1. Your Clinical Research Knowledge  B Smith, ORI, 2012

2. Clinical research is subject to federal regulations, ethical review, and university policies all of which are designed to provide protections and safeguards for clinical research participants. ? TrueFalse

3. A True. Two of the main safeguards for study volunteers are the Institutional Review Board (IRB) and Informed Consent Process. The IRB is a committee consisting of health care professionals, scientists, and non-medical people from the local community who review all studies to ensure that the participants’ safety is protected, their personal rights are respected, and they are informed fully about the research study. To help you decide if you want to be in a study, you will be given complete information about the study before you agree to take part. This is known as the informed consent process.

4. INFORMED CONSENT INVOLVES A PARTICIPANTS AGREEMENT TO JOIN AND REMAIN IN A CLINICAL RESEARCH TRIAL. ? TrueFalse ?

5. A False, While informed consent is designed to provide you with the knowledge to make an informed decision on volunteering for a study, you are ALWAYS free to choose to leave the study at any time.

6. IF A STUDY PARTICIPANT HAS A CONCERN OR COMPLAINT THAT THEY ARE NOT COMFORTABLE REPORTING TO THE STUDY DOCTOR, THE INFORMED CONSENT FORM PROVIDES A PHONE NUMBER TO CALL THAT IS SEPARATE AND INDEPENDENT OF THE STUDY DOCTOR. ? TrueFalse

7. A TRUE! It is IRB policy to provide a safe confidential, and reliable way for current, future, or past research participants to discuss problems, concerns, and questions. Call toll-free at 1-866-400-9428 to speak with a research integrity representative who is not associated with any specific research study.

8. Medical Research is the same as Medical Treatment. ? TrueFalse

9. A Source: Adapted from Alz.org False. Doctors choose medical treatment with some expectation regarding safety and effectiveness. Medical research is done according to a specific plan to answer a question. The fact is you may or may not benefit from being in the study. While the results may help others in the future, you should to be informed regarding both the potential risks and benefits involved in order to decide if you wish to participate.

10. If I join a treatment clinical trial, I could get a placebo. ? TrueFalse

11. A True, in certain types of clinical trials, some of the participants will receive an inactive placebo as part of the trial design. This is done “randomly” or by chance like flipping a coin. HOWEVER, other studies compare the study treatment to a standard treatment already available and approved by the Food and Drug Administration (FDA). ASK QUESTIONS IF YOU AREN’T CLEAR ABOUT YOUR CHANCES OF RECEIVING A PLACEBO!

12. IF THERE IS A CLINICAL TRIAL THAT COULD HELP ME, MY DOCTOR WILL TELL ME ABOUT IT. ? TrueFalseUnsure

13. A Source: Center for Information and Study on Clinical Research Participation http://ciscrp.org/ While physician referral is typically listed as the “preferred” source of clinical trial information, most surveys indicate that people find out about studies from other resources such as the media or direct or internet advertising. Your physician may be unaware of all the research studies in your area. For the most up-to-date information about University of Kentucky Clinical Research visit www.ukclinicalresearch.com or browse a National database at www.clinicaltrials.gov. www.ukclinicalresearch.comwww.clinicaltrials.gov

14. AN ESTIMATED________% OF MEDICATIONS APPROVED BY THE FOOD AND DRUG ADMINISTRATION (FDA) ARE LABELED FOR USE IN CHILDREN. ? 20 - 30 Source: FDA Consumer Information www.drugs.com/fda-consumer/should-your-child-be-in-a-clinical-trial-60.html 40 - 5070 - 80

15. A Historically, only 20-30% of FDA approved drugs are labeled for use in children. Since children aren’t “little adults” research is important to better understand how best to treat children. However parents must make informed decisions about their child’s participation in clinical trials. Children also have the right to agree to participate. Learn more at the FDA website, Should Your Child Be in a Clinical Trial? To learn from the experiences of parents, experts, and children who have participated, view the NIH Children & Clinical Studies Videos.Should Your Child Be in a Clinical Trial NIH Children & Clinical Studies Videos

16. Congratulations on completing the Clinical Research Participation Quiz For more information on clinical research and protection of study volunteers visit www.research.uky.edu/ori/human/participants.html www.research.uky.edu