2상 당뇨병 약물 시험 동의서
연구팀과 클리닉은 참가자가 진정으로 이해할 수 있는 IRB 스타일의 쉬운 언어 동의서 초안을 생성합니다.
입력 및 출력 미리보기
입력
- 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
출력 (발췌)
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.