Medical Research: A Consumer's Guide for Participation

TABLE OF CONTENTS
Medical Research: A Consumer’s Guide for Participation
I. Introduction........................................................3
II. The Basics of Medical Research ..................4
A. Translational vs. Clinical Research ........4
1. Translational Research........................4
2. Clinical Research ................................4
B. Regulation of Medical Research ............5
C. How Are Clinical Trials Conducted? ......6
1. Basics of Clinical Research Design ..6
2. Controlling Outside Factors................7
3. Randomized Trials ..............................7
4. The Phases of a Clinical Trial ............7
5. Where Are Clinical Trials
Conducted? ........................................8
6. How Can I Find Out About a
Clinical Trial? ......................................8
III. Protecting Research Volunteers ....................9
A. What Is an Institutional
Review Board?........................................9
B. What Is a Data Safety
Monitoring Board?..................................9
C. How Do I Make Sure My
Decision Is Voluntary? ........................10
D. What Is Informed Consent? ................10
E. How Are Vulnerable Populations
Protected in Medical Research? ..........11
IV.
Rights and Responsibilities of
Research Volunteers ......................................13
A. What Documents Must I Sign? ............13
B. How Is My Information Used?..............13
C. What Are My Privacy Rights? ..............14
D. Who Can I Contact if I Have
Complaints or Concerns? ....................14
E. What Are My Responsibilities as a
Research Volunteer? ............................15
V. Payment for Research Treatments ..............16
A. Who Will Pay for My Care While
I Am a Research Volunteer? ................16
B. Will My Insurance Plan Pay for
My Care? ..............................................16
C. How Do Health Plans Define
“Research”?..........................................16
D. Are the Costs Associated with Clinical
Trial Participation Covered?..................16
E. Can Coverage Continue After the
Clinical Trial Has Ended?......................16
F. Can Research Volunteers Be Paid for
Participating in a Clinical Trial? ............17
G. What Will Insurance Plans Cover? ......17
H. What Is Medicare’s Payment Policy ....17
I. What Payment Rules Apply if the
Research Involves a Device?................18
J. What About Off-Label Uses of
Drugs or Devices? ................................18
K. What Other Government Programs
Help Pay for the Costs of Care? ..........19
L. Which States Require Coverage of
Certain Costs Incurred During a
Clinical Trial? ........................................19
M. What Questions Should I Ask to
Determine Whether Coverage
Will Be Provided? ................................19
VI. Conclusion ......................................................20
Appendix A: Glossary............................................21
Appendix B: States Mandating Insurance
Coverage of Clinical Trials ....................................24
Appendix C: Online Resources ............................31
Author Profiles ........................................................32
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