Course 3: Ethics of Innovation

Introduction

How should one think about the ethics of innovation?   There are clear ethical rules that govern innovation in medical care, such as the regulatory ethics paradigm.  The regulatory ethics paradigm states that deviations from standard care involve a degree of experimentation that requires a set of procedures to assure the protection of the rights and welfare of research subjects.  For example, any innovative research or new medical procedure must be reviewed and approved by an Institutional Review Board.  This paradigm also requires the preparation of investigational protocols according to sound evidence and methodological standards. In so doing, it creates a presumption that innovations that are not rigorously validated are ethically dubious. However, no such rules govern innovative practices in global health.  How does one innovate while focusing on quality and ensuring that the idea is evidence-based?  How does one evaluate whether an idea is likely to work effectively and cost-effectively?  What are ethical issues involved with social entrepreneurship?  Questions such as these remain unanswered.  This article seeks to lay down basic ground rules for innovative practices in global health delivery. 

Best Practices in Innovation

When designing and implementing innovative tools or programs in the developing world, it is important to ascribe to best practices in order for products to be successful and ethical.   Important factors to consider include:

• Impact:  How much difference will the innovation make to improve health?

• Appropriateness: Will the intervention be affordable, robust and adjustable to health care settings in developing countries, and will it be socially, culturally and politically acceptable?

• Burden: Will the innovation address the most pressing health needs?

• Feasibility: Can it realistically be developed and deployed in a time frame of 5–10 years?

• Knowledge gap: Does the innovation advance health by creating new knowledge?

• Indirect benefits: Does it address issues such as environmental improvement and income generation that have indirect, positive effects on health? (1)

As with all health programs, global health innovations must be founded on best practice principles in public health.  The worst practices that are often employed by some organizations can do significant harm and create more substantial barriers to care.  Below are several questions that should be asked of any innovative technology or program:

Does the innovation involve local community members?

Diffusing a new innovation requires understanding the local environment. Social, economic, and cultural environments vary greatly across and even within countries, and deploying new programs requires an understanding of these environments. Innovators must consider the need for expertise in sociology, anthropology, public policy, and economics, and establish coherent criteria for selecting countries to target based on social, economic, and cultural realities.(2)   An invention always engages closely with cultural practice and systems, and it must already have a close relation to the contingencies that surround it and that will influence its fate.(3)

Does the innovation foresee unintended impacts and consequences?

A global health intervention may lead to unintended and undesired consequences due to error on the part of the implementer. This is often due to the assumption that actions which have in the past led to the desired outcome will continue to do so.  In order to anticipate the impact of an innovation, proper research should be conducted.

Is there a way to evaluate the success of the innovation?

Evaluation needs to focus on measuring outcomes that reveal the extent and kinds of impact the project has on its participants. Impact could be reported in the amount of change in behavior, attitude, skills, knowledge or condition of the target population. Ultimately, information on outputs and outcomes is essential for public health action, and it is the foundation for policy making, planning, programming, and accountability.  Health metrics are necessary and important to ensure accountability and achieve best practice standards.  Unfortunately, high quality health information is not widely available in developing countries, and outcomes are frequently not measured by organizations.  

Ethical Frameworks for Innovation

Several ethical frameworks have been suggested to guide the development and implementation of an innovation and to ensure that it will not be harmful. Two of these frameworks, utilitarianism and human rights are outlined below.(4)  As each framework contains major strengths and serious flaws, it is important to consider both and avoid narrowly committing to one over the other.

Utilitarianism: The greatest good for the greatest number

Strengths as an Ethical Guide

• Encourages efficiency and productivity.

• Parallels profit maximization.

• Encourages looking beyond the individual to assess impact of decisions on all constituencies.

Weaknesses as an Ethical Guide

• Virtually impossible to quantify all important variables.

• Can result in unjust allocation of resources, particularly when some individuals or groups lack representation of “voice”.

• Can result in abridging some people’s rights to achieve the utilitarian outcome.

Rights: An Individual’s rights should not be violated

Strengths as an Ethical Guide

• Protects the individual from injury and establishes spheres of freedom.

• Establishes standards of social behavior that are independent of outcomes.

Weaknesses as an Ethical Guide

• Can encourage individualistic, selfish behavior that interferes with order and cooperation.

• Establishes personal prerogatives that may present obstacles to productivity and efficiency.

Conclusion

Innovation in global health today goes hand-in-hand with social entrepreneurship.  Social entrepreneurship combines the passion of a social mission with business ideas of discipline, innovation, and determination.  Social entrepreneurs in global health are creative, willing to think outside the box, and ready to apply ideas to new situations.

Of course, not all social innovations are successful.  While failures inform social entrepreneurs about what to avoid in a future enterprise, they can cause significant harm to “test” populations.  Because social entrepreneurs work in different social contexts, they must always evaluate their innovative ideas within a variety of ethical frameworks.

Footnotes

(1) Daar, A. S., H. Thorsteinsdottir, D. K. Martin, A. C. Smith, S. Nast, and P. A. Singer. 2002. Top ten biotechnologies for improving health in developing countries. Nat. Genet. 32:229-232.

(2) Rogers, E.M. Diffusion of Innovations, Fifth Edition. Free Press, New York, 1995.

(3) Attridge, Derek. 1999. “Innovation, Literature, Ethics: Relating to the Other.” PMLA 114:20–31.

(4) Page, Robert. Ethics in Innovation. Survey Insights. Unpublished material.