i need help to begin to formulate ethical questions and make ethical considerations related to lab and diagnostic testing by identifying the components of these tests and identify reasons why each test might be ordered:

  • Complete Blood Count (CBC) with differential
  • Comprehensive Metabolic Panel (CMP)
  • Arterial Blood Gases (ABGs)
  • Urinalysis
  • Lipid Profile
  • Coagulation Studies
  • Cardiac Bio-marker

2. Create a table identifying at least two main reasons why each group of tests could be ordered. (Use the template below)

3-   Discuss your views on ethical issues in lab and diagnostic testing (refer to this weeks reading assignment articles), Your discussion may be based on the articles or you may introduce a different ethical dilemma.

TEST

INDICATION

1

Complete Blood Count

1. General patient assessment

2. Pre-operative screening

3. Monitor side effects from medication

2

Complete Blood Count with differential

3

4

5

6

7



the right not to know • spring 2014 19

Is There a Right
Time to Know?
The Right Not
to Know and
Genetic Testing
in Children
Pascal Borry, Mahsa Shabani,
and Heidi Carmen Howard

Introduction
In the last few decades, great progress has been made
in both genetic and genomic research. The develop-
ment of the Human Genome Project has increased
our knowledge of the genetic basis of diseases and has
given a tremendous momentum to the development of
new technologies that make widespread genetic test-
ing possible and has increased the availability of previ-
ously inaccessible genetic information. Two examples
of this exponential evolution are the increasing imple-
mentation of next-generation sequencing technolo-
gies in the clinical context and the expanding com-
mercial offer of genetic tests directly-to-consumers.

Firstly, the rapid development of next generation
sequencing technologies (i.e., high-throughput and
massively parallel DNA sequencing technologies)
has substantially reduced both the cost and the time
required to sequence an entire human genome. These
technologies are increasingly being used in the clinical
setting with the goal of diagnosing conditions of pre-
sumed genetic origin that cannot be explained by tar-
geted sequencing approaches. By exploring the whole
genome of individuals, the likelihood of detecting
genetic variants with reproductive or clinical implica-
tions, as well as genetic variants with unknown sig-
nificance, becomes an increasing reality.1 Cases are
being reported about the implementation of next
generation sequencing technologies in adults2 as well
as in children.3 A recent publication also showed the
potential benefit of using exome sequencing or whole
genome sequencing (WGS) in a symptomatic new-
born, allowing in a short time, the differential diag-
nosis and faster progression to genetic and prognostic
counseling.4 Looking at the entire genome will reveal
“incidental” findings, which are unrelated to the clini-
cal request, as well as a number of genetic variants for
which the meaning remains unclear. This new situa-

Pascal Borry, Ph.D., is Assistant Professor of Bioethics at the
Centre for Biomedical Ethics and Law (University of Leuven,
Belgium). He is the Programme Coordinator of the Erasmus
Mundus Master of Bioethics. Within the European Society
of Human Genetics, he is a member of the Professional and
Public Policy Committee (2008-2014) and an elected mem-
ber of the board (2012-2017). Pascal Borry is involved in
various national and international research projects, such
as Eurogentest, Genebanc, Engage, Eucellex and Pacita.
Mahsa Shabani, LL.M., is a Ph.D. researcher at the Center for
Biomedical Ethics and Law (University of Leuven, Belgium).
In 2011 she graduated from the Erasmus Mundus Master of
Bioethics program and subsequently has been involved in a
variety of research activities in t

THE ETHICS OF FERTILITY PRESERVATION FOR PAEDIATRIC CANCER
PATIENTS: FROM OFFER TO REBUTTABLE PRESUMPTION

ROSALIND MCDOUGALL

Keywords
fertility preservation,
paediatrics,
oncology

ABSTRACT
Given advances in the science of fertility preservation and the link between
fertility choices and wellbeing, it is time to reframe our ethical thinking
around fertility preservation procedures for children and young people with
cancer. The current framing of fertility preservation as a possible offer may
no longer be universally appropriate. There is an increasingly pressing
need to discuss the ethics of failing to preserve fertility, particularly for
patient groups for whom established techniques exist. I argue that the
starting point for deliberating about a particular patient should be a rebut-
table presumption that fertility preservation ought to be attempted. Consid-
eration of the harms applicable to that specific patient may then override
this presumption. I outline the benefits of attempting fertility preservation;
these justify a presumption in favour of the treatment. I then discuss the
potential harms associated with fertility preservation procedures, which
may justify failing to attempt fertility preservation in an individual patient’s
particular case. Moving from a framework of offer to one of rebuttable
presumption in favour of fertility preservation would have significant impli-
cations for medical practice, healthcare organizations and the state.

As long-term survival rates for paediatric cancers improve,
oncologists are increasingly focusing on patients’ future
quality of life beyond their immediate treatment.1 One
element of this broadened focus has been patient fertility.
Cancer treatments can have negative effects on patient
fertility, varying in degree depending on the nature of the
treatment. The risk of infertility approaches 100% for
some treatments,2 however the overall risk is much lower.
The British Fertility Society writes that:

[s]ome 15% [of children treated for cancer] will have a
high risk (95%) of early and irreversible gonadal

failure, whereas others may have lesser extents of com-
promised reproductive capacity.3

A range of fertility preservation strategies have been
developed that are applicable to this group of children
and young people. These strategies are outlined in
Table 1. Some of these strategies are experimental and
some are established techniques. All the strategies avail-
able for prepubertal patients are currently experimental.
My argument in this article applies primarily to the older
paediatric groups for whom established techniques exist,
and assumes that the patient is undergoing cancer treat-
ment with the intent of cure.

Given the rapid progress in the science of fertility pres-
ervation and the links between fertility choices and well-
being, it is time to reframe the ethical question posed in
relati

The Journal of Law, Medicine & Ethics, 45 (2017): 333-340. © 2017 The Author(s)
DOI: 10.1177/1073110517737531

controversies in clinical research ethics • fall 2017 333

The Continuing
Evolution of
Ethical Standards
for Genomic
Sequencing in
Clinical Care:
Restoring Patient
Choice
Susan M. Wolf

Introduction
Large-scale genome and exome sequencing is rapidly
moving from research investigation into clinical care.
When cancer patients fail to respond to conventional
treatment, sequencing can suggest new molecular
targets for chemotherapy and other treatment. When
children present with puzzling neurodevelopmental
anomalies, sequencing can shorten the diagnostic
odyssey by revealing potentially causative genetic vari-
ants. Sequencing can even be used to help diagnose
critically ill individuals in order to save lives.

With sequencing transitioning into clinical care,
controversy has erupted over how to manage inciden-
tal or secondary findings. Whenever a physician orders
genomic analysis for a particular indication, certain
genes are of focal concern and their analysis yields pri-
mary findings. However, sequencing, especially on a
large scale — potentially up to whole exome or whole
genome sequencing — may yield additional findings
on genes that are not germane to the original indica-
tion but nonetheless may hold clinical significance
because they indicate another risk, disease process, or
condition. An enormous literature now addresses the
question of how to handle these additional findings,
both in research and in clinical care.1

The American College of Medical Genetics and
Genomics (ACMG)2 — the leading professional soci-
ety for medical geneticists in the United States — has
issued a series of policy statements to guide manage-
ment of incidental or secondary findings that arise in
clinical sequencing. However, the complexity of this
issue has thwarted easy resolution. ACMG exercises
a leadership role in multiple domains of genomic
medicine, from clinical prescribing to laboratory prac-
tice, electronic health records (EHR), and insurance
coverage. But the question of incidental findings has
prompted College statements every year since 2012.

This article traces the evolution of ACMG policy on
incidental or secondary findings and argues that fur-
ther change is needed. Current ACMG policy urges a
regime involving a routine search for an expanding set
of extra genes, offering patients only an opt-out from
the entire set. The routinization of this search con-
tinues to constitute opportunistic screening without
the empirical foundation for this public health mea-
sure. Moreover, routine screening with an opt-out is
far different from informed consent offering patients
the opportunity to opt-in to extra testing. And forc-

Susan M. Wolf, J.D., is McKnight Presidential Professor of
Law, Medicine & Public P

SPECIAL ISSUE PAPERS

PRENATAL SCREENING: CURRENT PRACTICE, NEW DEVELOPMENTS,
ETHICAL CHALLENGES

ANTINA DE JONG, IDIT MAYA AND JAN M.M. VAN LITH

Keywords
prenatal screening,
NIPT,
ethical issues,
informed consent,
reproductive autonomy

ABSTRACT
Prenatal screening pathways, as nowadays offered in most Western coun-
tries consist of similar tests. First, a risk-assessment test for major
aneuploides is offered to pregnant women. In case of an increased risk,
invasive diagnostic tests, entailing a miscarriage risk, are offered. For
decades, only conventional karyotyping was used for final diagnosis.
Moreover, several foetal ultrasound scans are offered to detect major
congenital anomalies, but the same scans also provide relevant information
for optimal support of the pregnancy and the delivery.

Recent developments in prenatal screening include the application of
microarrays that allow for identifying a much broader range of abnomalities
than karyotyping, and non-invasive prenatal testing (NIPT) that enables
reducing the number of invasive tests for aneuploidies considerably. In the
future, broad NIPT may become possible and affordable.

This article will briefly address the ethical issues raised by these tech-
nological developments. First, a safe NIPT may lead to routinisation and as
such challenge the central issue of informed consent and the aim of pre-
natal screening: to offer opportunity for autonomous reproductive choice.
Widening the scope of prenatal screening also raises the question to what
extent ‘reproductive autonomy’ is meant to expand. Finally, if the same test
is used for two different aims, namely detection of foetal anomalies and
pregnancy-related problems, non-directive counselling can no longer be
taken as a standard. Our broad outline of the ethical issues is meant as an
introduction into the more detailed ethical discussions about prenatal
screening in the other articles of this special issue.

INTRODUCTION

Most developed countries have some form of prenatal
screening for Down’s syndrome and other major foetal
anomalies. This article gives a general overview of current
practice in developed countries, looks at future scenarios
and charts the main ethical challenges. As such, it serves
as an introduction to the other articles in this special issue
that will address in more depth various ethical questions
regarding current and future prenatal testing scenarios.
The contributions reflect the oral presentations and
discussions at a conference on ‘Individualised choice: a

new approach to reproductive autonomy in prenatal
screening?’, held at the Brocher Foundation, Switzerland,
on 6–7 April 2013.

In this article screening is defined as the systematic
offer by health professionals of a medical investigation to
the population, or to specific population groups, address-
ing persons who themselves have no health probl

AJPH HISTORY

August 2017, Vol 107, No. 8 AJPH Bayer Peer Reviewed Public Health Then and Now 1259

The End of Written Informed Consent for HIV
Testing: Not With a Bang but a Whimper
Ronald Bayer, PhD, Morgan Philbin, PhD, and Robert H. Remien, PhD

In 2014, only two states in the United States still mandated specific written informed consent for

HIV testing and, after years of controversy, New York ended this requirement, leaving only Ne-

braska. New York’s shift to opt-out testing meant that a singular feature of what had characterized

the exceptionalism surrounding HIV testing was eliminated. We trace the history of debates on

written informed consent nationally and in New York State. Over the years of dispute from when

HIV testing was initiated in 1985 to 2014, the evidence about the benefits and burdens of written

informed consent changed. Just as important was the transformation of the political configuration

of HIV advocacy and funding, both nationwide and in New York State. What had for years been the

subject of furious debate over what a rational and ethical screening policy required came to an

end without the slightest public protest. (Am J Public Health. 2017;107:1259–1265. doi:10.2105/

AJPH.2017.303819)

In 2014, New York and Nebraska were the only
states that still required written

informed consent for HIV

testing, a signature element of

public policy that dated from

the 1980s. New York then

abandoned the requirement.

Remarkably, despite a long and

often bitterly contested past

that engaged public health offi –

cials, clinicians, AIDS advocacy

groups, and civil liberties orga-

nizations, the fi nal elimination

of written informed consent for

HIV testing occurred with little

public debate.

Conventionally, the story of

HIV testing policy involves the

commitments that began when

the evidence for addressing both

the clinical and public health

challenges of AIDS was still very

uncertain. The conventional

narrative argues that public

health offi cials slowly became

convinced by evidence demon-

strating that written informed

consent impeded the rollout of

HIV testing on a mass scale, a

process that culminated in 2006

when the Centers for Disease

Control and Prevention (CDC)

issued recommendations for an

opt-out approach without writ-

ten informed consent. Those

who opposed this opt-out

approach were equally certain

that the evidence did not sup-

port the claim that written in-

formed consent was a barrier to

sound public healt