case report need patient permission?

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.

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.

What motivates patients to grant permission for publication of their cases?

Altruism is sometimes said to motivate patients to grant permission for publication of their cases; they wish to help others by promoting medical knowledge. We suspect that the patient's feelings about being asked and feelings about the specific doctor who is asking play a major role in the granting of permission under these circumstances.

What is a case report in medicine?

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.

Should patient confidentiality be protected in case reports?

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.

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.

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.

Does a case report 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.

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...

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.

How do you write an ethics report?

Identify and analyze an ethical problem, develop a position on that problem (e.g., a recommendation about what one of the stakeholders should do), develop an argument to support that position, and defend your position against at least one objection.

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.

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.

Is informed consent required?

Informed consent is required for any investigation or treatment proposed to a patient. Understanding of the nature of procedure, benefits and risks are the cornerstones of informed consent. While autonomy is one of the four main ethical principles, I argue that there is no absolute right to autonomy or consent.

What is a patient consent form?

The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.

What is a consent letter?

A consent letter is a formal letter written by one person or party to seek permission from another person or party. Writing a consent letter is important in order to take permission to initiate an action.

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.

Where is My Pham?

My Pham is a Marketing and Communications Intern at Elsevier, based in Amsterdam. Her previous roles include covering economic and political news as a Foreign Correspondent for Reuters in Vietnam and Southeast Asia. She has a master’s degree in Journalism, Media and Globalisation from the University of Amsterdam.

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 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 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.".

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.

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.

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 single case report?

A single, retrospective case report is an activity intended to develop information to be shared for medical and educational purposes. Under JHM policy, a “single case report” is a retrospective analysis of one, two, or three clinical cases but is not research that must be approved by the IRB. (If more than three cases are involved in ...

Where to find HIPAA authorization form?

The HIPAA authorization form used to obtain a patient’s authorization to use and disclose PHI for a single case report may be found at the JH Privacy Office website at: Use of Protected Health Information in a Case Report (A.2.1.v)

Do I need IRB approval for PHI?

Although IRB approval is not required, certain HIPAA Privacy Rule requirements apply to the use and disclosure of PHI for a single case report: Investigators who remove HIPAA identifiers from the case report data prior to disclosure of the data (e.g., prior to submission of the case report to a journal) do not need to obtain a signed privacy ...

Do you have to submit a HIPAA authorization to the IRB?

It is not necessary to submit this authorization form to the IRB for review.