CITI Program – Hamad Medical Corporation
Medical Research Center – Dr. Al-Hareth M. Al-Khater, Chairman Dr. David W. Matear, Dr. Anjum Susan John, Dr. Prem Chandra, Dr. Shajitha Theke Veetil, Dr. Asmaa Abubaker Al Musleh, Dr. Nacera Ouslimane, Ms. Kia Kornas, M. Anusha Abdul Khader
Medical Research CentreHamad Medical Corporation CITI Program Introduction
Objectives for the CITI Presentation
• Overview of the CITI program• HMC groups required to have CITI certification• HMC course requirements for each groups • Timelines for achieving certification • Registration process
Structure for the CITI Presentation
• Overview of the CITI program• HMC groups required to have CITI certification• Timelines for achieving certification • HMC requirements for clinical investigators• Clinical trials• Social and behavioral research • Research with animals • Laboratory research • Health Information Privacy and Security (HIPS) Course• Demonstration of the registration process• Next steps• Question time
CITI Program• Collaborative Institutional Training Initiative (CITI)
– A web based training program in human research subjects protections• Basic Courses in the Protection of Human Research Subjects
– Biomedical Focus – Social and Behavioral Focus– Refresher Courses
• Good Clinical Practice Course• Health Information Privacy and Security Course (HIPS)• Laboratory Animal Research Courses For Investigators and IACUC
Members – Animal Model Specific Courses.
• Responsible Conduct of Research (RCR) Courses. – Biomedical Research Focus – Social, Education, Behavioral Research Focus – Physical Sciences Research Focus – Scholarly Activities in The Humanities Focus – RCR for Engineers – RCR for Science Administrators
• Bio-Safety and Bio-Security
HMC CITI Program
• Basic Courses in the Protection of Human Research Subjects
• Good Clinical Practice Course• Laboratory Animal Research Courses For
Investigators and IACUC Members • Bio-Safety and Bio-Security • Health Information Privacy and Security Course
(HIPS)
CITI Program Groups at HMC
• Biomedical Researchers (BMR)• Social and Behavioral
Researchers (SBR)• Clinical Trials Investigators • Clinical Investigators • Clinical Research Students and
instructors Research Committee/Institutional Review Board (IRB) Members
• Medical Research Center (MRC) Reviewers
• Investigations Committee Members
• DSMB Members• MRC Staff• Marketers and Sponsoring
Companies
• Laboratory Animal Research – IACUC Members– Animal Laboratory
Researchers – Animal Laboratory Managers
and Technicians – Animal Laboratory Research
Students • Biosafety and Biosecurity
– HMC Biosafety Committee– Laboratory Researchers – Laboratory Managers and
Technicians – Hazardous Materials
Responders – Biosafety professionals – Laboratory Research Students
Timelines for Certification
• Certification required for investigators of all new proposals – April 1, 2011
• Certification required for investigators with ongoing studies – October 1, 2011
Laboratory and Animal Research
“Character is doing the right thing when nobody’s looking. There are too many people who think that the only thing that’s right is to get by, and the only thing that is wrong is to get caught”
~ J.C. Watts
How To Do The Right Thing?
Compliance• Conducting Research in Animals is A Privilege • Privilege can only be granted by the IACUC• IACUC approves Experimental Protocols
Objectives of the CITI Program
Research Conduct According to International Standards
Replacement: Replace animals with other research tools or techniques to adequately address the research question
Reduction: Means minimizing the number of animals needed to perform an experiment or teach a concept
Refinement: Means refining experimental protocols to minimize pain or distress whenever possible
CITI Program Requirements –Animal Researchers
• Three Courses 1) Animal Laboratory Researchers (25 modules)2) Aseptic Surgery(1 module)3) Reducing pain and distress in Laboratory Mice
and Rats(14 modules)
HMC Laboratory Researchers -Biosafety
Biosafety describes the policies and procedures adopted to ensure the
environmentally safe application of research without endangering public health or environmental safety
Obligation of Safety Standards of the Research Environment Provides— Safety of the Laboratory and Environment— Safety of the Staff— Welfare of the Experimental Animal
HMC Laboratory Researchers (BIO)
Required Biosafety Course –7 Modules1) Biosafety course overview2) Laboratory - Associated Infections3) Risk management – emergency Procedures4) OSHABloodborne pathogens Archived 134805) Bloodborne Pathogens6) Select Agents7) Biosecurity
Take the CITI Training…
Let Us Do The Right Thing
Health Information Privacy and Security Course (HIPS)
CITI Program Requirements HIPS
• Clinical Investigators – 4 Modules
• Clinical research students and instructors – 4 Modules
• Marketers and Sponsoring Companies – 8 Modules
• Medical Research Center (MRC) Reviewers – (All Modules)
• Research Committee/Institutional Review Board (IRB) Members – (All Modules)
• MRC Staff– (All Modules)
About the "HIPS" HIPAA education series* (ID: 1416)
Privacy Rules: Introduction to Federal and State Requirements* (ID: 1417)
Privacy Rules: Clinicians* (ID: 1418)
Privacy Rules: Clinical Investigators* (ID: 1419)
Privacy Rules: Students and Instructors* (ID: 1420)
Privacy Rules: Fundraisers* (ID: 1421)
Privacy Rules: Marketers* (ID: 1422)
Security Rules: Basics of Being Secure, Part 1* (ID: 1423)
Security Rules: Basics of Being Secure, Part 2* (ID: 1424)
Security Rules: Protecting your Computer* (ID: 1425)
Security Rules: Picking and Protecting Passwords** (ID: 1449)
Security Rules: Protecting your Portables* (ID: 1427)
Security Rules: Protecting your identity* (ID: 1428)
Security Rules: Safer Emailing and IM-ing, Part 1* (ID: 1429)
Security Rules: Safer Emailing and IM-ing, Part 2* (ID: 1430)
Security Rules: Safer Web Surfing* (ID: 1431)
Security Rules: Introduction to Federal and State Requirements* (ID: 1432)
Security Rules: Issues for Work/Workers Off-Site* (ID: 1433)
Completing the Privacy and Security Course (ID: 1434)
Clinical Investig
ators
Clinical Research
Students and instructors
IRB Members/
MRC Reviewers
MRC Staff
Marketers/Sponsoring Companies
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HIPAA (Health Insurance Portability and Accountability Act)
What is the HIPAA Privacy Rule?• A federal law that protects the privacy of
individually identifiable health care information• Protection applies to all forms of information-
electronic, paper, and oral• The law creates the floor for health care privacy
HIPPA applies to the following types of Research:
• Biomedical Research• Social and Behavioral Research• Epidemiological Research• Basic Science Research• Psychological Research• And Others…..
Privacy
The desire of a person to control the disclosure of personal health information
Privacy Solutions:• Forbid the collection of data that might be
misused• Allow the collection of health information
within a structure, but with rules and penalties for violation pertaining to collecting organizations
• Generate policies to which individual information handlers must adhere
Confidentiality
The ability of a person to control release of personal health information to a care provider or information custodian under an agreement that limits further release of that information
Security
Protection of privacy and confidentiality through policies, procedures and safeguards.
Why do they matter?
• Ethically, privacy and confidentiality are considered to be rights (in our culture)
• Information revealed may result in harm to interests of the individual
• The provision of those rights tends to ensure that the information is accurate and complete
• Accurate and complete information from individuals benefits society in limiting spread of diseases to society
• The preservation of confidentiality assists research which in turn assists patients
Users of Health Information
• Patient• Health insurance company• Laboratory• Hospital• Researcher• State bureau• Accrediting organization• Employer• Life insurance companies• Medical information bureau• Lawyers
HIPS Summary
• Research subjects must sign an authorization form that describes the use and disclosure of their protected health information (PHI) for research purposes
• Develop security and confidentiality policies
• HIPS authorization wording may be part of informed consent document or a separate form
Requirements for Clinical Investigators and
Social and Behavioral Researchers
Clinical Investigators
The persons responsible for the conduct of research involving human participants/ using material from human origin for his/her research
Social and Behavioral Researchers
• The persons responsible for the conduct of studies on human and animal functioning at the level of individual, small groups, institutions, organizations or communities
• Surveys • Questionnaires, Interviews• Direct observations • Standardized tests• Economic analyses• Statistical modeling• Ethnography• Evaluations
CITI Basic Program Requirements
Clinical Investigators
Basic course: 7 modules + one on conflict of interest in research involving human subjects (total 8)
Refresher course: 101 option (7 modules)
Repeated every 3 years
Social and Behavioral Researchers
Basic Course: 8 modules + one on conflict of interest in research involving human subjects (total 9)
Refresher Course: 101 option (6 modules)
Repeated every 3 years
The Modules (BMR)
• Hamad Medical Corporation
• Belmont report and CITI course introduction
• History and ethical principles
• Basic IRB regulations
• Informed consent• Records-based
research • Genetic research in
human populations • Research with
protected populations
The Modules (SBR)
• Hamad Medical Corporation
• Belmont report and CITI course introduction
• Students in research • History and ethical
principles• Defining research with
human subjects
• The regulations and social and behavioral sciences
• Assessing risk and social and behavioral sciences
• Informed consent• Privacy and
confidentiality
Researchers – Clinical Trials
• Good Clinical Practice (GCP)– 11 modules
• Optional Modules (not compulsory unless recommended by MRC Reviewer)
CITI User Registration If your organization is a participant in the CITI Program and this is your first time at the CITI Course site, you must register for the course. This is an easy process.
From the Home Page, choose New Users, "Register Here" then:
1)Choose your institutional affiliation2)Choose a Username and Password3)Provide contact information required by your institution4)You will be given the opportunity to register with another institution (e.g., the institution of a collaborator). This is a handy option as you will not be required to complete the same modules required by both institutions more than once5)Answer 1 or more questions about your research focus or research role so that the software will present you with the appropriate customized curriculum.6)After you select the curriculum, the software will present you with the "Learners Main Menu“7)You will then "Click on this Grade book link to enter the course". 8)The modules will then be displayed.
HMC CITI Program Registration Demonstration
https://www.citiprogram.org/Default.asp?
HMC CITI Program Summary
• Overview of the CITI program• HMC groups required to have CITI certification• Timelines for achieving certification • HMC requirements for clinical investigators• Clinical trials• Social and behavioral research • Research with animals • Laboratory research • Health Information Privacy and Security (HIPS) Course• Registration procedure • Next steps• Questions?
Next Steps
• Register on the HMC CITI website
• Take the programs
• Obtain certification
Questions
• Call the Medical Research CenterMs. Kia Kornas,
Director of Research Administration
Ext. 5320
• E-mail [email protected]
Thank you!