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self index.cfm
site_filepath /www/sites/mfapp/templates/main/
 
Alan Trachtenberg, Md  
     
     
PRIM&R
2006 PRIM&R workshop handouts from DC

2006 PRIM&R workshop handouts from DC.  Password = washington06

Thursday, November 16, 2006

                                                                                                                                                                                                                                                                                                                                                                                                                      
 

Panel I

 
 

The Concept of  Vulnerability: Who Are We Talking About?

 
 

 
 

A1

 
 

Accreditation:  What?s Involved, What?s Required?  

 
 

 
 

A2

 
 

An  Introduction to IRBs: Purposes, Challenges, and  Responsibilities    

 
 

 
 

A3

 
 

Evaluating the  Conflict of Interest (COI) Issues While Conducting an IRB Review

 
 

 
 

A4

 
 

The Evolution  and Future of the Community/IRB Partnership: The Long and Winding Road to More Meaningful  Community Participation  

 
 

 
 

A5

 
 

Human Research  Protection Education for Investigators and Other Research Personnel: Who  Should Do It and How?  

 
 

 
 

A6

 
 

How to Assess  an Individual?s Capacity During the Informed Consent Process 

 
 

 
 

A7

 
 

When and How  to Seek an Emergency Exception to
  Informed Consent 

 
 

 
 

A8

 
 

Clinical Trial  Registries and Databases: Problems and Solutions

 
 

 
 

A9

 
 

Identifying  and Addressing Conflicts of Interest for Academic and Hospital-Based Review  Boards, As Well As for Independent IRBs  

 
 

 
 

A10

 
 

Practical  Issues to Consider When Engaging in International Research:  Industry-Sponsors, Non-Academic Institutions, and More  

 
 

 
 

A11

 
 

The Relationship  Between ESCROs and IRBs: Early Experiences and Best Practices  

 
 

 
 

A12

 
 

Collaboration  Agreements Between Local and Central IRBs: Pitfalls, Perils, and Policy  Development  

 
 

 
 

A13

 
 

How to Write  SOPs  

 
 

 
 

A14

 
 

Looking Beyond  the Credentials When Hiring, Firing, and Managing the IRB Staff 

 
 

 
 

A15

 
 

Techniques for  HRPP Post-Approval Monitoring: New Opportunities for Educating, Training, and  Problem-Solving With Investigators and Key Research Personnel 

 
 

 
 

A16

 
 

Re-Visioning  and Revising Consent in Pediatric Clinical Trials: The Work of the Children?s  Oncology Group  

 
 

 
 

A17

 
 

Specific  Abstracts TBA 

 
 

 
 

A18

 
 

A  Social/Behavioral/Education Science Primer: The Fundamentals of Doing SBE  Research

 
 

 
 

A19

 
 

Chairing an  Effective and Productive Meeting (And We?re Not Just Talking About IRB  Meetings)  

 
 

 
 

A20

 
 

I?ve Always  Wondered, but Never Had a Chance to Ask?Conversations With Staff From the NIH  About Federal and Local Review of Gene Transfer Clinical

 
 

 
 

A21

 
 

An Overview of  the Federal Regulations for Human Research Protections: OHRP and  FDA  

 
 

 
 

A22

 
 

Introduction  to Component Analysis  

 
 

 
 

A23

 
 

Finding  Flexibility in the Federal Regulations:  Exemptions, Expedited Review,  Waivers, and Defining Research Involving Human Subjects  

 
 

 
 

A24

 
 

Scholars and  Their Students: Studying Teaching and Learning in Your Own Post-Secondary School Classroom  

 
 

 
 

A25

 
 

Biostatistics  for the IRB Member

 
 

 
 

A26

 
 

Can a 35-Page  Consent Form be Reduced to 3 Pages: How to Write Comprehensive and  Comprehensible Consents Forms That Avoid Exculpatory Language  

 
 

 
 

Panel II

 
 

Identifying,  Evaluating, and Communicating Risk in Social/Behavioral Research

 
 

 
 

Panel III

 
 

In Their Own  Voices ? Research Subjects Speak

 
 

 
 

B1

 
 

Accreditation:  Learning From Those Who Have Gone Before Us

 
 

 
 

B2

 
 

Exempt,  Expedited, or Full-Committee Review? Which Review Process is Appropriate?   

 
 

 
 

B3

 
 

Social/Behavioral/Educational  Chairs? Forum: It?s a Tough Job, but Somebody Has to Do It!  

 
 

 
 

B4

 
 

The Balancing  Act:  Weighing Risks and Benefits, Science and Ethics, and the Needs of  Subjects and Researchers When Reviewing a Protocol  

 
 

 
 

B5

 
 

Responsible  Conduct of Research Education Programs: Examples of Successful  Models  

 
 

 
 

B6

 
 

The  Uncertainty Principle: Is Clinical Equipoise an Ethical Mandate for  Undertaking Clinical Trials Involving Human Subjects?

 
 

 
 

B7

 
 

Ethical and  Compliance Issues Raised by Research Involving Wards of the State

 
 

 
 

B8

 
 

Meet the  ?IRB-Sponsor Roundtable?   (Industry  Track)

 
 

 
 

B9

 
 

Clinical-Trial  Contracts and Problematic Clauses: Subject Injury, Compensation, and  Publication Delays 

 
 

 
 

B10

 
 

Global Human  Subjects Protection: Interpreting and Applying Different Governmental and/or  Agency Guidelines  

 
 

 
 

B11

 
 

Collaboration  Between the IRB and the Institutional Biosafety Committee in the Review of  Human Gene Transfer Research: Creating Synergy and Ensuring Optimal Protocol  Review

 
 

 
 

B12

 
 

Injury,  Insurance, and Indemnification: The Three ?I?s? Every Site and Sponsor Need  to Understand  

 
 

 
 

B13

 
 

Continuation  Reviews: When to Expedite and How to Be Thorough 

 
 

 
 

B14

 
 

How to  Streamline the IRB Process and How to Avoid Getting Bogged Down in the  Procedural Minutiae  

 
 

 
 

B15

 
 

Adverse Event  Reporting: A Case Study 

 
 

 
 

B16

 
 

Reviewing  Research Involving Adults with Impaired Decision-Making Capacity (Including a  SACHRP Update)

 
 

 
 

B17

 
 

Specific  Abstracts TBA  

 
 

 
 

B18

 
 

A Primer on Dealing  Effectively With Your Local IRB 

 
 

 
 

B19

 
 

Ask Us About  Certification for IRB Professionals (CIP®): Types of Questions, How to  Prepare, and How to Know if This Test?s
  For You!  

 
 

 
 

B20

 
 

I?ve Always  Wondered, but Never Had a Chance to Ask?Conversations With Staff From  OHRP   

 
 

 
 

B21

 
 

Conducting  Research Within the Department of Veterans Affairs

 
 

 
 

B22

 
 

Application of  Component Analysis