patient consent case report

by Mr. Miguel Gaylord 7 min read

Informed Consent for Case Reports - PMC

36 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


Do you need patient consent to write 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 before publishing.

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 you need patient consent 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 ask for consent in a case report?

I_________________________________________ [insert full name] give my consent for this information about MYSELF OR MY CHILD OR WARD/MY RELATIVE [insert full name]:_________________________, relating to the subject matter above (“the Information”) to appear in a journal article, or to be used for the purpose of a thesis ...

How do you write a patient case report?

III. Patient case presentationDescribe the case in a narrative form.Provide patient demographics (age, sex, height, weight, race, occupation).Avoid patient identifiers (date of birth, initials).Describe the patient's complaint.List the patient's present illness.List the patient's medical history.More items...•

What are the 5 elements of consent?

The Elements of Informed Consent. Literature of bioethics often analyzes informed consent in terms of the following elements: (1) disclosure; (2) comprehension; (3) voluntariness; (4) competence; and (5) consent (see U.S. National Commission, 1978, U.S. President's Commission, 1982; Meisel and Roth, 1981).

What is patient consent form?

A document with important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.

Why is consent important in a case study?

Consent is an important element of medical treatment for both patient and treating clinician. Participating in valid consent gives the patient access to the chosen medical treatment and gives the doctor the legal authority to proceed with the treatment.

What should a case report include?

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.

What is meant by case report?

Listen to pronunciation. (kays reh-PORT) A detailed report of the diagnosis, treatment, and follow-up of an individual patient. Case reports also contain some demographic information about the patient (for example, age, gender, ethnic origin).

What is a patient case presentation?

A patient case presentation is a demonstration of a learner's knowledge and skills related to the management of disease states and drug therapies through application to an actual patient case. Typical Information Included in a Patient Case Presentation. 1.

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. Doctors will give you information about a particular treatment or test in order for you to decide whether or not you wish to undergo a treatment or test.

What 7 elements should a patient consent form contain?

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.

Patient Consent Form - Wiley Online Library

CONSENT FORM FOR CASE REPORTS - Marshall University

Case Report Consent Form Template | Jotform

Consent Form for Case Reports

Our confidentiality policy

Our policy is based on the UK's data protection law and the English common law of confidentiality. UK authors should be aware that the General Medical Council has extensive guidance on patient consent and confidentiality and that our policy is in line with GMC advice.

Images of Patients

Our policy on obtaining consent for publication of pictures or videos of patients is a subset of our general policy on patient confidentiality.

Best practice for authors on obtaining consent for publication

This document provides guidance for authors on obtaining consent for publication including best practice for obtaining consent from individuals who may lack capacity to consent on their own behalf and minors.

Who retains written consent?

Written consents must be retained by the author and copies of the consents or evidence that such consents have been obtained must be provided to Elsevier on request. The form of written consent complies with each requirement of all applicable Data Protection and Privacy Laws.

Where should particular care be taken with obtaining consent?

Particular care should be taken with obtaining consent where children are concerned (in particular where a child has special needs or learning disabilities), where an individual's head or face appears, or where reference is made to an individual's name or other personal details.

Where do authors need to obtain appropriate consents, permissions and releases?

Appropriate consents, permissions and releases must be obtained where authors wish to include case details or other personal information or images of patients and any other individuals in an Elsevier publication

Who must give written consent to Elsevier?

That individual, legal guardian or person with legal authority must give his/her explicit written consent. If such consent is made subject to any conditions (for example, adopting measures to prevent personal identification of the person concerned), Elsevier must be made aware in writing of all such conditions.

Can you use patient names in a research?

Patients' and research subjects' names, initials, hospital or social security numbers, dates of birth or other personal or identifying information should not be used. Images of patients or research subjects should not be used unless the information is essential for scientific purposes and explicit permission has been given as part of the consent.

Should identifying details be omitted?

Even where consent has been given, identifying details should be omitted if they are not essential . If identifying characteristics are altered to protect anonymity, authors should provide assurances that such alterations do not distort scientific meaning.

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.

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 ...

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.

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.