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 treatments, medications or procedures that must be “standard” 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.
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.
Consent-Template.docx