Is obtaining ethical clearance/approval essential/mandatory for case report, report of cases or case series? Must an ethical approval be sought and obtained prior to writing case report or case series?
I think that is a question you should ask to the approval body at your school. What is required might be interpreted differently at different schools.
In my opinion, if you are going to quote any person involved in a case study, either from interviews or their actual work, you should get approval, because you are using data you have collected from them.
Yes, you need ethical clearance. In fact it is highly needed as you are not only going to use personal data but you are going to use photos (even if you do not show the face). I think the BMJ case reports is useful
Hi. i'm not referring to patient consent; i knew this is essential. however, since case report not case study are not often planned for, is it after a clinician or clinical researcher come across a case that is worth reporting, that he will now seek ethical approval? i checked the BMJ guideline and ethical approval was not listed as requirement; rather they listed patient consent
From my viewpoint, YES it is required. Since the informed consent is must before publishing patient's data, this should be ethically challenged & cleared accordingly. Furthermore, the ethical body would have look to consenting whether the participant/s were independent to consent.
Hi. I think to get it from patient is essential .but not ethical comitte , because you are using the data of patient himself . And you are not using files or records of other patients
The general rule locally is that for a single case study, patient informed consent (and written assurances of anonymity) are required. Ethics approval is only required in addition if the case report is on two or more cases.Check with your local REC/IRB.
Ethically, Yes. Legally, Debatable, depends on country. Real life: depends on the journal, and the type of case. The best approach is obviously to get written informed consent, do not use photos, do not use real names, and do not use the actual initials either. In a journal I co-edit, we stopped give authorship for cases: author can write a commentary to the case with attribution, but the case itself is anonymous.
I'm not sure what Journal Jeff is referring to that doesn't give authorship for cases (or perhaps doesn't accept case reports at all?), but rest of Jeff's post is spot on. Case reports are often not worth the paper they are printed on, and are certainly not "evidence" to be weighed seriously in the EBM world.
However, what is "ethical" is not so clear either; it depends on the context ...
As an IRB chair, I would not feel it is "ethical" to waste my time and anyone else's on a standard case report that does no more than report on an interesting clinical case to an interested audience that might benefit; a simple singular case report that protects ALL identifiable patient information is not generally considered to constitute "research."
Thus, such a case cannot would not fall into any standard research-regulation framework. Asking an IRB to adjudicate on such issues would generally be a waste of everyones time.
An N=1 study, or a case series, on the other hand, IS likely to fall under the research regulation umbrella and should be properly reviewed by the ethics committee or IRB with jurisdiction.
The NEJM study that first described a case series of MSM patients in LA with a strange new immunocompromised state in 1983, was an important STUDY....and I believe it was published with IRB approval as it should have been.
yes i also think that the patient consent is needed as you are going to use the data. and as far as ethical consent it is also required everytime. not for publication matter but for the issues of permission.
Certainly due to the issue of confidentiality and/or GDPR compliance as you may want to use patients' data. However, most journals do not ask for the ethical approval at the time of publication.
there are various factors, that include local guidelines in the institute you are working.
secondly, case reports are basically considered basically a low evidence article that highlights something unusual or adds knowledge to the medical field. Such articles do not introduce a new intervention to apply or any prevention to be considered which basically comes from research articles ( like Cross-sectional studies, randomized control trials, and so on). Therefore ethical approval usually as per my perception is not required ( but the local institutional committee may have a different policy).
Patient consent is indeed required.
But there are difficult scenarios as well,
For example, a patient is in ICU, intubated, and there is a diagnosis that comes during his stay in ICU which is unusual and one wants to publish. Later on, if that patient passes away and there is no next of kin as well. Then, still, can it be published??? Or how we can deal in that scenario as we don't have consent, and i believe in this state, the institution and local guidelines can help in my humble opinion