Example

 

“Participants will receive ancillary care beyond the scope of the trial as required. Any adverse events or complications arising from trial participation will be promptly addressed, and necessary medical interventions will be provided at no cost to the participants. Ancillary care will extend to managing conditions unrelated to the trial that may arise during the study period, ensuring the overall well-being of the participants.

…

Post-trial care will be provided to participants, particularly for any ongoing effects or complications related to the trial interventions. Participants will have access to appropriate medical care and follow-up visits, ensuring continuity of care beyond the trial’s conclusion.

…

Provisions for compensation will be in place for participants who may suffer harm from trial participation. In the event of an adverse event directly attributable to the study interventions, compensation will cover medical expenses, additional treatments, and any other related costs. The compensation process will be transparent, fair, and in compliance with local regulations and ethical guidelines [501]. 

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Explanation

 

The provision of ancillary care refers to the provision of care beyond that immediately required for the proper and safe conduct of the trial, and the treatment of immediate trial procedure-related adverse events. It is generally agreed that trial sponsors and investigators have an ethical obligation to plan to provide care for participants’ health care needs that arise as a direct consequence of trial participation [2, 502, 503]. It is also important to consider whether care should be provided for certain ancillary needs that may otherwise arise during trial participation. Provision of care for ancillary needs reflects the fact that participants implicitly, but unavoidably, entrust certain aspects of their health to the research team.

 

The scope of entrustment will vary depending on the nature of the trial (e.g., setting, health condition under study, investigations performed). Additional factors that influence the strength of the responsibility to provide ancillary care include participants' vulnerabilities, uncompensated burdens and harms, the intensity and duration of the participant-researcher relationship, and the degree to which participants are uniquely dependent on the research team for health care.

 

The Declaration of Helsinki states that “appropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured. … In clinical trials, the protocol must also describe appropriate arrangements for post-trial provisions [2]. This principle is particularly relevant when research enabling the development and regulatory approval of interventions is performed in countries where subsequent access to the interventions is limited by cost or lack of availability [502-504].  

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Reviews of two samples of 108 and 292 trial protocols from 2016 found that 56% and 32% addressed ancillary and post-trial care [9, 10]. 

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The protocol should describe any plans to provide or pay for ancillary care during the trial, and identify any interventions, benefits, or other care that the trial organisers will continue to provide to participants and host communities after trial completion. Any plans to compensate participants for trial-related harms should also be outlined. If no plans exist for ancillary and post-trial care, this should be clearly stated, with rationale provided for why not.

 

Summary of key elements to address

• Any plans to provide or pay for ancillary care during the trial

• Any care or benefits that will be provided to participants or host communities after trial completion

• Any plans to compensate participants for trial-related harms

• If no plans for ancillary and post-trial care, this should be stated with reasons