Basic parts of the Consent Document |
Principles for protection of study participants
Resources, News, and Perspectives |
Important 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 questions.
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 this study
What possible risks can I expect from taking part in this study?
See also about frequency tables and important points about side effects
What possible benefits can I expect from taking part in this study?
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 this study?
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 - biobanking etc.):
What possible risks can I expect from taking part in this study?
About Frequency Tables and Important points about side effects
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 treatment too):
• The study doctors do not know who will or will not have side effects.
• 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 children.
• 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 effects.
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:
Resources, News, and Perspectives:
The Belmont Report - the basic ethical principles that most be followed:
Giving Tissue and Blood - an advocate's perspective PDF
NEJM: Readability Standards for Informed-Consent
Forms as Compared with Actual Readability http://bit.ly/1bjYTEo
FDA.gov: Informed Consent Information Sheet Guidance for IRBs, Clinical Investigators, and Sponsors http://1.usa.gov/1oZYWbv
Science Based Medicine: Beyond Informed Consent: Shared Decision-Making http://bit.ly/TuK9XV
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 http://1.usa.gov/1k8El68
Typically the possible side effects (with frequency information) is included in the informed consent document in a tabular format.
Simplification of Informed Consent Documents cancer.gov (fixed 7/14)
Principles for protection of study participants
B. Basic Ethical Principles
The Belmont Report | HHS.gov http://1.usa.gov/28P3UVi
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 autonomy.
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 respect itself.
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.