case report consent of patient

Explicit consent from the patient or an approved legal representative for publication of a case report and associated images in a medical journal or book is an essential requirement. If the patient has the capacity to consent, it is their decision whether to consent to publication or not.

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 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.

Do case reports need IRB approval?

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 are the 5 parts of consent?

Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient's role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient's ...

What are the 3 types of consent we can gather from a patient?

There are three common ways to collect informed consent from your patient before a medical procedure. You can request written consent, use an online form or ask for oral consent.

Do case reports need consent?

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

Do you need consent for a case series?

For all case reports and case series, a signed HIPAA authorization should be obtained from the patients or their legally authorized representatives for the use and disclosure of their Protected Health Information.

What are the 4 types of consent?

Implied Consent. Participation in a certain situation is sometimes considered proof of consent. ... Explicit Consent. ... Active Consent. ... Passive Consent. ... Opt-Out Consent. ... Key Takeaway.

What are the 4 principles of informed consent?

There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency.

How do you obtain patient consent?

What are the requirements for obtaining a valid consent? Four core criteria must be met: the patient giving consent must have capacity • the consent must be freely given • the consent must be sufficiently specific to the procedure or treatment proposed • the consent must be informed.

What are the 8 elements of informed consent?

B. Basic Elements of Informed ConsentDescription of Clinical Investigation. ... Risks and Discomforts. ... Benefits. ... Alternative Procedures or Treatments. ... Confidentiality. ... Compensation and Medical Treatment in Event of Injury. ... Contacts. ... Voluntary Participation.

What are the 2 types of consent?

The essential difference between expressed and implied consent is that expressed consent is typically given with words, either on paper or verbally, while implied consent is usually understood through actions.

What are some examples of informed consent?

I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost. I understand that I will be given a copy of this consent form. I voluntarily agree to take part in this study.

Does a doctor have to disclose your name?

Dr. (insert name) is obligated to protect your privacy and not disclose your personal information (information about you and your health that identifies you as an individual e.g. name, date of birth, medical record number). When the case report is published or presented, your identity will not be disclosed.

Can a case report be published?

A case report may be published ( in print and/or via internet dissemination) for others to read, and/or presented at a conference. This form explains the purpose of this case report. Please read this form carefully and take your time to make your decision and ask any questions that you may have.

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 should I do after writing a case report?

Once you have written a draft of the case report, you should seek feedback on your writing, from experts in the field if possible, or from those who have written case reports before .

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.

Is it free to publish a case report?

Be aware that it may not be free to publish your case report. Many journals charge publication fees. Of note, many open access journals charge author fees of thousands of dollars. Other journals have smaller page charges (i.e. $60 per page), and still others will publish for free, with an "open access option".

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.

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 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.

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.

How many authors should be in a case report?

Case reports should have a maximum of four authors, of which at least one must have been involved in the patient’s care. All authors must have made an individual contribution to the writing of the article and not just been involved with the patient’s care.

Is BMJ a copyright?

Copyright and authors’ rights. BMJ Case Reports authors are required to grant B MJ an assignment of the copyright in the report unless an author is a Crown employees or where BMJ has agreed CC BY applies, in which case a non exclusive licence is granted to BMJ.

Does BMJ accept case series?

BMJ Case Reports does not accept case series. However, if we feel that an article makes a point better by including more than one case, we will consider the article. If your case report involves more than three patients, please contact the editorial office so that we can assess your case. Each case will be peer reviewed by at least two external ...