IN THIS ISSUEFAQs on Using the CITI Program

Review some of the most frequently asked questions that we receive from new and existing customers to ensure that you are getting the most out of your CITI Program subscription.

What’s New with the CITI Program

Discover the latest courses, modules, products, and features that the CITI Program has to offer.

Meet the CITI Program’s Biosafety and Biosecurity (BSS) Series Leader

A talk with the BSS series leader, Ben Fontes, regarding his role with the CITI Program and what the series has to offer.

Event Schedule

Plan a time to meet with a CITI Program team member after reviewing our spring 2013 conference schedule.

CITI Program’s Content Offerings

Make sure that you are taking full advantage of all our current content offerings.

March 2013 | Newsletter

CONTACT THE CITI PROGRAM

(305) 243-7970

citisupport@med.miami.edu

www.citiprogram.org

1 March 2013 | Newsletter

USING THE CITI PROGRAM: THE MOST FREQUENTLY ASKED QUESTIONS FROM NEW AND EXISTING USERS

Who may access CITI Program training?

Access to our comprehensive learning materials is available to all non-profit, for-profit, government, and academic organizations, and individual learners worldwide, via a per site organizational subscription or as an independent learner.

The annual subscription fee covers enrollment into CITI Program training for an unlimited number of learners at your organization, per site.

What content is available with an annual subscription?

The annual subscription fee provides access to all courses and modules in the following web-based training series: Animal Care and Use (ACU), Good Clinical Practice (GCP), Human Subjects Research (HSR), Information Privacy and Security (IPS), and Responsible Conduct of Research (RCR) including the new Conflicts of Interest (COI) course. For an additional fee, the Biosafety and Biosecurity (BSS) and Export Control (EC) series may be added to your organization’s training offerings.

Select CITI Program content is available in languages other than English, including Arabic, French, Japanese, Korean, Mandarin, Portuguese, Russian, Spanish, and Thai. Further translations may be commissioned for an additional fee.

How can the CITI Program help manage my learner base?

In order to meet the differing roles and responsibilities that individuals play within an organization, our software allows an organization to divide its affiliates into different learner groups. Each of these may be customized, including different module requirements, refresher cycles, passing scores for courses, and language restrictions. Learners will automatically be placed into their correct learner group based on answers provided to a unique series of questions asked during the registration process.

Upon a learner’s successful completion of a course, a completion report will beinstantaneously available to the learner and any designated administrators at the organization. This document serves as the official record that the training was completed.

How can I determine the best training modules for my organization?

Before selecting new courses or adding content to your existing training, we suggest looking at the current expanded array of content offerings via the CITI Program demo and our course catalogs.

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If you have specific questions regarding content, feel unsure about which courses are right for you or your organization, or would like to add a course or module, please e-mail citisupport@med.miami.edu. Continued on Page 2...

The Scientists Center for Animal Welfare (SCAW) is composed of research professionals dedicated to the promotion of animal welfare and excellence in basic and applied scientific inquiry. SCAW affirms that the potential benefit to humans and animals from research is of paramount importance. By addressing animal research challenges directly through education, training, and problem solving initiatives, SCAW serves to facilitate open discussion between stakeholders, including representatives from USDA and OLAW. This, in turn, provides a forum in which federal representatives can engage in a constructive dialogue with the research community in order to craft solutions and promote best practices in the advancement of science and medicine.

SCAW’s goals are the development, acceptance, and implementation of best practices for the promotion of animal welfare with the conviction that quality animal care and use improves both the quality of scientific results and engenders public support for scientific research; provision of an ongoing forum for the exchange and evaluation of scientific information about the care, treatment, well-being, and ethical use of animals.

Other initiatives of SCAW are:

Encouragement of the development and adoption of effective and efficient standards and measures of performance standards; employment of communications media to inform the scientific community, institutional officials, Institutional Animal Care and Use Committees (IACUCs), institutional animal care personnel, public policy makers, and the general public about the results of its activities; cooperation with other groups, associations, and agencies that have goals similar to those of SCAW.

Individual and Institutional Memberships are available. Get involved and become a member; membership forms are on the web at www.scaw.com.

Scientists Center for Animal Welfare (SCAW)7833 Walker Drive, Ste 410Greenbelt, MD 20770Tel: 301-345-3500

2 March 2013 | Newsletter

CITI PROGRAM FAQs CONTINUEDCan I supplement the training with custom modules?

Yes! You may optimize your organization’s training by adding custom modules to any course. This allows content and training resources specific to your organization to be displayed on the CITI Program platform for learners to view. To add a custom module to your organization’s training, contact citisupport@med.miami.edu for pricing and instructions.

May I use CITI Program materials in a classroom setting?

CITI Program course materials may be integrated into a classroom setting depending on their intended use. If you wish to introduce CITI Program content as a classroom aid, please contact us at citisupport@med.miami.edu with a detailed description of your request and we will review it for approval.

How can I subscribe to the CITI Program?

To get started on the subscription process, please fill out an order form at www.citiprogram.org. You may also e-mail us at citisales@med.miami.edu or call (305) 243-7970 and one of our representatives will help guide you through the process.

Restoring Professionalism & Integrity in Research

Sometimes Good Make

Researchers Bad Decisions

The Restoring Professionalism and Integrity in Research (RePAIR) program provides intensive professional devel-opment education for investigators who have engaged in wrongdoing or unprofessional behavior, including persistent noncompliance.

The RePAIR program was developed with NIH funding (UL1RR024992) by a team of clinical, organizational, and developmental psychologists with input from remediation trainers, ethicists, lawyers, investigators, and research administrators.

The RePAIR Program Coordinator can be reached by phone at 314-977-1070 or by email at repair@slu.edu.

>> For more information please visit www.repairprogram.org

New Courses

Conflicts of Interest (COI)

Developed in conjunction with the Association of American Medical Colleges (AAMC) and the University of Miami, the CITI Program’s COI Course provides learners with a review of the revised Public Health Service (PHS) regulations associated with financial conflicts of interest. The course includes an option for organizations to provide instructional materials related to their own policies and procedures via the CITI Program platform.

IACUC Community Member

The IACUC Community Member course is intended for community representatives within an institutional animal care and use committee (IACUC). Community representatives should take this course, not the Essentials for IACUC Members course, as it is specifically designed for them. The course covers ethics, regulations and the IACUC, IACUC basics, full-committee review and DMR, and other responsibilities as well as additional tips for IACUC community members.

Working with Fish in Research Settings

This course addresses issues in the use of fish in research. It reviews topics such as taxonomy, research mandates, occupational health, alternatives, humane standards, housing, source, acclimation and quarantine, biological features, recognizing pain and distress, collection, identification, and routes of administration, anesthesia, analgesia, surgery, postoperative care, and euthanasia.

WHAT’S NEW WITH THE CITI PROGRAM? Earn AMA PRA Category 1 TM

credits towards your recertification while meeting

your organization's training requirements. Go to

www.citiprogram.org.

Continued on Page 3...

2 in 1

3 March 2013 | Newsletter

New HSR Courses WHAT’S NEW CONTINUED

IRB Chair

The IRB Chair course is intended for institutional review board (IRB) chairs and vice-chairs. The course covers the IRB Chair’s role and responsibilities, meeting responsibilities, and their role outside of the IRB meeting.

New Human Subjects Research (HSR) Refresher Courses

By the end of March 2013, the CITI Program’s current refresher offerings in biomedical research (101, 200, and 201 courses), and social and behavioral research (101 and 201 courses) will be updated and restructured so that they are more closely tied to their basic level modules. Updates will include title name changes, a new numbering sequence, content updates, and a change in the term “social and behavioral research (SBR)” to “social, behavioral, and educational (SBE).”

New HSR Modules Unanticipated Problems and Reporting Requirements in Biomedical Research

This module provides guidance to investigators on complying with U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) reporting requirements. It includes an overview of unanticipated problems, unanticipated adverse device effects, and the relationship between adverse events and unanticipated problems involving risk to subjects or others. The module presents a discussion on how to detect unanticipated problems and report them.

Unanticipated Problems in Social & Behavioral Research

This module provides learners with an overview of the Office for Human Research Protections’ (OHRP) criteria used to determine if an incident, experience, or outcome constitutes an unanticipated problem. The module continues with a discussion of reporting requirements and the various corrective actions or substantive changes that an IRB can consider in response to an unanticipated problem.

Cultural Competence in Research

This module provides learners with an overview of the essentials of practicing cultural competence in research. It describes the importance of understanding the subjects’ demographics, historical contexts, communication styles, customs, values, and beliefs of research study populations. A discussion of how IRBs and researchers can operate to support this work is also presented. This module may be added to either the Biomedical or Social, Behavioral, and Educational course in the Human Subjects Research series.

Add a new course or module to your training:

E-mail your request to the Help Desk at citisupport@med.miami.edu.

Continued on Page 4...

New RCR Module Plagiarism

Plagiarism violates academic integrity standards and is one of the major forms of research misconduct. This module is designed to present learners with a detailed discussion of what constitutes plagiarism. It presents the parameters of plagiarism according to definitions developed by U.S. federal agencies, the basic principles of scholarship, the distinction between summarizing and paraphrasing text, and proper paraphrasing skills as well as use of citations.

Are You Thinking About Being in a Research Study?

This module is meant to help individuals understand what research involving human subjects is, their rights as a human subject, what questions they should ask before deciding on being a human research subject, what the informed consent process is, what they can expect after saying “yes” to being a human research subject, and who protects people who agree to be research subjects.

New Public Access Module

4 March 2013 | Newsletter

WHAT’S NEW CONTINUED

Good Clinical Practice (GCP) Guide

MEET BEN FONTES, THE CITI PROGRAM’S BIOSAFETY AND BIOSECURITY (BSS) SERIES LEADER

The CITI Program is pleased to now offer a supplemental resource for the CITI Program's web-based GCP training. It is intended to serve as a quick reference guide for GCP in both drugs and biologics, as well as devices. The GCP Guide is the first in a series for the CITI Program.

Be sure to check back in the coming months as we will be releasing additional guides for other content series.

The GCP Guide is priced at $40 per guide and will be available for purchase in March 2013 upon the completion of a course or by visiting www.citiprogram.org/publications. You may order a copy today by calling (305) 243-7970 or at citisales@med.miami.edu.

Ben Fontes, MPH, CBSP, is the Biosafety Officer and Manager of the Safety Advisor Program for the Environmental Health and Safety Office at Yale University. Fontes is the primary author of the BSS educational modules and he currently serves as the leader of the CITI Program’s Biosafety Development Group.

What does the BSS series provide to an organization?

It offers an opportunity to achieve compliance with a variety of core regulatory educational requirements in biosafety. The CITI Program provides individual training areas such as bloodborne pathogens, shipping, and the NIH guidelines, to help meet specific training requirements applicable to research organizations, as well as groups of modules designed for more comprehensive education in biosafety and biosecurity. The BSS series is targeted for a range of employees and staff, including principal investigators, researchers, clinical lab staff, institutional biosafety committee (IBC) members, and new biosafety professionals.

Why is it important for organizations to consider the CITI Program’s BSS training?

It is important for organizations to confirm that their employees and staff are obtaining baseline information that will help identify work situations that represent a risk to biohazards along with helping to document compliance with educational requirements. It is also important to recognize that no educational program can serve as a replacement for the hands-on experience of field training. Although the CITI Program does not provide the hands-on training that a host organization can, it does provide a solid introduction to a wide range of biosafety and biosecurity topics.

Are there plans to expand upon the BSS series in the future?

The CITI Program has been asked to develop a Lab Chemical Safety Training program and there has been some discussion on providing educational modules for organizations that conduct research with Risk Group 3 pathogens or a BSL3 Containment program.

The CITI Program’s Biosafety Development Group periodically updates the BSS educational modules as applicable. The flagship educational module is Shipping Regulated Biological Materials, which helps to ensure compliance with U.S. Department of Transportation (DOT) and the and the International Air Transport Association (IATA) rules and regulations. Experts within the group work hard to keep this segment up to date to ensure that organizations can keep their staff in compliance with these intricate regulations. With this being said, it won’t provide the site-specific requirements that are part of any training, but it does hit on all required regulatory elements.

How can an organization make the BSS training site-specific?

Several organizations take advantage of the BSS series by working directly with the CITI Program to modify modules to make the available content site-specific to their institution. The Biosafety Developers Group encourages this, as there is no way to develop one module that meets site-specific criteria for each location.

Learn more about the fees to access the BSS

training and place your order at

citisales@med.miami.edu.

5 March 2013 | Newsletter

THE CITI PROGRAM’S SPRING 2013 CONFERENCE SCHEDULE

NWABR 2013 IACUC Regional Education ConferenceFebruary 25, 2013 in Seattle, WA

2013 OHRP Community ForumMarch 15, 2013 in Orlando, FL

PRIM&R 2013 IACUC Conference March 18-19, 2013 in Baltimore, MD

2013 AAHRPP ConferenceApril 3-5, 2013 in Miami, FL

ACRP Global Conference & Exhibition April 13-16, 2013 in Orlando, FL

MAGI’s Clinical Research Conference - East 2013May 5-8, 2013 in Boston, MA

ASM 2013 ConferenceMay 18-21, 2013 in Denver, CO

ASCO Annual 2013 MeetingMay 31-June 4, 2013 in Chicago, IL

Send a request to citisupport@med.miami.edu to meet with a CITI Program representative at one of the conferences listed above. We look forward to seeing you!

Working in research ethics is both challenging and constantly evolving, that’s why we’re here to help.

For additional information, visit our website or contact us at: +1 347 862 9321 ph | +1 347 862 9323 fax | info@thehrpconsultinggroup.com | thehrpconsultinggroup.com

HRP Consulting Group (HRP) and our network of Associates have multiple decades of experience in almost all facets of research and research ethics. Helping Research Professionals (HRP) is who we are! Our consulting firm is capable of assisting in all areas of research ethics and compliance, including IRB, IACUCs, Biosafety & Biosecurity, RCR, Misconduct, and Research Administration. We provide expert advice to organizations ranging from the creation of new programs to improving existing programs. If it relates to research ethics, you can count on us to lend you a helping hand. HRP offers the following services and products to help you and/or your organization achieve its goals.

Services: Education and Training in all areas research ethics and regulatory compliance (IRB, IBC, IACUC, & RCR) / Process Development / Program Evaluations, Documentation Development (Customizable SOPs, Submission Forms, and Reviewer Checklists for IRBs, IACUCs and IBCs) / Investigator Monitoring / Collaborative IRB & IACUC development / IRB & IACUC Ethics committee Start-up / Regulatory (IRB, IBC, IACUC, & RCR) Management Solutions / Accreditation Assistance and Assistance Responding to Federal Agencies.

Training and Consulting in Human Research Protections IRB Management Solutions

2013 Advancing EthicalResearch (AER) Conference

November 7-9, Boston, MAPre-Conference Programs:

November 6

Visit www.primr.org/aer13.

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6 March 2013 | Newsletter

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

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7 March 2013 | Newsletter

CITI PROGRAM COURSES RESPONSIBLE CONDUCT OF RESEARCH (RCR)��������5&5�IRU�%LRPHGLFDO�6FLHQFHV��������5&5�IRU�(QJLQHHULQJ���������5&5�IRU�+XPDQLWLHV���������5&5�IRU�3K\VLFDO�6FLHQFHV��������5&5�IRU�5HVHDUFK�$GPLQLVWUDWLRQ��������5&5�IRU�6RFLDO��%HKDYLRUDO��DQG�(GXFDWLRQ�6FLHQFHV

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