CITI Program – Hamad Medical Corporation

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 CentreHamad Medical Corporation CITI Program Introduction

3. Overview of the CITI program HMC groups required to have CITI certification HMC course requirements for each groups Timelines for achieving certification Registration process Objectives for the CITI Presentation

4. 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 Structure for the CITI Presentation

5. 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 CITI Program

6. 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) HMC CITI Program

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

9. Laboratory and Animal Research

10. “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. 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) CITI Program Requirements –Animal Researchers

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

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 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)

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. Requirements for Clinical Investigators and Social and Behavioral Researchers

29. Clinical InvestigatorsThe 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

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. 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. CITI User Registration

36. HMC CITI Program Registration Demonstration https://www.citiprogram.org/Default.asp?

37. 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? HMC CITI Program Summary

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

39. Questions • Call the Medical Research Center Ms. Kia Kornas, Director of Research Administration Ext. 5320 • E-mail questions citiqueries@hmc.org.qa

50. Thank you!