The inclusion of participants who lack the capacity for informed consent is essential for ensuring the generalizability of clinical trial outcomes, particularly in studies involving populations under the age of consent or those with cognitive impairments, critical illnesses, or developmental disorders. In such trials, obtaining informed consent from a Legally Authorized Representative (LAR) or proxy is both an ethical and regulatory necessity. An LAR is a spouse, guardian, healthcare power of attorney or another individual designated by law depending on the specific situation and jurisdiction. The consent – in many trials, the reconsent – of the LAR needs to be documented and associated with the participant’s record.
That said, the process of proxy consent and re-consent introduces complexities in documentation, assessment scheduling, and data management, posing significant challenges to trial integrity and efficiency. In some cases, these complexities lead to the exclusion of populations who are directly affected by the condition under study.
For example, trials evaluating hip replacements in aging populations often exclude individuals with cognitive impairment due to the challenges of obtaining proxy consent, thereby limiting the applicability of study findings to real-world patient populations.
Similarly, informed consent from an LAR or proxy is used in clinical trials focused on infants, children and cognitively impaired and vulnerable adults. The time-saving workflow can also support:
- Critical care of emergency medicine trials: Studies for treatments of conditions like stroke, cardiac arrest, severe COVID and trauma.
- End-of-life or palliative care trials: Research on pain management, quality of life interventions or treatments for terminal illness.
- Psychiatric or behavioral trials: Trials for severe psychiatric conditions like schizophrenia, bipolar disorder or major depressive disorders.
- Development disorders trials: Research on treatments for autism spectrum disorder, down syndrome or cerebral palsy.
- Vulnerable populations: Trials involving individuals in custodial care, such as prisons or long-term care facilities who may have impaired autonomy.
Expanding the inclusion of these participants improves the generalizability of clinical trial outcomes, making them more relevant for clinical practice and regulatory decision-making.
OpenClinica’s Automated LAR Workflow for Clinical Trials
That’s why OpenClinica created a digital workflow for Legally Authorized Representatives that solves the informed consent pain point for such clinical trials.
In short, the time-saving LAR workflow connects the records of the clinical trial participant and their study partner(s), while enabling them to be managed independently. This digital relationship between the clinical trial participant and study partner enables each to be on a study calendar that is separate and distinct yet connected. Throughout a clinical trial with vulnerable participants, there usually are LAR-specific assessments that have a cadence, triggering events and data that is different from the primary participant assessment cadence, triggers and data. All data must remain related, but separate.
It’s a time-saving workflow for clinical trials that is so rare, yet so critical, that some OpenClinica clients use our EDC just to leverage this functionality. When the alternative is reams and reams of paper files and manual tracking, it’s easy to understand the appeal of our LAR workflow.
The matrix provides clear line of sight for researchers to easily understand where participants and their study partners are within the consent and re-consent process.
Benefits of OpenClinica’s Automated LAR Workflow for Clinical Trials
In all clinical trials requiring an LAR, the OpenClinica automated LAR workflow ensures:
- Simplified data collection
- Accurate and separate consent/re-consent/assessment cadence
- Clear link between patient record and LAR record, or records in the case of two parents or multiple LARs
- Clear separation and privacy of data between patient and LARs
- Adherence to regulatory compliance for consent and re-consent
Learn More About OpenClinica’s Automated LAR Workflow
If you are a frequent OpenClinica blog reader, you likely know we are steadfastly committed to using technology and digital solutions to eliminate manual processes, saving clinical trials time and money and improving quality. The LAR workflow is one of a series of targeted micro solutions to streamline clinical trial processes. Stay tuned for future blogs illuminating additional time-saving workflows for clinical trials.
For a demo of how OpenClinica’s Legally Authorized Representative workflow solves the pain point of informed consent, re-consent and assessments for vulnerable populations, contact us here.