|
Adult & Adolescent Informed Consent to
Participate in Clinical Research Study Authorization to Use and Disclose Health Information |
Study Title: Survey that measures the Street value of an immediate-release stimulant vs. the Street value of a long-acting stimulant
Sponsor: Shire Pharmaceuticals Inc (Shire)
Approval Date: November 17, 2005
Principal Investigator: George M. Bright, M.D.
Please take the time
to read this consent form carefully and ask the study doctor or the study staff
to explain any information that you do not clearly understand. Please make sure
all your questions are answered before you sign the form. The information obtained
from this form and from talking to the study staff may help you decide if you
want to take part in this research study. If you choose to take part in this
research study, you must sign your name at the end of the form.
INTRODUCTION:
You are being asked to take part in a research project that involves answering questions in a survey format. Please note that your responses will be strictly confidential and we ask that your responses be as openly and honestly as possible.
PURPOSE OF THE STUDY:
Compare the abuse ability and street value of common prescription attention-deficit/hyperactivity disorder (ADHD) stimulant medications:
NATURE OF THE STUDY:
The study is being conducted by distributing a survey that addresses the questions of the potential misuse/abuse of short acting/immediate release stimulants vs. long-acting stimulants. The survey also addresses the abuse of illegal/illicit drugs along with the prescribed stimulants. The survey will also include demographic questions, for example: Age, Level of Education, Employment history, etc...
Patient Population:
Our goal is to distribute 1000 surveys to subjects who have been diagnosed with ADHD as well as subjects who do not have ADHD. Responses to the questions within the survey will be kept strictly confidential.
We are distributing the survey to adolescents and adults.
Inclusion Criteria:
Males and Females, aged 13 yrs and above (no age limit cut-off), who have or have not been diagnosed with ADHD, but have used short-acting (immediate-release) stimulants and/or long-acting stimulants for either prescribed use or used for misuse/abuse. Subjects who have also used illegal/illicit stimulants should also be included.
Exclusion Criteria:
None
Study Procedures:
Identify 1000 subjects with DSM-IV diagnosed ADHD or without ADHD but have a history of stimulant use. Each survey will be distributed to each subject meeting the Inclusion criteria and completion of the surveys will done while at their regular office visit.
Risks of the Study:
There will be no known risks to you since the review of your medical chart will be done as a statistical analysis and any demographic information will in no way reveal your identity. However, please note that due to the sensitivity of the questions regarding illicit/illegal drug use, some of the questions may not be appropriate to some subjects based on their age and any subject under the age of 18 should have parental or guardian consent before the survey is taken. Please also note that all responses will be confidential. If the question or the subject matter of the question does not pertain to you in any way, please disregard the question(s).
Benefits:
We cannot guarantee that you will benefit from taking part in this study. However, studies such as this give us information that could help us improve the treatment available for ADHD.
Confidentiality:
Your agreement to this form will authorize the study staff to collect and use information from the completed survey. Since this is a survey-based clinical trial and the information collected will be for statistical purposes only, every effort will be afforded to keep your identity disclosed from any future document or publication that develops as the direct result from this study. It is our intent to keep all information about you confidential to the extent permitted by applicable laws and/or regulations.
Signature of Consent:
By agreeing to this form, you certify that you have thoroughly read and understand the information contained in this form, have been given a chance to ask questions and have received satisfactory answers to your questions. You voluntarily consent to allow Dr. George M. Bright, M.D., and his study staff to review and retrieve data from your medical records and to enter this information into a statistical analysis format.