patient permission for case report

by Russel Renner PhD 6 min read

Informed Consent for Case Reports - PMC

12 hours ago A new international standard of editorial policy calls for written informed consent by the subject of every case report. Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy. >> Go To The Portal


Don’t publish a case report without the patient’s 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. However, there is an exception for publishing a case report without patient consent when the benefit of publication toward to society outweighs potential harm for individual.

Don't publish a case report without the patient's 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.
Mar 6, 2019

Full Answer

Should case reports be published without consent of the patient?

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.

Do I need consent to submit to BMJ case reports?

You must have signed informed consent from patients (or guardians) before submitting to BMJ Case Reports. Please anonymise the patient’s details as much as possible, eg, specific ages, ethnicity, occupations.

Is it ethical to request informed consent for case reports?

Although this appears to be ethically appealing, the authors posit that in some situations, requesting informed consent may be unethical, can harm patients, and may erode the use of case reports as a valuable teaching method in psychiatry and psychotherapy.

Do you need consent to publish patient information UK?

Patient consent Publication of any personal information about an identifiable living patient requires the explicit consent of the patient or guardian. This is a requirement under the UK’s Data Protection legislation. We expect authors to use the latest BMJ consent form, which is available in several languages.

How do you consent a patient for a case report?

For a patient's consent to publication of information about them in a journal or thesisThe Information will be published without my name/child's name/relatives name attached and every attempt will be made to ensure anonymity. ... The Information may be published in a journal which is read worldwide or an online journal.More items...

Do you need IRB approval for case report?

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.

Does case report need 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 should be included in a patient consent form?

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.

Do case reports need patient permission?

Don't publish a case report without the patient's 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.

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.

How do you write ethics approval and consent to participate?

Ethics approval and consent to participate include a statement on ethics approval and consent (even where the need for approval was waived) include the name of the ethics committee that approved the study and the committee's reference number if appropriate.

How do you write an ethics approval?

Tips for obtaining ethics approval in the minimum time frameAllow time. ... Communicate clearly. ... Ensure your application is self-explanatory and self-sufficient. ... Use the guidelines available to help you. ... Ensure your application package is complete. ... Label your documents. ... Place yourself in the role of a participant.

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 5 essential elements of informed 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 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.

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.

What is PHI in healthcare?

This is known as safe harbor de-identification.

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 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 a medical/educational activity that does not meet the DHHS definition of “research”, which is: "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.".

Do journals require an IRB letter?

Background: Many journals now require a letter, or other acknowledgement, from an IRB prior to publication of a case report. Specifically, they wish to know whether IRB approval was obtained or was not required for the described case. The JHM IRBs have adopted a policy to address the following question and answers.

Does a case report have to be approved by the IRB?

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.

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.

What is single blind peer review?

The journal operates single blind peer review whereby the names of the reviewers are hidden from the author. Manuscripts authored by a member of a journal’s editorial team are independently peer reviewed; an editor will have no input or influence on the peer review process or publication decision for their own article.

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 ...

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.

Is BMJ a preprint?

BMJ does not consider the posting of an article in a dedicated preprint repository to be prior publication. Preprints are reports of work that have not been peer-reviewed; Preprints should therefore not be used to guide clinical practice, health-related behaviour or health policy.