Preventing Coercion in Human Trials

What's it all worth to a participant? People take part in human trials for all sort of reasons - perhaps they are sensitive to the cause? They might have a heritable factor within their family putting them at risk of a certain condition. Maybe they lost a friend to a disease? At other times, participants are fairly up-front about just wanting some extra cash. But therein lies the ethical dilemma - how can we incentivise participants to take part in clinical trials without coercing them of exerting undue influence? What and when is too much? When are we at risk of exploiting desperation or financial interests?

‍

‍

Be Ethical! : Key Concepts and Examples

‍

Coercion

Coercion involves threatening or forcing an individual to participate in a clinical trial. It compromises a person's ability to freely choose to participate by making them feel they have no reasonable alternative. For example:

‍

• A patient might feel coerced if a clinician implies that refusing to join a trial could result in a withdrawal of care or diminished access to medical treatment.
• A participant might be threatened with losing employment or benefits if they do not consent to participate.

‍

‍

Undue Influence

Undue influence involves excessive persuasion or incentives that impair a participant’s ability to make a fully autonomous decision. This typically occurs when an offer is so attractive that it compromises the participant’s ability to assess risks rationally. Examples include:

‍

• Offering disproportionately large financial incentives to economically disadvantaged individuals, making them overlook potential risks.
• Implying that participation will guarantee better medical outcomes or access to otherwise unavailable treatments.

‍

‍

Here are our core 9 strategies you can implement to help ensure that you're designing and conducting your study as ethically as possible.

‍

‍

1. Strengthening Informed Consent Processes

Informed consent is the cornerstone of ethical research. To ensure participants make voluntary decisions:

• Use Plain Language: Avoid technical jargon and use culturally appropriate language that participants can easily understand.
• Interactive Sessions: Allow participants to ask questions and engage in discussions to clarify their understanding.
• Reiteration: Revisit consent periodically, especially in long-term studies, to ensure participants remain informed and comfortable.

‍

2. Minimizing Financial Pressure

Financial incentives are often necessary but can become coercive if disproportionate. To address this:

• Reasonable Compensation: Provide payments that reflect time, inconvenience, and travel costs rather than large sums that might unduly influence decisions.
• Transparency: Clearly communicate that compensation is not contingent on study completion to reduce pressure.

‍

3. Ensuring Voluntary Participation

Participants must always feel they have the freedom to join or withdraw without repercussions:

• Clear Withdrawal Policies: Emphasize that participants can leave the study at any time without impacting their medical care.
• Third-Party Oversight: Use independent advocates or ethics boards to monitor participant interactions and address concerns.

‍

4. Training Researchers and Staff

The behavior of clinical trial staff significantly impacts participants’ experiences:

• Ethics Training: Regularly train staff on ethical recruitment and interactions to avoid undue influence.
• Empathy and Sensitivity: Encourage a patient-centric approach that prioritizes the well-being and autonomy of participants.

‍

5. Addressing Power Dynamics

Power imbalances, especially in trials involving vulnerable populations, can exacerbate coercion:

• Community Engagement: Involve community leaders or representatives to foster trust and mutual understanding.
• Independent Counseling: Offer participants access to third-party advisors to discuss their concerns and options.

‍

6. Leveraging Technology for Transparency

Digital tools can enhance transparency and accountability:

• Digital Consent Platforms: Provide video and interactive content to explain trial procedures.
• Automated Feedback Systems: Allow participants to anonymously report concerns or unethical practices.

‍

7. Ongoing Ethical Oversight

Ethics committees and institutional review boards (IRBs) play a pivotal role:

• Regular Audits: Conduct audits to assess whether trials are meeting ethical standards.
• Participant Feedback: Collect and act on participant feedback to improve processes continuously.

‍

8. Safeguarding Vulnerable Populations

Special care must be taken when involving children, economically disadvantaged groups, or individuals with limited capacity to consent:

• Guardian Oversight: Ensure legal guardians or advocates are present during the consent process.
• Tailored Communication: Use methods suited to the cognitive and emotional needs of the population.

‍

9. Promoting a Culture of Ethical Research

Organizations conducting clinical trials must prioritize ethics:

• Institutional Commitment: Develop and enforce policies that prioritize participant welfare.
• Public Accountability: Regularly publish ethical audits and trial outcomes to maintain transparency.

‍