations can create introductory modules to provide information specific to their IACUC and ACU program.

For more details regarding module customization, please contact our Help Desk. Additionally, our staff members are available to help administrators modify their existing curriculum to best suit the needs of the individual organization.

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INTERNATIONAL ACTIVITIES

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Office for Human Research Protection’s (OHRP) JPS Research Day 2013 (www.jpsresearchday.org) in Fort Worth, TX. His presentation, “Bioethical Research in the Developing World: The MHRP Experience,” focused on the exploration of ethical challenges related to collaborative research between developed and developing countries, particularly with vaccine trials and placebo controlled studies.

Overall, the CITI Program is rapidly expanding internationally and now provides more educational tools for the global research community than ever before. We look forward to these continued efforts and collaborations.

Learn More

In addition to our existing content, the CITI Program offers the ability to generate custom modules that deliver content specific to the country or region where an organization is located. This has allowed many international organizations to educate their learners on regulations and ideas pertaining to research ethics in various parts of the world. Furthermore, the CITI Program may commission additional language translations to broaden the range of this type of content.

Contact us for more information about our international activities or to talk to a representative about international content for your organization.

A Brief History

As a part of the CITI Program’s overall mission, we continuously work to fostereducational programs that will help strengthen research integrity and human subjects protection around the world.

To date, more than 350 international organizations have subscribed to the CITI Program, which constitutes an important part of the community of investigators, students, technicians, and research ethics committee members that are benefiting from our training.

The growth of our international presence is thanks in large part to a Fogarty International Center – National Institutes of Health (NIH) grant provided to the Pan American Bioethics Initiative (PABI). PABI is a joint endeavor between the CITI Program, University of Miami Ethics Programs, and numerous scholars and specialists from several Latin American countries who have adapted or created educational content that is contextually appropriate to their region. In all cases, the development of new content is discussed and finally agreed upon by means of workshops, which trigger an enriching and fruitful exchange between experts.

Chennai is located.

Global Updates for 2013

In India, the CITI Program and our Center of Excellence based at Sri Ramachandra University in Chennai, co-sponsored a well-attended meeting on research methodology and research integrity this March. The meeting was enthusiastically supported by the governor of Tamil Nadu, the state where

In Japan, a joint proposal formulated by Shinshu University, Fukushima Medical University, Kitasato University, Sophia University, and the Okinawa Institute of Science and Technology Graduate University, was awarded with a five year grant provided by the Japanese government to develop curricular content on research ethics and research integrity, which will be delivered using the CITI Program’s online platform.

In Vietnam, the CITI Program was invited to collaborate on a project funded by a Columbia University-NIH grant (Columbia University’s Center for the History and Ethics of Public Health [CHEPH]) that involves Hanoi Medical University and the Ministry of Health. This project focuses on public health ethics, which CHEPH will provide the lead on. During a workshop carried out in April 2013, the CITI Program had the privilege of being included on the creation of original educational content developed by Vietnamese experts, with support from Columbia University and University of Miami faculty members.

Aside from these educational experiences, the CITI Program continues its collaboration with our Center of Excellence in Seoul, South Korea and is looking forward to the imminent creation of a new Center of Excellence in Bogotá, Colombia.

In June 2013, the CITIProgram’s International Director, Dr. Sergio Litewka, had the honor of presenting as the keynote speaker at the

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NEWLY APPOINTED EXECUTIVE ADVISORY BOARD (EAB)

Ernest Prentice, PhDInterim Chair as appointed by the Provost

Dr. Prentice is the Associate Vice Chancellor for Academic Affairs at the University of Nebraska Medical Center and is a nationally recognized expert in the ethics and regulation of both human and animal research. He is a frequent lecturer at national and international conferences, and consultant to hospitals, universities, and law firms.

Ada Sue Selwitz, MS

Ms. Selwitz is the Director of the Office of Research Integrity at the University of Kentucky (UK), Adjunct Professor in Behavioral Sciences, and Co-Director of the Regulatory and Research Ethics Core of the NIH-funded UK Center on Clinical and Translational Sciences. She has co-authored multiple publications, serves on the PRIM&R Board, and is a founding member of the CITI Program.

Jerry Castellano, PharmD, CIP

Dr. Castellano is the Corporate Director - Institutional Review Boards at Christiana Health System and Adjunct Associate Professor at the University of Delaware. He has presented and published over 850 programs, as well as articles in various areas of ethics on the local, national, and international level.

Juan Pablo Uribe, MD Dr. Uribe is the Director General of the Fundación Santa Fe de Bogotá. He is the former Vice Minister of Health for Colombia and former National Director of Public Health, and has been a board member for various organizations worldwide. A physician and public health expert by training, he has worked closely with health systems across Latin America, Asia, and the Pacific.

Sally L. Mann, MS Mrs. Mann is a Human Subjects Protection and Editorial Services Consultant for the CITI Program at the University of Miami. She served at the University of Nebraska as a Research Coordinator for 20 years and as an IRB Administrator for 10 years. She is currently a member on two institutional review boards.

Jack Lord, MD Dr. Lord is a Professor of Pathology at the University of Miami. He previously served as the Chief Operating Officer and VP for Medical Administration of the University of Miami’s Miller School of Medicine. He has extensive experience in medicine and healthcare in the non-profit, for-profit, and government sectors.

Cynthia Gates, RN, JD, CIP Ms. Gates is the President of Rise and Shine, Inc. She is the former VP of Operations and Regulatory Affairs for WIRB, and worked as a registered nurse for over 24 years including service in the U.S. Air Force Reserve Nurse Corps.

Susan M. Miller, MD, MPH Dr. Miller is an Associate Professor of Clinical Medicine at Weill Cornell Medical College of Cornell University and is the Deputy Chief of the Department of Family Medicine at The Methodist Hospital. She also serves as the Director of the Chao Program for International Research Ethics and is the Chair of The Methodist Hospital Research Institute’s IRB.

Executive Advisory Committee (EAC), along with UM, developed the concept for the EAB. A better understanding of how the CITI Program accomplishes its goals and mission will enable the University of Miami to appreciate the program’s footprint and develop an understanding of how to best nurture it

into the future.

The EAB will be holding its first meeting in August 2013 as the last official meeting of the EAC was held in June 2013. With this being said, the CITI Program is sincerely grateful to all past

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The above newly appointed Executive Advisory Board (EAB) members were selected by the Provost of the University of Miami (UM) to provide strategic business and organizational guidance to not only the CITI Program's leaders, but also to senior leadership at UM. Dr. Ernest Prentice and the CITI Program’s

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Page 4

CITI Program Establishes A Program Advisory Committee (PAC)The CITI Program’s Executive Advisory Committee (EAC) has established the PAC to maintain current program materials and facilitate the development of new modules and courses as necessary. The PAC will operate to keep the CITI Program fresh and relevant for the global research community. New content suggestions should be sent to Dr. Jaime Arango at [email protected].

PAC Members

Jaime Arango, EdD, CIPCITI Program at the University of MiamiHuman Subjects Research (HSR) Series Leader

Karen Arts, BSN (Hons), RN, CCRCOntario Institute for Cancer ResearchInternational Focus

Jason Borenstein, PhDGeorgia Institute of TechnologyResponsible Conduct of Research (RCR) Series Leader

Reid Cushman, PhDUniversity of MiamiInformation Privacy and Security (IPS) Series Leader

Benjamin Fontes, MPH, CBSPYale UniversityBiosafety and Biosecurity (BSS) Series Leader

Lorna Hicks, MS, CIPDuke UniversitySocial and Behavioral Research with Human Subjects Focus

Sergio Litewka, MD, MPHUniversity of MiamiCITI Program International Director

EAB Continued

Michael Mann, PhDUniversity of Nebraska Medical Center (Retired)Animal and Care Use (ACU) Series Leader

Randall Nelson, PhDUniversity of Tennessee Health Science CenterAnimal Care and Use (ACU) Focus

Daniel Vasgird, PhDInterim ChairWest Virginia UniversityResponsible Conduct of Research (RCR) Focus

Kathy Wadsworth, CPIA, CIPCITI Program at the University of MiamiAnimal Care and Use (ACU) Consultant

CITI Program Stats as of July 2013More than 4.9 million courses have been

completed by learners from around the globe.

Over 2,000 organizations currently subscribe to our online training.

75 countries have organizations that are subscribers.

www.citiprogram.org has been visited by more than 70 percent of the world map.

EAC members including: Karen Hansen, CITI Program Co-Founder, Ernest Prentice, PhD, EAC Chair; Jason Borenstein, PhD; Jerry Castellano, PharmD, CIP; Lorna Hicks, MS, CIP; Michael Mann, PhD; Helen McGough, MA, CIP; Susan M. Miller, MD, MPH; Daniel Vasgird, PhD; David Forster, JD, MA, CIP; Ken Goodman, PhD, FACMI; Bruce Gordon, MD; and Cyd Gillett, DVM, DACLAM, CPIA.

This group, led by Dr. Prentice for the past six years, provided an invaluable service to the CITI Program and has allowed it to hold the status that it does today.

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Page 5

CITI Program Welcomes Senior Research Analyst, Dr. Janice Adelman

Role at CITI Program

Dr. Adelman joins the CITI Program

team as a Senior Research Analyst,

where she is applying her skills at survey

design and data analysis to help evaluate

program effectiveness and needs in the

realm of research ethics education.

Through her position at the CITI

Program, Dr. Adelman is also a part of

the Miami Clinical and

Translational Science Institute’s (CTSI)

research ethics program. In this

capacity, she is working on developing a

line of “research on research.” In all of

these activities, Dr. Adelman aims to

contribute towards her goal of

addressing public needs with sound

research science. In her other life, Dr.

Adelman teaches ballet fitness classes at

Barrebox studio in Miami and private

West Coast Swing dance lessons.

Purchase a copy at

www.citiprogrampublications.org.

Brandeis University. She has

conducted research in Israel, the

Palestinian Territories, and the U.S. on

topics ranging from early life predictors

of adult depression to factors of support

for political violence. Her research

incorporates theories of social identity,

nationalism, religion, and collective

action. Prior to joining the CITI

Program, Dr. Adelman worked as a

research scientist exploring predictors

of radicalization and the motivations for

joining terrorist organizations.

She is an active member of both the

Society for the Psychological Study of

Social Issues (SPSSI) and the

International Society of Political

Psychology (ISPP), having served in

elected positions for both societies’

governing councils. Currently, Dr.

Adelman is in a three-year term as

SPSSI’s newsletter editor.

Background

Dr. Adelman is an applied social

psychologist with research interests in

violent group conflict, applied social

issues, and research ethics. She received

her PhD in psychology from Claremont

Graduate University. She also holds an

MSc in neurobiology from The Hebrew

University of Jerusalem and a BA in

neuroscience and psychology from

NWABR 2013 IACUC Regional Education Conference

2013 OHRP Community Forum

PRIM&R 2013 IACUC Conference

2013 AAHRPP Conference

ACRP Global Conference & Exhibition

MAGI’s Clinical Research Conference - East 2013

ASM 2013 Conference

ASCO Annual 2013 Meeting

DIA 2013 49th Annual Meeting

If we missed you, please...

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�¥��(PDLO�FLWLVDOHV#PHG�PLDPL�HGX�WR� request a meeting at one of our fall

conferences.

Spring 2013 Conference Recap (February through June)

Page 7: IN THIS ISSUE - Collaborative Institutional Training ...Chennai is located. Global Updates for 2013 In India, the CITI Program and our Center of Excellence based at Sri Ramachandra

CITI PROGRAM CONTENT HUMAN SUBJECTS RESEARCH (HSR) - BIOMEDICAL MODULES REFRESHERS AVAILABLE ON SELECT MODULES

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HUMAN SUBJECTS RESEARCH (HSR) - SOCIAL-BEHAVIORAL-EDUCATIONAL (SBE) MODULES REFRESHERS AVAILABLE ON SELECT MODULES

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HUMAN SUBJECTS RESEARCH (HSR) - ADDITIONAL MODULES OF INTEREST �������&XOWXUDO�&RPSHWHQFH�LQ�5HVHDUFK��������&RQIOLFWV�RI�,QWHUHVW�LQ�5HVHDUFK�,QYROYLQJ�+XPDQ�6XEMHFWV��������+RW�7RSLFV���������,�+DYH�$JUHHG�WR�EH�DQ�,5%�&RPPXQLW\�0HPEHU��1RZ�:KDW"��������,QWHUQDWLRQDO�6WXGLHV��������6WXGHQWV�LQ�5HVHDUFK��������7KH�,5%�$GPLQLVWUDWRU¶V�5HVSRQVLELOLWLHV��������7KH�,5%�0HPEHU�0RGXOH���³:KDW�(YHU\�1HZ�,5%�0HPEHU���������1HHGV�WR�.QRZ´��������9XOQHUDEOH�6XEMHFWV��5HVHDUFK�,QYROYLQJ�:RUNHUV�(PSOR\HHV��������6WHP�&HOO�5HVHDUFK�2YHUVLJKW��3DUW�,���������6WHP�&HOO�5HVHDUFK�2YHUVLJKW��3DUW�,,�

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Page 8: IN THIS ISSUE - Collaborative Institutional Training ...Chennai is located. Global Updates for 2013 In India, the CITI Program and our Center of Excellence based at Sri Ramachandra

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