patient consent sample for clinical case report

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.

How do you consent a patient for a case report?

Secure written consent from patient Keep in mind that your patient is your partner in completing a case report, therefore make sure to discuss the report proactively with them including being explicit about any potential images that you are going to use, especially if they show or could identify the patient.

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

What 7 elements should a patient consent form contain?

The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) ...

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 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 components of consent?

Listen to the patient's concerns and answer any questions.Assess the patient's apparent understanding to make a decision.Respect the patient's decision.Consider relevant legislation regarding minors or mentally incapable patients.

What are the 3 elements of valid consent?

For consent to be considered valid:it must be voluntary.the patient must have the mental capacity to consent.the patient must be properly informed.

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.

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.

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.

Do I need IRB approval for case reports?

If this is true for your case report, then it most likely does not require IRB approval because it not considered research. If you have more than one patient, your study could qualify as a Case Series, which would require IRB review. If you have questions, you chould check your local IRB's guidelines on reviewing case reports.

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).

What is the BMJ?

BMJ is a member of CrossCheck by CrossRef and iThenticate which is a plagiarism screening service that verifies the originality of content submitted before publication . iThenticate checks submissions against millions of published articles, and billions of web content. Authors, researchers and freelancers can also use iThenticate to screen their work before submission by visiting www.ithenticate.com.

What is a preprint?

Preprints foster openness, accessibility and collaboration by allowing authors to make their findings immediately available to the research community and receive feedback on an article before it is submitted to a journal for formal publication.

What is single blind peer review?

The journal operates single blind peer review whereby the names of the reviewers are hidden from the author. Manuscripts authored by a member of a journal’s editorial team are independently peer reviewed; an editor will have no input or influence on the peer review process or publication decision for their own article.

What is competing interest?

A competing interest exists when professional judgement concerning a primary interest (such as patients’ welfare or the validity of research) may be influenced by a secondary interest (such as financial gain or personal rivalry). It may arise for the authors of an article when they have a financial interest that may influence, probably without their knowing, their interpretation of their results or those of others.

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 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.

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 ...

What is PHI in healthcare?

This is known as safe harbor de-identification.

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 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:

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.

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.