Informed Consent for Publication

Key Considerations for the e-Journal Praxis de la Medicina (e-Rev. P. Med.), and International Regulations:

Declaration of Helsinki: This consent form aligns with the ethical principles of the World Medical Association's Declaration of Helsinki, which establishes the importance of informed consent, the protection of privacy, and the well-being of participants in medical research.
CIOMS Guidelines: The CIOMS "International Ethical Guidelines for Health-related Research Involving Humans" have been considered, which emphasize the need for clear informed consent, risk management, and the importance of research for the benefit of public health.
Clarity and Understandability: The language used is clear and concise, avoiding excessive technical jargon to ensure that the patient or their legal representative fully understands the scope of the authorization.
Right to Withdraw: The patient's right not to participate or to withdraw at any time, without negative consequences, is reaffirmed.

Anonymization: Strict data anonymization is emphasized to protect patient privacy, a crucial aspect in case reports.
Scope of Authorization: The type of material (photographs, videos, medical images, biological material) that the patient can authorize for publication is clearly outlined, granting granular control over their information.
Journal Responsibility: Although consent is managed by the authors, the e-Journal Praxis de la Medicina must ensure that appropriate consent for publication has been obtained and may request authors to certify that a consent form has been signed that meets all the required elements. Therefore, it is important that the journal has its own consent policy template for the publication of case reports/research. This document, entitled “Informed Consent Template,” is available to researchers who wish to publish in our journal.

Confidentiality of signed forms: It is suggested that the signed consent form be kept by the institution or the research authors, and not sent directly to the journal, to avoid legal liabilities related to the privacy of sensitive data. The journal may require confirmation that consent has been obtained and retained by the authors.

INFORMED CONSENT FORM

Title of Case Report/Research:……………………………………..

………………………………………………………………………………………………..

Purpose of this Document: To provide you with clear and complete information so that you can make a free and voluntary decision about whether to authorize the authors [Name(s) of the publication author(s)] to publish, in the e-Journal Praxis de la Medicina (e-Rev. P. Med.) (or within the framework of a scientific or academic activity), the clinical characteristics and other relevant data of the disease [Name of the clinical case report] or [Title of the Research].

What Does Your Participation Entail?:

If you agree to participate in this study, you will only be asked to sign this informed consent form. For publication, you will not undergo any procedures beyond those already necessary for your routine medical care. The information will be collected from your medical record and/or directly from you or the person you represent. The compilation will be carried out by [Name of person(s) - authors], who possess(s) knowledge in [Title of the Research or Clinical Case Report] and the capabilities to protect confidentiality.

Potential Risks:

The main risk associated with authorizing the publication of a case report is the potential loss of confidentiality, meaning that your personal information could be disclosed under certain circumstances. However, all necessary measures will be implemented to safeguard your privacy. This includes the removal of any personally identifiable information (name, address, date of birth, etc.), with only the clinical characteristics of the diagnosis being reported. Only the report authors and trained personnel working on the study will have access to your identifiable information, and all of them will sign a confidentiality agreement.

Benefits:

There is no direct benefit to you or the person you represent by authorizing this case report or participating in the study. However, the publication of this research or clinical case will significantly contribute to the advancement of medical knowledge about [Name of the disease], both nationally and internationally. This type of publication is essential for improving the diagnosis, treatment, and understanding of the disease in others.

Compensation:

No financial or other compensation will be offered for your participation in this case report or investigation.

Confidentiality and Data Protection:

Strict confidentiality of all information will be guaranteed. Any data that could identify you or the person you represent will be removed from the report, maintaining strict anonymity. Only the author(s) and the team directly involved in preparing the report or investigation will have access to the complete information in your file and will be bound by a confidentiality agreement. Your name, address, date of birth, and any other information that could identify you will not be disclosed without your express written consent.

Voluntary Participation:

Your decision to authorize or not the publication of information about your case or the case of the person you represent is entirely voluntary and requires no justification. If you choose not to authorize it, this will not affect your access to the health services and treatments to which you are entitled in any way.

Contact for Questions:

If you have any questions at this time, please feel free to ask them. If you have any further questions or concerns in the future, you can contact [Author(s) Name(s)] at xxxx@-xxxxx or by phone at [phone number, if applicable].

Permission to Publish Additional Material (Please mark YES, NO, or N/A as appropriate):

Type of Material	Yes	No	N/A
Photographs
Videos
Audio recordings
Medical images (X-rays, ultrasounds, CT scans and/or MRIs, other - specify:(____________________)
Biological material and related information (organs, tissues, blood, plasma, skin, serum, DNA, RNA, proteins, cells, hair, nail clippings, urine, saliva or other body fluids)

Participant/Legal Representative Declaration:

I hereby declare that:

I have voluntarily decided to authorize the publication of my case or that of the person I represent in the e-Journal Praxis de la Medicina (e-Rev. P. Med.).
I authorize the collection and use of clinical information, as well as photographs, videos, audio recordings, medical images, and pathology samples, as described in this form.
I have read and understood all the information contained in this form. I have been given the opportunity to ask questions, and these have been answered satisfactorily by the person who provided me with the information.
I have read, or had read to me, all the information described in this form before signing it.

Therefore, I agree to the publication of information regarding the clinical characteristics of the disease diagnosed in me or the person I represent.

You will be given a signed copy of this form for your records.

SIGNATORIES OF THE INFORMED CONSENT: Patient or Legal Representative

Study Participant/Legal Representative

Name
ID Number
Signature
Date

SIGNATORIES OF THE INFORMED CONSENT: Researchers

Name
ID Number
Signature
Date