do you need patient approval to publish a case report

Full Answer

Can you publish a case report without patient consent?

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.

Why should we care about published case reports?

Published case reports provide essential information for optimal patient care because they can describe important scientific observations that are missed or undetected in clinical trials, and provide individual clinical insights thus expanding our knowledge base [3].

Do you need an IRB approval to publish a case report?

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.

How do I publish case report data with HIPAA identifiers?

Investigators who wish to publish case report data with HIPAA identifiers will need to obtain from the patient a signed HIPAA compliant authorization. This authorization does not need to be submitted to the IRB for review. The appropriate authorization form for use with a single case report may be found on the HIPAA web site HERE.

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 you need IRB approval to write a 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.

Can anyone write a case report?

Informed consent in an ethical requirement for most studies involving humans, so before you start writing your case report, take a written consent from the patient as all journals require that you provide it at the time of manuscript submission. In case the patient is a minor, parental consent is required.

How do you consent a patient to 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...

Is informed consent required for 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 before publishing. The CARE guidelines recommend obtaining informed consent AND the patient's perspective on the treatment/outcome (if possible).

How do you publish a case report?

Ten Steps to Writing an Effective Case Report (Part 1)Step 1: Identify the Category of Your Case Report. ... Step 2: Select an Appropriate Journal. ... Step 3: Structure Your Case Report According to the Journal Format. ... Step 4: Start Writing. ... Step 5: Collect Information Related to the Case.

Can you publish a case report on yourself?

You can write it up and submit it. You may have more success if you get a senior physician in the relevant field on it as well. If all else fails, you can publish it in an open access journal as long as your check clears. Thanks for the advice.

Does a case report count as a publication?

Case reports have now been developed and accepted as a scholarly publication to disseminate knowledge to a wide medical audience.

Can I publish a case study?

Submit your case study through your chosen channel's online submission site, find author support and understand your next steps to publish your case study.

Are case studies exempt from IRB review?

As a result, case studies generally qualify for exempt review by the IRB provided that the study (a) does not involve a sensitive topic, (b) is conducted in a manner that protects subjects' identity, and (c) does not involve at-risk or special populations.

Does case report count as research?

The case report is a research design where an unexpected or novel occurrence is described in a detailed report of findings, clinical course, and prognosis of an individual patient, which might be, but not mandatory, accompanied by a review of the literature of other reported cases.

Is case report a research publication?

A case report with a literature review cannot be considered as an original research article. You can maybe consider publishing the case report first and then build on the idea for a separate original research article.

What research requires IRB approval?

IRB review and approval is required for projects that: Meet the definition of research. Involve human subjects and. Include any interaction or intervention with human subjects or involve access to identifiable private information.

Why are case reports important?

As a method of documenting a single clinical observation, case reports offer timely and valuable information , especially with regards to rare diseases. They show medical professionals how fellow practitioners have acted in similar situations and thus aid in the decision-making process by sharing best practices.

What happens if a case is unique but not well documented?

This is not only a waste of your precious time but also a discouragement which might prevent you from producing more case reports in the future.

Can you publish a case report without consent?

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.

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?

Case reports generally involve the description of medical treatment in a patient or a few patients with a unique treatment, disease course, or outcome based on a retrospective review of medical records or they can involve a description of a unique diagnostic finding or uncommon presentation .

Is a case report considered human subjects?

Several major research institutions have concluded that a case report involving the description of the medical cases of three or fewer patients does not constitute human subjects research and is therefore exempt from IRB review.

Can a case report be a biospecimen?

In addition, testing of a patient's biospecimen (e.g., special stain, immunohistochemistry, molecular studies) is not typically permissible as part of a case report.

Do I need to acknowledge an IRB?

Many journals require acknowledgement from an IRB prior to publication of a single case report or a case series. If asked to provide acknowledgement from the IRB prior to publication, either use this guidance as documentation from the IRB or contact the Health Sciences IRBs Office for assistance.