Presentation on theme: "CITI Program – Hamad Medical Corporation"— Presentation transcript:
1 CITI Program – Hamad Medical Corporation Medical Research Center – Dr. Al-Hareth M. Al-Khater, ChairmanDr. 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 programHMC groups required to have CITI certificationHMC course requirements for each groupsTimelines for achieving certificationRegistration process
4 Structure for the CITI Presentation Overview of the CITI programHMC groups required to have CITI certificationTimelines for achieving certificationHMC requirements for clinical investigatorsClinical trialsSocial and behavioral researchResearch with animalsLaboratory researchHealth Information Privacy and Security (HIPS) CourseDemonstration of the registration processNext stepsQuestion time
5 CITI Program Collaborative Institutional Training Initiative (CITI) A web based training program in human research subjects protectionsBasic Courses in the Protection of Human Research SubjectsBiomedical FocusSocial and Behavioral FocusRefresher CoursesGood Clinical Practice CourseHealth Information Privacy and Security Course (HIPS)Laboratory Animal Research Courses For Investigators and IACUC MembersAnimal Model Specific Courses.Responsible Conduct of Research (RCR) Courses.Biomedical Research FocusSocial, Education, Behavioral Research FocusPhysical Sciences Research FocusScholarly Activities in The Humanities FocusRCR for EngineersRCR for Science AdministratorsBio-Safety and Bio-Security
6 HMC CITI ProgramBasic Courses in the Protection of Human Research SubjectsGood Clinical Practice CourseLaboratory Animal Research Courses For Investigators and IACUC MembersBio-Safety and Bio-SecurityHealth Information Privacy and Security Course (HIPS)
7 CITI Program Groups at HMC Biomedical Researchers (BMR)Social and Behavioral Researchers (SBR)Clinical Trials InvestigatorsClinical InvestigatorsClinical Research Students and instructors Research Committee/Institutional Review Board (IRB) MembersMedical Research Center (MRC) ReviewersInvestigations Committee MembersDSMB MembersMRC StaffMarketers and Sponsoring CompaniesLaboratory Animal ResearchIACUC MembersAnimal Laboratory ResearchersAnimal Laboratory Managers and TechniciansAnimal Laboratory Research StudentsBiosafety and BiosecurityHMC Biosafety CommitteeLaboratory ResearchersLaboratory Managers and TechniciansHazardous Materials RespondersBiosafety professionalsLaboratory Research Students
8 Timelines for Certification Certification required for investigators of all new proposals – April 1, 2011Certification required for investigators with ongoing studies – October 1, 2011
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? ComplianceConducting Research in Animals is A PrivilegePrivilege can only be granted by the IACUCIACUC approves Experimental Protocols
12 Objectives of the CITI Program Research Conduct According to International StandardsReplacement: Replace animals with other research tools or techniques to adequately address the research questionReduction: Means minimizing the number of animals needed to perform an experiment or teach a conceptRefinement: Means refining experimental protocols to minimize pain or distress whenever possible
13 CITI Program Requirements –Animal Researchers Three Courses1) 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 safetyObligation of Safety Standards of the Research Environment ProvidesSafety of the Laboratory and EnvironmentSafety of the StaffWelfare of the Experimental Animal
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 Investigators4 ModulesClinical research students and instructorsMarketers and Sponsoring Companies8 ModulesMedical Research Center (MRC) Reviewers(All Modules)Research Committee/Institutional Review Board (IRB) MembersMRC Staff
19 About the "HIPS" HIPAA education series* (ID: 1416) Clinical InvestigatorsClinical Research Students and instructorsIRB Members/ MRC ReviewersMRC StaffMarketers/Sponsoring CompaniesORHAbout 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 informationProtection applies to all forms of information- electronic, paper, and oralThe law creates the floor for health care privacy
21 HIPPA applies to the following types of Research: Biomedical ResearchSocial and Behavioral ResearchEpidemiological ResearchBasic Science ResearchPsychological ResearchAnd Others…..
22 PrivacyThe desire of a person to control the disclosure of personal health informationPrivacy Solutions:Forbid the collection of data that might be misusedAllow the collection of health information within a structure, but with rules and penalties for violation pertaining to collecting organizationsGenerate policies to which individual information handlers must adhere
23 ConfidentialityThe 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 SecurityProtection 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 individualThe provision of those rights tends to ensure that the information is accurate and completeAccurate and complete information from individuals benefits society in limiting spread of diseases to societyThe preservation of confidentiality assists research which in turn assists patients
26 Users of Health Information PatientHealth insurance companyLaboratoryHospitalResearcherState bureauAccrediting organizationEmployerLife insurance companiesMedical information bureauLawyers
27 HIPS SummaryResearch subjects must sign an authorization form that describes the use and disclosure of their protected health information (PHI) for research purposesDevelop security and confidentiality policiesHIPS authorization wording may be part of informed consent document or a separate form
28 Clinical Investigators and Social and Behavioral Researchers Requirements forClinical 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 communitiesSurveysQuestionnaires, InterviewsDirect observationsStandardized testsEconomic analysesStatistical modelingEthnographyEvaluationsIndividual : Cognition, memory, language, perception, personality, emotion, motivationSmall groups : Structure & dynamics of couples, families, work groupsInteractions : Within and between two groups – like sociocultural factors on cognitive processes or emotional responsesEnvironmental factors : climate, noise, environmental hazards and their effects on behavioral and social functioning
31 CITI Basic Program Requirements Clinical InvestigatorsBasic course: 7 modules + one on conflict of interest in research involving human subjects (total 8)Refresher course: 101 option (7 modules)Repeated every 3 yearsSocial and Behavioral ResearchersBasic 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 introductionHistory and ethical principlesBasic IRB regulationsInformed consentRecords-based researchGenetic research in human populationsResearch with protected populations
33 The Modules (SBR) Hamad Medical Corporation Belmont report and CITI course introductionStudents in researchHistory and ethical principlesDefining research with human subjectsThe regulations and social and behavioral sciencesAssessing risk and social and behavioral sciencesInformed consentPrivacy and confidentiality
34 Researchers – Clinical Trials Good Clinical Practice (GCP)11 modulesOptional 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 affiliationChoose a Username and PasswordProvide contact information required by your institutionYou 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 onceAnswer 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 https://www.citiprogram.org/Default.asp?
37 HMC CITI Program Summary Overview of the CITI programHMC groups required to have CITI certificationTimelines for achieving certificationHMC requirements for clinical investigatorsClinical trialsSocial and behavioral researchResearch with animalsLaboratory researchHealth Information Privacy and Security (HIPS) CourseRegistration procedureNext stepsQuestions?
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 AdministrationExt. 5320questions