Litigation Guides
Informed consent is a central tenet of the physician-patient relationship, as well as a critical legal right owed to a patient. The preservation of a patient’s right that they are fully informed of the benefits, risks, and side effects of any medical treatment or procedure is even more significant in the gynecological context, such as when delivering babies or treating diseases, when such information affects not just the patient but also the patient’s unborn or newborn children as well as future fertility.
Medically Reviewed
Informed consent is the process by which a patient is advised of the nature, purpose, and risks of the medical procedure they are undergoing. A signed informed consent is an agreement between the patient and provider that the patient was made aware of, and fully understands, the procedure. Failure to obtain informed consent from a patient can result in a medical malpractice claim.
However, there are exceptions to obtaining informed consent, such as during life-threatening emergencies or when the patient cannot give consent because they are anesthetized or refusing necessary medical interventions.
According to the ethics committee guidelines of the American College of Obstetrics and Gynecologists, informed consent should include a discussion of the benefits and risks of available treatment options in the context of the patient’s values and priorities. Informed consent should be patient-centered and tailored to their particular medical needs. The conversation should include “benefits and risks of available treatment options in the context of a patient's values and priorities” and is contingent upon “[giving] the patient adequate, accurate, and understandable information and requires that the patient has the ability to understand and reason through this information and is free to ask questions and to make an intentional and voluntary choice, which may include refusal of care or treatment.”1
Patients who possess the requisite decision-making capacity maintain the right to refuse treatment, during pregnancy, labor, and delivery, when the treatment is necessary for the health and survival of the patient and/or the patient’s fetus.2 A patient is considered to have decision-making capacity when she has the intellectual ability to understand the consequences of refusing treatment.
According to a 2015 publication in The Obstetrician & Gynaecologist, a patient must be assumed to have capacity unless determined otherwise by a trained professional. All steps must be taken to ensure effective and appropriate communication before assuming the patient does not have decision-making capacity. A patient does not lack capacity simply because they do not make a decision the provider likes. If lacking in capacity, the decisions made for the patient must be in their best interest and with minimum breach of the patient’s rights in order to achieve the desired goal.3
The Royal College of Obstetricians & Gynecologists suggests that obstetrical and gynecological surgical procedures such as an oophorectomy (the surgical removal of an ovary) warrant special care and performing these procedures without obtaining informed consent should be avoided.4 As they explain: “To avoid the possibility of oophorectomy without consent being undertaken, the possible need for oophorectomy should always be discussed with all women undergoing hysterectomy and their preferences recorded. Oophorectomy at the time of hysterectomy for unexpected disease detected at surgery should not normally be performed without previous consent.”4
The Royal College of Obstetricians & Gynecologists also notes that informed consent may not always be possible during potentially unforeseen events, including when an oophorectomy is performed. But physicians must explain to patients that “during a procedure, complications may sometimes arise whereby, if no further procedure is performed, the patient’s life or quality of life could be compromised.”4
In certain emergency situations when lifesaving measures must be taken, the safety of the patient may trump informed consent concerns. In some instances, it is not possible to obtain written consent, in which case, verbal consent is acceptable. However, the patient should still be given the information necessary to make a decision.5
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1.
Informed Consent and Shared Decision Making in Obstetrics and Gynecology | ACOG. URL
2.
Is patient consent required in emergency situations? (n.d.). URL
3.
Treharne, A., & Beattie, B. (2015). Consent in clinical practice. The Obstetrician & Gynaecologist, 17(4), 251–255. https://doi.org/10.1111/tog.12219. URL
4.
Obtaining Valid Consent. (2015). www.rcog.org.uk. URL
5.
Treharne, A., & Beattie, B. (2015). Consent in clinical practice. The Obstetrician & Gynaecologist, 17(4), 251–255. https://doi.org/10.1111/tog.12219. URL
6.
Hickey, M., Ambekar, M., & Hammond, I. (2009). Should the ovaries be removed or retained at the time of hysterectomy for benign disease? In Human Reproduction Update (Vol. 16, Issue 2, pp. 131–141). Oxford University Press. URL
7.
Mohr, C., Nezhat, F. R., Nezhat, C. H., Seidman, D. S., & Nezhat, C. R. (2005). Fertility considerations in laparoscopic treatment of infiltrative bowel endometriosis. JSLS : Journal of the Society of Laparoendoscopic Surgeons / Society of Laparoendoscopic Surgeons, 9(1), 16–24. /pmc/articles/PMC3015563/. URL
About the authors
Mariam Ghantous, MD, MPH
Mariam Ghantous, MD, MPH, is a Medical Affairs Professional, Physician, and Scientist with a rich background in Immuno Oncology, Targeted Therapy, and public health. Dr. Ghantous has built a notable career with experience in academic clinical research, medical-legal communication, consulting, and the pharmaceutical industry. Currently serving as a Medical Science Liaison in GI Oncology at AstraZeneca in New York, she has demonstrated her expertise through significant roles, including a consulting intern in Value-Based Care at Ronald McDonald House New York and extensive medical-legal consultancy. Her academic credentials are equally impressive, with a Doctor of Medicine degree from the American University of Beirut and a Master's in Public Health from Columbia University, emphasizing her commitment to advancing healthcare through innovative research and informed, policy-driven approaches.
Her tenure at AstraZeneca and roles in various organizations highlight her adeptness in bridging the gap between clinical research and practical medical applications, particularly in oncology. Dr. Ghantous's work is underpinned by her substantial contributions to medical research, evident in her publications on topics such as sex-specific pharmacotherapy for back pain and the neuroscientific aspects of chronic pain. Her interdisciplinary experience, spanning clinical trials, neuroscience research at Northwestern University Feinberg School of Medicine, and medical-legal consulting, positions her as a pivotal figure in the integration of medical science and healthcare policy.
Wendy Ketner, M.D.
Dr. Wendy Ketner is a distinguished medical professional with a comprehensive background in surgery and medical research. Currently serving as the Senior Vice President of Medical Affairs at the Expert Institute, she plays a pivotal role in overseeing the organization's most important client relationships. Dr. Ketner's extensive surgical training was completed at Mount Sinai Beth Israel, where she gained hands-on experience in various general surgery procedures, including hernia repairs, cholecystectomies, appendectomies, mastectomies for breast cancer, breast reconstruction, surgical oncology, vascular surgery, and colorectal surgery. She also provided care in the surgical intensive care unit.
Her research interests have focused on post-mastectomy reconstruction and the surgical treatment of gastric cancer, including co-authoring a textbook chapter on the subject. Additionally, she has contributed to research on the percutaneous delivery of stem cells following myocardial infarction.
Dr. Ketner's educational background includes a Bachelor's degree from Yale University in Latin American Studies and a Doctor of Medicine (M.D.) from SUNY Downstate College of Medicine. Moreover, she is a member of the Board of Advisors for Opollo Technologies, a fintech healthcare AI company, contributing her medical expertise to enhance healthcare technology solutions. Her role at Expert Institute involves leveraging her medical knowledge to provide insights into legal cases, underscoring her unique blend of medical and legal acumen.
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