[Verified Answer]: 10 Informed consent-institutional review…

10 Informed consent-institutional review board Competency III. 5 Because of your HIM background, your pregnant cousin emailed you a copy of the infor consent she received regarding participation in a research study on gestational diabetes. unfamiliar with this type of document and wants to be sure it addresses all aspects that it sh Assess the document based on the criteria for research informed consents and give her opinion. Be sure to defend your judgment. 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 participate 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 gesta- tional diabetes and will have regular follow-up appointments with our team of physicians, as will your infa 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 guara Women who become pregnant in the future and their children may benefit from the information obtained this study. Results of significance will be shared with test subjects as the study progresses. Medications will be provided free of charge while participating in this study. Physician visits for the 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 continum participation once you have started. You will incur no penalty nor lose any benefits to which you are entitled if you decide to terminate your participation. Your relationship with our health network will not suffer because of termination. You may call J. Jackson at 999-999-9999 or email J. Jackson at J.Jackson@health.hlt with any questions that you have. This includes questions regarding the study, or questions regarding developing physical or psychological issues that you believe to be unusual or unexpected. CONSENT OF SUBJECT (or Legally Authorized Representative) Signature of Subject or Representative There are four major issues with the informed consent form provided in the case study. Please discuss these in four separate paragraphs. Also, there is at least one general rule that is not being followed. Please identify the general rule.