Example

 

“Each child has an audiometry assessment and a clinical assessment (both routine procedures for those attending these clinics) before they are assessed for eligibility to enter the trial. The participating clinician further assesses eligibility, provides the potential participant’s parent/legal guardian with a verbal description of the trial and, if they are interested, provides a comprehensive Participant Information Sheet (PIS). All potential participants’ parents/legal guardians are given sufficient time to read the PIS, ask questions and consider participation before being asked to provide written informed consent if they are willing for their child to participate. Age-appropriate pictorial information sheets are also be provided for children who are old enough to use them.

 

Parents/legal guardians who consent to take part are asked to sign a consent form, which is also signed by the clinician who is taking consent. Parents/legal guardians are informed that they have the right to withdraw consent from participation in the OSTRICH trial at any time, and that the clinical care of their child is not affected at any time by declining to participate or withdrawing from the trial. Assent may be given by children who are able to understand the age-appropriate information provided and express an opinion regarding their participation [485]. 

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“An investigator team composed mainly of nurses has been trained in all study procedures … Written informed consent will be obtained from each participant before any trial-related procedures are carried out [486]. 

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Explanation

 

The notion of acquiring informed consent involves the presentation of understandable and comprehensible information about the research to potential participants, confirmation that they understand the research, and assurance that their agreement to participate is voluntary. The process typically involves discussion between the potential participant and an individual knowledgeable about the research; the presentation of written material (e.g., an information leaflet or consent document); and the opportunity for potential participants to ask questions. Assent represents a minor's affirmative agreement to participate in the trial, which typically involves signing a document that provides age-appropriate information about the study.

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The content, quantity, and mode of delivery of consent information can affect trial recruitment, participant comprehension, anxiety, retention rates, and recruitment costs [208, 487-490]. Reviews of two samples of 108 and 292 trial protocols from 2016 found that 15% to 18% of trials protocols approved in 2016 did not describe the process of obtaining informed consent [9, 10]. 

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The protocol should include details of the consent process as well as the role, experience, and training (if applicable) of the individuals obtaining consent or dissent. In paediatric trials, where applicable regulations may stipulate obtaining affirmative assent for participation from children above a certain age [491] the protocol should describe how pertinent information will be provided to potential participants, and how their understanding and assent will be ascertained. When potential participants lack decisional capacity for reasons other than young age (e.g., mental status), and proxy consent can be obtained from a legally-authorised representative, the protocol should describe who will determine an individual's decisional capacity, whether a formal capacity instrument will be utilised, and how the individual's informed agreement to continue participation will be secured should they regain decisional capacity [492]. For certain trials, such as cluster randomised trials, it may not be possible to acquire individual informed consent from participants before randomisation, and the consent process may be modified accordingly. An explanation should be provided in the protocol in these instances [493]. ​

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Summary of key elements to address

• Role, experience, and training of individuals obtaining consent

• How consent will be obtained from potential participants

• If applicable, how assent will be obtained from paediatric participants who are too young to consent, including:

• How information will be provided to potential participants

• How their understanding and assent will be ascertained

• Any plans to obtain proxy consent from potential adult participants who lack decisional capacity, including:

• Who will determine the individual's decisional capacity

• Any formal capacity instrument to be used

• Any plan for securing informed agreement to continue participation once decisional capacity is regained