Medical Research: A Consumer's Guide for Participation

More documents

Recommendations

Info

VI. Conclusion Through medical research, scientists and clinicians improve prevention, diagnosis and treatment of disease, and improve the quality of life of those suffering from disease. The decision to volunteer to participate in a medical research program is an important decision. We hope this guidebook has provided you with information that will help you make that decision. We encourage you to ask questions, be informed, and be active in your healthcare. 20
APPENDIX A GLOSSARY There are many special words that are used to describe and talk about research. To help you better understand issues related to medical research, a glossary of commonly used terms is provided below. While not all of the words in this glossary appear in this Guidebook, they are helpful to know as you decide whether or not to participate in a clinical trial. Assent: The process of obtaining one’s agreement to participate in research. Bench Research: General scientific research that occurs in a laboratory. Bias: Permitting expectations or hopes to influence decisions or analysis of data. Biologic: A substance made from a living organism that is used to prevent, diagnose or treat a disease, such as a vaccine. Biomarker: A protein occurring in the blood that indicates health or the presence of an illness. Biorepository: A facility that collects and stores tissue and body fluids for research, also referred to as a tissue bank. Blinded: A study design used to decrease bias. In a single-blinded study, the research volunteer does not know if she is receiving the study product. In a double-blinded study, neither the research volunteer nor the principal investigator knows who is receiving the study product. Case Reports: A research and teaching approach that uses a detailed discussion of the clinical progress of one person or several people (case series) and follows the progress of the person’s disease or treatment. Researchers hope to learn more about the disease and its treatment by examining how the disease progresses and what effect a given treatment has. Case-Control Study: A research approach that compares detailed information about two very similar groups of people (one that has a disease and one that doesn’t). Researchers use this technique to try to identify what causes one group to be sick and the other to be healthy. Case Report Form (CRF): The form used to collect and submit information and data about a research study. Cells: The basic functional units of the body. Groups of cells that perform common functions create tissues. Clinical Trial: Research into how a new medical approach works in people. Clinical trials can study prevention, diagnosis, and treatment options. Also referred to as clinical research. Cohort Study: A cohort is a group of people who have common characteristics. A cohort study looks at outcomes and compares groups of people who are alike in many ways but have some differences. Common Rule: The term used for the regulations that were developed to guide research that is supported by the federal government and involves human volunteers as participants. Compassionate Use Trial: A clinical trial that permits use of a new, possibly helpful treatment by people who have a serious disease but do not qualify to be included in a clinical trial exploring the treatment. Control Group (also control arm): The group of people in a clinical trial that do not have the disease or do not receive the experimental product. Control group participants may receive a placebo, an alternate treatment, or no treatment. Controlled Clinical Trial (also controlled study): A clinical trial that uses a control group as comparison to the experimental product. Cross-Over: A study design where the experimental and control groups switch halfway through the trial so that each group receives the study product for onehalf of the trial. Data and Safety Monitoring Board (DSMB): A group of people who review data during a clinical trial to determine whether the risk/benefit ratio remains acceptable. Device: A product that is used to prevent, diagnose or treat disease, but which does not work by a chemical reaction or metabolism. A device is often an item that is implanted or applied to the body. Diagnostic Trial (also screening trial): A clinical trial that looks for better diagnostic tests for diseases. Dose: The amount of drug or biologic given at one time. 21
Page 1 and 2: H e a l t h L a w y e r s ’ P u b
Page 3: TABLE OF CONTENTS Medical Research:
Page 6 and 7: II. The Basics of Medical Research
Page 8 and 9: Research involving drugs and device
Page 10 and 11: therapy to assess safety and effect
Page 12 and 13: different risks are subject to freq
Page 14 and 15: consent rules. The IRB may also hav
Page 16 and 17: determine whether the product is sa
Page 18 and 19: V. Payment for Research Treatments
Page 20 and 21: agent), the clinically appropriate
Page 24 and 25: Dose-Limiting: The dose at which si
Page 26 and 27: STATES MANDATING INSURANCE COVERAGE
Page 28 and 29: Maine Legislation: 24-A: Maine Insu
Page 30 and 31: New Mexico Legislation: Senate Bill
Page 32 and 33: • U.S. Department of Veterans Aff
Page 34 and 35: ABOUT THE AUTHORS Reesa Benkoff, Es
Page 36: 1025 Connecticut Avenue, NW, Suite

Medical Research: A Consumer's Guide for Participation

Create successful ePaper yourself

Delete template?

Save as template?