Transcript Slide 1

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 Centre
Hamad Medical Corporation
CITI Program Introduction
Objectives for the CITI Presentation
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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
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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
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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
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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
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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 Modules
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Biosafety course overview
Laboratory - Associated Infections
Risk management – emergency Procedures
OSHABloodborne pathogens Archived 13480
Bloodborne Pathogens
Select Agents
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
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• MRC Staff
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Clinical
Investig
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Clinical
Research
Students and
instructors
IRB
Members/
MRC
Reviewers
About the "HIPS" HIPAA education series* (ID: 1416)
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Privacy Rules: Introduction to Federal and State Requirements* (ID: 1417)
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Privacy Rules: Clinicians* (ID: 1418)
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Privacy Rules: Clinical Investigators* (ID: 1419)
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Privacy Rules: Students and Instructors* (ID: 1420)
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Privacy Rules: Fundraisers* (ID: 1421)
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Privacy Rules: Marketers* (ID: 1422)
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Security Rules: Basics of Being Secure, Part 1* (ID: 1423)
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Security Rules: Basics of Being Secure, Part 2* (ID: 1424)
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Security Rules: Protecting your Computer* (ID: 1425)
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Security Rules: Picking and Protecting Passwords** (ID: 1449)
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Security Rules: Protecting your Portables* (ID: 1427)
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Security Rules: Protecting your identity* (ID: 1428)
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Security Rules: Safer Emailing and IM-ing, Part 1* (ID: 1429)
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Security Rules: Safer Emailing and IM-ing, Part 2* (ID: 1430)
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Security Rules: Safer Web Surfing* (ID: 1431)
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Security Rules: Introduction to Federal and State Requirements* (ID: 1432)
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Security Rules: Issues for Work/Workers Off-Site* (ID: 1433)
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Completing the Privacy and Security Course (ID: 1434)
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MRC
Staff
Marketers/
Sponsoring
Companies
HIPAA
(Health Insurance Portability and Accountability Act)
What is the HIPAA Privacy Rule?
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A federal law that protects the privacy of
individually identifiable health care information
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Protection applies to all forms of informationelectronic, paper, and oral
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The law creates the floor for health care privacy
HIPPA applies to the following types of Research:
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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
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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:
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Choose your institutional affiliation
Choose a Username and Password
Provide contact information required by your institution
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 once
Answer 1 or more questions about your research focus or research role
so that the software will present you with the appropriate customized
curriculum.
After you select the curriculum, the software will present you with the
"Learners Main Menu“
You will then "Click on this Grade book link to enter the course".
The modules will then be displayed.
HMC CITI Program
Registration Demonstration
https://www.citiprogram.org/Default.asp?
HMC CITI Program Summary
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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
Center
Ms. Kia Kornas,
Director of Research Administration
Ext. 5320
• E-mail questions
[email protected]
Thank you!