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

2. Medical Research Centre Hamad Medical Corporation CITI Program Introduction

3. 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

4. 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

5. 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

6. 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)

7. 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

8. Timelines for Certification
Certification required for investigators of all new proposals – April 1, 2011
Certification required for investigators with ongoing studies – October 1, 2011

9. Laboratory and Animal Research

10. “Character is doing the right thing when nobody’s looking
“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

11. 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

12. 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

13. 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)

14. 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

15. HMC Laboratory Researchers (BIO)
Required Biosafety Course –7 Modules
Biosafety course overview
Laboratory - Associated Infections
Risk management – emergency Procedures
OSHABloodborne pathogens Archived 13480
Bloodborne Pathogens
Select Agents
Biosecurity

16. Take the CITI Training…
Let Us Do The Right Thing

17. Health Information Privacy and Security Course (HIPS)

18. CITI Program Requirements HIPS
Clinical Investigators
4 Modules
Clinical research students and instructors
Marketers and Sponsoring Companies
8 Modules
Medical Research Center (MRC) Reviewers
(All Modules)
Research Committee/Institutional Review Board (IRB) Members
MRC Staff

19. About the "HIPS" HIPAA education series* (ID: 1416)
Clinical Investigators
Clinical Research Students and instructors
IRB Members/ MRC Reviewers
MRC Staff
Marketers/
Sponsoring Companies O R H
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 ing and IM-ing, Part 1* (ID: 1429)
Security Rules: Safer ing 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)

20. 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

21. HIPPA applies to the following types of Research:
Biomedical Research
Social and Behavioral Research
Epidemiological Research
Basic Science Research
Psychological Research
And Others…..

22. 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

23. 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

24. Security
Protection of privacy and confidentiality through policies, procedures and safeguards.

25. 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

26. Users of Health Information
Patient
Health insurance company
Laboratory
Hospital
Researcher
State bureau
Accrediting organization
Employer
Life insurance companies
Medical information bureau
Lawyers

27. 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

28. Clinical Investigators and Social and Behavioral Researchers
Requirements for
Clinical Investigators and Social and Behavioral Researchers

29. Clinical Investigators The persons responsible for the conduct of research involving human participants/ using material from human origin for his/her research

30. 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
Individual : Cognition, memory, language, perception, personality, emotion, motivation
Small groups : Structure & dynamics of couples, families, work groups
Interactions : Within and between two groups – like sociocultural factors on cognitive processes or emotional responses
Environmental factors : climate, noise, environmental hazards and their effects on behavioral and social functioning

31. 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

32. 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

33. 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

34. Researchers – Clinical Trials
Good Clinical Practice (GCP)
11 modules
Optional Modules (not compulsory unless recommended by MRC Reviewer)

35. 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:
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.

36. HMC CITI Program Registration Demonstration

37. 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?

38. Next Steps Register on the HMC CITI website Take the programs
Obtain certification

39. Questions Call the Medical Research Center E-mail questions
Ms. Kia Kornas,
Director of Research Administration
Ext. 5320
questions

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50. Thank you!