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Health Research Ethics: Final Rule Seeks To Respond To Realities of 21st Century Human Subject Research

Discomforts that arise from the conduct of research involving humans subjects- be it social, behavioral, collaborative or transdisciplinary health research- are the bread and butter of health research ethics.  Health research ethics, in our books, is the delicate balance of the altruistic demands of science on those individuals who elect to assume risk (human subjects) and the duty of researchers in preserving their human dignity.

Taking the lead in crafting a solution to this central problem of ethical conduct of research have been the Americans. This (leadership role), is an apparent extension of their defacto status as world police in the aftermath of World War II. Notably, for human subject research, the horror showcase that was the Nuremberg trials demanded action.

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 by the generous contribution of the American taxpayer to human advancement. Through various federal agencies,  the United States of America bank rolls the majority of biomedical research.

Following the money in human subject research, often reveals a case of whoever pays the piper choosing the tune. In order to qualify for research funding  from American dollars- especially for NIH funded research- 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

To understand the architecture of biomedical research funding, we will be better served unpacking collaborative multinational health research. This is because it is easier to follow the money in international health research. Reducing the layered process of design and implementation of biomedical research to money speak, allows us to better characterize the big brother role that federal agencies play in regulation of human subject research.

Funding for Health Research & How 21st Century Interpretations of NPM are in play

Here, money (NIH and other federal agents money) flows from the rich north, to the poorer south. 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 21st century interpretations of the principles of The New Public Management (NPM). 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.

Three models of public administration

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

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

The key assumption that drives NPM interventions is that everyone is motivated by the desire to maximize personal preferences. Such an 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 in turn seen attempts at  modelling the concept of “Fair Study Benefits”.

What is the 10/90 gap in health 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

On the other hand, resource providers (American taxpayers/pharmaceutical, biomedical and medical devices firms) strive for maximizing returns for their capital. As a consequence, we’ve ended up with 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 writing 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, it is easy to find semblance between the 10/90 gap and the disaster of “structural adjustment” policies. Both are products of  public management constructs. 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.

How The Final Rule Is Different From The Common Rule:

With a broad brush, being alive to these developments in practice and new challenges gives the successor to the ‘Common Rule‘, the final revisions to the “Common Rule” or simply: the ”Final Rule”; the requisite edge to guide 21st century health research ethics.

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

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

“was 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 such as the human genome project; reversal of trends in HIV/Aids-the worst pandemic in modern times known to mankind; gene editing technology; artificial intelligence and emergence of behavioral economics.

But the “Common Rule”  hasn’t always been enough. 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”.

Doing Globalization Differently and How this Ushers the “Final Rule”

At the turn of the 21st century, the rave was on collaboration within and beyond borders and disciplines. Today with Brexit and the Trump presidency, the debate is on how to better do globalization. The two happenings with geopolitical implications shed light on the phenomenon of “those left behind by globalization”.

For the global research and development industry, doing globalization better demands mindfulness of changes nee by the fourth industrial revolution and their anticipated effects on health research.  For international health research, the birth of multinational super brands thanks to M&A activities in contract research organizations space adds to the conundrum in 21st century health research ethics.These M&A activities layer potential company culture conflicts atop existent sociocultural dogmas.

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 is achieved is vide 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.

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