Basic parts of
the Consent Document |
Principles for protection of study
Resources, News, and
points about side effects for study drugs
"The goal of the informed consent
process is to provide people with sufficient information for
making informed choices .. without coercion or by overstating
possible benefits or understating the risks. The process
should not be rushed. The patient should be encouraged to ask
The informed consent document provides a concise summary of the clinical
study and the individual's rights as a research participant. It
serves as a starting point for the necessary exchange of
information between the investigator and potential research
participant. The document should be concise (6 to 9
pages) and written in lay language.
The required elements for consent documents for NCI-sponsored trials
are listed here.
Study Title for Study Participants and
the Official Study Title
What is the usual approach ...
What are my other choices if I do not take part in this study?
Why is this study being done?
What are the study groups?
How long will I be in this study?
What extra tests and procedures will I have if I take part in
What possible risks can I expect from taking part in this
See also important points about
side effects below
COMMON, SOME MAY BE SERIOUS In 100 people receiving
XYZ, more than 20 and up to 100 may have:
OCCASIONAL, SOME MAY BE SERIOUS In
100 people receiving XYZ, from 4 to 20 may have:
RARE AND SERIOUS In 100 people
receiving XYZ, 3 or fewer may have:
What possible benefits can I expect from taking part in this
Can I stop taking part in this study?
What are my rights in this study?
What are the costs of taking part in this study?
What happens if I am injured or hurt because I took part in
Who will see my medical information?
Where can I get more information?
Who can answer my questions about the study?
ADDITIONAL STUDIES SECTION
(for optional study choices):
Resources, News, and Perspectives:
The Belmont Report -
the basic ethical principles that most be followed:
Giving Tissue and
Blood - an advocate's perspective
NEJM: Readability Standards for Informed-Consent
Forms as Compared with Actual Readability
FDA.gov: Informed Consent
Information Sheet Guidance for IRBs, Clinical Investigators, and
Medicine: Beyond Informed Consent: Shared
Clinical trials - Bioethics.net:
Is Hope a Culprit in Cancer Clinical Trials?
"... the study is right
to point out that these are people going through a
traumatic time in their lives. So perhaps they aren't as
focused on the informed consent form rhetoric because
they are fighting for their lives. Go figure."
CTEP: Possible side effects for commonly prescribed oncology drugs
Typically the possible side
effects (with frequency information) is included in the informed
consent document in a tabular format.
Simplification of Informed Consent Documents
Principles for protection of study participants
B. Basic Ethical Principles
The Belmont Report | HHS.gov
The expression "basic
ethical principles" refers to those general judgments that serve as
a basic justification for the many particular ethical prescriptions
and evaluations of human actions. Three basic principles, among
those generally accepted in our cultural tradition, are particularly
relevant to the ethics of research involving human subjects:
the principles of respect of persons, beneficence and justice.
1. Respect for Persons. --
Respect for persons incorporates at least two ethical convictions:
first, that individuals should be treated as autonomous agents, and
second, that persons with diminished autonomy are entitled to
protection. The principle of respect for persons thus divides into
two separate moral requirements: the requirement to acknowledge
autonomy and the requirement to protect those with diminished
An autonomous person is an individual capable of deliberation about
personal goals and of acting under the direction of such
deliberation. To respect autonomy is to give weight to autonomous
persons' considered opinions and choices while refraining from
obstructing their actions unless they are clearly detrimental to
others. To show lack of respect for an autonomous agent is to
repudiate that person's considered judgments, to deny an individual
the freedom to act on those considered judgments, or to withhold
information necessary to make a considered judgment, when there are
no compelling reasons to do so.
However, not every human being is capable of self-determination. The
capacity for self-determination matures during an individual's life,
and some individuals lose this capacity wholly or in part because of
illness, mental disability, or circumstances that severely restrict
liberty. Respect for the immature and the incapacitated may require
protecting them as they mature or while they are incapacitated.
Some persons are in need of extensive protection, even to the point
of excluding them from activities which may harm them; other persons
require little protection beyond making sure they undertake
activities freely and with awareness of possible adverse
consequence. The extent of protection afforded should depend upon
the risk of harm and the likelihood of benefit. The judgment that
any individual lacks autonomy should be periodically reevaluated and
will vary in different situations.
In most cases of research involving human subjects, respect for
persons demands that subjects enter into the research voluntarily
and with adequate information. In some situations, however,
application of the principle is not obvious. The involvement of
prisoners as subjects of research provides an instructive example.
On the one hand, it would seem that the principle of respect for
persons requires that prisoners not be deprived of the opportunity
to volunteer for research. On the other hand, under prison
conditions they may be subtly coerced or unduly influenced to engage
in research activities for which they would not otherwise volunteer.
Respect for persons would then dictate that prisoners be protected.
Whether to allow prisoners to "volunteer" or to "protect" them
presents a dilemma. Respecting persons, in most hard cases, is often
a matter of balancing competing claims urged by the principle of
2. Beneficence. -- Persons are
treated in an ethical manner not only by respecting their decisions
and protecting them from harm, but also by making efforts to secure
their well-being. Such treatment falls under the principle of
beneficence. The term "beneficence" is often understood to cover
acts of kindness or charity that go beyond strict obligation. In
this document, beneficence is understood in a stronger sense, as an
obligation. Two general rules have been formulated as complementary
expressions of beneficent actions in this sense: (1) do not harm and
(2) maximize possible benefits and minimize possible harms.
The Hippocratic maxim "do no harm" has long been a fundamental
principle of medical ethics. Claude Bernard extended it to the realm
of research, saying that one should not injure one person regardless
of the benefits that might come to others. However, even avoiding
harm requires learning what is harmful; and, in the process of
obtaining this information, persons may be exposed to risk of harm.
Further, the Hippocratic Oath requires physicians to benefit their
patients "according to their best judgment." Learning what will in
fact benefit may require exposing persons to risk. The problem posed
by these imperatives is to decide when it is justifiable to seek
certain benefits despite the risks involved, and when the benefits
should be foregone because of the risks.
The obligations of beneficence affect both individual investigators
and society at large, because they extend both to particular
research projects and to the entire enterprise of research. In the
case of particular projects, investigators and members of their
institutions are obliged to give forethought to the maximization of
benefits and the reduction of risk that might occur from the
research investigation. In the case of scientific research in
general, members of the larger society are obliged to recognize the
longer term benefits and risks that may result from the improvement
of knowledge and from the development of novel medical,
psychotherapeutic, and social procedures.
The principle of beneficence often occupies a well-defined
justifying role in many areas of research involving human subjects.
An example is found in research involving children. Effective ways
of treating childhood diseases and fostering healthy development are
benefits that serve to justify research involving children -- even
when individual research subjects are not direct beneficiaries.
Research also makes it possible to avoid the harm that may result
from the application of previously accepted routine practices that
on closer investigation turn out to be dangerous. But the role of
the principle of beneficence is not always so unambiguous. A
difficult ethical problem remains, for example, about research that
presents more than minimal risk without immediate prospect of direct
benefit to the children involved. Some have argued that such
research is inadmissible, while others have pointed out that this
limit would rule out much research promising great benefit to
children in the future. Here again, as with all hard cases, the
different claims covered by the principle of beneficence may come
into conflict and force difficult choices.
3. Justice. -- Who ought to
receive the benefits of research and bear its burdens? This is a
question of justice, in the sense of "fairness in distribution" or
"what is deserved." An injustice occurs when some benefit to which a
person is entitled is denied without good reason or when some burden
is imposed unduly. Another way of conceiving the principle of
justice is that equals ought to be treated equally. However, this
statement requires explication. Who is equal and who is unequal?
What considerations justify departure from equal distribution?
Almost all commentators allow that distinctions based on experience,
age, deprivation, competence, merit and position do sometimes
constitute criteria justifying differential treatment for certain
purposes. It is necessary, then, to explain in what respects people
should be treated equally. There are several widely accepted
formulations of just ways to distribute burdens and benefits. Each
formulation mentions some relevant property on the basis of which
burdens and benefits should be distributed. These formulations are
(1) to each person an equal share, (2) to each person according to
individual need, (3) to each person according to individual effort,
(4) to each person according to societal contribution, and (5) to
each person according to merit.
Questions of justice have long been associated with social practices
such as punishment, taxation and political representation. Until
recently these questions have not generally been associated with
scientific research. However, they are foreshadowed even in the
earliest reflections on the ethics of research involving human
subjects. For example, during the 19th and early 20th centuries the
burdens of serving as research subjects fell largely upon poor ward
patients, while the benefits of improved medical care flowed
primarily to private patients. Subsequently, the exploitation of
unwilling prisoners as research subjects in Nazi concentration camps
was condemned as a particularly flagrant injustice. In this country,
in the 1940's, the Tuskegee syphilis study used disadvantaged, rural
black men to study the untreated course of a disease that is by no
means confined to that population. These subjects were deprived of
demonstrably effective treatment in order not to interrupt the
project, long after such treatment became generally available.
Against this historical background, it can be seen how conceptions
of justice are relevant to research involving human subjects. For
example, the selection of research subjects needs to be scrutinized
in order to determine whether some classes (e.g., welfare patients,
particular racial and ethnic minorities, or persons confined to
institutions) are being systematically selected simply because of
their easy availability, their compromised position, or their
manipulability, rather than for reasons directly related to the
problem being studied. Finally, whenever research supported by
public funds leads to the development of therapeutic devices and
procedures, justice demands both that these not provide advantages
only to those who can afford them and that such research should not
unduly involve persons from groups unlikely to be among the
beneficiaries of subsequent applications of the research.
Important points about side effects (from NCI informed consent)
here are important points about side
effects (copied from the NCI informed consent template for research
- hence the term "study doctor" ... but these apply to regular
• The study doctors do not know who will or will not have side
• Some side effects may go away soon, some may last a long time, or
some may never go away.
• Some side effects may interfere with your ability to have
• Some side effects may be serious ... (usually rare)
Here are important points about how you and the study doctor can
make side effects less of a problem:
• Tell the study doctor if you notice or feel anything different so
they can see if you are having a side effect.
• The study doctor may be able to treat some side effects.
• The study doctor may adjust the study drugs to try to reduce side
Possible Side Effects of ABC
COMMON, SOME MAY BE SERIOUS
In 100 people receiving ABC, more than 20 and up to 100 may have:
OCCASIONAL, SOME MAY BE SERIOUS
In 100 people receiving ABC, from 4 to 20 may have:
RARE, AND SERIOUS
In 100 people receiving ABC, 3 or fewer may have: