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

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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 questionscitiqueries@hmc.org.qa

Thank you!