+1(978)310-4246 credencewriters@gmail.com
  

This case comes from an article written by two university professors. It was published in:

https://theconversation.com/the-ethical-case-for-allowing-medical-trials-that-deliberately-infect-humans-with-covid-19-144240

Read the case below and address the questions that follow:

The ethical case for allowing medical trials that deliberately infect humans with

COVID-19

Despite the urgent need to beat COVID-19, health officials may be delaying the development of an effective vaccine.

Authorities in the U.S. and elsewhere are yet to authorize an ethically charged research procedure called “

human challenge trials

” Challenge trials entail deliberately infecting volunteers with the disease – which explains the official reticence – but they could substantially expedite the development of a vaccine.

The debate over human challenge trials has been

raging for months

among health professionals and academics. But only now – some eight months into the pandemic – are

authorities in the U.S. beginning to consider

them in a bid to speed up the vaccine-development process.

Sitting and waiting

A vaccine has to

go through multiple stages

(链接到外部网站。)

before it can be rolled out. After establishing its ability to trigger an immune response and its safety, developers must test it for efficacy. Inefficient vaccines may not justify the tiny risk inherent even in safe vaccines, may be enormously wasteful, may divert resources from better alternatives and may harm immunization rates.

There are two principal ways with which to measure efficacy. Under the conventional method, researchers vaccinate tens of thousands of volunteers and then passively wait for some of them to get infected. The frequency of infection is then compared to a non-vaccinated control group.

In the second method, human challenge trials, a much smaller group of volunteers is intentionally infected after receiving the experimental vaccine or a placebo. This allows for a much faster and efficient determination of vaccine efficacy.

To date,

more than 33,000 people from 151 countries

(链接到外部网站。)

e trials for COVID-19 in the U.S. or other Western countries. This means that vaccine developers are forced to vaccinate many more volunteers –

typically about 30,000 are involved

for each candidate vaccine – and then release them into the general population, with the hope that enough data would soon accumulate.

This is

where we presently are in the U.S.

waiting for enough participating volunteers to catch the virus by happenstance.

Paradoxically, these giant and expensive studies – American taxpayers have already spent

billions of dollars on vaccine development

– are slowed down by government efforts to minimize infection rates through quarantines, closures, masks usage or social distancing. Back in May, leading developers of potential COVID-19 vaccines, including the biotechnology company Moderna and Oxford University,

issued a warning

that low-level infections among their volunteers may delay the development of their vaccines.

It is possible, of course, that the conventional studies will

yield the required data

(链接到外部网站。)

. But there is a distinct possibility that challenge trials could speed up things.

Medical ethics

Opposition to human challenge studies for COVID-19 is based, first and foremost,

on ethical considerations

(链接到外部网站。)

. Since at present there is no cure for COVID-19, intentional infection can result in death or serious impairments. It is therefore

argued by people like Michael Rosenblatt

(链接到外部网站。)

, a former dean of Tufts University School of Medicine and a present adviser to Moderna, that the risks are too high, and that volunteers cannot give a valid “informed consent” for intentional infection.

The argument that willing adults cannot consent to risking their health for the greater good is, we believe, inconsistent with how society views other acts of volunteerism. Volunteer firefighters, for example, also face unknown dangers. Moreover, few countries refrain from risking the health and lives of their young citizens on the world’s battlefields, if they deem that the common good requires such sacrifice. And while COVID-19 human challenge trials would include only volunteers, most battlefields also include people who are forced into service.

Delaying a vaccine may also endanger volunteering health care workers. Current estimates put the number of U.S. health care workers’ deaths from COVID-19

at around 1,000

(链接到外部网站。)

. Health care volunteers continue risking their lives as long as vaccine development is delayed.

The opposition to human challenge trials derives from justified sensitivity to medical experiments on humans, and the horrific history of such experiments – which often ignored the interests and rights of their subjects. These included

the experiments performed by the Nazis

(链接到外部网站。)

on prisoners or the

notorious Tuskegee Study

(链接到外部网站。)

of untreated syphilis, which was conducted on unsuspecting African Americans. And of course, even medical experiments that subjects consent to

can go terribly wrong

(链接到外部网站。)

.

Lives at stake

But rapid development of an effective vaccine could save hundreds of thousands of lives worldwide. At present, more than

5,000 people die of COVID-19 each day

(链接到外部网站。)

. At that rate, every month of delay in vaccine availability costs 150,000 lives.

The indirect costs are tremendous as well. For example, the United Nations recently announced that pandemic-linked hunger is tied to

10,000 child deaths each month

(链接到外部网站。)

. From these perspectives, the arguments against human challenge trials appear far less convincing.

We believe that the decision to allow human challenge trials for COVID-19 should not be examined solely through the narrow lens of medical ethics – with its cardinal principal of doing no harm to the individual patient or the volunteer. The COVID-19 epidemic is a global disaster, and decisions concerning it should be made with the wider perspectives of public health and general morality. In other words, the decision may be more suitable for high level policymakers than for medical ethics committees.

In April,

some American lawmakers did weigh in

(链接到外部网站。)

: 35 members of the U.S. House of Representatives sent a letter to the heads of the U.S. Food and Drug Administration and the Department of Health and Human Services, voicing support for human challenge trials. So far, however, this effort has had no effect.

There is no doubt that human challenge trials carry significant risks for volunteers; but they also carry the chance of significant benefits for humanity. Instead of regarding these volunteers as uninformed, society may do better to valorize their altruism and heroism.

We believe that, given present circumstances, human challenge trials for COVID-19 are not morally wrong: To the contrary, they express humanity’s most noble values.

(highlight added)

Assignment

You are a senior member of the

U.S. Food and Drug Administration (FDA).

Stephen Hahn, Commissioner of the FDA has called a meeting of his top leadership team and tells them that he wants a vote on implementing “human challenge trials.” This means that volunteers will be infected with COVID-19 and those who show symptoms of the disease will then be vaccinated with various trial drugs to determine their effectiveness.

In three or four detailed paragraphs respond to the following

:

As a senior member of the FDA, what ethical issues are you

facing with your vote?

Review the information provided in Chapter 2 of our text to make an informed response.

Take a close look at how the “Eight Steps to Sound Ethical Decision Making in Business,” on page 53, might apply to this scenario.

When the Commissioner brings the issue to a vote – will you vote to permit “human challenge trials,” and agree with the authors of the above article, or not? Explain your rationale.

Opinion
OPINION | DUFF MCDONALD
Harvard Business School earns an incomplete
in ethics
CHARLES KRUPA/ASSOCIATED PRESS/FILE
The Baker Library on the Harvard Business School campus.
By Duff McDonald
SEPTEMBER 25, 2017
If you spend too much time watching cable news, you could be forgiven for thinking that our
country’s most pressing problem is that the gap between left and right is widening every day.
But is it, really? The fringes may be moving farther away from the rest of us, but the center,
for what it is, still holds. The majority of us are not unreasonable people. Here’s what is
widening: the gap between the haves and the have-nots. The ruling class of American society
has untethered itself from the rabble, and is pulling away in a ship full of stock options,
excessive pay, and tax shelters.
The ruling class, of course, sees things a little differently. Their view can be found in the
multi-year “US Competitive Project” out of the educational nucleus of establishment power,
the Harvard Business School, a “fact-based” effort to understand how American inequality
can be on the rise even as the country’s largest firms are prospering. Surveys of HBS alumni
(of their opinions, which aren’t really facts) point to reasons galore — taxes, infrastructure,
regulation — but none so simple as the truth: that the decisions of actual people have made it
so, with MBAs foremost among them.
The latest such report, released earlier this month, points the finger at self-interested
politicians. Last year’s was at least surprising, in that it tried to present inequality as
something that is equally felt by all. At which point, those pesky facts intervened: between
2000 and 2014, real incomes fell for the 60th percentile and below, but were flat or rising for
the 80th percentile and above. Our goal, the authors concluded, should not be “reducing
inequality,” but “creating shared prosperity.” That’s the kind of thing you say when you’re on
the winning side of an imbalance, where it becomes difficult to recognize, let alone admit,
your own ethical failings.
We’re not even talking about illegal stuff, such as fraud, price-fixing, or employee
discrimination. We’re talking about the thorny questions: How much should CEOs be paid?
What responsibilities do organizations have to their communities? To whom is a director of a
public company accountable?
i
i h b
ki
h f h l d
f fi
kl
© 2017 Boston Globe Media Partners, LLC
hi
h
CAREER PLANNING
Why We Created the MBA Oath
by Max Anderson
JUNE 08, 2009
I am part of a team of 25 graduating Harvard MBAs who created the MBA Oath, pledging to lead
professional careers marked with integrity and ethics. My classmates and I are aware of the low
opinion many people have of MBAs, especially in the wake of the financial crisis. We don’t want to
be known as the least respected profession in America (though some polls say MBAs hold that
distinction). We want to be known as professionals, who look after the best interests of their clients,
customers, employees and shareholders.
Our goal is to begin a widespread movement of MBAs who aim to lead in the interests of the greater
good and who have committed to living out the principles articulated in the Oath. This year, U.S.
schools will award more than 100,000 MBA degrees, more than twice the number of law degrees and
medical degrees combined. And yet the MBA does not make you a professional like these other
degrees do. What if it did?
The oath began as a voluntary, opt-in grassroots initiative among our classmates to get 100 HBS
students to sign by graduation. We based our oath language largely on a draft of an oath completed
by Professors Nitin Nohria and Rakesh Khurana in the Harvard Business Review last October, with a
few edits of our own. We thought 100, or more than 10% of the class, would have symbolic power.
As of June 8, 2009, more than 50% of Harvard’s graduating MBA class has signed the oath. Beyond
Harvard, more than 200 students at other business schools, from Stanford to Wharton to Oxford,
have also signed the Oath. Just this week, we received a request to translate the oath into Spanish for
an MBA program in Colombia.
The oath is a voluntary pledge for graduating MBAs to create value responsibly and ethically. The
oath begins with the following premise and conclusion:
“As a manager, my purpose is to serve the greater good by bringing people and resources together to
create value that no single individual can build alone. Therefore I will seek a course that enhances
the value my enterprise can create for society over the long term.”
We hope the Oath will accomplish three things: a) make a difference in the lives of the students who
take the oath, b) challenge other classmates to work with a higher professional standard, whether
they sign the oath or not and c) create a public conversation in the press about professionalizing and
improving management. The third goal may be the easiest to measure. We’ve been featured on NPR,
the Economist, The New York Times, The Financial Times, and countless blogs. Whether they agree
with us or not, people are talking about business’s duties to society, which we think is a healthy
development.
As for the first two goals, only time will tell. The power of the oath is not in the moment of taking it,
but in the thousands of decisions which are later influenced by the oath. Substantial research
suggests that public commitments of this kind do influence behavior, even in the absence of a
“stick” to punish non-conformity to the principles. That said, we are exploring ideas to give the oath
some “teeth” in the form of peer accountability and welcome any suggestions.
We are hopeful that this is an important, if small, step towards professionalizing management,
restoring public trust in MBAs, and building a more ethical, thoughtful business culture.
This article is about CAREER PLANNING
 FOLLOW THIS TOPIC
Related Topics: ETHICS
Comments
Leave a Comment
POST
0 COMMENTS
 JOIN THE CONVERSATION
POSTING GUIDELINES
We hope the conversations that take place on HBR.org will be energetic, constructive, and thought-provoking. To comment, readers must sign in or
register. And to ensure the quality of the discussion, our moderating team will review all comments and may edit them for clarity, length, and relevance.
Comments that are overly promotional, mean-spirited, or off-topic may be deleted per the moderators’ judgment. All postings become the property of
Harvard Business Publishing.
SHORT VERSION
As a manager, my purpose is to serve the greater good by bringing together people and resources to
create value that no single individual can build alone. Therefore I will seek a course that enhances the
value my enterprise can create for society over the long term. I recognize that my decisions can have
far‐reaching consequences that affect the well‐being of individuals inside and outside my enterprise,
today and in the future. As I reconcile the interests of different constituencies, I will face difficult
choices.
Therefore I promise:
1. I will act with utmost integrity and pursue my work in an ethical manner.
2. I will safeguard the interests of my shareholders, co‐workers, customers and the society in
which we operate.
3. I will manage my enterprise in good faith, guarding against decisions and behavior that
advance my own narrow ambitions but harm the enterprise and the societies it serves.
4. I will understand and uphold, both in letter and in spirit, the laws and contracts governing
my own conduct and that of my enterprise.
5. I will take responsibility for my actions, and will represent the performance and risks of my
enterprise accurately and honestly.
6. I will develop both myself and other managers under my supervision so that the profession
continues to grow and contribute to the well‐being of society.
7. I will strive to create sustainable economic, social, and environmental prosperity worldwide.
8. I will be accountable to my peers and they will be accountable to me for living by this oath.
This oath I make freely, and upon my honor.
FULL VERSION
Preamble
As a manager, my purpose is to serve the greater good by bringing together people and resources to
create value that no single individual can build alone. Therefore I will seek a course that enhances the
value my enterprise can create for society over the long term. I recognize that my decisions can have
far‐reaching consequences that affect the well‐being of individuals inside and outside my enterprise,
today and in the future. As I reconcile the interests of different constituencies, I will face difficult
choices.
Therefore I promise:
1. I will act with utmost integrity and pursue my work in an ethical manner. My personal
behavior will be an example of integrity, consistent with the values I publicly espouse.
2.
I will safeguard the interests of my shareholders, co­workers, customers and the
society in which we operate. I will endeavor to protect the interests of those who may not
have power, but whose well‐being is contingent on my decisions.
3.
I will manage my enterprise in good faith, guarding against decisions and behavior
that advance my own narrow ambitions but harm the enterprise and the people it
serves. The pursuit of self‐interest is the vital engine of a capitalist economy, but unbridled
greed can be just as harmful. I will oppose corruption, unfair discrimination, and
exploitation.
4.
I will understand and uphold, both in letter and in spirit, the laws and contracts
governing my own conduct and that of my enterprise. If I find laws that are unjust,
antiquated, or unhelpful I will not brazenly break, ignore or avoid them; I will seek civil and
acceptable means of reforming them.
5.
I will take responsibility for my actions, and will represent the performance and risks
of my enterprise accurately and honestly. My aim will not be to distort the truth, but to
transparently explain it and help people understand how decisions that affect them are
made.
6.
I will develop both myself and other managers under my supervision so that the
profession continues to grow and contribute to the well­being of society. I will consult
colleagues and others who can help inform my judgment and will continually invest in
staying abreast of the evolving knowledge in the field, always remaining open to innovation.
I will mentor and look after the education of the next generation of leaders.
7.
I will strive to create sustainable economic, social, and environmental prosperity
worldwide. Sustainable prosperity is created when the enterprise produces an output in the
long run that is greater than the opportunity cost of all the inputs it consumes.
8.
I will be accountable to my peers and they will be accountable to me for living by this
oath. I recognize that my stature and privileges as a professional stem from the respect and
trust that the profession as a whole enjoys, and I accept my responsibility for embodying,
protecting, and developing the standards of the management profession, so as to enhance
that trust and respect.
This oath I make freely, and upon my honor.

Purchase answer to see full
attachment

  
error: Content is protected !!