Согласие на клиническое испытание препарата от диабета (Фаза II)
Исследовательские команды и клиники создают черновики согласий в стиле IRB на простом языке, которые участники действительно понимают.
Показать предпросмотр ввода и вывода
Ввод
- Procedure Info
- Phase II randomized controlled trial of a new oral diabetes medication (Drug X 500mg) vs. placebo over 12 weeks, including blood draws every 2 weeks and one MRI scan. Participants are adults with Type 2 diabetes. Compensation provided for travel.
- Procedure Type
- clinical-trial
- Risk Level
- moderate
- Audience
- research-participant
- Language Level
- plain-language
Вывод (фрагмент)
Consent to Take Part in a Research Study What is this study? We are testing a new diabetes pill (Drug X) to see how well it lowers blood sugar. You will be randomly placed in either the Drug X group or a placebo (no medicine) group. Neither you nor the doctor chooses which. What will happen? Over 12 weeks you will have blood drawn every 2 weeks and one MRI scan. Possible risks: Low blood sugar, mild bruising from blood draws. Your participation is voluntary and you may stop at any time.