Unit 3 Learning Outcomes

After completing Unit 3 the student will be able to:

1. Explain the importance of principles of ethical conduct in research using human and
animal subjects.
2. Analyze the notion of informed consent with respect to research involving human
subjects.
3. Analyze the conditions under which research involving human subjects is morally
permissible.
4. Analyze the principle of equal consideration of interests with respect to using animals for
scientific research.
5. Analyze the conditions under which research involving animal subjects is morally
permissible.
6. Summarize short arguments on a variety of issues in science and technology.

Introduction to Unit 3: Ethical Conduct in

Research
To introduce ourselves to the topic ethical conduct in scientific research, consider below the real
life case of Jesse Gelsinger (1981–1999):

Gene therapy is viewed as having the potential to produce the most impressive advances in
medical treatment. In 1992, an investigator with an excellent reputation as a genetic researcher
founded a company with the intent to commercialize successful gene therapies. Corporate
investors contributed millions of dollars to this company. Following the establishment of this
business venture, the investigator designed a clinical trial in which a genetically engineered cold
virus was used to deliver genes to correct a genetic liver disorder. This virus had been tested in
animals, but not yet in humans, prior to the beginning of the trial. The investigator’s original
proposal involved testing this gene therapy in terminally ill newborns, but this plan was rejected
by the institutional bioethicist. Following this setback, the investigator modified the proposed
research protocol and decided to test the gene therapy on stable patients with the previously
identified genetic liver disorder. Institutional approval was provided in 1995, and the trial
commenced at multiple study sites. In 1999, Jesse Gelsinger, an 18-year-old subject who had the
genetic liver disorder, but was asymptomatic and living a normal life, was enrolled in this gene
therapy clinical trial at the University of Pennsylvania.

At the same time, researchers from other study sites began to contact the investigator expressing
concern about the safety of the use of the cold virus. The trial continued, and Jesse Gelsinger, the
next to last patient enrolled in the clinical trial, received a dose that was 300 times the dose
received by the first patient. Gelsinger died from a massive immune system response to the gene
therapy. The Food and Drug Administration (FDA) immediately shut down all gene therapy
research at the University of Pennsylvania. . .

Questions raised by the death of Jesse Gelsinger

Should high-risk research be conducted on “healthy, stable” persons?

Was this particular research protocol ready for human trials?

Were adverse events ignored? Misinterpreted? Apparent only in retrospect?

Did a financial conflict of interest (the investigator owned the gene therapy company) bias the
researcher’s judgment?[1]

In this unit we will examine ethical principles of responsible conduct in scientific research that
involve human and animal subjects. A number of highly publicized cases of research
misconduct, such as the Jesse Gelsinger case above, have alarmed members of the public and
made them question whether sufficient controls are placed on scientists.[2] In response to these
worries, many universities now require that all science majors receive instruction in research
ethics. One of the leading ethical concerns stemming from the Gelsinger case was that a
participant was “not given full information about the risks of participating in this study.”[3] One
might ask, for instance, had he known of the risks, would he have signed up as a participant in
the first place?

These considerations point us toward an important ethical concept that is found in much of
applied ethics: informed consent. In this context, informed consent refers to the process by
which a participant grants permission to participate on the basis of relevant information and
facts. That is to say, consent is granted by a participant on the basis of being informed of the
relevant risks and consequences of their participation. This notion of informed consent lies at the
heart of much of bio-medical ethics and research ethics today.

The roots of the justification for informed consent go back at least to Kant’s deontological ethics
(you may recall here Callahan’s discussion of Kant’s ethics in the assigned Unit 2 reading). Kant
had argued that the most basic and essential feature of humanity was (what he called) “rational
autonomy.” Contemporary Kantians often refer to this Kantian notion as the human capacity for
“reflective endorsement,” namely, the human capacity to rationally consider (and ultimately
endorse) the merit of one course of action over another on the basis of reasons. From out of this
notion, Kant had generated an ethical principle that is often referred to as his principle of
“respect for humanity.” This principle ultimately requires that the rational autonomy of human
beings ought to be respected and never disrespected. In more applied terms, respect for
autonomy means that one should not intentionally deceive or mis-inform a human being who is
trying to form a judgment on the basis of available facts. In other words, proper respect for
humanity means that simply receiving consent from someone is not itself ethically sufficient;
that consent must also be informed.
From this perspective we can see how the Gelsinger case could be seen as a case of ethical
failure on the part of the researchers. Gelsinger may have willingly consented to participation,
but he did not do so on the basis of the relevant information (e.g., on the basis of the risks). This
would therefore be considered, according to Kantians, to be an instance of the ethical failure to
respect the rational autonomy of a human being.

From these considerations we can draw upon the “structure of moral reasoning” that was
presented by Callahan (pp. 14–15) in the previous unit to help elucidate this particular moral
judgment:

Premise 1: It is morally wrong to disrespect rational autonomy (general moral principle).

Premise 2: The gene therapy researchers did not respect the rational autonomy of Jesse
Gelsinger (factual claim).

Conclusion: The gene therapy researchers were morally wrong in their treatment of Jesse
Gelsinger (moral judgment).

A number of noteworthy considerations can be drawn from this moral argument concerning the
gene therapy research. First of all, it is worth noticing that the first premise was not drawn from
science itself. Right or wrong, we have here a moral argument about science that requires our
thinking to go outside of science. Going “outside of science” does not therefore mean
abandoning logic or good reasoning. It simply means drawing upon reasoned considerations that
stem from thinking deeply and seriously about the human condition (as Kant did).

Second, notice that this particular moral judgment was drawn without appeal to the law or the
legal system. It could be that the researcher’s actions were illegal (or even legal), but either way
the conclusion in this argument claims that their actions were morally wrong. Here we can see
why ethics and legality are not necessarily synonymous. They may often overlap, but they are
not wholly identical.

Third, there are a number of ways in which this argument could be evaluated and criticized. It
may be helpful once again to return to the ways in which Callahan suggested that one could
evaluate moral arguments (pp. 15–19). One might, for instance, reject premise 1 as an adequate
moral principle. Or perhaps one might claim that the researchers did sufficiently respect Jesse
Gelsinger’s rational autonomy. To engage in these sorts of questions and dialogue is what it
means to engage in what Callahan calls “moral debate.”

As you can imagine, the moral debate(s) surrounding the issue of research ethics can become
quite varied and complicated. Perhaps we might think that the moral failure in the case of Jesse
Gelsinger is clear-cut, but what if Gelsinger was not rational, that is, cognitively disabled?
Would that warrant the researchers for treating him in this way? Or, what if not informing one
research participant contained the potential reward of curing the diseases of thousands upon
thousands of people? Or, what if the subjects of the research were non-human animals? Non-
human animals do not even have a capacity to provide informed consent, so does this mean
researchers can treat them in whatever way they want?
These are certainly not easy questions to answer. The readings in this unit outline the terrain
surrounding these questions and seek to provide a pathway toward generating thoughtful and
reasoned responses.

In order to help keep certain topics clearer in our minds, we will separate the sets of readings for
this unit into two parts.

In the first part, one of the required readings will have us returning to On Being a Scientist, in
which the authors discuss “Human Participants and Animals Subjects in Research.” The second
reading within this part, by Roy, Williams, and Dickens, provides a historical background to
research ethics involving humans. These three authors ultimately provide an account of the
conditions under which research on human subjects should be considered morally permissible.

In the second part of assigned readings, from Singer and then Taylor, we find authors who are
more specifically dealing with the topic of using non-human animals in scientific research.
Singer’s arguments have been particularly influential in contemporary bio-ethics.

Our unit will then conclude with a “Tools for Analysis” section in which we will discuss the skill
of summarizing arguments.

[1] Janet Houser, Nursing Research (Boston: Jones and Bartlett, 2008). 64.

[2] For allegations of misconduct by the Food and Drug Administration against the principal
investigator in this case, see Food and Drug Administration, Centre for Biologics Evaluation and
Research, “Notice of Initiation of Disqualification Proceeding and Opportunity to Explain,”
November 30, 2000.

[3] Jocelyn Downie and Matthew Herder, “Reflections on the Commercialization of Research
Conducted in Public Institutions in Canada.” McGill Journal of Law and Health 1, no. 1 (April
2007): 39. Available at https://mjlhmcgill.files.wordpress.com/2017/07/mhlp-full-text.pdf

Required Readings 3A
Guiding Questions
As you do the required reading, keep the following questions in mind:

1. What are some of the benefits of scientific research? What kinds of harm can scientific
research cause?
2. Have you ever heard of a case of unethical scientific research? What features of the
research made it unethical? For example, certain medical experiments conducted in Nazi
Germany are widely considered to have been unethical.[1]
3. Under what conditions is research on human subjects ethical? What role does informed
consent play in this topic?
Read the Following
“Human Participants and Animals Subjects in Research ,” by the Committee on Science,
Engineering, and Public Policy

“Research Ethics: Historical Background ” by David J. Roy, John R. Williams, and Bernard M.
Dickens

Footnotes

[1] See, for example, Robert Jay Lifton, Medical Killing and the Psychology of Genocide: The
Nazi Doctors (New York: Basic Books), 1986.

Study Guide Questions 3A

1. Under what conditions do Roy, Williams, and Dickens claim that it is morally justifiable
to use humans in scientific experimentation?
2. Would you say that Roy, Williams, and Dickens employ a teleological or deontological
approach to research ethics on humans? Justify your answer (you may find it help to
consult Callahan, pages 19–21, for this question).
3. What role do you think informed consent should play in research ethics involving human
subjects? Do you think informed consent is sufficient for covering all cases of research
on humans? Why or why not?

Required Readings 3B
There has been a marked change in public opinion about the use of animals in scientific
experimentation over the last several years. Partly as a result of this shift in public opinion,
changes have been made in laboratory practice. Fewer animals are used to demonstrate
biological principles in classrooms, for example. Nevertheless, a significant number of animals
are still used, especially in experiments designed to determine whether drugs and other
commercial products are safe and effective.

In this section, we will first read a statement about the ethics of animal investigation by the
Canadian Council on Animal Care, which was founded in 1968 as a standing committee of the
Association of Universities and Colleges of Canada “to work for the improvement of animal care
and use on a Canada-wide basis.”[1]
You will note that the Canadian Council on Animal Care assumes that the use of animals in
scientific experimentation is both necessary and justifiable, as long as certain principles are
followed. This assumption is questioned by those who consider animal experimentation to be
unjustifiable exploitation. The second reading for this section is written by Peter Singer, a
philosopher who has influenced the thinking of many people who oppose animal
experimentation. As you read the two selections, take careful note of the ethical principles used
to support the positions presented. Does Singer oppose all experimentation on animals? Under
what circumstances does he think it is justifiable?

Read the Following

“Appendix XV: Ethics of Animal Investigation ” by the Canadian Council on Animal Care

“All Animals Are Equal . . . ” by Peter Singer

“Tools for Research ” (excerpt) by Peter Singer

Footnotes

[1] Canadian Council on Animal Care, Guide to the Care and Use of Experimental Animals, vol.
1, 2nd ed., edited by Ernest D. Olfert, Brenda M. Cross, and A. Ann McWilliam (Ottawa:
Canadian Council on Animal Care, 1993) 1.

Study Guide Questions 3B

1. Under what conditions does the Canadian Council on Animal Care think it is justifiable
to use animals in research?
2. What does Singer mean by “speciesism”? Do you think it is a violation of the principle of
equality in the same way that racism and sexism are?
3. What is Singer’s “principle of equality”? Why does Singer think the principle applies to
members of species other than our own? How would society’s treatment of animals
change if we followed his principle of equality?
4. How does Singer employ use his principle of equality for determining when experiments
using animals are justifiable? Do you find the principle plausible? Why or why not?
Defend your answer carefully, making reference to the steps of Singer’s argument.
Tools for Analysis: Summarizing Arguments

In thinking through ethical issues in science and technology, it is useful to start from a
consideration of positions taken by people who have thought and written about the issue from
various points of view. It is important to be able to summarize their arguments accurately, to
demonstrate your understanding of their positions, and to prepare to evaluate them fairly. This
will give you a solid starting point from which to develop your own position.

In this section we briefly discuss how to summarize an argument. The same steps can be
followed in summarizing an entire article, or even a book, although the task will be more
complex. In subsequent units, we present standards for evaluating moral arguments.

In Unit 2 we discussed two important components of summaries of arguments:

 a statement of the issue in question, and

 a statement of the range of answers considered by the author.

The other important components are:

 statements of the answer or conclusion drawn,

 the reasons given to support the conclusion, and
 any unstated assumptions upon which the argument depends.

We will illustrate the parts that compose an argument summary by discussing three pages of the
argument by Peter Singer that animals feel pain. We will then show in a paragraph-length
summary how the parts fit together. Turn to the first reading by Peter Singer, “All Animals are
Equal . . .” and re-read page 9 (starting with the third full paragraph) to page 11.

The five steps to take in summarizing arguments are as follows:

Steps for Summarizing Arguments

Step 1. Identify the issue discussed by the author.
This step, and Step 2 below, were discussed in Unit 2. The issue discussed by
Singer in the argument we are considering is whether animals are capable of
suffering. If the argument you are summarizing is part of a longer work, you may
indicate the role of the argument in the overall thesis of the work.
Singer says he has to address the question of whether animals feel pain in order to
meet the objection that, since animals cannot suffer, there is no reason to say that
their interests should be taken into account in our deliberations about how to treat
them. In other words, if animals could not suffer, we could use them in any way
we chose.
It is preferable that you use your own words in summaries, to ensure that you
 understand the author’s position, although you may quote a few words of the
author if he or she has stated the issue clearly and briefly. Strive for accuracy in
your statement of the issue in question, in order to advance your own thinking
and to be fair to the author.
Step 2. Identify the possible answers to the issue question considered by the author.
Singer presents two possible answers to his issue question: “Yes, animals do feel
pain,” and “No, animals do not feel pain.” It is important to identify all answers to
the issue question discussed by the author. Later on in the course, when we
advance to the critical evaluation of arguments, you will want to ask whether an
author has considered all reasonable answers to the issue question. Without your
own reliable list of what the author does consider, effective critical evaluation
will be a challenge.
Step 3. Identify the author’s conclusion.
Singer concludes that animals can feel pain, which is a form of suffering.
Step 4. Identify the reasons (or premises) the author gives to support the conclusion.
Singer bases his argument that animals feel pain on the similarity of their
behaviour to the behaviour of humans in circumstances in which humans feel
pain, and on the similarity between the nervous systems of animals and humans.
He also notes the similar evolutionary histories of humans and animals and the
fact that pain has the evolutionary advantage of causing humans and animals to
avoid injuries. He acknowledges that, since we cannot directly experience the
pain of others, we cannot know with certainty that other humans are feeling pain,
but he dismisses this argument as a “philosophical puzzle” and concludes that, if
we assume that other humans feel pain, there is no reason to deny that animals do
too.
It is important that you focus on clearly and accurately reporting an author’s
reasons for his or her concluding judgment. This is because, when you are
evaluating an author’s position, it is not enough to simply agree or disagree with
it. For example, it will not do to say, “Singer believes that animals feel pain, but I
don’t think they do.” When tools of critical evaluation are introduced later in the
course, you will use those tools on the reasons for judgments and not on the
judgments themselves.
Step 5. Identify unstated assumptions.
This step is tricky, but it is an important one to complete. Most arguments rely on
unstated assumptions. For example, if you argue that researchers should obtain
informed consent from research participants in order to respect participants’
autonomy, you are assuming that autonomy is valuable and should be respected.
Someone who strongly disagreed, who wanted to argue that achieving research
results is more important than respecting autonomy, might identify your unstated
assumption in order to argue against it.
Unstated assumptions are more difficult to detect when you find yourself
agreeing with the author’s argument. Start by asking yourself if there are any gaps
in the author’s reasoning and what assumptions might fill out the argument. If
that doesn’t help, try pretending you are someone who strongly disagrees with
what he or she is reading. Still having problems? Get in touch with your tutor for
 assistance. Practice and acquaintance with a variety of ethical theories is
necessary to identify unstated assumptions, so do not be discouraged if you find
this step difficult.
In the pages we are summarizing, Singer assumes—but does not argue—that
there is nothing about non-human animals (e.g., a defense mechanism) that would
make us think they are feeling pain when they are not.

Below you will find a brief summary of Singer’s argument that animals are capable of suffering.

Note 1: An argument summary does not contain any criticism or evaluation of the argument.
This means that, when you summarize an argument, you report only on what the author’s
position is. You do not evaluate or criticize it. This does not mean you are being asked to agree
with what you are reading.

Note 2: In Assignment 1, one of the argument summary choices is from the Singer material we
have just analyzed. There is an important difference, however. If you choose to do the Singer
argument summary, it is much broader than his argument that many non-human animals feel
pain.

Sample Summary
On pages 9 to 11 of Animal Liberation, Peter Singer argues that animals are capable of suffering.
He does this to counter an objection to his view that the principle of equality applies to animals
as well as humans, and we must therefore take their interests into consideration in our treatment
of them. The objection he is responding to is that, since animals cannot suffer, they do not have
interests, thus we may treat them in any way we wish.

Singer’s argument is based on several similarities between humans and animals. Animals act in
ways similar to humans when they are injured, and have physiological responses similar to those
of humans in circumstances in which humans feel pain. Furthermore, humans and animals have
similar nervous systems and similar evolutionary histories. Singer also notes that the ability to
feel pain is an evolutionary advantage to both humans and animals, because it causes them to
avoid injury.

Singer acknowledges that, since we cannot directly experience the pain of others, we cannot
know with certainty that they are feeling pain, but he dismisses this argument as a “philosophical
puzzle” and concludes that, if we assume that other humans feel pain, there is no reason to deny
that animals do too.

In presenting his argument that animals are capable of suffering, Singer assumes, but does not
argue, that there are no differences between animals and humans that would make us think that
animals feel pain when they only appear to feel it.

Note: The tools for analysis will be of great help when writing your assignments and preparing
for the final exam.
Conclusion
In this unit you gained an elementary understanding of ethical concepts and principles of conduct
in scientific research involving human and animal research. In more advanced courses on
research ethics, other controversial issues may be introduced, such as concerns related to
eugenics and newgenics. In the next unit, we will continue our discussion of the ethical
responsibilities of scientists.

Bibliography
You may borrow most of the following books and articles from the Athabasca University
Library.

To view e-books, search for their titles in the AU Library Catalogue and follow the links.

Arluke, Arnold. Just a Dog: Understanding Animal Cruelty and Ourselves. Philadelphia: Temple
University Press, 2006.

Banyard, Philip. Ethical Issues and Guidelines in Psychology. London: Routledge, 2005. [E-
book]

Baylis, Françoise, Jocelyn Downie, Barry Hoffmaster, and Susan Sherwin. Chapter 8, “Research
Involving Human Subjects.” In Health Care Ethics in Canada, 2nd ed. Toronto: Nelson, 2004.

Birke, Lynda. Feminism, Animals, Science: The Naming of the Shrew. Bristol, PA: Open
University Press, 1994.

Canadian Council on Animal Care. Animal Care Committees: Role and Responsibilities. Ottawa:
Canadian Council on Animal Care, 1992.

_____. Guide to the Care and Use of Experimental Animals, Vol. 1, 2nd. Ed. Edited by Ernest D.

Olfert, Brenda M. Cross, and A. Ann McWilliam. Ottawa: Canadian Council on Animal Care,
1993.

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of
Canada, Social Sciences and Humanities Research Council of Canada. Tri-council Policy
Statement: Ethical Conduct for Research Involving Humans, Edition Aug. 1998, with 2000,
2002, 2005 amendments. Ottawa, ON: Interagency Secretariat on Research Ethics, c2005 (Saint-
Lazare, Quebec: Gibson Library Connections, 2009). [E-book]

Cavalieri, Paola. Questione animale. [English] The Animal Question: Why Nonhuman Animals

Deserve Human Rights. Translated by Catherine Woollard and revised by the author. Oxford:
Oxford University Press, 2001. [E-book]
Denzin, Norman K., and Michael D. Giardina, eds. Ethical Futures in Qualitative Research:
Decolonizing the Politics of Knowledge. Walnut Creek: Left Coast Press, 2007.

DeRenzo, Evan G., and Joel Moss. Writing Clinical Research Protocols: Ethical Considerations.
Burlington, MA: Elsevier Academic, 2006. [E-book]

Foster, Claire. The Ethics of Medical Research on Humans. New York: Cambridge University
Press, 2001. [E-book]

Gruen, Lori. “Animals.” In A Companion to Ethics. Edited by Peter Singer, 343–353. Oxford:
Basil Blackwell, 1991.

Harding, Sandra. Whose Science? Whose Knowledge?: Thinking from Women’s Lives. Ithaca,
NY: Cornell University Press, 1991.

Harding, Sandra, and Jean F. O’Barr, eds. Sex and Scientific Inquiry. Chicago: University of
Chicago Press, 1987.

Holton, Gerald. Einstein, History, and Other Passions: The Rebellion Against Science at the End
of the Twentieth Century. Reading, MA: Addison-Wesley, 1996. (See especially “Chapter 7: On
Doing One’s Damnedest: The Evolution of Trust in Scientific Findings,” a discussion of the
historical context of research ethics.)

Iltis, Ana Smith, ed. Research Ethics. London: Routledge, 2006. [E-book].

Kirsch, Gesa. Ethical Dilemmas in Feminist Research: The Politics of Location, Interpretation,
and Publication.Albany: State University of New York Press, 1999. [E-book]

Lemmens, Trudo, and Duff Waring Lifton, eds. Law and Ethics in Biomedical Research:
Regulation, Conflict of Interest, and Liability. Toronto: University of Toronto Press, 2006. [E-
book]

Loue, Sana. Textbook of Research Ethics: Theory and Practice. New York: Kluwer, 2002. [E-
book].

Resnik, David B. Playing Politics with Science. Balancing Scientific Independence and
Government Oversight.New York: Oxford University Press, 2009. [E-book].

Rollin, Bernard E. Animal Rights and Human Morality. Buffalo, NY: Prometheus Books, 1981.

_____ . The Unheeded Cry: Animal Consciousness, Animal Pain, and Science. Oxford: Oxford
University Press, 1990.

Sales, Bruce D., and Susan Folkman, eds. Ethics in Research with Human Participants.
Washington, DC: American Psychological Association, 2000.
Shamoo, Adil E., and David B. Resnik. Responsible Conduct of Research. Oxford: Oxford
University Press, 2003. [E-book]

Shrader-Frechette, Kristin. Ethics of Scientific Research. Lanham, MD: Rowman and Littlefield,
1994.

Singer, Peter. Animal Liberation, 2nd ed. New York: New York Review of Books, 1990.

Singer, Peter, ed. In Defence of Animals. Oxford: Basil Blackwell, 1985.

Sunstein, Cass R., and Martha C. Nussbaum, eds. Animal Rights: Current Debates and New
Directions. New York: Oxford University Press, 2004. [E-book]

Taylor, Angus MacDonald. Animals and Ethics: An Overview of the Philosophical Debate.
Peterborough, ON: Broadview, 2003.