how to ask for patient consent case report

by Rico Stamm Sr. 5 min read

Informed Consent for Case Reports - PMC - PubMed …

23 hours ago Abstract. 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 … >> Go To The Portal


  1. Tell a story The best way to compose a case report is to tell a story. ...
  2. Get the details right ...
  3. Employ pictures/figures where relevant ...
  4. Formulate short and sharp titles ...
  5. Secure written consent from patient ...

Full Answer

Who can obtain an informed consent from the patient?

MCARE defines informed consent as follows: (a) Duty of physicians. Except in emergencies, a physician owes a duty to a patient to obtain the informed consent of the patient or the patient's ...

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).

What is the purpose of a consent to treatment form?

The purpose of these documents is to ensure that the patient is fully aware of and accepts a particular treatment. This not only helps protect the patient`s rights, but also protects the provider – a signed consent form for treatment prevents the patient from coming back later and saying otherwise in a malpractice claim.

What is patient consent?

A patient consent form is a document a patient signs to indicate that he gives his consent for a particular action. For example, a patient may sign this type of form to acknowledge that he is aware of the risks of a particular medical procedure and gives his consent for the treatment.

image

Is patient consent required for case report?

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 patient consent statement?

Informed consent is a process of communication between you and your health care provider that often leads to agreement or permission for care, treatment, or services. Every patient has the right to get information and ask questions before procedures and treatments.

How do you write a patient case report?

In general, all case reports include the following components: an abstract, an introduction, a case, and a discussion....CasePatient description.Case history.Physical examination results.Results of pathological tests and other investigations.Treatment plan.Expected outcome of the treatment plan.Actual outcome.

What are 5 pieces of information that must be on a consent form?

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 ...

How do you obtain patient consent?

The process of obtaining informed consent should be documented in the patient's medical records, detailing the name of the study and the date on which consent was obtained. The entry should be dated and signed by the person authorised and responsible for conducting and obtaining the patient's informed consent.

What are the 4 types of consent in healthcare?

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 is the purpose of the case report form?

A case report form (CRF) is a printed, optical, or electronic document designed to record all protocol-required information on each subject in a clinical research study.

What is meant by case report?

Case reports are defined as the scientific documentation of a single clinical observation and have a time-honored and rich tradition in medicine and scientific publication. This article discusses the role and relevance of case reports in the current evidence-based medical literature.

How do you write an introduction for a case report?

First, you want to introduce the topic not discuss the actual case. Therefore, you should not include details about your client until the case description section. The introduction should only give the background on why this case report was written and some background on the condition of interest.

What are some examples of informed consent?

I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost.

What are the 3 types of informed consent?

Types of Informed Consent There are three common ways to collect informed consent from your patient before a medical procedure. You can request written consent, use an online form or ask for oral consent.

What is informed consent document?

Written in English and local or vernacular languages of the participant. The document must detail the risks that can be anticipated and explain that the consent is voluntary and the participant has the right to withdraw consent for participation at any time point during the study period.

What are some examples of informed consent?

I have read and I understand the provided information and have had the opportunity to ask questions. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason and without cost.

What are the 3 types of informed consent?

Types of Informed Consent There are three common ways to collect informed consent from your patient before a medical procedure. You can request written consent, use an online form or ask for oral consent.

What is an example of informed consent in healthcare?

I (patient name) give permission for [practice name] to give me medical treatment. I allow [practice name] to file for insurance benefits to pay for the care I receive. I understand that: [practice name] will have to send my medical record information to my insurance company.

What are the 4 types of consent NHS?

Consent FormsConsent Form 1 – Patient agreement to investigation, treatment or procedure.Consent Form 2 – Parental agreement to investigation, treatment or procedure for a child or young person.Consent Form 3 – Patient Parental agreement to investigation, treatment or procedure where consciousness not impaired.More items...•

Why is it important to give consent for a treatment report?

It is important for the author to be certain that the patient had consented to publication and not just treatment.

What is informed consent to publish?

Informed consent to publish means that the patient must enter into the agreement to publish voluntarily and with a full understanding of the implications for the subject; a copy of the proposed manuscript should be shared with the patient before it is published.

What are the two key aspects of patient privacy?

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.

Why are case reports important?

This becomes even more serious when we consider medical case reports, which describe clinical observations for a single patient (or a small group of similar patients). Such studies can provide a timely way of advancing scientific knowledge of rare medical conditions and complications, inform clinical study design, and support pharmacovigilance decisions. Professor Margaret Rees, Editor in Chief of Case Reports in Women’s Health, commented “Patients consenting to publication are providing the gift of their unique experience to science.” However, by their very nature they report on individuals, often tying photographs together with additional identifiable clinical information, and they therefore present challenges around privacy and consent.

Why is it important for authors to protect the privacy of patients?

In these situations, authors, editors and publishers share a collective responsibility to safeguard the privacy of patients to ensure they can continue to trust their practitioners, and so readers can trust the research is presented ethically and consensually.

When is consent valid?

If the patient has diminished mental capacity or a fluctuating/deteriorating condition: If the patient consented, it is valid only if and when they had the capacity to do so. In changing conditions, the patient might be able to give consent during a remission or in the early stages of the disease, but it is uncertain whether they would have done so at a later stage. The reason for a legal representative signing a consent form should be detailed in the submission.

Do authors need to provide consent to patients?

Authors must obtain appropriate consents and permissions from a patient or their legal representative in order to include case details or other personal information or images of the patient in their article, and must include a statement on their paper confirming that informed consent was obtained. However, authors should not provide copies of consent forms, and nor should the editor or publisher request them because of the additional security levels required to receive and store consent forms, which are considered sensitive.

What is written consent?

The form of written consent complies with each requirement of all applicable Data Protection and Privacy Laws. 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.

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.

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

Do you need consent for an image?

Formal consents are not required for the use of entirely anonymised images from which the individual cannot be identified- for example, xrays, ultrasound images, pathology slides or laparoscopic images, provided that these do not contain any identifying marks and are not accompanied by text that might identify the individual concerned.

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.

Can you anonymize a photo if you have not been contacted?

If consent has not been obtained, it is generally not sufficient to anonymise a photograph simply by using eye bars or blurring the face of the individual concerned.

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.

How many paragraphs should a patient share their perspective?

The patient should share their perspective on the treatment (s) they received in one to two paragraphs. It is often best to ask for informed consent and the patient’s perspective before you begin writing your case report. Appendices (If indicated). Submission to a scientific journal.

What should be included in a short acknowledgement?

Acknowledgements. A short acknowledgements section should mention funding support or conflicts of interest, if applicable.

Is it easier to write sections of a case report in a different sequence than the order in which the sections?

Know that it is easier to write the sections of a case report in a different sequence than the order in which the sections appear in a published case report.

Is it easy to write a case report?

Writing a case report accurately and transparently is not easy. We provide online training in writing case reports at Scientific Writing in Health and Medicine (SWIHM) which includes access to CARE-writer, an online app that can be used to write case reports or case report preprints.

Can you submit a case report to a scientific journal?

Follow author guidelines and journal submission requirements when writing and submitting your case report to a scientific journal. You may wish to contact the journal before submitting your manuscript. (Download a partial list of journals that accept case reports.) Journals that do not explicitly accept case reports may publish case reports as components of other articles. Online training in writing case reports is available from Scientific Writing in Health and Medicine (SWIHM).

What is a case report?

Case reports are typically used to share new unique information experienced by one patient during his/her clinical care that may be useful for other physicians and members of a health care team. A case report may be published (in print and/or via internet dissemination) for others to read, and/or presented at a conference. This form explains the purpose of this case report. Please read this form carefully and take your time to make your decision and ask any questions that you may have.

What is the purpose of this case report?

The purpose of this case report is to inform other physicians that (insert specific reason i.e. patients presenting to the ER with X) may be related to Y , however, was masked by a common over the counter medication Z).

Can a case report be published?

A case report may be published ( in print and/or via internet dissemination) for others to read, and/or presented at a conference. This form explains the purpose of this case report. Please read this form carefully and take your time to make your decision and ask any questions that you may have.

Can you receive compensation for allowing your information to be used in this case report?

Allowing your information to be used in this case report will not involve any additional costs to you. You will not receive any compensation.

Does a doctor have to disclose your name?

Dr. (insert name) is obligated to protect your privacy and not disclose your personal information (information about you and your health that identifies you as an individual e.g. name, date of birth, medical record number). When the case report is published or presented, your identity will not be disclosed.

Is a case report confidential?

Although your personal information collected or obtained will be kept confidential and protected to the fullest extent of the law, there is a limited risk associated with this case report that could result in a loss of confidentiality by virtue of your unique experience. You will not directly benefit from participating in this case report. The information that can be shared with other health care professionals, however, may improve the care that is received by others in the future.

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.

image