rascalconsentformbuildersampletext.docVIP

RASCAL CONSENT FORM BUILDER SAMPLE TEXT Information on Research Text Sub-Heading INTRODUCTION INTRODUCTION The purpose of this form is to give you information to help you decide if you want to take part in a research study. This consent form includes information about: - why the study is being done; - the things that you will be asked to do if you are in the study;- any known risks involved;- any potential benefit; and - options, other than taking part in this study, that you have. The principal investigator (the lead researcher for this project) [INSERT OTHER APPROPRIATE TITLE IF THE PI WILL NOT CONDUCT THE DISCUSSION] will discuss the study with you. If at any time you have questions about the study, please ask a member of the study team. Take all the time you need to decide whether you want to take part in this research study. The purpose of this research is described below in the What is Involved in This Study? section of this consent form. This consent form is written to address a research subject. If, however, you will be providing permission as [INSERT, AS APPLICABLE] the parent or legal guardian of a minor [OR] a legally authorized representative, the words you and your should be read as [INSERT, AS APPLICABLE] your child [OR] the research subject. Invitation to Participate WHY IS THIS STUDY BEING DONE? PURPOSE Study purpose We are doing this research study to find out [INSERT PURPOSE OF THE STUDY IN LAY TERMS. IF INVESTIGATIONAL DRUGS (OFF LABEL OR UNAPPROVED) OR DEVICES WILL BE USED, INSERT APPLICABLE SAMPLE TEXT]. You are being asked to take part in this study because [INSERT GENERAL INCLUSION CRITERIA]. About [INSERT TOTAL NUMBER OF SUBJECTS] people are expected to be enrolled in this study [EXPLAIN WHETHER THIS IS AT THIS SITE OR AT ALL SITES]. Study Purpose Off label use of an approved drug [INSERT DRUG NAME] is being used in an investigational manner (not for the purpose that it is approved for) in this research stud