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writing informed consent documentsPart Two: ExhibitDeveloped by:U-MICUniversity of Michigan IRB Collaborative

Part One: Fundamentalsreadability comprehensibilitycharacteristics of effective consent languageaccessibilitybrevityclaritydirectness

Part Two: ExhibitExamine problematic consent language.Identify flaws.Revise.3Developed by:U-MICWriting consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia.Writing consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal.Writing consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age.Writing consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms.Writing consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease.Writing consent documents (part two)

Study purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

9Developed by:U-MICUse everyday language.Define necessary technical terms.Eliminate inessential detail.Compose simple sentences.Stay on topic.Make affirmative statements.Use verbs in the active voice.We youtechnicalwordydisorganizedaccessiblebriefclearvaguedirectWriting consent documents (part two)

Writing consent documents (part two)

10Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

11Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

12Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

13Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

14Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

15Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Writing consent documents (part two)

16Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purpose

ProceduresWriting consent documents (part two)

17Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purpose

ProceduresWriting consent documents (part two)

18Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States.

ProceduresWriting consent documents (part two)

19Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States.

ProceduresWriting consent documents (part two)

20Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States.

ProceduresWriting consent documents (part two)

21Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth.

ProceduresWriting consent documents (part two)

22Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresWriting consent documents (part two)

23Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

Procedures

Writing consent documents (part two)

24Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo.

Writing consent documents (part two)

25Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo.Writing consent documents (part two)

26Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo. A placebo is a fake drug. It looks exactly like the real drug but contains no medicine. Well use a random method (like a flipping a coin) to decide whether to give you the real nozerost or the placebo. Youll have no way of knowing which one you receive.Writing consent documents (part two)

27Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo. A placebo is a fake drug. It looks exactly like the real drug but contains no medicine. Well use a random method (like a flipping a coin) to decide whether to give you the real nozerost or the placebo. Youll have no way of knowing which one you receive.Youll take two pills every day for the next six weeks. You should take one pill when you get up in the morning and the other pill around dinnertime.Writing consent documents (part two)

28Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo. A placebo is a fake drug. It looks exactly like the real drug but contains no medicine. Well use a random method (like a flipping a coin) to decide whether to give you the real nozerost or the placebo. Youll have no way of knowing which one you receive.Youll take two pills every day for the next six weeks. You should take one pill when you get up in the morning and the other pill around dinnertime.Well also ask you to write down your dry mouth symptoms every day in a journal. Next to each symptom, youll rate its severity on a scale of 1 to 5.Writing consent documents (part two)

29Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo. A placebo is a fake drug. It looks exactly like the real drug but contains no medicine. Well use a random method (like a flipping a coin) to decide whether to give you the real nozerost or the placebo. Youll have no way of knowing which one you receive.Youll take two pills every day for the next six weeks. You should take one pill when you get up in the morning and the other pill around dinnertime.Well also ask you to write down your dry mouth symptoms every day in a journal. Next to each symptom, youll rate its severity on a scale of 1 to 5.Writing consent documents (part two)

30Developed by:U-MICStudy purposeThis study is aimed at assessing the effectiveness of an oral pharmacological agent for the treatment of xerostomia. To this end, subjects will be asked to self-administer 25 mg nozerost or placebo twice daily (a.m. and p.m.) over a six-week period, and will record dry mouth symptomsindicating their severity on a five-point scalein a daily journal. Xerostomia has in past research been found to be prevalent among approximately 24% of U.S. adult females and approximately 18% of U.S. adult males up to 88 years of age. Available data suggest a link between low salivary flow and xerostomia in adults toward the lower end of the age spectrum studied, whereas a more complex constellation of factors (including but not limited to low salivary flow) in older and elderly adults may contribute to xerostomic symptoms. Xerostomia is a known side effect of a range of prescription and over-the-counter medications, and is also associated with various medical conditions, such as diabetes and Parkinsons disease. Development of a topical anti-xerostomic formula comparable in its effects with the oral agent under examination in this study is not currently foreseen by the researchers.

Study purposeDry mouth (xerostomia) affects many adults in the United States. It often occurs as a side effect of medicine. Certain health conditions, such as diabetes and Parkinsons disease, can also cause dry mouth. In this study, we want to find out how helpful a drug called nozerost might be in treating dry mouth.

ProceduresIf you decide to take part in this study, well give you a six-week supply of pills to take at home. The pills will be either nozerost (25 milligrams each) or a placebo. A placebo is a fake drug. It looks exactly like the real drug but contains no medicine. Well use a random method (like a flipping a coin) to decide whether to give you the real nozerost or the placebo. Youll have no way of knowing which one you receive.Youll take two pills every day for the next six weeks. You should take one pill when you get up in the morning and the other pill around dinnertime.Well also ask you to write down your dry mouth symptoms every day in a journal. Next to each symptom, youll rate its severity on a scale of 1 to 5.

(Use readability formulas with caution.)Writing consent documents (part two)

31Developed by:U-MICWriting informed consent documentsthank you.Brian SeaboltTechnical WriterIRBMED32Developed by:U-MICOther594309.75