Revoked parental consent

Case number:
15-09

Case text (Anonymised)

Our journal publishes case reports describing the evaluation, diagnosis and treatment of unusual cases. Parents must provide written informed consent prior to manuscript submission. No cases are presented with unique identifiers and each is anonymised as much as possible.

A manuscript was submitted with written consent that was accepted for publication and assigned to an issue. Just before the issue was to be folioed, the parents contacted the authors and revoked consent. The journal was able to pull the article prior to publication. The editorial board is concerned about this happening again and what the course of action would be if consent is withdrawn from a case that has already been published.

Question(s) for the COPE Forum
• Once written consent is provided, can it be revoked?
• If the article was already published, what would be the reasonable course of action? Retraction?

Advice: 

The case provoked much discussion among the Forum and raised many interesting questions. Do people really understand the full implications of giving consent to publish? Do patients really understand what consent means? Do patients/carers understand that once a paper is published online, it is very difficult to remove it? A journal can take down the paper, but it may have already been downloaded and/or printed copies may be in circulation. Hence a paper can never be removed completely from the internet.

The Forum stressed that patients should be made fully aware of this before they provide consent. The fact that a paper can be read by anyone should be made very explicit to patients. In genetic studies on pedigrees for example, a paper may potentially identify not only the patient, but the patient’s family, and therefore it may be difficult and complex to obtain consent in this situation. Hence the Forum advised that a journal should strive to avoid a situation where a patient or carer wants to revoke consent by providing clear instructions on what it means to provide consent in the first place. Also, the journal may wish to have their own consent form which could provide clear and detailed information on consent.

The Forum agreed that consent can be revoked and that a journal should respect the wishes of a patient if they wish to revoke consent. The journal should then remove the paper from their website but leave a place marker, with a note saying that the paper has been removed and stating the reasons why. The journal should inform the patient that although the paper has been removed, there is little that can be done regarding copies already in circulation.

For consent in children and young adults, some journals use a "minor assent form" along with parental permission, which is tailored to the age of the child. The child can then give their "assent".

The issue of consent forms has been raised at COPE in the past and the suggestion of a universal consent form was put forward. However, it was felt that one consent form could not cover all situations and instead, COPE plans to publish various on the COPE website examples of best practice journal consent forms for others to see and perhaps use for their own journal. 

Follow up: 

The editor was satisfied with the guidance the Forum provided. Based on feedback from the Forum, the journal is creating a sample parental consent form for authors to use as a template. The journal hopes to clarify what it means to give consent to publish a child’s case in the journal so that the parent is fully aware. The editor would be interested in any formal guidance on consent issues from COPE. The editor considers the case closed.

Resolution: 
Case Closed
Year: 

Comments

  • Posted by Brian Birch, 14/3/2016 8.50pm

Just two points:
1. Young persons aged 16-18 should be able to give consent in normal circumstances
2. What do you do with a person <16yrs who does not give assent but whose parents have consented ? I would be inclined to respect the child's wishes but what do others think?

  • Posted by GLM, 28/3/2016 7.56pm

Consent is obviously important and should be respected. However, don't the authors also have some rights? If they have received consent, done a huge amount of work to do the study, and not acted deceptively, surely they also have interests that should be taken into account. One might also suggest that the benefits of publication to science or health should also be a factor.

I wouldn't say that such considerations should allow one to waive the requirement for consent, but changes of mind at the last moment are not the same as originally denying consent and should perhaps be subject to some scrutiny and evaluation, just as all work with human subjects requires a weighing of benefits and costs.