Medical and Regulatory Affairs

ISO Guidelines for Medical Device Trials: Ethical Considerations and Informed Consent

With increasing demands for evidence of clinical efficacy and safety, applying sound research practices to medical device development is crucial for a product’s success.

The Need for High Standards in Study Design

When bringing a new medical device to the market — or even reevaluating an existing product — device companies must answer to:

  • Regulators placing greater scrutiny on devices prior to market approval
  • Payers requiring more information to back up product value claims for reimbursement
  • Physicians and healthcare systems requesting more evidence to inform purchasing decisions
  • Patients wanting more transparency in the development process

Satisfying the needs of these four groups often comes down to quality study design. Associated clinical trials need to do more than simply meet regulatory requirements; device companies also use the data gathered by clinical trials to differentiate their products, positioning them for earlier adoption and success on an increasingly competitive market. With those goals in mind, medical device trials must be designed to:

  • Verify performance characteristics as defined by the manufacturer
  • Identify any undesirable side effects that may occur under normal use
  • Facilitate an informed risk-to-benefit ratio in relation to the intended performance of the device

ISO Standards for Device Trials

In many ways analogous to ICH recommendations for drug trials, ISO 14155:2011 sets the international standard for good clinical practices for medical device trials. A thorough understanding of these guidelines will aide sponsors in designing trials that meet regulatory requirements. The purpose of these global standards for design, conduct, recording, and reporting are to:

  • Protect the rights, safety, and well-being of human subjects
  • Ensure scientific conduct of clinical investigators and the credibility of results
  • Define the responsibilities of both the sponsor and the principal investigator clearly

It is important to note that these guidelines do not apply to in vitro diagnostic medical devices.

Official Adoption of ISO Standards

Global conformity to the ISO standard would help to harmonize good clinical practices internationally, ensuring the reliability and integrity of data submitted for market approval and protecting patients — both during development and after a device has been brought to market.

While not yet universal, an increasing number of regulatory agencies utilize this standard. It is not part of the official U.S. FDA regulatory requirements for medical devices, but the FDA does recognize the principles it sets forth. Likewise, these standards also apply to investigations for non-regulatory purposes and should be followed.

ISO Standards and Ethics

The basis of ISO 14155:2011 comes from the ethical principles originating from the Declaration of Helsinki, putting the rights, safety, and well-being of individuals above the interests of science and society at large. When local ethics requirements are less strict than ISO, sponsors should follow the more stringent requirement, ensuring patient safety and streamlining the market approval process worldwide.

The ethical considerations common to all clinical research include:

  • Study design
  • Recruitment methods
  • Informed consent
  • Data protection
  • Institutional Review Board/Ethics Committee (IRB/IEC) approval and updates
  • Payments to study participants and investigators, incentives, and conflicts of interest
  • Insurance and indemnity

Components of Informed Consent

ISO standards require informed consent before performing any study procedures in a medical device trial. The process typically involves carefully written consent forms that include:

  • A general description of the study and its purpose
  • Potential benefits of patient participation
  • Potential risks and inconveniences patients may experience
  • Existing alternative treatments and procedures for an indication, along with the potential risks and benefits of each
  • A confidentiality statement that includes the level of privacy given to patient information
  • The process and level of compensation offered for study-related injuries and adverse events, when applicable
  • Estimated out-of-pocket expenses for the patient
  • Contact information for questions, injury reporting, and emergency situations
  • Information about conditions that would result in study termination or termination of the patient’s participation in the study

It’s also important to keep in mind that informed consent can be an ongoing process. If additional information becomes available that has the potential to significantly affect the patient’s health and medical care, it should be provided to patients in writing. In such cases, it may be appropriate to confirm their continued informed consent. While not always legally required, payments, incentives, and conflicts of interest should also be included as part of informed consent procedures.

While just one aspect of sound research practices in medical device development, the ethics of informed consent are a cornerstone of ISO 14155:2011.