SAMPLE FORMAT FOR INFORMED CONSENT UMENT知情同意文件样本格式.doc

SAMPLE FORMAT FOR INFORMED CONSENT DOCUMENT (For Parental Permission Only) SUNY Upstate Medical University (or print on department letterhead) Title of Study: A Phase 3 randomized study comparing Behavioral Therapy to Clumisol for the Treatment of Clumsiness. Consent / Authorization Form Background/Purpose: State why this particular person is being asked to participate. Your child is being asked to participate in a research study because your child has been diagnosed with clumsiness (add diagnosis)…. or ….. because your child has already decided to undergo behavioral therapy for clumsiness. Research studies include only those individuals who choose to take part. Please take your time to make your decision. Please ask the study doctor or the study staff to explain any words or information that you do not understand. You may also want to discuss it with your friend and family. Add a paragraph of pertinent background information. This paragraph should make it clear why the study is being done. Currently, we have no drugs, which can treat clumsiness (add specific diagnosis). It is felt that clumisol (add specific drug) may be helpful because…. OR The current treatment for clumsiness is behavioral therapy; however behavioral therapy is only successful in a small number of people (about 1 in 100). In early studies, subjects responded well to clumisol. Include study objectives. The purpose of this research study is to see if the investigational drug, clumisol, is safe and effective in treating people with clumsiness. An investigational drug is a drug which has not been approved by the Food and Drug Administration (FDA) for general use. Add how many total subjects will be participating in the study. Twenty people are expected to participate in this research study. Study Procedures: Explain all study procedures in easy to understand language. Use short paragraphs to explain procedures in the order in which they will occur. If you agree to allow your child to participate,