what if you cannot obtain patient consent for a case report

Some members of the Forum argued that a paper containing identifiable details of a patient cannot be published without consent unless the patient is dead or the patient has given informed consent to publication. In this case, consent cannot be obtained and therefore the presumption should be that the case report should not be published.

Full Answer

Do patients read consent forms?

They often do not read consent forms carefully because they assume that someone else has scrutinised the risks and benefits on their behalf. Interviews with 103 patients showed that many factors influence a decision to take part in medical research (Hastings Center Report 1996;26 (5):25-9).

Is your medical consent properly informed?

Informed consent to medical treatment is fundamental in both ethics and law. Patients have the right to receive information and ask questions about recommended treatments so that they can make well-considered decisions about care. Successful communication in the patient-physician relationship fosters trust and supports shared decision making.

What is a patient consent?

The physician provided his patient with a dense seven-page consent form, in which specific surgical risks, like tissue necrosis, were mentioned; she signed the consent form. However, the physician did not engage in any detailed discussions with his patient ...

Is informed consent possible?

Informed consent is not only required for clinical trials but is an essential prerequisite before enrolling each and every participant in any type of research involving human subjects including; diagnostic, therapeutic, interventional, bioequivalence, social and behavioral studies and for all research conducted domestically or abroad.

Do case reports require patient consent?

As explained above, informed patient consent is mandatory for the publication of your case reports. Ignoring this requirement can result in a rejection for your work and worse, ruin your relationship and reputation with patients.

What happens if informed consent is not obtained?

In both medical and legal terminology, this is called "informed consent." If a doctor does not get informed consent from a patient, and the patient is injured, the patient may have grounds to sue the doctor for medical malpractice.

What are some consequences for not obtaining consent?

Informed consent is meant to honor your right to decide what's done with your body. Rules and the law pertaining to this topic have changed over the years, but one thing hasn't: Failure to obtain informed consent is a crime—medical malpractice, specifically—and the doctor can be charged with negligence and battery.

Do case reports require ethical approval?

Case reports and studies intended for quality improvement are often considered not research and do not need IRB approval. Nevertheless, there should be some processes of clearing those studies with respect to ethical handling of patients and related data.

What legal action can be taken if you fail to obtain consent?

Failure to obtain consent properly can lead to problems including legal or disciplinary action against you, or rarely criminal prosecution for battery (contact with an individual without consent.)

Is consent a legal requirement?

Consent forms Written consent is not usually required by law, but is considered good practice. It serves as a record of the information given to the patient, and of the patient's consent. Modern consent forms usually include details of the risks and benefits of the procedure.

Why is it important to obtain consent?

Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.

Can you treat a patient without informed consent?

If adult patients are mentally able to make their own decisions, medical care cannot begin unless they give informed consent. The informed consent process makes sure that your health care provider has given you information about your condition along with testing and treatment options before you decide what to do.

Can the lack of medical consent ever be justified?

The project concludes that lack of medical consent can never be justified but for a few exceptions falling into the category of medical treatment.

Do we need IRB approval for case report?

Yes. Under HIPAA, a case report is an activity to develop information to be shared for medical/educational purposes. Although the use of protected health information to prepare the paper does not require IRB review, the author of a case report must comply with HIPAA.

What is ethics in the medical field?

Health care ethics (aka “medical ethics” or “bioethics”), at its simplest, is a set of moral principles, beliefs and values that guide us in making choices about medical care. At the core of health care ethics is our sense of right and wrong and our beliefs about rights we possess and duties we owe others.

What does BMC Medical Ethics stand for?

BMC Medical Ethics is an open access journal publishing original peer-reviewed research articles in relation to the ethical aspects of biomedical research and clinical practice, including professional choices and conduct, medical technologies, healthcare systems and health policies.

Why are case reports important?

Case reports in medicine are fundamentally individual patient stories generally describing unique or unexpected findings in terms of disease or treatment. Anecdotally based, they are considered to be less rigorous an evidentiary base than other types of research. As described by Jenicek (1), although case reports rank low on the scale of types of evidence to be relied on, they are highly important in their frequent role as the “first line of evidence”. Historically, case reports were published without consent of the patient. However, standards have been evolving in law and ethics such that consent should now be viewed as mandatory. The remainder of the present commentary provides justification for this assertion.

How is confidentiality protected?

Confidentiality is protected through federal and provincial legislation regarding information generally and health information specifically (57-7). Such legislation would require, at the least, that case reports not contain any identifiable information about a patient without the patient’s consent. Likewise, a number of medical journals have enshrined the protection of confidentiality into their guidelines for publication. The International Committee of Medical Journal Editors (8) requires informed consent for publication if identifiable information is to be used, but does not refer specifically to case reports. This is similar to the approach of the Paediatrics & Child Healthjournal (9).

Is consent required for a confidentiality analysis?

This takes us to the bottom line. Consent is certainly required under a confidentiality analysis for the publication of case reports that contain any identifiable information. Consent is arguably required under an autonomy analysis for all case reports.

What to do if you have medical treatment without consent?

If non-emergency medical treatment was performed on you without sufficient informed consent, you should consult with an experienced hospital medical malpractice attorney as soon as possible to learn what your options are for holding the hospital liable for damages.

What happens if informed consent is not obtained?

If informed consent is not obtained when it is required, the hospital can be held liable for damages. The hospital can be held liable in one of two ways: Vicarious liability. This is liability assigned to the hospital by virtue of the fact that hospital employees are considered agents of the hospital. In vicarious liability cases, both the ...

What is hospital negligence?

Hospital negligence is defined by whether a reasonable hospital would have acted differently or had different policies or procedures in place. A hospital that fails to create or enforce an informed consent policy can be considered negligent in its own right.

Can a hospital be held liable for medical malpractice?

Hospitals are expected to have policies in place in order to ensure that you give informed consent and if they do not have such a policy or if the policy is not followed, you may be able to hold the hospital liable for hospital medical malpractice. Table of Contents. Informed Consent Rules and Exceptions. Liability for Lack of Informed Consent.

Do you have to give consent to a medical procedure?

Before undergoing a medical procedure, you typically must give informed consent to that procedure. This means you must be informed of the risks and benefits of the procedure, of how the procedure will be performed and by whom, of alternative treatment options and of what your prognosis is both if you have the procedure or if you do not.

Can a patient give informed consent?

When a patient comes to the hospital in a state of emergency or unconsciousness, the patient obviously cannot give informed consent. In such emergency situations, the patients’ close family members or healthcare proxy (person given power of attorney to make decisions) will be asked to consent to procedures.

Do hospitals have to provide informed consent?

According to the Centers for Medicare and Medicaid Services (CMS), hospitals have an obligation to ensure that hospital employees and staff obtain informed consent. Among the CMS guidelines is a requirement that signed consent forms be on file before surgery is performed and a mandate that hospitals must be responsible for ensuring ...

What does it mean when a doctor says no informed consent?

A failure to get signed consent may be proof that there was no informed consent, even if the doctor says that the patient gave verbal consent. Each state has its own laws about what constitutes informed consent, so malpractice cases can vary a lot depending on location.

When informed consent is not required, is it necessary?

When Informed Consent is Not Required. There are cases in which consent does not have to be given before a patient receives medical care, and in these cases it may not be possible to prove negligence because of lack of informed consent. Exemptions include emergencies, situations that are clear and that will not hold up well when a patient claims ...

What is Informed Consent?

Informed consent is an important step in any type of medical care. It means that the patient is given information about care and consents to receive that care. Simple informed consent happens all the time. When a patient takes and uses a prescription from a doctor, sees a recommended specialist, or allows a blood or urine test to be conducted, he or she is consenting after the doctor makes a simple explanation for why it is being done. This is the kind of consent used for basic types of care that are low-risk.

What is the process of giving informed consent?

For any type of medical care that comes with significant risks, the informed consent that must be given is more complex. There is a process that physicians are supposed to go through to make sure the patient can actually give reliable informed consent: Providing adequate information about benefits and risks.

Why is informed consent important?

Informed consent is important for patient safety because, when done correctly, it means a patient or the person caring for the patient has all the information necessary to make the right decision about a procedure, treatment, or diagnostic test. When a patient does not have all the information, specifically about risks, ...

What happens if a patient does not have all the information?

When a patient does not have all the information, specifically about risks, they may end up undergoing a treatment that causes harm and that they would not have consented to if they had all the information. Medical malpractice suits sometimes cite a lack of informed consent as a breach of duty on the part of a physician and a reason for negligence.

Why was the woman not given full informed consent?

The woman alleged that she was not given full informed consent because she was not aware of the risk of a uterine rupture with vaginal delivery after a previous cesarean. The case was settled in the plaintiff’s favor.

What happens if a doctor doesn't give consent?

If a doctor fails to obtain informed consent for non-emergency treatment, he or she may be charged with a civil offense like gross negligence and/or a criminal offense such as battery or gross negligence which is the unauthorized touching of the plaintiff's person. In a civil suit, the patient would have to show two elements. Medical treatment could be unauthorized because the doctor didn’t fully explain either the procedure or the risks associated with the procedure. First, the patient must show that the doctor performed the treatment or procedure without her informed consent. Second, the patient has to show that had she known about the risks of the procedure, she would’ve decided not to have it done and, therefore, avoided the injury.

What is informed consent?

Informed Consent. Virtually all states have recognized, either by legislation or by common law, the right to receive information about one's medical condition, treatment choices, risks associated with the treatments, and prognosis.

Why is medical treatment unauthorized?

Medical treatment could be unauthorized because the doctor didn’t fully explain either the procedure or the risks associated with the procedure. First, the patient must show that the doctor performed the treatment or procedure without her informed consent.

What is the first step in a patient's medical history?

First, the patient must show that the doctor performed the treatment or procedure without her informed consent. Second, the patient has to show that had she known about the risks of the procedure, she would’ve decided not to have it done and, therefore, avoided the injury.

What to do if you second guess a doctor?

Second-guessing a doctor’s behavior can be intimidating, especially with complicated legal concepts like informed consent and negligence. If you would like to know if you have a case or just what rights you have, you can contact a medical malpractice attorney. That way, you could make an informed decision about your next steps.

Is informed consent legal?

The informed consent process isn’t only an ethical obligation for doctors -- it is also a legal one. State laws often take a patient-centered approach.

Can a minor give consent to medical treatment?

Minors, unlike adults, are generally presumed to be incompetent. Therefore, they are unable to give consent to medical treatment and procedures. In these cases, the parent or guardian of the child must give consent on the minor’s behalf.

When case reports describe or discuss unique or rare circumstances, as they often do, it may be difficult or impossible to answer?

When case reports describe or discuss unique or rare circumstances, as they often do, it may be difficult or impossible to de-identify those cases such that there is no reasonable expectation that the individuals included can be identified, so patient authorization generally would be required.

What is a case report?

A case report is an unsystematic clinical observation that states the outcome or response of a single patient to a diagnostic strategy or treatment . Case reports serve to document and share novel cases amongst the medical community for educational purposes.

When safe harbor de-identification is not possible or the opportunity to identify the patient exists, even after de-ident?

When safe harbor de-identification is not possible or the opportunity to identify the patient exists, even after de-identification, the expert determination method for de-identification can be considered. For purposes of de-identification, an expert is defined as: A person with appropriate knowledge of and experience with generally accepted statistical and scientific principles and methods for rendering information not individually identifiable:

Is PHI de-identified under HIPAA?

It is important to understand that determining whether data are de-identified under HIPAA is a more restrictive determination than determining whether private information is individually identifiable under the Common Rule. The HIPAA rule considers PHI as any information that may identify an individual; was created or received by a member of a HIPAA covered entity; and relates to the individual's past, present, or future physical/mental health or condition, health care, or payment for health care. HIPAA recognizes two methods for de-identification of data.

What is required to submit a case report?

Journals often have specific requirements for publishing case reports, which could include a requirement for informed consent, a letter or statement from the IRB and other things.

What is a case report?

What is a case report? A medical case report, also known as a case study, is a detailed description of a clinical encounter with a patient. The most important aspect of a case report, i.e. the reason you would go to the trouble of writing one, is that the case is sufficiently unique, rare or interesting such that other medical professionals will learn something from it.

Why is it important to write a case report?

the reason you would go to the trouble of writing one, is that the case is sufficiently unique, rare or interesting such that other medical professionals will learn something from it.

Does CHM have funding for publication?

It is best practice to check the journal's Info for Authors section or Author Center to determine what the cost is to publish. CHM does NOT have funds to support publication costs, so this is an important step if you do not want to pay out of pocket for publishing.

Do you need informed consent for a case report?

Although not technically required, especially if the case report does not include any identifying information, some journals require informed consent for all case reports. The CARE guidelines recommend obtaining informed consent AND the patient's perspective on the treatment/outcome (if possible).

Do journals have informed consent?

Journals may have their own informed consent form that they would like you to use, so please look for this when selecting a journal. Once you've identified the case, selected an appropriate journal (s), and considered informed consent, you can collect the required information to write the case report.

Does HIPAA apply to case reports?

First, you will be collecting protected health information, thus HIPAA applies to case reports. Spectrum Health has created a very helpful guidance document for case reports, which you can see here: Case Report Guidance - Spectrum Health. While this guidance document was created by Spectrum Health, the rules and regulations outlined could apply ...