16 hours ago Indeed, this is the position taken by the Journal of Medical Case Reports , which has adopted a blanket requirement of informed consent before publication. In the case of immature minors and those unable to provide consent, consent is required from the parents or guardians. No case report is to be published in the absence of consent. It is notable that this Journal, which exclusively deals with case reports, has taken this strong stance … >> Go To The Portal
BMJ case reports would be ideal except for the whole consent thing. As far as I can tell Journal of Clinical Psychiatry accepts case reports, and they do not require consent. I will likely submit it here first.
Full Answer
Not all medical journals explicitly accept case reports; however, case reports may appear within another publication type, including a brief report, a letter to the editor, or a hypothesis article.
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.
For example, The New England Journal of Medicine (NEJM) does not accept free-standing case reports; however, other articles in this journal may contain case reports.
We recommend initially considering at least 3 journals – one first choice, and two backups in the event your first choice does not accept your case report. When considering different journals, the “author guidelines section” is often helpful.
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).
Exceptions to Informed Consent Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent.
It depends. In general, permission should be obtained from both parents before a child is enrolled in research. However, the Institutional Review Board (IRB) may find that the permission of one parent is sufficient for research to be conducted under 46.404 or 46.405.
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.
You can only be treated for a physical health problem without your consent if: you lack capacity, or. your physical health problem is a symptom or underlying cause of a mental health problem. In this case, the Mental Health Act says that you can be given treatment against your wishes.
Waiver of Documentation of Informed Consent (45 CFR 46.117) A waiver of documentation is permissible when: The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.
What is the difference between consent and assent? Consent may only be given by individuals who have reached the legal age of consent (in the U.S. this is typically 18 years old). Assent is the agreement of someone not able to give legal consent to participate in the activity.
The subject must give voluntary informed consent to participate in research. Guardians must give consent for minors to participate.
Thus, in most research studies, if children under the age of 18 are to be enrolled, the parent or guardian of the child must provide informed consent on behalf of the child.
In IRB SOP 407: Determining When a Proposal Meets the Definition of Human Subjects Research, the IRB excludes case series of 5 or fewer patients from review. Case series with 6 or more cases must be submitted to the IRB as research or for a determination that they do not meet the definition of research.
Although most institutions require IRB approval, consent is usually not required as the IRB will ensure that steps are taken to ensure the anonymity of the data. The answer would be "it depends" on what you mean by retrospective.
A: Yes. Approval from a formally constituted review board (Institutional Review Board or ethics committee) is required for all studies involving people, medical records, and human samples. Q: Do I need patient consent for the use of retrospective data? A: Informed consent by participants should always be sought.