CITI Developer Meeting CITI Developer Meeting

Human Subjects ResearchHuman Subjects Research

October 23, 2009October 23, 2009

Meeting CDMeeting CD

CITI International ProgramsCITI International Programs

CITI Worldwide Footprint CITI Worldwide Footprint 9-1-099-1-09

World wide n = 1324International n = 65sites / 38 countries

CITI InternationalCITI International

• >1324 sites around the world>1324 sites around the world• >65 international sites in 38 countries. (5%)>65 international sites in 38 countries. (5%)• CITI Collaborating CentersCITI Collaborating Centers

– Develop sustainable CITI Programs for the Develop sustainable CITI Programs for the international research community.international research community.

• Latin America Latin America • TaiwanTaiwan• Japan Japan • KoreaKorea• IndiaIndia• Middle EastMiddle East• CanadaCanada

Multilanguage Course SiteMultilanguage Course Site

• Multi-language Course Site. 11-2007Multi-language Course Site. 11-2007• Updated in 2008 and 2009 to accommodate UTF-8 character sets.Updated in 2008 and 2009 to accommodate UTF-8 character sets.• Languages.Languages.

– EnglishEnglish– Spanish (NAID, FIC)Spanish (NAID, FIC)– Portuguese (NAID, FIC)Portuguese (NAID, FIC)– ChineseChinese– Japanese Japanese – French (NIAID)French (NIAID)– Thai (US Army)Thai (US Army)– Russian Russian (US Army)(US Army)– KoreanKorean– Kartuli (FIC)Kartuli (FIC)– ArabicArabic

CITI International CentersCITI International Centers

• CITI International Collaborating CentersCITI International Collaborating Centers– CITI - India Anil Sharma, MD CITI - India Anil Sharma, MD

– CITI - Korea - B.I. Chou Ph.D.CITI - Korea - B.I. Chou Ph.D.

– Caribbean/Latin America/South America – Sergio Litewka , MDCaribbean/Latin America/South America – Sergio Litewka , MD

– CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D.CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D.

– CITI - Japan – Iekuni Ichikawa, MDCITI - Japan – Iekuni Ichikawa, MD

– CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.Research.

CITI IndiaCITI India

Anil Sharma MDAnil Sharma MD

Initial WorkshopInitial Workshop

• November 24,25,26November 24,25,26• SRU- Sri Ramachandra UniversitySRU- Sri Ramachandra University

– Prominent University in ChennaiProminent University in Chennai– More than 43,000 studentsMore than 43,000 students– Has Medical, Pharmacy, Nursing and Dental Schools.Has Medical, Pharmacy, Nursing and Dental Schools.– Affiliated with Harvard Medical International Affiliated with Harvard Medical International

Organizing CommitteeOrganizing Committee

• Paul BraunschweigerPaul Braunschweiger

• Mansoor AhmedMansoor Ahmed

• Ram AgarwalRam Agarwal

• Anil SharmaAnil Sharma

• S.P. ThyagarajanS.P. Thyagarajan

• Melody LinMelody Lin

• Chiu LinChiu Lin

• Jerry CastellanoJerry Castellano

INDO - US WORKSHOP "PROMOTING RESEARCH ETHICS EDUCATION IN INDIA"

Organized by Sri Ramachandra University, India andCITI Program, University of Miami, USA

November 24th to 26th 2009http://srmc.edu/indo_us_2010/index.htm

3 Day seminar3 Day seminar

• Researchers from Academia and industry are Researchers from Academia and industry are invited to discuss content development.invited to discuss content development.

• Over 100 researchers attending 3 day meeting.Over 100 researchers attending 3 day meeting.• Guest speakers include ICMR officials.Guest speakers include ICMR officials.

OHRP grantOHRP grant

• We thank OHRP for their generous We thank OHRP for their generous support to help start CITI India.support to help start CITI India.

CITI International CentersCITI International Centers

• Update on Collaborations since October 2008– Paul Update on Collaborations since October 2008– Paul BraunschweigerBraunschweiger

• CITI International Cooperative CentersCITI International Cooperative Centers– CITI - India Anil Sharma, MD CITI - India Anil Sharma, MD

– CITI - Korea - B.I. Chou Ph.D.CITI - Korea - B.I. Chou Ph.D.

– Caribbean/Latin America/South America – Sergio Litewka , MDCaribbean/Latin America/South America – Sergio Litewka , MD

– CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D.CITI -Taiwan – Benjamin Kuo, MD /Paul Braunschweiger Ph.D.

– CITI - Japan – Iekuni Ichikawa, MDCITI - Japan – Iekuni Ichikawa, MD

– CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer CITI - Canada – Karen Arts, MS - Ontario Institute of Cancer Research.Research.

CITI-KoreaCITI-Korea

B.I. Chou Ph.D.B.I. Chou Ph.D.

Caribbean/Latin America/South Caribbean/Latin America/South America America

Sergio Litewka , MDSergio Litewka , MD

CITI - TaiwanCITI - Taiwan

Benjamin KuoBenjamin Kuo

HSP progress HSP progress in Taiwan in Taiwan 

Benjamin I. Kuo, MD, DrPHBenjamin I. Kuo, MD, DrPH CIPCIPSecretariat, Joint Institutional Review BoaSecretariat, Joint Institutional Review Boa

rd rd

Chinese version of CITIChinese version of CITI

Statistics of Taiwan CITI usersStatistics of Taiwan CITI usersupdated Sep.3 2009 updated Sep.3 2009

Future planFuture plan

• Enhancement of CITI Chinese Enhancement of CITI Chinese version to be more friendly for non-version to be more friendly for non-scientific IRB members.scientific IRB members.

• Translation of Responsible Conduct Translation of Responsible Conduct Research (RCR) in CITI.Research (RCR) in CITI.

• Set up of Humans Subject Set up of Humans Subject Protection Association in Taiwan Protection Association in Taiwan (HuSPAT) – PRIM&R Taiwan (HuSPAT) – PRIM&R Taiwan version.version.

CITI - JapanCITI - Japan

Iekuni Ichikawa, MDIekuni Ichikawa, MD

CITI – CanadaCITI – Canada

Karen Arts, M.S.Karen Arts, M.S.

CITI Developer Meeting CITI Developer Meeting

Human Subjects ResearchHuman Subjects Research

October 23, 2009October 23, 2009

Physiology Break Physiology Break

10:00 – 10:3010:00 – 10:30

Course UpdatesCourse Updates

• HSRHSR

• BioSafetyBioSafety

• International public accessInternational public access

• Lab AnimalLab Animal

• RCR Course.RCR Course.

CITI Bio-safety & Bio-security CITI Bio-safety & Bio-security CourseCourse

Bio-Safety and Bio-SecurityBio-Safety and Bio-SecurityBen Fontes, Yale UniversityBen Fontes, Yale University

• OverviewOverview • Lab acquired infectionsLab acquired infections • Risk AssessmentRisk Assessment • Risk ManagementRisk Management • Work PracticesWork Practices • PPEPPE • Engineering ControlsEngineering Controls • Lab DesignLab Design

• Emergency ProceduresEmergency Procedures • BBPBBP • NIH rDNA GuidelinesNIH rDNA Guidelines • Human gene transferHuman gene transfer • Bio-securityBio-security • Shipping*Shipping* • Animal BiosafetyAnimal Biosafety • Select Agents, BioterrorismSelect Agents, Bioterrorism

Bio-safety and Bio-Security Bio-safety and Bio-Security Course ReviewersCourse Reviewers

• Eric Cook - Dartmouth U Eric Cook - Dartmouth U • Michael Spath - CUNY Michael Spath - CUNY • Andy Cockburn - U. West VirginiaAndy Cockburn - U. West Virginia• Marcia Finucane - U. KentuckyMarcia Finucane - U. Kentucky• Norma Epley - ECU Norma Epley - ECU • Jairo Betancourt - U of Miami Jairo Betancourt - U of Miami • Paul Braunschweiger - U. MiamiPaul Braunschweiger - U. Miami

Reviews are due back to the office by 10-1-09.Reviews are due back to the office by 10-1-09.

Course - ready for the PRIM&R meeting.Course - ready for the PRIM&R meeting.

Bio-Safety and Bio-SecurityBio-Safety and Bio-SecurityBen Fontes, Yale UniversityBen Fontes, Yale University

• OverviewOverview • Lab acquired infectionsLab acquired infections • Risk AssessmentRisk Assessment • Risk ManagementRisk Management • Work PracticesWork Practices • PPEPPE • Engineering ControlsEngineering Controls • Laboratory DesignLaboratory Design

• Emergency ProceduresEmergency Procedures • BBPBBP • NIH rDNA GuidelinesNIH rDNA Guidelines • Human gene transferHuman gene transfer • Bio-securityBio-security • Shipping*Shipping* • Animal BiosafetyAnimal Biosafety • Select Agents, BioterrorismSelect Agents, Bioterrorism

Reviews are due back to the office by 10-1-09.Course - ready for the PRIM&R meeting.

International public access courseInternational public access course

• www.irbtrainining.org• Training for non-US collaborators on Us funded Training for non-US collaborators on Us funded

projects.projects.• Developed in 2003-2004 through NIH funded Developed in 2003-2004 through NIH funded

“IRB enhancement grants”“IRB enhancement grants”– Platform, translation tools and translations. Platform, translation tools and translations. – Materials in English, Spanish, Portuguese, Chinese Materials in English, Spanish, Portuguese, Chinese

and French languagesand French languages

• Move training database CITI platformMove training database CITI platform

Lab Animal Welfare CourseLab Animal Welfare Course

Mike Mann Ph.D.Mike Mann Ph.D.

Responsible Conduct of Responsible Conduct of Research CourseResearch Course

Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.

Funded by CITI and the ORI / DHHS.Funded by CITI and the ORI / DHHS.

CITI Program Content LibraryCITI Program Content Library

• RCRRCR– BiomedicalBiomedical– Social and Behavioral Research*Social and Behavioral Research*– Physical SciencesPhysical Sciences– Humanities*Humanities*– EngineeringEngineering– RCR and Science AdministratorsRCR and Science Administrators

New additions to the New additions to the ProgramProgram

• The RCR with lab animalsThe RCR with lab animals– Paul Braunschweiger Ph.D.Paul Braunschweiger Ph.D.

• The RCR with human subjects.The RCR with human subjects.– Jason Borenstein Ph.D.Jason Borenstein Ph.D.

• RC of scholarly activities in the humanitiesRC of scholarly activities in the humanities– Sharon Shriver Ph.D.Sharon Shriver Ph.D.

• RCR in the social and behavioral sciencesRCR in the social and behavioral sciences– Dan Vasgird Ph.D.Dan Vasgird Ph.D.

Content EditingContent Editing

• Hired a science and technology editor to resolve Hired a science and technology editor to resolve outstanding issues in the CITI RCR modules.outstanding issues in the CITI RCR modules.– Comments regarding typos in the modulesComments regarding typos in the modules

– Grammatical errorsGrammatical errors

– Poor quiz question.Poor quiz question.

• Deliver is November 14. Deliver is November 14. • Reviewed and reconciled by December 1, 2009.Reviewed and reconciled by December 1, 2009.• Implemented by 1-1-10Implemented by 1-1-10

RCR Course Site UsageRCR Course Site Usage

RCR Course Completion RCR Course Completion Reports (C.R.) awardedReports (C.R.) awarded

YearYear 2009*2009* 20082008

SitesSites 222 222 (45%)(45%) 136136

Total C.R.Total C.R. 23,36123,361 18,84918,849

C.R./monthC.R./month 2596 2596 (65%)(65%) 15711571

C.R./dayC.R./day 87 (~1200)87 (~1200) 5252

* 1-1-09 to 10-1-09, public access and institutional RCR set-ups* 86 new institutional RCR set-ups, 2009

CRs ALL DISCIPLINESCRs ALL DISCIPLINES 328,999328,999 330,227330,227

RCR CRs / ALL CRsRCR CRs / ALL CRs 6.8%6.8% 5.6%5.6%

10-1-09

RCR Course Completion Reports (C.R.) RCR Course Completion Reports (C.R.) Awarded via The Public Access Portal.Awarded via The Public Access Portal.

* 1-1-09 to 10-1-09

Public Access (PA) onlyPublic Access (PA) only 2009*2009* 20082008P.A. RegistrationsP.A. Registrations 7152 (795/m) 64%7152 (795/m) 64% 5835 (486/m)5835 (486/m)

P.A. SBRP.A. SBR 14171417 12731273P.A. biomedP.A. biomed 960960 935935

PA - HumanitiesPA - Humanities 203203 324324PA - PSEPA - PSE 157157 9494

Total PA C.R.Total PA C.R. 2737 (39%)2737 (39%) 26262626PA_C.R./monthPA_C.R./month 304 (12%)304 (12%) 219 (14%)219 (14%)

RCR Learner feedbackRCR Learner feedback

RCR Satisfaction SurveyRCR Satisfaction Survey

I believe that it is very important that the entire research team (PI, I believe that it is very important that the entire research team (PI, Investigators, staff, students and administrators) and not just the PI, Investigators, staff, students and administrators) and not just the PI,

should have a clear understanding of the responsible conduct of should have a clear understanding of the responsible conduct of research, to insure that the data is collected and distributed with research, to insure that the data is collected and distributed with

integrity and to the highest ethical standards.integrity and to the highest ethical standards.

Strongly disagree strongly agree

Having completed the CITI Course in the Responsible Conduct of Having completed the CITI Course in the Responsible Conduct of Research and gained a better understanding of how damaging Research and gained a better understanding of how damaging

research misconduct can be to students, to the institutions and to research misconduct can be to students, to the institutions and to other investigators, I am now more likely to report a clear act of other investigators, I am now more likely to report a clear act of

research misconduct to an appropriate person at my organization. research misconduct to an appropriate person at my organization.

Strongly disagree strongly agree

Rate the course.Rate the course.RCR L.A.W.

H.S.P

Poor outstanding

Poor outstanding

Poor outstanding

Research SurveyResearch SurveyMentoring and Mentoring ExperiencesMentoring and Mentoring Experiences

Participation in Human Subjects ResearchParticipation in Human Subjects Research

New Modules New Modules

Karen HansenKaren Hansen

AcknowledgementsAcknowledgements

Karen, Paul, Sally and Susan Karen, Paul, Sally and Susan

CITI Support StaffCITI Support Staff

Not shown Pablo Velascelo and Ryan Roelans

The CITI HSR ProgramThe CITI HSR Program

ContentsContents

Software updatesSoftware updates

UsageUsage

Learner FeedbackLearner Feedback

CITI Program Content LibraryCITI Program Content Library

• Human subjectsHuman subjects– BiomedicalBiomedical

• Community Member Community Member • ESCROESCRO

– Social and BehavioralSocial and Behavioral

• Good Clinical PracticeGood Clinical Practice– EnglishEnglish– SpanishSpanish– PortuguesePortuguese– ChineseChinese– ThaiThai– French, not posted.French, not posted.

• HIPSHIPS

CITI Program Content LibraryCITI Program Content Library

• RCRRCR– BiomedicalBiomedical– Social and Behavioral Research*Social and Behavioral Research*– Physical SciencesPhysical Sciences– Humanities*Humanities*– EngineeringEngineering– RCR and Science AdministratorsRCR and Science Administrators

• Bio-safety and Bio-securityBio-safety and Bio-security

Software and hardware Software and hardware updates updates

CITI SoftwareCITI Software

• Software update - 8-10-09 Software update - 8-10-09 – Mike Fallon and the VA software team Mike Fallon and the VA software team

• Changes to the code and new hardware - 2,500 concurrent users. Changes to the code and new hardware - 2,500 concurrent users. (3x (3x increase computing power.)increase computing power.)

• ““Look Back” utility is now fully functionalLook Back” utility is now fully functional– Institutions can give credit for modules completed previously at any time at any institution.Institutions can give credit for modules completed previously at any time at any institution.

• Improved tools for CITI support staff, and more levels of authoring Improved tools for CITI support staff, and more levels of authoring permissions permissions

CITI SoftwareCITI Software

• Software updateSoftware update– UTF-Character set fully implementedUTF-Character set fully implemented

• Installed: French, Russian and Thai language templates.Installed: French, Russian and Thai language templates.

– Portal system fully implemented. Portal system fully implemented. • 3 institutions are using the portal system, 3 institutions are using the portal system,

• 8 more are being installed.8 more are being installed.

– Content and registrations and user data from Content and registrations and user data from www.IRBTraining.org is being transferred to the is being transferred to the www.CITIProgram.org platform. platform.

CITI SoftwareCITI Software

• Software updateSoftware update– CITI Japan- many enhancementsCITI Japan- many enhancements

– Learner’s menu updated- less clutter and more relevant info to Learner’s menu updated- less clutter and more relevant info to learner learner

– A new category of module added to gradebooks- “optional”A new category of module added to gradebooks- “optional”

– Gradebook simplified- now only one course per gradebook Gradebook simplified- now only one course per gradebook (reduced programming complexity and enhanced site speed) (reduced programming complexity and enhanced site speed)

New CITI HardwareNew CITI Hardware

• Hardware 8-10-2009 - ~$33KHardware 8-10-2009 - ~$33K– 4 new web servers4 new web servers– 2 new database servers. 2 new database servers. – 3Tb back up3Tb back up

• Server and Software Upgrades- at least triple computing capacity, many code rewrites to improve efficiency as part of transition to new servers

• Improved database backups- even less chance of data loss

• Improved training record downloads- many different formats, greater flexibility

“The need for speed”

Ongoing UpgradesOngoing Upgrades

• At discretion of institution, allow credit for other At discretion of institution, allow credit for other institution’s modules and coursework. institution’s modules and coursework.

• Implement method of giving “credit” to employees for Implement method of giving “credit” to employees for didactic training taken outside the CITI web platform.didactic training taken outside the CITI web platform.

• Implement an automated method for institutional Implement an automated method for institutional administrators to assign new coursework to groups or administrators to assign new coursework to groups or subgroups of learners.subgroups of learners.

Ongoing UpgradesOngoing Upgrades

• Security question implementation for learners- Security question implementation for learners- easier password recoveryeasier password recovery

• Better tools to translate course and site pagesBetter tools to translate course and site pages

• More seamless implementation of remote portalsMore seamless implementation of remote portals

• Migration to Cold Fusion to simplify programming Migration to Cold Fusion to simplify programming and more easily add new featuresand more easily add new features

CITI Program UsageCITI Program Usage

CITI Program MembershipCITI Program Membership

Subscriber BreakdownSubscriber Breakdown

Category % Non-USUniversity 36% 3%Med. Center 18% 2%Veterans Affairs 14%HealthCare 7%Res, Institutes 7%Small Colleges 6%Government 6%Industry 3%Commercial IRB 2%CRO 1%

Professional Society <1%

2004 2005 2006 2007 2008 2009 20102004 2005 2006 2007 2008 2009 2010

9-2009*

Courses completed per dayCourses completed per day

2004 2005 2006 2007 2008 2009 2010

CITI Business issuesCITI Business issues

• Professional timeProfessional time– 0.7 FTE0.7 FTE

• Office PersonalOffice Personal– 9.5 FTE9.5 FTE

• ConsultantsConsultants– ContentContent– TechnicalTechnical

• Program developmentProgram development• MeetingsMeetings

– $230,000$230,000

Feed back from the learnersFeed back from the learners

Human Subjects Satisfaction Human Subjects Satisfaction SurveySurvey

HSR Survey HSR Survey

• NavigationNavigation• Perceived valuePerceived value• UtilityUtility• Intentions Intentions • Research ComponentResearch Component

– Participation in researchParticipation in research– Mentoring experiencesMentoring experiences

Survey respondersSurvey responders

22% Student Researcher - Graduate 1% Research Administrator

14% Principal Investigator 1% Data manager

13% Student Researcher - Undergrad 1% Social Worker

12% Research Assistant 1% Site Coordinator

11% Clinical Researcher 1% Site Coordinator

7% Co-Investigator 1% Pharmacist

4% Study Coordinator <1% Statistician

4% Study nurse <1% Lab. Researcher

3% Research Fellow - Post Graduate <1% IRB administrator

2% Interviewer <1% Recruiter

2% Lab. Research Staffn=160,104

Survey submissions Survey submissions May and September 2009May and September 2009

I believe that ongoing instruction in human subjects protection I believe that ongoing instruction in human subjects protection for ALL members the research team is essential for assuring for ALL members the research team is essential for assuring

the ethical conduct of research with human research subjects.the ethical conduct of research with human research subjects.September 2009 Surveys n=14,156/51,000September 2009 Surveys n=14,156/51,000

It was easy to register at the Home Page It was easy to register at the Home Page and enroll in the CITI course.and enroll in the CITI course.

Navigation through the CITI Course was easy and Navigation through the CITI Course was easy and intuitive.intuitive.

Now that I have completed the CITI Course, I feel Now that I have completed the CITI Course, I feel that the time I invested was time well spent.that the time I invested was time well spent.

Now that I have completed the course, I am more confident in my Now that I have completed the course, I am more confident in my ability to advise a student or a colleague on an issue of human ability to advise a student or a colleague on an issue of human subjects protection and the ethical conduct of human subjects subjects protection and the ethical conduct of human subjects

research.research.September 2009 , n=13,716September 2009 , n=13,716

Now that I have completed this instruction in the protection of human research subjects, Now that I have completed this instruction in the protection of human research subjects, I intend to take a more active role in assuring that the research at my institution is I intend to take a more active role in assuring that the research at my institution is

conducted to the highest ethical standards.conducted to the highest ethical standards. I intend to go to more seminars on human I intend to go to more seminars on human subjects issues, pursue professional certification (e.g., CIP), join an IRB / Research subjects issues, pursue professional certification (e.g., CIP), join an IRB / Research

Ethics Committee or join a Data Safety Monitoring Board (DSMB) or take a course in Ethics Committee or join a Data Safety Monitoring Board (DSMB) or take a course in Good Clinical Practice?Good Clinical Practice?

How would you rate the "The Basic Course How would you rate the "The Basic Course in the Protection of Human Research in the Protection of Human Research

Subjects”?Subjects”?

Since I completed the Basic Course, I have taken a more active role in Since I completed the Basic Course, I have taken a more active role in assuring that the human subjects research at my institution is conducted to assuring that the human subjects research at my institution is conducted to

the highest ethical standards. I have obtained professional certification (e.g., the highest ethical standards. I have obtained professional certification (e.g., CIP), volunteered to be a member of an IRB / Research Ethics Committee or CIP), volunteered to be a member of an IRB / Research Ethics Committee or

joined a Data Safety Monitoring Board (DSMB). N=5102joined a Data Safety Monitoring Board (DSMB). N=5102Median time from completing the basic course = 2 yrs.Median time from completing the basic course = 2 yrs.

2% Joined a DSMB

4% Obtained professional certification (e.g., CIP)

6% Completed and advance course such as GCP

6% Joined an IRB or Ethics Committee

56% 13% Gone to more research ethics seminars

44% 68% I have done little more than complete the CITI Basic Course

Data from 9-09

Looking back, I believe that the CITI Basic course, I Looking back, I believe that the CITI Basic course, I completed previously, provided me with the ethical foundation completed previously, provided me with the ethical foundation to conduct my human subjects research to the highest ethical to conduct my human subjects research to the highest ethical

standards?standards?Median time from completing the basic course = 2 yrs.Median time from completing the basic course = 2 yrs.

How would you rate the Refresher How would you rate the Refresher Course, overall ? Course, overall ? n=4798n=4798

I believe that the course I just completed will help me do I believe that the course I just completed will help me do better science.better science.

Looking back, since completing the Basic Course I am more Looking back, since completing the Basic Course I am more likely to have the confidence to engage in a discussion of likely to have the confidence to engage in a discussion of

human subjects protection or the ethical conduct of human human subjects protection or the ethical conduct of human subjects research with students and colleagues.subjects research with students and colleagues.

Median time since completion of the basic course is 2 yrs.Median time since completion of the basic course is 2 yrs.

Basic CourseRefresher Course

strongly disagree strongly agree strongly disagree strongly agree

Research SurveyResearch Survey

Participation in Human Subjects Participation in Human Subjects ResearchResearch

Human subjects research is crucial for finding cures for debilitating diseases, Human subjects research is crucial for finding cures for debilitating diseases, the prevention of deadly pandemics and providing a better understanding of the prevention of deadly pandemics and providing a better understanding of

who we are and why we do the things we do.who we are and why we do the things we do.September 2009, n= 14,956September 2009, n= 14,956

Have you ever participated in Clinical Research as Have you ever participated in Clinical Research as a subject? a subject?

62% NO I have never been a subject in Clinical Research

5% The study involved genetic tests

11% The study was specific for a medical condition I have

12% The study involved the testing of a new drug, biological or medical device (e.g., vascular stent)

17% The study involved blood tests (not genetics)

55% The study involved questions about my life, behaviors or beliefs

If you were asked previously to be a subject If you were asked previously to be a subject in a Clinical Research Trialin a Clinical Research TrialSeptember 2009, n=7195September 2009, n=7195

4% I felt that participating in the study posed considerable risk to me

4% I felt the study was not worth my time to be a subject.

5% When asked, I declined to enroll in the trial.

38% I felt that the study was likely to contribute important knowledge to help others

48% I felt that participating in the study posed little risk to me

Would you participate in a Clinical Research Trial Would you participate in a Clinical Research Trial as a as a control subjectcontrol subject if the study involved if the study involved

7% Bone marrow biopsies

10% Under no circumstances would I participate in a clinical research trail as a control subject.

11% Endoscopy or colonoscopy18% Skin biopsies38% Genetic testing

51% Non-invasive testing (X-rays or ultrasounds for example)

55% A blood draw88% Questionnaires about your life, behaviors, or beliefs

If you had a If you had a chronic medical condition chronic medical condition (e.g., diabetes, psoriasis, (e.g., diabetes, psoriasis, rheumatoid arthritis) and found out about a research study from your rheumatoid arthritis) and found out about a research study from your

physician, would you participate if the study required:physician, would you participate if the study required:n= 36,496 responses from 14,400 peoplen= 36,496 responses from 14,400 people

15% No, I would not participate in such a trial.

19% Entering a randomized study of a conventional surgical approach and a new experimental approach

24% Testing a new vaccine for an infectious disease

37% Entering a randomized study of a new medicine and a placebo. You do not know which one you will get

40% Taking a new investigational medication and multiple blood draws

53% Obtaining genetic information that might reveal information about the disease or its treatment.

86% Completing surveys about the usual treatment you would get from your physician

If you were If you were gravely ill with a life threatening gravely ill with a life threatening condition (Cancer, condition (Cancer, stroke, heart failure, aneurism) and had exhausted the stroke, heart failure, aneurism) and had exhausted the

conventional treatment options, would you participate in a trial conventional treatment options, would you participate in a trial that required: that required:

16%16% No, I would not participate as a subject in a clinical trial. I would want No, I would not participate as a subject in a clinical trial. I would want the best current treatment.the best current treatment.

44%44% Entering a randomized study comparing a conventional surgical Entering a randomized study comparing a conventional surgical approach and a new innovative experimental surgical treatment.approach and a new innovative experimental surgical treatment.

47%47% Entering a randomized study of a new medication and a placebo in Entering a randomized study of a new medication and a placebo in which you would not know which you were getting.which you would not know which you were getting.

60%60%Obtaining genetic information from you that might reveal information Obtaining genetic information from you that might reveal information about the disease or its treatment or perhaps the likelihood that others about the disease or its treatment or perhaps the likelihood that others in your family were at increased risk to the same condition.in your family were at increased risk to the same condition.

63%63% Taking a new investigational medication and multiple blood draws.Taking a new investigational medication and multiple blood draws.

68%68% Completing surveys about the usual treatment you would get from Completing surveys about the usual treatment you would get from your physicianyour physician

If my mother had a qualifying illness or condition, I would If my mother had a qualifying illness or condition, I would recommend that she participate in a clinical trial to test the recommend that she participate in a clinical trial to test the

effectiveness a new drug for that condition. effectiveness a new drug for that condition.

If asked, I would permit my child to participate in a trial that tests the If asked, I would permit my child to participate in a trial that tests the efficacy of a new vaccine for an infectious disease?efficacy of a new vaccine for an infectious disease?