Invitation We invite you to take part in a research study about general topic of the study. We are inviting you because explain why the person is being asked to participate in the study, (e.g. have been diagnosed with a certain condition or meeting certain eligibility requirements. This is being done to see if If you agree, you will be in this study for about and will need to visit the research site about times. You do not have to take part in this research. If you decide not to take part, you can receive the care you would usually receive at . There are risks to taking part in this research. The main risks include . There are additional risks and these risks are listed later in this document. We cannot promise any benefits to you or others if you decide to join this research; but we hope that this research will . We expect people at will join and about around the U.S or worldwide to participate in this research. As you read this consent document, ask questions about anything that is not clear. If you want to talk to your family and friends before making your decision, you can. Once we have answered all your questions, you can decide if you want to be in the study. This process is called “informed consent.” Why are researchers doing this study? Explain the goals of the study in non-technical/lay terms. As briefly as possible, explain why this study is needed. The purpose of this research is to describe the purpose of the study. We are doing this research because provide relevant, non-technical background information, including a brief reason why the research needs to be conducted and how the study will help address this need (e.g. what the product does). Include the following statement if this is a multicenter Otherwise, delete: This study is being done at and at other sites around the U.S. or world. If the study is funded, add: Funding for this is provided by agency/company/foundation that is sponsoring the study. is being paid to conduct this study. trial
Instructions: Arrange risk information in a logical, intuitive order, such as grouping risks in order of frequency, by drug, or by procedure. Describe reasonably foreseeable and discomforts associated with any treatment, procedure, or activity that subjects will undergo because they are in the research study. Include risks of “standard” treatments, medications or procedures that must be administered/performed as specified by the protocol rather than per local clinical practice. If this research involves drugs, devices of procedures that may harm an embryo, fetus or breast feeding infant, include the Contraception Model Language If this research involves genetic testing, include Genetic Research Model Language If this research involves genomic data sharing (with NIH), include Genomic Data Sharing Model Language When obtaining information on sensitive topics (e.g. mental health, sexuality, traumatic events) may cause anxiety, distress, embarrassment, feelings of sadness, or discomfort, describe these possible psychosocial risks. Use language, bruising vs. hematoma, high blood pressure vs. hypertension. Explain the health implications of side effects, especially for potentially serious adverse effects (e.g. low white blood cell count, which can increase your risk of infections). When describing the frequency of adverse effects, use phrases like, this happens in 20 or more out of 100 people, rather than 20%. In addition to these risks, this research may hurt you in ways that are unknown. These may be a minor inconvenience or may be so severe as to cause death. We will tell you about any new information that may affect your health, welfare, or choice to stay in the research. Include one of the statements below: For studies involving only non-sensitive data: There is a risk that your information could become known to someone not involved in this study. For studies that collect data with psychosocial risks, such as information on genetic predisposition to diseases, drug or alcohol abuse, illicit behaviors, etc.: There is a risk that your information could become known to someone not involved in this study. If this happens, it could result in damage to your reputation, which could also affect your relationships with family and friends, affect your employment, or make it harder to get insurance or a job.
My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the subject, and that consent was freely given by the subject. Signature of witness to consent process Date Printed name of person witnessing consent process Signature Block for Children Your signature documents your permission for the named child to take part in this research. Printed name of Signature of parent or individual legally authorized to consent to the child’s general medical care Date ____ Parent ____ Individual legally authorized to consent to the child’s general medical care (See note below) Printed name of parent or individual legally authorized to consent to the child’s general medical care Note: Investigators are to ensure that individuals who are not parents can demonstrate their legal authority to consent to the child’s general medical care. Contact legal counsel if any questions arise. Signature of parent Date Printed name of parent If signature of second parent not obtained, indicate why: (select one) _____ The IRB determined that the permission of one parent is sufficient. [Delete if the IRB did not make this determination] _____ Second parent is deceased _____ Second parent is unknown _____ Second parent is incompetent _____ Second parent is not reasonably available _____ Only one parent has legal responsibility for the care and custody of the child