Challenges and Ethical Considerations in Biomedical Engineering

The uniquely multidisciplinary field of biomedical engineering requires interactions among professionals in engineering, biology, physics, medicine and mathematics.¹ It’s a high-stakes field, with research and development of biomedical devices directly affecting human health. As a result, the challenges that biomedical engineers face are more nuanced and complex than those in other fields. Additionally, as technology advances, the already-crucial role that biomedical engineers (BMEs) play in healthcare will continue to grow.

This article will examine various challenges and ethical considerations in biomedical engineering.

Patient Safety and Risk Assessment

Safety and risk assessment are not just practical concerns for biomedical engineers, but also ethical ones. This is because biomedical engineers' design decisions directly affect patient health; it’s incumbent upon them to consider every factor that might influence those outcomes.

Biomedical engineers’ responsibilities regarding patient care extend to rigorous testing, transparency in reporting potential risks and ongoing monitoring once new medical devices are in use. Neglecting these could be disastrous, as in the case of the Therac-25 radiation therapy machine, in which lapses in safety design and risk assessment led to patient fatalities.²

Informed Consent and Human Testing

While informed consent is not new in healthcare, attention to ethical concerns is essential in regard to human testing.³ If a trial involves medical devices being implanted into human subjects, for example, it’s paramount that participants agreeing to take part fully understand what they’re consenting to, including the surgical risks and potential hazards. In this sense, it’s up to BME professionals to address the full scope of informed consent beyond the standard signature on a form.

Accessibility and Affordability

A central challenge to promoting diversity and inclusion in BME is accessing educational resources, such as special training programs, state-of-the-art research facilities and mentorship opportunities. Without broader access to affordable education and training, people from underserved and/or rural communities or social minorities are likely to remain underrepresented in key areas of research.

Current data show a severe lack of diversity in biomedical research. For example, according to the National Institutes of Health (NIH), Black scientists are 30% less likely than their white colleagues to receive NIH grants, and they represent only 1.5% of the applicant pool for the Research Project (R01) grant—”an award made to support a discrete, specified, circumscribed project to be performed by the named investigator(s) in an area representing the investigator's specific interest and competencies, based on the mission of the NIH.”^4,5 This disproportionate access can ultimately lead to healthcare disparities in which implicit biases harm research, design and innovation.

Privacy and Data Security

Ethical conduct in these areas involves the need for biomedical engineers to:

• Protect patient data
• Ensure that patients, through providing their personal information, are not made vulnerable to cybersecurity threats
• Collect and share information responsibly

They can ensure data security by using encryptions, implementing strict access controls and regularly updating security protocols. To ensure that information is only shared with trusted sources, BMEs rely on strict vetting processes and data-sharing agreements.

Dual-Use Dilemmas

In biomedical research, the dual-use dilemma is an ethical consideration regarding the potential misuse or abuse of certain biomedical technologies.⁶ For instance, research on a deadly virus such as H1N1 (swine flu) could potentially lead to advances in treatment, but it also poses risks if the dangerous pathogen gets into the wrong hands. Therefore, biomedical engineers must weigh the pros and cons of their research and seek to mitigate any misuse of dangerous substances by implementing strict security measures, ethical guidelines and oversight.

Intellectual Property and Innovation

Biomedical researchers regularly face ethical dilemmas regarding their innovations, so it’s essential that they understand how to navigate intellectual property laws, and that their ethical principles are firmly in place. For instance, an engineer who’s developed a device that could save lives will face patenting questions. That person might have to choose between the personal financial allure of keeping a patent private or the further-reaching benefit of making the invention widely available, which has broader implications for public health.⁷

Ethical Review and Oversight

Institutional review boards (IRBs), also known as independent ethics committees, play an essential role in meeting ethics standards. They act as an additional safeguard against ethical transgressions in biomedical research. The various functions of IRBs include:⁸

• Approving research
• Providing ethical oversight
• Conducting periodic reviews
• Requiring modifications to procedures
• Complying with state and federal guidelines and statues

Environmental Impact

Professionals in every branch of science must consider the environmental impact of their work. Common strategies to help reduce the environmental footprint of biomedical research include using sustainable practices with proper recycling and disposing of medical devices.⁹

Cultural Sensitivity and the Need for Diversity, Equity and Inclusion

In the field of biomedical engineering, there is a growing recognition of the importance of emotional intelligence and cultural competency. By understanding and accounting for personal, cultural and scientific differences, professionals can bridge healthcare disparities and promote more ethical practices in cross-cultural settings.¹⁰

As we’ve noted in another post on this site, diversity and inclusion in biomedical engineering are essential due to the integrative nature of the field, which “combines various disciplines, including biology, physics, mathematics, medicine and engineering science. As a result, it’s essential to recognize not just personal and cultural differences, but also the scientific differences within the vast network of professionals in the industry. Additionally, considering that medical engineering is continuously transforming and evolving, promoting diversity and inclusion is fundamental to the future of healthcare innovation.”

Biosecurity and Biotechnology

The unpredictable speed and direction of technological advancements mean biomedical engineers must always consider their impact on patient care when exploring new biotechnologies. For example, scientists working on perfecting the creation of complex tissues and fully-formed bioengineered organs must confront ethical challenges such as ensuring patient safety, addressing long-term health risks and considering the moral implications of organ creation. It is, therefore, crucial to establish ethical frameworks parallel to ongoing research to guide advancements in the field responsibly.¹¹

Professional Responsibility

Established in 1968, the Biomedical Engineering Society (BMES) is the professional organization for biomedical engineering students, faculty, researchers and industry professionals. The Society’s Code of Ethics “outlines the norms and obligations our professional society believes are required to fulfill a biomedical engineer’s commitment to honesty and conscientiousness in scientific inquiry and technology development, and to advancing public health.” It includes promoting transparency, implementing reporting systems for violations and establishing ethical decision-making models to standardize procedures.¹²

Case Studies

Bjork-Shiley Heart Valve

The Bjork-Shiley heart valve was a popular prosthetic heart valve developed in Boston in 1976.¹³ Despite early indications of anomalies and reports of malfunctions, the valves were not withdrawn from the market for years, leading to many adverse consequences, including over 600 valve failures and at least one fatal outcome.¹⁴

Space Shuttle Challenger

On the evening of January 27, 1986, four company officials at NASA contractor Morton Thiokol overruled their engineers’ recommendations and approved the launch of the Space Shuttle Challenger, bowing to pressure to meet deadlines and fulfill publicity purposes.¹⁵ The following day, Thiokol’s engineers’ safety concerns were vindicated when the shuttle exploded during launch, killing all seven crew members on board.

Such tragedies underscore why researchers must always keep ethical issues in perspective, adhere to professional standards and effectively resist external pressure.

Claim the Case Western Reserve Advantage

The future of biomedical engineering is full of opportunity. In the online MS in Biomedical Engineering program from Case Western Reserve University, you’ll learn from expert faculty who understand the unique challenges within the field. Our flexible, fully online program allows you to learn at a pace and schedule that suit your needs while providing networking opportunities to connect with other professionals.

To learn more, contact one of our admissions outreach advisors today.