Informed Consent in Clinical Trials: Nuances and Remedies

Whether you’re running a Decentralized Clinical Trial or a conventional clinical trial, obtaining informed consent from participants before involving them in clinical trials is legally paramount in most jurisdictions. And ethically paramount in all of them. After initial consent, the consent of participants must actively persist throughout the trial. Legally speaking, it is important to document said consent in order to avoid any potential liability. Some jurisdictions may mandate that you store consents digitally, or store them analogically, but most of the time you can obtain your initial consent documents before storage by involving either approach, or both. 

That said, a lack of consent doesn’t always present in black and white. Consent may be withdrawn at any time. Obtaining informed consent is more than a form to be signed, and filed away somewhere. Obtaining consent is an ongoing process and signed forms are a part of documenting the process.

Because of potential language barriers and cultural misinterpretation, there are a number of nuances to consent. Cultural misinterpretation is not exclusive to transnational interactions. Even different people born and raised in the same city may have widely differing cultural backgrounds. There are a few actions any organization can take to ensure valid consent across cultural divides and linguistic barriers and we’d like to shed light on three such actions of particular importance.

1. Get the Right Help

To avoid potential cultural and linguistic hindrances towards obtaining consent, start with hiring or soliciting voluntary help from the right people. If the consent documents are not in a language all trial participants understand, translate the consent to the relevant languages and get the translation approved by the applicable IRB. If not enough people on your team speak all the languages of your participants, it may be a good idea to hire independent translators. Provide your entire team of CRAs and Admin staff with cultural training relevant to all the participants in a trial, to help them interpret potential nuances in the consent process at any point of the clinical trial. Ensure that everyone in your clinical trial is comfortable enough to express potential concerns or even outright refusal at any given time, without the least hint of pressure to begin or continue a trial procedure. If any action, expression, or conversation with a trial participant could reasonably be interpreted as interfering with the participant’s consent to a trial procedure, or the trial as a whole, provide the participant with active support to express themselves very clearly.

2. Investigate Non-Verbal Cues

Non-verbal cues include things such as unintentional or semi-intentional body language, hand or head signals, and non-linguistic sounds. For whatever reason, be it cultural or otherwise, a trial participant could feel compelled to participate in a trial. Maybe someone’s exploiting them to obtain any compensation they might be owed for the trial, particularly in the case of minors (but not exclusively). Maybe their medical counselor misrepresented their options for an ulterior motive. Maybe they simply have trouble voicing their concerns or changes of heart. Whatever the reason, you should be on the lookout for non-verbal cues. Aside from being the ethical thing to do, the last thing we want is for regulatory authorities to later determine that we could have reasonably concluded that the trial participant was under duress.

3. Keep Participants Informed

Whatever your team is investigating may also be investigated by other organizations, or even other teams from your organization. This is why you should follow outside developments relevant to your subject of investigation. If a relevant warning is issued by any regulatory agency, globally, your trial participants have a right to know. If another team of researchers discovers something relevant to your subject of investigation, you should inform your participants. Any new information relevant to your subject of investigation could result in the withdrawal of participants’ consent. Any information they do not learn, which you could have reasonably imparted to them in a timely fashion, could be used to argue that their consent beyond a certain point was definitely not “informed”.

You may reasonably voice a concern in light of the above nuances and recommended remedial actions regarding Decentralized Clinical Trials in the past. Luckily, integrating video consent procedures into digital solutions for Decentralized Clinical Trials nowadays has become more common. Any clinical research team eager to monitor for consent nuances nowadays should have little trouble doing so, whether they’re running a conventional clinical trial or a Decentralized Clinical Trial.