case report of deceased patient consent

In the case reports, as in any clinical investigation, the will of the patient should prevail over the interests of research and researchers, even when he is unable to consent, like the minors, the disabled or the deceased, enforcing the legal rules and addressing to the active involvement of the guardians and the relatives.

Full Answer

What are the principles of consent for the deceased?

Principles of consent: Deceased people. Consent given prior to death, is believed to extend beyond death. However, relatives may have a different opinion, once their relative has died.

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 collect tissue from the deceased?

If you intend to collect tissue from a deceased person, to use tissue removed from the deceased or to conduct a post mortem purely for research purposes consent is required across the UK.

Does consent extend beyond death?

Consent given prior to death, is believed to extend beyond death. However, relatives may have a different opinion, once their relative has died. In legal terms, the General Data Protection Regulation (GDPR) and the Data Protection Act no longer applies to identifiable data that relate to a person once they have died.

Do you need a consent from patient 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 write a patient consent statement?

The informed consent document should succinctly describe the research as it has been presented in the IRB application. Use the second (you) or third person (he/she) to present the study details. Avoid use of the first person (I). Include a statement of agreement at the conclusion of the informed consent document.

How do you write a patient case report Example?

This section provides the details of the case in the following order:Patient description.Case history.Physical examination results.Results of pathological tests and other investigations.Treatment plan.Expected outcome of the treatment plan.Actual outcome.

Do you need IRB approval for case report?

Under HIPAA, a single case report is an activity to develop information to be shared for medical/educational purposes. Therefore, the use of protected health information to prepare a paper for publication of a single case report does not require IRB review for HIPAA purposes.

What is an example of written consent?

I have been informed of the risks and benefits involved, and all my questions have been answered to my satisfaction. Furthermore, I have been assured that any future questions I may have will also be answered by a member of the research team. I voluntarily agree to take part in this study.

What are some examples of consent?

Non-Verbal ConsentHead nod.Thumbs up.Pulling someone closer.Nodding yes.Making direct eye contact.Actively touching someone.Initiating sexual activity.

How do you start a case report?

Case reports should encompass the following five sections: an abstract, an introduction with a literature review, a description of the case report, a discussion that includes a detailed explanation of the literature review, and a brief summary of the case and a conclusion.

How do you take a case history of a patient?

Procedure StepsIntroduce yourself, identify your patient and gain consent to speak with them. ... Step 02 - Presenting Complaint (PC) ... Step 03 - History of Presenting Complaint (HPC) ... Step 04 - Past Medical History (PMH) ... Step 05 - Drug History (DH) ... Step 06 - Family History (FH) ... Step 07 - Social History (SH)More items...

What should a patient case study include?

Case: This section provides the details of the case in the following order:Patient description.Case history.Physical examination results.Results of pathological tests and other investigations.Treatment plan.Expected outcome of the treatment plan.Actual outcome.

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 is the difference between a case study and a case report?

Case studies are widely used in psychology to provide insight into unusual conditions. A case study, also known as a case report, is an in depth or intensive study of a single individual or specific group, while a case series is a grouping of similar case studies / case reports together.

Is a case report an original article?

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.

How do you create a consent form?

0:242:17HOWTO Create a consent form - YouTubeYouTubeStart of suggested clipEnd of suggested clipAttention. Content fill in a description about the consent you're asking for think about your targetMoreAttention. Content fill in a description about the consent you're asking for think about your target audience. And be specific about why you're collecting the data and what it will be used for.

What should be included in a medical 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.

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.

What is the law regarding disclosures after death?

There is guidance and legislation regarding disclosures after death; the GMC’s guidance on confidentiality and the Access to Health Records Act 1990. As a general rule, you should seek a patient’s express consent before disclosing identifiable information for purposes other than the provision of their care or local clinical audit, such as financial audit and insurance or benefits claims; however, this was not practicable in this case as Fred had passed away. Fred had not signed a consent form with his insurance policy, either.

What is the primary concern of a doctor?

Ultimately, a doctor’s primary concern is patient safety and ensuring that the patient is cared for. So long as your reasons for disclosing patient information are justified, you will be able to defend your actions.

What is the importance of confidentiality in healthcare?

Confidentiality is one of the cornerstones of trust that enables patients to be open with doctors about their symptoms and problems , and it is generally implied that when a patient consults a doctor, the information about the patient is kept confidential.

Basic principles

Patient privacy and consent are subject to guidance such as the CARE guidelines and COPE, which cover two key aspects: informed consent and removal of patient identifiers from manuscripts as well as clinical images, figures and datasets.

Did they really consent?

Authors and editors must critically assess whether consent for publication (distinct from consent for treatment) was truly given prior to writing or considering a case report for publication. When the patient is considered particularly vulnerable e.g. from a minority group, a child, a prisoner, having disabilities or diminished mental capacity etc.

What happens when things go wrong?

If a paper was published without appropriate consent and it cannot be obtained retroactively, this is an extremely serious matter and the paper may need to be retracted or withdrawn/removed depending on the sensitivity of the content and publication stage.

Katie Eve

Katie Eve is a Communications Manager in Elsevier’s Global Publishing Development department. She joined Elsevier in 2010 and worked as a Publisher for journals across earth sciences and energy before moving into her communications position in 2017.

Catriona Fennell

Following graduation from the National University of Galway, Ireland, Catriona Fennell joined Elsevier as a Journal Manager in 1999. She later had the opportunity to learn about the intricacies of peer review while supporting and training hundreds of editors during the introduction of Elsevier Editorial System (EES).

Margaret Rees

Margaret Rees has an international reputation of leadership in women's midlife health and is the Executive Director of the European Menopause and Andropause Society. A gynaecologist, she is Editor-in-Chief of Case Reports in Women’s Health and Emeritus Editor of Maturitas.

What happens if you don't consent to someone before death?

If the person was not able to consent for themselves prior to death (due to lack of capacity ), someone else may have been asked to provide consent, assent or advice on their behalf (visit 'Principles > Adults who are not able to consent for themselves' ). Consent given before death should be respected, even when relatives may initially disagree.

What are the principles of consent?

Principles of consent: Deceased people. Consent given prior to death, is believed to extend beyond death. However, relatives may have a different opinion, once their relative has died. This should be handled sensitively with relatives being encouraged to respect the deceased person's wishes (or in certain cases, ...

Can you give consent to research before death?

Although legal details may vary between the nations within the UK, the same basic legal and ethical principles apply in terms of the consent required: The person themselves can give consent for their tissues to be used for research prior to their death.

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.

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.

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.

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.