Question: there are at least 9 items missing in this consent form housing IRB? RESEARCH on the topic of Gestational Diabetes Management You are invited to
there are at least 9 items missing in this consent form housing IRB?
RESEARCH on the topic of Gestational Diabetes Management
You are invited to participate in a research study examining the effects of Metformin in the treatment of gestational diabetes. The decision to engage in participation or not is strictly yours. This study plans to address the correlation between the use of Metformin and the effect it may have on the fetus.
Participants will engage in a double-blind research study. You will take a medication to treat your gestational diabetes, and will have regular follow-up appointments with our team of physicians, as will your infant after birth. This study will begin at the onset of the gestational diabetes diagnosis and follow you through the first year of the infant's life.
Your participation in the study may be terminated at the discretion of the investigators without your consent.
Risks that may be associated with the study include:
- Adverse effects of the medication
The benefit from this research may include control of your gestational diabetes, but there is no guarantee. Women who become pregnant in the future and their children may benefit from the information obtained from this study.
Medications will be provided free of charge while participating in this study. Physician visits for the infant will be covered monthly after delivery. Mileage to these visits will be paid.
Your participation in this research study is voluntary. There is no requirement to participate or to continue participation once you have started. You will incur no penalty nor lose any benefits that you are entitled to if you decide to terminate your participation. Your relationship with our health network will not suffer as a result of termination.
You may call J. Jackson at 999-999-9999 or e-mail J. Jackson a..n@health.hltwith any questions that you have. This includes questions regarding the study, or questions regarding physical or psychological issues that are developing which you believe to be unusual or unexpected.
CONSENT OF SUBJECT
(or Legally Authorized Representative)
_____________________________________ ____________________________
Signature of Subject of Representative Date
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