Navigate Liabilities in Clinical Research

Navigate Liabilities Clinical research is a high-risk activityLiability cannot be waived

Control Risk & Liability Navigate Liabilities

Liability can not be waived but risk can be controlled.This ethical responsibility should be shared byInvestigators (& HC profession)Sponsors (& Industry)Study sites administrationRECs

Basic considerations

What is the risk? Is it fair to expose human subjects to such risk?Is it worthy to take the risk?Can myself, the organization bear the risk? Indemnity & insurance are last resorts for transferring / financing risk, one must aim at prevention Research-related Liability Involves MalpracticeSponsor: usu. not liable (indemnity is often conditional)

Research organization (RO):Navigate Liabilities

Vicarious liability (direct liability if allowed unqualified persons to conduct research)Damage to credibility Regulatory enforcement Should be covered by malpractice insurance

Investigator: Disciplinary & legal proceedings No Malpractice Sponsor: Compensation according to indemnity agreement Research organization (RO): When there is no external sponsor, the RO is deem to be the sponsor If the financial risk is not transferred to a third-party through an indemnity or insurance arrangement (may not be covered by malpractice insurance)

Investigator: the research institute & investigators are liable to bear the financial consequence Indemnity & Insurance Indemnity by Sponsor usually excludes malpractice, negligence, error, omission, or protocol violation,etcAn insurance backed indemnity is most preferable It is desirable for a research institute to acquire additional insurance for research activities Vicarious Liability An employer is vicariously liable for negligent acts or omissions by her employee in the course of employment.

Vicarious liability does not apply if:employee was not negligent employee is acting in his/her own right rather than on the employer’s business investigator is not an employeeIs a trial without ethical approval part of the RO’s business? Is research part of the terms of appointment of an honorary staff? Case: a Govt driver used a Govt vehicle for his own purpose & the Court ruled that Govt (employer) was not liable Special Considerations Investigator is not an employee Vicarious liability does not apply.

insurance does not cover RO may be charged direct liability of granting patient access / research rights to an unsuitable person RO bears OS&H liability to investigator Study site is not affiliated to ROREC has no jurisdiction over non-affiliated sites RO has no control over non-affiliated sites Investigator has duty of care to research subjects & RO by endorsing the research may be vicariously liable for negligent acts or omissions by her employee Adopt a cautious approach & a more stringent standard in planning, review & study oversight REMINDER Liability should be managed proactively Indemnity & insurance are last resorts for transferring / financing risk

Product and Clinical Trial liability

Product Liability insurance is indispensable for meeting contractual obligations with medical facilities during trials, adhering to statutory or country-specific mandates, and shielding the company from legal actions and claims alleging damages.

Instances of product liability may encompass devices manufactured with defects or flawed designs, improper fitting or insertion of devices, and inadequate warnings about potential consequences of product use. Liability claims can also stem from software malfunctions or the promotion of device use for unintended purposes.

Moreover, insufficient or inaccurate end-user training, whether directed at clinicians or patients, can expose the company to substantial liability. Errors in human diagnostic testing, including those made by contracted clinicians or laboratories, may lead to allegations of malpractice.

Errors & Omissions (E&O) insurance

In the realm of professional liability, Errors & Omissions (E&O) insurance plays a crucial role. Should the company or any collaborating third-party entity demonstrate negligence or fail to execute any part of the trial accurately, they could face accountability for resulting damages. For instance, if a delay in bringing a product to market stems from a hiccup during the clinical trial process, this could lead to significant consequences. E&O insurance specifically addresses the risk and liability tied to the possibility of delivering flawed work, commonly termed as “other financial loss.”

Medical professional liability insurance

Medical professional liability insurance, also referred to as medical malpractice insurance, is a crucial form of professional liability coverage designed to safeguard physicians and various licensed healthcare professionals (such as dentists and nurses) from liability stemming from wrongful practices. This includes situations leading to bodily injury, personal injury such as mental anguish, medical expenses, property damage, and the expenses associated with defending against related lawsuits. Given these risks, it’s essential for healthcare entities and professionals involved in patient care to have this insurance coverage in place.

Cyber liability

Cyber criminals may perceive clinical trials as an enticing opportunity to disrupt operations and pilfer valuable company and patient data. Implementing robust data privacy protocols becomes imperative to safeguard both the company and its participants. Incorporating a cyber liability policy into the risk mitigation strategy is crucial.

With the escalating demand for connectivity, cybercrime finds itself in a favorable position, given the exponential increase in potential targets. The competitive landscape in medical product development intensifies, prompting companies to embrace cutting-edge technologies to maintain their edge. These technologies encompass mobile applications and internet-connected sensors that transmit sensitive data. Consequently, the exposure isn’t merely financial and legal; it extends to potential health hazards for patients.