212-LAWYERS or (212) 344-1000

Are Patients Really Providing Consent that is Informed?

In many circumstances, before doctors and other medical professionals can provide patients with a course of treatment or other procedure, it is necessary (even required) to obtain the informed consent of the patients. One common way for medical professionals to obtain and document that the patient’s consent has been given for the procedure is by having the patient sign or fill out a consent form.

But do patients truly understand exactly what they are consenting to? A new study indicates that often patients may not. Patients who do not fully understand the risks involved in a study or medical procedure and are subsequently injured, may look for help from attorneys experienced in medical malpractice law.

Not Fully Informed Consent?

A recent study by the New England Journal of Medicine suggests that many of the consent forms used in medical research studies are written at a level too high for the average participant to understand. The study found that the reviewed consent forms were written three reading levels above what institutional review boards (IRB) recommend. IRBs recommend consent forms be written at a grade-8 level and the reviewed forms were written at a grade-11 level.

Conducted by Madhav Swaminathan, MD, the director of perioperative echocardiography in the Division of Cardiothoracic Anesthesiology and Critical Care Medicine and an associate professor of anesthesiology at Duke University School of Medicine, the study analyzed 15 consent forms using "five validated, standardized readability tests."

Discussing the results of the study with Anesthesiology News, William Tremaine, MD, director of the Office of Human Research Protection at Mayo Clinic, said that consent forms need to be only part of the process of obtaining informed consent. He said: "Potential participants need to have an opportunity to ask questions, including questions about the meaning of words and phrases in the written consent documents. They need to get answers in lay language they can understand so that they are fully informed about the details of the study."

In addition to being beneficial to patients, Dr. Swaminathan said that the results of the study could positively affect medical research studies: "Subjects who do not fully understand a consent form may initially consent to participate, but withdraw after realizing they are receiving an intervention or procedure they did not understand or agree with at the outset of the study."

While this study of consent forms only looked at documents used for medical studies, the results raise possible questions and concerns about the process of obtaining informed consent in other aspects of medical care and treatment, specifically in patient care.

Informed Consent

Generally speaking, informed consent is the process of discussing the potential benefits and risks of a course of treatment, surgical procedure or other care, along with any alternative treatment or procedures that may exist, with patients so that they can make a fully informed decision about their medical care. Patients ultimately provide their consent or authorization for a medical procedure by signing a document that acknowledges they were provided with the information necessary to make the decision.

The process of obtaining informed consent from patients should be more than just signing a document, but actually be a conversation between physician and patient. This is especially important with surgical procedures, which inherently carry many risks. A conversation with the patient not only clarifies the dangers involved, but may also help the physician avoid surgical mistakes.

To help ensure that patients provide informed consent, the American Medical Association (AMA) suggests that medical professionals discuss and disclose certain information with their patients, including:

  • Patient’s diagnosis;
  • The proposed treatment or procedure’s nature and purpose;
  • The proposed treatments or procedure’s risks and benefits;
  • Any alternative treatments or procedures that may be available;
  • The alternative treatments’ risks and benefits; and
  • The risks and benefits of foregoing any treatments or procedures.

The AMA notes that the treating physician should speak to patients when seeking consent for a procedure, this should not be delegated to a nurse or other medical professional.

The informed consent process is not just a one-way street. Both the AMA and Dr. Tremaine state that patients, whether about to participate in medical research or undergo a procedure or treatment, should be afforded the opportunity to have any questions or concerns clarified and answered before providing consent.

Informed consent may be necessary in many instances – and absolutely necessary in some instances, like medical trials – but it is not needed in every instance. For example, routing "procedures" during an exam or check up and emergency situations will not require doctors to obtain informed consent.

If you believe you were not fully informed of the entire situation before undergoing a medical treatment or procedure, speak with a medical malpractice attorney. An attorney can help you get to the truth of the situation, did the doctor not personally speak with your about the procedure or treatment or answer your questions? Was the document you were asked to sign too complicated to understand? Or was there another reason that you were not able to provide informed consent?

NYC Personal Injury lawyer - RMFW Law Logo Inverted

Get a Free Consultation

No Win No Fee
April Johnson
April Johnson
15:54 30 Jun 23
Easy access to thr firm with a very nice Lawyer
Benjamin Roussey
Benjamin Roussey
19:03 29 Jun 23
No firm gets it done like RMFW. They are the best.They are awesome - for sure.
Roberto Martinez
Roberto Martinez
19:02 24 May 23
I’ve been in the personal injury field as an investigator for 29 years. All in New York City. Out of all the hundreds of Law Firms I’ve worked with, Rosenberg Minc Falkoff & Wolf, would have to be at the very top of my list. Amazing staff great attorneys.If you want the job done right, these are you guys.
Julio Ochoa
Julio Ochoa
20:49 18 May 23
I highly recommend Rosenberg, Minc, Falkoff & Wolff, LLP for their outstanding assistance in obtaining a settlement for an Erb's Palsy birth injury case. Their knowledge, dedication, and compassionate attitude were important in attaining a successful end. Their professionalism and assistance were simply outstanding from beginning to end. I am deeply thankful for their representation and would enthusiastically recommend them to anyone seeking justice in a similar situation.
Aisha Neri
Aisha Neri
20:29 18 May 23
I recently had the privilege of working with Rosenberg, Minc, Falkoff & Wolff, LLP on my daughter’s birth injury case involving Erb's Palsy, and I cannot express enough gratitude for their exceptional legal services. From the initial consultation to the successful settlement, they demonstrated profound expertise, unwavering dedication, and genuine compassion for my family's situation.From the very beginning, the team proved their commitment to justice. They thoroughly investigated the circumstances surrounding my child Erb's Palsy birth injury, leaving no stone unturned. Their extensive knowledge and understanding of medical malpractice law, coupled with their deep expertise in birth injury cases, provided us with tremendous confidence in their ability to handle our case.The attorneys at Rosenberg, Minc, Falkoff & Wolff consistently displayed exceptional professionalism and attention to detail throughout the entire legal process. They meticulously gathered evidence, consulted with medical experts, and built a compelling case that clearly outlined the negligence and liability on the part of the medical professionals involved. One aspect that truly stood out was the genuine care and compassion exhibited by Daniel Minc, Lorraine Licul, and the entire team at Rosenberg, Minc, Falkoff & Wolff. They treated us not just as clients but as individuals with unique emotions and concerns. They took the time to listen attentively to our worries, provided constant updates on the progress of our case, and promptly responded to our inquiries, ensuring we felt supported and reassured throughout the process. Their empathy and understanding made an immeasurable difference during such a challenging and emotionally taxing time.When it came time to negotiate a settlement, Daniel Minc demonstrated remarkable skill and tenacity. He fought fiercely on our behalf, advocating for fair compensation to cover any potential long-term effects of Erb's Palsy on my child's life. His negotiation skills were truly impressive, as they secured a settlement that exceeded our expectations and provided the financial resources necessary to support my child's future needs.I cannot recommend Rosenberg, Minc, Falkoff & Wolff highly enough to anyone seeking legal representation in Erb's Palsy birth injury cases or any other medical malpractice matters. Their extensive experience, unwavering dedication, and empathetic approach make them an exceptional choice for families navigating the complexities of birth injury litigation. Thanks to Rosenberg, Minc, Falkoff & Wolff, my family now has the means to provide the best care and opportunities for my child's future.If you are seeking a law firm that combines legal expertise with genuine compassion, look no further than Rosenberg, Minc, Falkoff & Wolff, LLP. They will tirelessly fight for your rights and ensure your voice is heard, providing you with the support and justice you deserve.
Aoki R
Aoki R
17:14 17 May 23
I highly recommend Rosenberg, Minc, Falkoff & Wolff, LLP. They are a team of dedicated professionals fully committed to their clients. I have witnessed the firm's amazing work ethic in my experience with their attorneys and Lorraine Licul. Lorraine is a knowledable, empathetic and results-driven professional. Minc is an excellent attorney and I greatly appreciate the firm's expertise.
Michael Levites
Michael Levites
17:42 12 May 23
I have recommended this firm to some of my friends and I heard back only positive feedback about the client responsiveness, diligence and hard work put in by these attorneys. I will continue to refer anyone who suffered a personal injury to Rosenberg Minc..
See All Reviews