It is very essential that any research conducted will follow certain guidelines. Universities will have IRB and all projects defined by the IRB as “research” involving “human participants” must be reviewed and approved by the IRB before any research activities involving potential participants are initiated. Please see the details of the process from our University here.

http://www.uni.edu/rsp/irb-manual-irb-review-process-and-considerations

In complete agreement with Nageswara.

Dear @Ratan, case report Is a scientific work and, therefore, it is necessary to obtain ethical clearance.

Dear @ Nageswara, Costas and Abedallah, thanks for the input.

The BMC Medical ethics for case report has not given any requirement for taking ethical clearance. But it is strongly recommended to optain written and signed informed consent from patient/ guardians for publishing the case report.

The statement of world medical association ethical manual also surprisingly didn't discussed the compulsory requirements of ethical approval for reporting a case.

Here I am attaching the links of BMC, World medical association and statement of 59th WMA General Assembly, Seoul, Republic of Korea, October 2008. What is your views on this statements?

http://www.biomedcentral.com/bmcmedethics/authors/instructions/casereport

http://www.wma.net/en/30publications/10policies/b3/

Dear Ratan and all

I am not aware about the medical field, but if one writes a management case and interviews managers, etc., of the company concerned, then there is an implied understanding that s/he should obtain consent of the company before publishing such a case. In case, one has written the case without obtaining data from the employer/manager, but only on the basis of secondary data, or by interviewing managers anonymously then no such consent is required. Then, it comes under the freedom of speech and expression. But then, one can not write things that are malicious or defamatory, unless s/he has proof that what is written is true.

This is a double edged problem. As we all know, there are two types or sometims three types of CASE REPORT.

1. A case report with initial intention only to treat and not for research.

2.(a). Case report with initial intention to treat and for research and with apriori knowledege of the participant.

2(b). Case report with intention to treat and for research without apriori knowledege of the participant.

For the first type (1), application for ethical clearance will just be for academic purpose only. Even, in this case, it is always difficult to obtain informed consent. Infromed consent can only be obtain retrospectively only and if the the identity of the patient can not be concelled totally. Outside that, every other thing is just for academic purpose and I call it ''the sense of normalcy and conformity in research''.

In the second and third case (2a&b), it is necessary to have ethical clearance and obtain informed consent before the research.

Ethical clearance is required for most scientific (and other) research, especially when it involves human participants, and may range from a low-risk review to a more full consent process. It may be more specific in the medical field. For example, the National Health Service (NHS), UK, has a number of outlines for safe and ethical research, and various governing bodies whose approval is to be sought depending on the nature of the research. More details may be found here:

http://www.hra.nhs.uk/research-community/before-you-apply/determine-which-review-body-approvals-are-required/

Dear Caleb, I agree with you.

Unlike other research many time the case report are unplanned and they have less creditability when compare to other. I would say it is just a report which is develop after the interventions are started or finished. So the only option we have is taking patients consent before proceeding for publication. Other type of researches ranging from single case study to randomized controlled trials are well planned including clearing ethical issues before including the first sample.

If at all a case report requires clearing ethical issues what is the best time to obtain it, before the interventions?

It is important to have ethical approvals for all researches in medicine.

There are no strict guidelines of when to obtain the ethical clearance for writing and publishing a case report. But we should always have the Patient's or the guardian's concent before publishing it.

However it is possible to obtain ethical clearance of a case report at any stage-

-before starting the intervention if we feel the case is interesting and want to write a report for publication or

-during and after the intervention phase, e.g. if there is some remarkable change in the clinical symptoms while trying out a new strategy of management and want to document it in the case report.

It is always advisable and important to have ethical approval for research or reports with human participation.

Mr. Celeb has extensively pointed out the types and its requirements of ethical clearance.

Hi,

Stumbled across this question as it is relevant to my situation.  I conduct private practice psychological work (behavioural interventions for children with challenging behaviour) and am wanting to publish outcomes for a group of children.  Informed consent is obtained at the outset of services from the child's caregiver, and relevant organisations have provided agreement.

In seeking ethical approval going forward,   the university will  not approve private practice research (despite being employed there), as I am contracted separately for the work.  A further national ethics committee will not assess ethics regarding interventions.  Any suggestions?  I am in New Zealand.

Sarah

My opinoin is to have a ethical clearance even in case report

@

It depends on IRB/ ERC recommendation of the concerned institution. It is always a good option to proceed with formal ethical clearance for any type of research including case report though for individual case report (applicable for private setting) you can proceed with unit/ department clearance (written permission) with written informed consent of the case/ carer, guardian. But as I said, you need to have at least written permission from the hospital director/Unit head.

I do not think ethical clearance is required for case studies. it is just to update the knowledge and current practices.

As far as case report is concern generally we do not attempt any intervention in that. So in that case ethical clearance is not needed but client's rights like anonymity and confidentiality must be preserved for maintaining good ethical practice.

which authority in India issues an ethics approval certificate?

Dear Dr. Bilal, It depends on area from where you like to collect your participant. Each area have 1 or 2 IEC-HR committee.

Case studies typically involves an ethical clearance committee looking at the research aims and methodologies of researchers to make sure that the research will be conducted in a way that protects the dignity, rights and safety of the research participants, and that the research design is ethically sound and is likely to render the anticipated results.

Any research, involving human subjects, requires approval by a corresponding ethical compliance body. The name of such body might differ from country to country, but usually it is called institutional review board (IRB). The thing is that Case reports can sometimes reveal patients very personal information that may even possibly lead to their recognition by readers of the report, and at times photographs are used in case studies. With the result Reputed journal editors are requesting a copy of a signed consent form, before agreeing to publish case reports. A clear justification usually needs to be provided if a case report is submitted for publication without formal and specific written consent from the patient or guardian or in the case of a death, from the next of kin.

Can we use our clinical notes to present cases where no consent was obtained at the beginning of the treatment as there was no intention of using this data as a research?