Re: New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations
Sheehan is correct that the first condition of the regulation is for patients and the second is for their representatives. However, the second condition, which referred to the availability of a legal representative made no allowance for the urgent need to treat. Deferred consent would not have been permitted if a legal representative was available - their presence would necessitate informed consent prior to initiating treatment as part of a trial. This was in conflict with the urgent need to treat as the time taken to obtain informed consent would be prohibitive. The need to seek informed consent would have been legally binding and could not have been ‘ruled out’ on ethical grounds, as Sheehan proposed. Thankfully, the latest text of the EU Clinical Trials Regulation has been amended to address this conflict by making allowance for the urgent need to treat even if a representative is present1.
Correctly, Sheehan notes that the regulations do not use the term deferred consent but refer to clinical trials in emergency situations. However his proposed use of the term ‘waived consent’ would be misleading. Current examples of waived consent, such as the exception from informed consent requirement in the United States (US)2, have no formal requirement to obtain written consent to use data already collected. US practitioners are only required to provide information about the trial to the patient or legally authorised representative, and offer them the option to discontinue participation. With ‘deferred consent’, written consent is required for use of the data and continued participation. We therefore propose the continued use of the term ‘deferred consent’.
We share Sheehan’s concerns about the minimal risk and minimal burden criteria, which require further clarification. The amendments to the regulations have gone some way to addressing this, with reference to the risks of the trial treatments in comparison to standard treatment. Regulation amendments need to be extended to cover situations where there are no existing treatments, with consideration of the comparative risk being the risk to the patient’s condition if left untreated. The ethical implications of this proposal require consideration, which should involve consultation with key stakeholders to inform approaches to consent.
1. Council of the European Union. Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Brussels: Council of the European Union,, 2013.
2. U.S Department of Health and Human Services Food and Drug Administration. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsers. Exception from Informed Consent Requirements for Emergency Research. Rockvile, MD: U.S Department of Health and Human Services Food and Drug Administration, 2013.
Competing interests:
No competing interests
31 January 2014
Carrol Gamble
Deputy Director
Kerry Woolfall, research fellow; Paula Williamson, director; Richard Appleton, consultant pediatric neurologist; Bridget Young, director of communication skills
University of Liverpool
Department of Biostatistics, University of Liverpool, Liverpool, L69 7ZX
Rapid Response:
Re: New European Union regulation of clinical trials is conflicting on deferred consent in emergency situations
Sheehan is correct that the first condition of the regulation is for patients and the second is for their representatives. However, the second condition, which referred to the availability of a legal representative made no allowance for the urgent need to treat. Deferred consent would not have been permitted if a legal representative was available - their presence would necessitate informed consent prior to initiating treatment as part of a trial. This was in conflict with the urgent need to treat as the time taken to obtain informed consent would be prohibitive. The need to seek informed consent would have been legally binding and could not have been ‘ruled out’ on ethical grounds, as Sheehan proposed. Thankfully, the latest text of the EU Clinical Trials Regulation has been amended to address this conflict by making allowance for the urgent need to treat even if a representative is present1.
Correctly, Sheehan notes that the regulations do not use the term deferred consent but refer to clinical trials in emergency situations. However his proposed use of the term ‘waived consent’ would be misleading. Current examples of waived consent, such as the exception from informed consent requirement in the United States (US)2, have no formal requirement to obtain written consent to use data already collected. US practitioners are only required to provide information about the trial to the patient or legally authorised representative, and offer them the option to discontinue participation. With ‘deferred consent’, written consent is required for use of the data and continued participation. We therefore propose the continued use of the term ‘deferred consent’.
We share Sheehan’s concerns about the minimal risk and minimal burden criteria, which require further clarification. The amendments to the regulations have gone some way to addressing this, with reference to the risks of the trial treatments in comparison to standard treatment. Regulation amendments need to be extended to cover situations where there are no existing treatments, with consideration of the comparative risk being the risk to the patient’s condition if left untreated. The ethical implications of this proposal require consideration, which should involve consultation with key stakeholders to inform approaches to consent.
1. Council of the European Union. Proposal for a Regulation of the European Parliament and of the Council on Clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Brussels: Council of the European Union,, 2013.
2. U.S Department of Health and Human Services Food and Drug Administration. Guidance for Institutional Review Boards, Clinical Investigators, and Sponsers. Exception from Informed Consent Requirements for Emergency Research. Rockvile, MD: U.S Department of Health and Human Services Food and Drug Administration, 2013.
Competing interests: No competing interests