Graphic poster on the final rule featuring article's title and background image of a brown wall with shadows

Health Research Ethics In The 21st Century: Final Rule Seeks To Respond To Emerging Ethical Dilemmas Of Human Subject Research

Ethical dilemmas that arise during the conduct of research involving humans subjects- social, behavioral, collaborative or transdisciplinary health research- are the bread and butter of health research ethics. Health research ethics, in my books, is the delicate balance of the altruistic demands of science on those individuals and communities who elect to assume risk; and the duty of researchers in preserving human subject dignity, while being mindful of the goals of science, scientific community and society. The ‘final rule’ as suggested in it’s nomenclature, is this burgeoning field’s latest punt. Will it deliver on its promise?

It goes without saying that American institutions have taken the lead in crafting solutions to challenges facing ethical conduct of human subject research. This American leadership role, can be termed as an apparent extension of their de-facto status as ‘world police’; a role that begun with their role in ending the second world war. Notably, for human subject research, the horror showcase that was the Nuremberg trials demanded action. To that end, the ‘final rule’ – a body of ethical stipulations for human subject research- is the latest attempt by the Americans to ‘bring order’. But before we address how the “final rule” responds to realities of 21st century human subject research, some context.

Digging Up the Roots of American Leadership in Health Research Ethics

Money is only a tool. It will take you wherever you wish, but it will not replace you as the driver.

-Ayn Rand

In the conduct of 21st century biomedical research, American leadership in health research ethics is manifest in the generous contribution of the American taxpayer to health research. Through various federal agencies, the United States of America bank rolls the majority of biomedical research.

However, following the money in human subject research often reveals a case of whoever pays the piper choosing the tune. In this world, American dollars are both the carrot and stick. Case in point: In order to qualify for research funding from the NIH, the recipient university/ researcher/contract research organization must sign up to certain health research ethics stipulates.

the source of funding for biomedical research has bearing on health research ethics
This image shows a trend and source of biomedical research funding from 1994 to 2012

In order for us to understand the architecture of biomedical research funding, we will be better served unpacking the funding of collaborative multinational health research. This is because it is easier to follow the money in international health research. Because here, money (NIH and other federal agents money) flows from the rich north, to the poorer south.

Money Talks

By us reducing the layered process of design and implementation of biomedical research into money speak, we are able to better characterize the ‘big brother’ role that federal agencies play in regulation of human subject research. However, this ‘big brother’ role of the NIH and others isn’t limited to science and it’s goals. It encompass American interests which includes safeguarding American taxpayer and the greater public good.

Although partisanship is a common feature, in order to achieve this gargantuan mandate, federal bodies have to be guided by a organizational culture. In the public sector, organizational culture can be broadly classified as: public administration, public management and responsive governance.

In the next section, we highlight how these three ‘cultures’ influences how money by the second largest contributor to health research funding is handled; and how that in turn lays the bed for ground rules – in our case, ethical source documents like the ‘final rule’.

Funding for Health Research & How Federal Agencies Gleam 21st Century Interpretations of NPM

In this analysis, it cannot escape us that NIH and other federal money is American taxpayer money. It is public money, and thus subject to principles governing public sector performance. In the 21st century, the primal principles in play are: The New Public Management (NPM) and responsive governance. NPM took root in the 1980’s and still heavily informs public policy to date. NPM as a way of running government is a doctrine that combines economic theory and practical business management.

 Public administration Public management Responsive governance
Citizen-state relationship Obedience Entitlement Empowerment
Accountability of senior officials Politicians Customers Citizens and  stakeholders
Guiding principles Compliance with rules and regulations Efficiency and results Accountability, transparency and participation
Criteria for success Output Outcome Process
Key attribute Impartiality Professionalism  Responsiveness

Courtesy: United Nations :Unlocking the Human Potential for Public Sector Performance

Responsive governance on the other hand incorporates reflexivity in governance. It’s key attribute is shifting the focus from ‘output’ to ‘impact’. As we shall see, the ‘final rule’ moves human subject research in this direction where accountability, responsiveness, empowerment and participation reign supreme. In this regard, the ‘final rule’ presents a case for doing research differently. But, what does ‘differently’ mean?

Why we should do research ethics differently: The case of Fair Study Benefits & 10/90 gap

The key assumption that drives NPM is that agents are motivated by the desire to maximize personal preferences. This approach in international health research ethics has resulted in a situation whereby the recipients (human subjects, health systems and R&D infrastructure in the poorer south) seek to maximize compensation for bearing the risks of research.

The end game here has been discussions on the expansion of compensation to southern collaborators in collaborative health research for bearing the burdens of research. This has also been manifest in attempts at modelling the concept of “fair study benefits”. On the other side of the divide, resource providers (American taxpayers, charities, pharmaceutical, biomedical and medical devices firms) strive to maximize returns for their capital. Returns for capital in this context includes, but not limited to: influence in national politics, sway in the geopolitical arena and good old profit.

Global health practitioners have contributed to this debate by framing health disparities – that result from and are accelerated by the prevailing architecture of collaborative health research – as the 10/90 gap.

What is the 10/90 gap in health research? What influence does it have on crafting optimum ‘ground rules’ for human subject research?

sad picture of an emaciated African child suffering from ring worms. She might as well be the poster child of a central ethical dillema in health research ethics: The 10/90 gap
This image shows an African child, her head with visible manifestations of complicated ringworm infection, sitting on and staring into the dirt, deep in thought. Image | Courtesy.

The result of the strategic interplay of the spirit of maximization of utility by agents, as described above, and bureaucratic rigidity of existing rules of the game (read: the common rule) has been the 10/90 Gap problem. What is the 10/90 gap? To best answer the question we are drawn to the first paragraph of a May 13th, 2002 article “Fighting the 10/90 Gap” by Ricki Lewis for The Scientist Magazine. I quote:

While wealthy nations pursue drugs to treat baldness and obesity, depression in dogs, and erectile dysfunction, elsewhere millions are sick or dying from preventable or treatable infectious and parasitic diseases. It’s called the 10/90 gap. “Less than 10% of the worldwide expenditure on health research and development is devoted to the major health problems of 90% of the population,” explains Els Torreele, co-chair of a working group that provided background recently for an initiative announced by Medecins Sans Frontieres (MSF, or Doctors Without Borders) to fight the gap.

Looking at the table above, the key constructs of the different public sector management philosophies lead us to find semblance between the 10/90 gap and the disaster of Structural Adjustment Policies (SAP). Both, 10/90 gap and SAP, are products of an environment where public management overlaps with public administration. This comparison is necessary because the nature of undesirable outcomes from both are similar. These nasties illustrate how ‘organizational culture’ has a bearing on the nature of ‘ground rules’, which in turn has imprints on the outcomes and impacts.

Breaking the cycle

In the global south, for the increasing wealth gap with SAP, we have increasing health disparities evidenced by the 10/90 gap. For the liberalization of national assets that resulted in extraction of wealth from the global south to northern markets, we have the problem of justice that continues to plague collaborative health research. For corruption, we have research misconduct.

Whilst the table reflects chronology, reality is different. The source United Nations report explains; I quote:

The three models overlap in both historical time and substance. The last of the three—responsive governance—is not so much a historical model as an emergent set of trends. Its inclusion reflects a potential convergence of thinking, based on significant developments in practice and new challenges.

That the UN admits to the continuing existence of grey areas lends credence to why the ‘final rule’ in the first place. But what makes the ‘final rule’ an apt tool for guiding the governance of collaborative health research? Is it because the ‘final rule’ meets the threshold of being ‘trendy’ as intimated to by the UN above?

How The Final Rule Is Different From The Common Rule:

With a broad brush, by being alive to these developments in public management practice and new challenges to health research with emergent technologies, key amendments gave us the successor to the ‘common rule‘. Does the final revisions to the ‘common rule’ or simply the ‘final rule’ have the requisite edge to guide 21st century health research ethics? Some history first.

The ‘Common Rule’ & its Contribution to Biomedical Research

The principles of justice, beneficence and autonomy spelt out in The Belmont Report of 1974 provide a base for consensus building in protecting human subjects in research. The development of the common rule in 1981 had a similar, singular, but compound goal to:

“promote uniformity, understanding, and compliance with human subject protections as well as to create a uniform body of regulations across federal departments and agencies.”

It is upon this foundation that humanity has achieved great scientific feats. The mapping of the human genome project; reversal of trends in HIV/Aids-the worst pandemic in modern times known to mankind; the fist stages of development of gene editing technology; creating utility for artificial intelligence and the emergence of behavioral economics.

But the ‘common rule’  hasn’t always been enough. Moreover, thanks to a chequered past (Nazi medical war crimes, Tuskegee study and Willowbrook hepatitis study, for example) the relationship between science, technology and society hasn’t always been ideal. In bridging this chasm, the common rule has lagged behind.

Researchers cite stifling bureaucracies, ambiguity and lack of responsiveness as some of the shortfalls of the ‘common rule’. Over and above this, the wave of globalisation driven by information technology that took place at the turn of and late 20th century served only to accentuate its shortfalls. We begin our case for the ‘final rule’ with a look at globalization, a phenomenon with far reaching implications that has occupied the most eminent of thinkers recently.

For more concise overview of the revisions to the common rule and summary of the final rule see CITI program notes: Everything About the Revised Common Rule and CITI Program

Doing Globalization Differently and How this Ushers the ‘Final Rule’

In a Davos 2017 round table discussion hosted by Bloomberg’s Francine Lacqua “The Crisis Of The Middle Class” then Italian Economy and Finance minister, Pier Carlo Padoan, painted a picture of globalization in the 21st century.  Padoan submited that globalization will assume a form where national policies of nation states will shape global policy.

At the turn of the 21st century, the hashtag term was collaboration. To be with the times and sound more scinetific, one had to tout how their project illustrated collaboration within and beyond borders and disciplines. Today, with Brexit, plateauing of the rise of China, a rising Africa, #MeToo and the Trump presidency, the debate is now on how to better do globalization. As the world becomes multi-polar, the question of “those left behind by globalization” is ever more pressing as new voices emerge.

For the global research and development industry, doing globalization better demands mindfulness of changes nee by the fourth industrial revolution and climate change, and their anticipated effects on health research. For international health research, the birth of multinational super brands thanks to M&A activity in the contract research organizations space adds to the conundrum. These M&A activities layer potential company culture conflicts atop existent sociocultural dogmas and preexisting normative and structural ethical dilemmas within health research ethics.

This events can mean only one thing: That a rethink is needed. We simply need new tools, even if the new tools are merely improvements on existing ones. This is need what the ‘final rule’ seeks to be – at least, it was designed to be that way.

Designing Health Research Ethics Mechanisms for 21st Century Collaborative Health Research

An indictment of just how hard it is designing health research regulatory mechanisms for the 21st century  (and just how inadequate the ‘common rule’)  is found in the paper by Meslin, Were & Ayuku : “Because It Was Hard …”: Some Lessons Developing a Joint IRB Between Moi University (Kenya) and Indiana University (USA) . Here, these bioethics scholars argue for a responsive international health research ethics landscape. A research regulatory system sensitive to: socio-cultural differences and the developmental stage of the countries.

In another paper by the same authors,  Taking Stock of the Ethical Foundations of International Health Research: Pragmatic Lessons from the IU–Moi Academic Research Ethics Partnership. The authors offer why such degree of responsiveness is desired. One of the ways this has been achieved is vide the Obama’s bioethics commission. The authors vouch for the submissions of a report of the International Research Panel convened by the commission. Thanks to the report, we are guided on the realities that a modern health research ethics ought be cognizant of. I quote:

Rules, standards, and practices vary greatly around the globe. Not all transnational or national rules, standards, and practices are the same, nor are they harmonized. In addition, rules may be interpreted or implemented differently as a result of complex cultural, political, and economic influences.

Out With The old, into the New Frontier in Health Research Ethics: Enter the ‘Final Rule’

With the common rule stuck in 2005 after a decade of minimal reviews, the gap is indeed yawning. 21st century realities require that the successor to the common rule be guided by a new worldview. Of the three models of public administration, the salient qualities of  responsive governance: emphasis on process over outcome; citizens and stakeholder interests over customers; responsiveness over professionalism e.t.c., better suit resolution of ethical dilemmas in the 21st century.

The ‘final rule’ does exactly that. The final revisions to the “Common Rule” achieves this by fronting a reflexive approach to health research ethics. Refelexivity in biomedical research desires research participants  be active partners rather than passive subjects in health research. With a broad brush, what this means for human subject health research echos the stipulates of the European Union’s Horizon 2020. This approach to responsible research and innovation spells out a path to ethical biomedical research via these principles:

  • Engaging society more broadly in its research and innovation activities,
  • increasing access to scientific results,
  • ensuring gender equality, in both the research process and research content,
  • taking into account the ethical dimension, and
  • promoting formal and informal science education.

Disclaimer: The views expressed in this article, do not necessarily represent the official policy, standpoints or views of DeliverAfya.Org or Caleb & Sylvester Health, its employees, affiliates or partners. They are intended to inform.

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