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Clinical Trial Negligence

Participating in clinical trials contributes to the development of new treatments, aiding in disease management and enhancing life quality. However, despite strict protocols and informed consent procedures, there’s a risk of serious side effects. If you’ve suffered injury or illness due to a clinical trial, our solicitors can assist in pursuing compensation. At McCarthy + Co, we’re committed to supporting you throughout the claims process, handling your case comprehensively whilst facilitating access to essential medical care and rehabilitation support.

Doctor testing medicines, representing a clinical trial

Helpful Information

A clinical trial negligence claim is a legal action taken by a participant who has suffered harm due to the improper conduct of a clinical trial. This might involve inadequate informed consent, deviation from standard protocols, insufficient monitoring, or failure to manage adverse effects properly. The claim seeks compensation for injuries or illnesses directly resulting from the negligence encountered during the trial. It’s based on the premise that the trial’s organisers failed to adhere to established ethical and safety standards, thereby causing avoidable harm to the participant.

Bringing a clinical trial negligence claim

You may have the grounds to bring a claim if one or more of the following criteria matches your experience.  
  • Inadequate informed consent – Participants must be fully informed about the trial, including potential risks and benefits, before they agree to take part. Negligence can occur if the consent process is not thorough or if participants are misled or coerced.
  • Protocol deviation – Clinical trials have specific protocols or guidelines that need to be strictly followed. Negligence can occur if researchers deviate from these protocols without a valid reason, potentially endangering participants.
  • Insufficient monitoring and oversight – Ongoing monitoring of the trial and the participants’ health is crucial. Negligence can be claimed if there is a lack of adequate monitoring, leading to unaddressed health issues or side effects.
  • Failure to act on adverse events – If adverse events or unexpected side effects occur during the trial, researchers are obligated to take appropriate actions, which may include modifying the trial or stopping it altogether. Negligence occurs if these events are ignored or not properly managed.
  • Poor study design or execution – This includes flaws in how the study is designed or conducted, such as inadequate sample size, poor selection of participants, or unreliable data collection methods.
  • Lack of competency – If the individuals conducting the trial lack the necessary skills, qualifications, or experience, this can lead to negligent conduct of the trial.

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Frequently Asked Questions

Some of the questions often posed to our medical negligence team.

  • Who regulates clinical trials in Ireland?

    Clinical trials are regulated by the Health Products Regulatory Authority (HPRA). The HPRA oversees the authorisation, monitoring, and inspection of clinical trials to ensure they comply with national and European Union regulations. This includes evaluating applications for trial approval, ensuring the protection of participant rights and welfare, and verifying the quality and safety of the medical products being tested. The HPRA works in conjunction with ethics committees, which also play a crucial role in reviewing and approving clinical trial protocols from an ethical standpoint. Further information on this can be found on the HPRA's website here.

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  • Can I make a complaint to the HPRA about a clinical trial?

    Yes, you can. The HPRA accepts and investigates complaints related to the conduct of clinical trials, including concerns about participant safety, ethical issues, or regulatory non-compliance. Complaints can be submitted by participants, healthcare professionals, or the public. It's important to provide detailed information about the specific issues or concerns to facilitate a thorough investigation. The HPRA ensures confidentiality and impartiality in handling these complaints. Information on safety reporting in clinical trials is available here.

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  • What are SUSARs in clinical trials?

    Suspected Unexpected Serious Adverse Reactions (SUSARs) are adverse events that are both unexpected and serious, occurring in participants during the clinical trial. "Unexpected" means the event is not consistent with the drug's known safety profile, as described in the trial protocol or product information. "Serious" refers to events that result in death, are life-threatening, require hospitalisation or prolongation of existing hospitalisation, result in persistent or significant disability/incapacity, or cause a congenital anomaly/birth defect. SUSARs must be reported promptly to regulatory authorities and ethics committees to ensure participant safety and trial integrity.

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  • Will I only have grounds to bring a clinical trial negligence claim if it involves a SUSAR?

    No, grounds for a clinical trial negligence claim are not limited to incidents involving SUSARs. You may have a claim if you experienced any harm or injury due to negligence in the conduct of a clinical trial. This includes, but is not limited to, failure to obtain informed consent, inadequate monitoring, protocol breaches, or failure to act on known risks. It's important to demonstrate that the harm was directly caused by the negligence of the trial conductors.

Start your clinical trial claim

If you have taken part in a clinical trial, and you believe the organisers of the trial behaved negligently due to one or more of the reasons above, you may have the grounds to bring a compensation claim. Call us on 1800 390 555 and an experienced member of staff will discuss your situation and potential next steps. You can also email on info@mccarthy.ie and we will get back to you as soon as we can.
Medical Negligence Team at McCarthy + Co

About McCarthy + Co

With more than 30 years of experience in dealing with product liability and medical negligence claims, McCarthy + Co. has expertise in a wide variety of fields including medical product liability. We are a family-run business, and we pride ourselves on offering honest, impartial and helpful advice.

Our offices are based in Dublin and Cork, but we work with clients throughout Ireland in locations ranging from Galway to Waterford. You can count on us for legal advice, guidance and assistance on any form of personal injury.

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Flor McCarthy

Flor McCarthy

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wears multiple hats, not only as the managing partner of one of Ireland’s leading law firms, but also as an author, speaker and an acknowledged expert in client service, innovation and marketing.

Beginning his academic journey at UCC, Flor furthered his education with a master’s degree in law from UCD. After gaining valuable experience as a solicitor in Dublin, the allure of home and the family brought him back to West Cork to contribute his expertise to the family business.
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John McCarthy

John McCarthy

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is a seasoned solicitor with almost 20 years of experience, specialises in personal injury and medical negligence claims, focusing particularly on high-value compensation cases. His extensive litigation experience spans Circuit Court, High Court and Supreme Court levels.

John's practice involves a diverse range of cases, from personal injury and wrongful death to property damage, defective products, professional negligence and judicial reviews.
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