Informed Consent Out of Context Sven Ove Hansson

ABSTRACT. Several attempts have been made to

transfer the concept of informed consent from medical

and research ethics to dealing with affected groups in

other areas such as engineering, land use planning, and

business management. It is argued that these attempts are

unsuccessful since the concept of informed consent is

inadequate for situations in which groups of affected

persons are dealt with collectively (rather than individu-

ally, as in clinical medicine). There are several reasons for

this. The affected groups from which informed consent is

sought cannot be identified with sufficient precision.

Informed consent is associated with individual veto

power, but it does not appear realistic to give veto power

to all individuals who are affected for instance by an

engineering project. Most importantly, the concept of

informed consent puts focus on the public’s acceptance of

ready-made proposals rather than on its participation in

the decision-making process as a whole, which includes

the development of alternatives for the decision. There-

fore, the concept of informed consent is not applicable to

a company’s relations with groups and collectives. It may,

however, be applicable to a company’s relations with

individual persons such as customers and employees.

KEY WORDS: informed consent, stakeholder, veto,

engineering ethics, planning, democracy, participation

Introduction

In the second half of the 20th century, medical ethics

was transformed from an older paternalistic tradition

to a new way of thinking with a strong emphasis on

patient autonomy and self-determination. This

development was largely triggered by disclosures

from the Nuremberg trials and elsewhere of grave

misuses of human subjects. In the new medical

ethics, informed consent became a central concept

(Faden and Beauchamp, 1986). The World Medical

Association’s declaration on Ethical Principles for

Medical Research Involving Human Subjects (the

Helsinki Declaration) is the most authoritative

statement of medical research ethics. Its central

paragraph on informed consent reads as follows:

‘‘In any research on human beings, each potential

subject must be adequately informed of the aims,

methods, sources of funding, any possible conflicts

of interest, institutional affiliations of the

researcher, the anticipated benefits and potential

risks of the study and the discomfort it may entail.

The subject should be informed of the right to

abstain from participation in the study or to with-

draw consent to participate at any time without

reprisal. After ensuring that the subject has under-

stood the information, the physician should then

obtain the subject’s freely given informed consent,

preferably in writing. If the consent cannot be

obtained in writing, the non-written consent must

be formally documented and witnessed.’’ (http://

www.wma.net/e/policy/b3.htm)

It is important to observe that in medical ethics and

research ethics, informed consent is considered to be a

necessary but not a sufficient condition for an inter-

vention to be acceptable. According to the Helsinki

declaration, the physician who takes part in medical

research always has a duty to ‘‘protect the life, health,

privacy, and dignity of the human subject.’’ Informed

consent does not absolve her from that duty.

Proposals have been made to extend the applica-

tion of informed consent to at least three areas outside

of medicine and research, namely engineering, land

use planning, and business management.

Sven Ove Hansson is Professor of philosophy and head of the

Department of Philosophy and the History of Technology,

Royal Institute of Technology, Stockholm. He is also a

member of the Swedish government’s advisory board of re-

searchers. His books include Setting the limits. Occupa-

tional Health Standards and the Limits of Science

(OUP 1998), A Textbook of Belief Dynamics. Theory

Change and Database Updating. (Kluwer 1999) and

The Structures of Values and Norms (CUP 2001).

Homepage: http"//www.infra.kth.se/~soh.

Journal of Business Ethics (2006) 63: 149–154 � Springer 2006DOI 10.1007/s10551-005-2584-z

Already in the first edition of their now-classic

textbook in engineering ethics, Mike Martin and

Roland Schinzinger claimed that the practice of

engineering should make use of the concept of in-

formed consent. Their major argument for this

approach is that the outcome of engineering projects

is uncertain. Therefore, such projects can in their

view be seen as ‘‘experiments’’ using human subjects

(Martin and Schinzinger, 1983). They recommend

us to ‘‘think of engineering corporations as con-

ducting society-wide experiments on the ‘subjects’

affected by their risky ventures.’’ (Schinzinger and

Martin, 1983, p. 67)

Obviously, the word ‘experiment’ is not used

here in the same sense as in research ethics. In sci-

ence, an experiment is a fact-finding activity that

gains its legitimacy from being so constructed that it

contributes to the systematic development of new

knowledge. Medical experiments that do not satisfy

this criterion are not accepted in the medical ethics

community, irrespective of how informed and

consenting the subjects are. Most engineering

projects are not experiments in this sense.

The second new area for informed consent is land

use planning. Simmons (1987) proposed that ‘‘one

way of looking at the moral position of the profes-

sional planner’’ is to see it as ‘‘similar in certain

important respects to the moral position of the

physician.’’ (p. 6) Just as a physician needs the in-

formed consent of the patient, a professional planner

needs the consent of those affected by the plans

under consideration. To be at all valid, such consent

has to be informed; thus the planner should seek to

‘‘obtain the same kind of informed consent a phy-

sician needs to justifiably treat a patient.’’ (p. 8)

Likewise, Shrader-Frechette (1993) has argued for

the use of informed consent as a criterion in the

siting of nuclear waste facilities (Cf. English, 1991).

The third area is business management. According

to stakeholder theory, business managers are

responsible not only to the owners of their respective

companies, but also to various stakeholders, viz.

groups and individuals who are affected by the

activities of the firm. This includes employees, cus-

tomers, neighbours, environmental groups, etc.

(Freeman, 1984) Rowan (1998) maintains that, since

stakeholder theory treats all stakeholder relations as

contractual, and a contract is only valid if the con-

ditions of informed consent are satisfied, informed

consent is an inherent feature of stakeholder theory.

Other attempts to integrate consent in stakeholder

theory have been made by Cohen (1995) and Van

Buren (2001).

But can the concept of informed consent be

successfully transferred from its specific context in

medical ethics and the ethics of research to quite

different settings for decision-making such as engi-

neering, land use planning, and business manage-

ment? It is the purpose of the present contribution to

show that this is in fact not possible. More specifi-

cally, my claim is that the concept of informed

consent is not serviceable when agreement is sought

with a collective of affected persons rather than

individually with each person. This applies to all the

three proposed extensions mentioned above. An

engineering company that introduces new technol-

ogy with society-wide implications strives for wide

social acceptance of the innovation but it has no

need for signed informed consent forms from each

and every affected person. A similar form of wide

public acceptance is desired by managers of land

planning projects (but in addition they also have

individual, contractual dealings for instance with

landowners). Stakeholder theory is explicitly con-

cerned with a company’s relations with affected

groups and their representatives, rather than with

each affected individual. In what follows, I will refer

to these situations as collective arrangements, to distin-

guish them from the individual arrangements that are

exemplified by the physician’s relations to a patient

and the experimenter’s relations to an experimental

subject.

Several authors have already pointed out practical

problems that are encountered when the concept of

informed consent is transferred to new areas. In

Section ‘‘Practical problems’’ I will show that two

major such arguments apply in general to collective

arrangements. In Section ‘‘Consent or full partici-

pation in decision-making?’’ I will show that in-

formed consent is also a too restricted ideal for such

applications, since it puts focus on the acceptance of

ready-made proposals rather than on participation in

the decision-making process as a whole, which

includes the development of alternatives for the

decision. In Section ‘‘Individual arrangements,’’ I

will argue that the concept of informed consent can

be meaningfully applied to a company’s individual

arrangements with buyers and employees.

150 Sven Ove Hansson

Practical problems

The transfer of informed consent to new fields gives

rise to two major practical problems. The first of

these has been called the consenter identification problem

(Scbinzinger and Martin, 1983, p. 71). It was high-

lighted by Long (1983) in a comment on Martin and

Schinzinger’s proposal to apply informed consent to

engineering. As Long noted, the persons affected by

an engineering project can in typical cases not be

identified. There are many degree of affectedness,

and it is not possible to draw a sharp line between

affected and unaffected persons. In many cases, such

as that of a power plant, those affected are distributed

over a large geographical area. It is, in Long’s words,

a major difference between engineering and medi-

cine that ‘‘the results of engineering practice,

whether predictable or not, typically are widespread

and have ill-defined boundaries. A surgical proce-

dure or an hour with a psychiatrist is for a specific,

known individual.’’ (pp. 60–61) The process of

obtaining informed consent for an engineering

project from all concerned cannot even get started in

a proper way, since the persons whose consent

should be sought cannot be identified.

Long’s argument is equally applicable to other

situations in which the boundaries between affected

and unaffected persons are vague. Such vagueness is

characteristic of the contexts in which agreement or

acceptance is sought from a collective of affected

persons, including the two other such contexts that

were mentioned above, namely land use planning

and business management, Therefore, the consenter

identification problem is applicable to collective

arrangements in general.

In a reply to Long, Martin and Schinzinger (1983)

claimed that informed consent in engineering

projects can take place through vicarious decision-

making. They wrote:

‘‘Some members of the public have special inter-

ests or concerns (financial, social, environmental,

moral, or religious) that may not be shared by the

mainstream, such as the PG&E [Pacific Gas and

Electric Company] customer who does not want

to contribute to the buildup of nuclear wastes or

the patient who objects to blood transfusions. If

such minorities are adequately represented by

interest groups or government agencies that can

act as proxies, the engineer’s task is facilitated

greatly. Vicarious or substituted informed consent

can be obtained through interaction with the

proxies’’ (Schinzinger and Martin, 1983, p. 74).

Here, the term ‘‘informed consent’’ is applied to

procedures that are radically different from those that

this term refers to in research ethics. In the latter

context, each individual research subject has to be

adequately informed and to consent individually.

The Helsinki declaration makes an exception only

for ‘‘a research subject who is legally incompetent,

physically or mentally incapable of giving consent or

is a legally incompetent minor.’’ Research can be

performed on such subjects only if this is necessary to

promote the health of their own group. In these

cases, informed consent must be obtained from each

person’s legally authorized representative, and in

addition assent must be obtained from the subject

her- or himself whenever this is possible.

The whole point of the new medical research

ethics, as expressed in the Helsinki declaration, was

to protect each individual research subject and to

ensure that her participation was the outcome of her

own autonomous and well-informed decision. A

system, like that proposed by Martin and Schinzin-

ger, in which a government agency can act as a

proxy for a minority group, and give consent on

their behalf, is the very antonym of what the

informed consent concept was intended to achieve.

Therefore, such usage of the term should be resisted.

In the proper sense of the term, informed consent is

not obtainable from the large and vaguely defined

groups that are involved in collective arrangements

such as those in engineering, planning and business.

It is worth noting that informed consent from all

affected persons is in fact neither sought nor

achievable in medical ethics either. The family of a

patient or a research subject are certainly concerned

by what is going on, but informed consent is only

required from the patients and research subjects

themselves. Similar restrictions are of course possible

in the other areas; hence it would be possible to

apply an informed consent procedure in land use

planning only to those who may have to leave their

homes as a consequence of the plans under discus-

sion. However, such limited procedures do not seem

to correspond to the goals of the scholars and

activists who have proposed extended applications of

informed consent. They want to find ways to deal

Informed consent out of context 151

with the worries of all those concerned, not only

those most concerned or those with a legal right in

the matter.

The second practical problem can be called the

veto power problem. As was pointed out by Fotion

(1987) in the land use context, consent is a veto

power concept. If the informed consent of everyone

affected were required before a road could be built,

then not many roads would be built. Similar argu-

ments apply to business decisions and decisions on

engineering projects. (Hansson, 2003) It is charac-

teristic of situations with collective arrangements

that the number of affected persons is so large that a

decision rule requiring unanimity would make it

extremely difficult to move forward in any direction.

Therefore, the veto power problem applies to col-

lective arrangements in general.

It might be tempting to try to solve this problem

by redefining informed consent as something like

majority consent. However, as was also noted by

Fotion, it is far from clear why we should then not

instead use more well-established terms such as

democracy or majority decision. Furthermore, one

of the major roles of informed consent in post-

Nuremberg medical research ethics is to ensure that

the rights of individual research subjects are not

subdued under group interests or group decisions.

Therefore, it is inappropriate to use the term

‘‘informed consent’’ for procedures that leave

individuals without the right to opt out.

Consent or full participation in

decision-making?

The criticism against extending informed consent to

collective arrangements that was developed in the

previous section concerns its practicability, not its

status as a normative ideal. This criticism is compat-

ible with the standpoint that informed consent is an

unattainable but nevertheless perfect ideal, and that

we should therefore adopt a procedure that comes as

close to it as possible. In this section I will show that

informed consent is not a tenable ideal for collective

arrangements even in this weakened sense. The

argument is based on a fundamental limitation of

informed consent: It only refers to the final stage of a

decision process in which the options have been se-

lected and what remains is to choose between them.

An excellent account of the stages of a decision

process was provided by Condorcet in his motiva-

tion for the French constitution of 1793. Condorcet

divided decision processes into three stages. In the

first stage, one ‘‘discusses the principles that will

serve as the basis for decision in a general issue; one

examines the various aspects of this issue and the

consequences of different ways to make the deci-

sion.’’ At this stage, the opinions are personal, and

no attempts are made to form a majority. After this

follows a second discussion in which ‘‘the question is

clarified, opinions approach and combine with each

other to a small number of more general opinions.’’

In this way the decision is reduced to a choice

between a manageable set of alternatives. The third

stage consists of the actual choice between these

alternatives (Condorcet, [1793] 1847, pp. 342–343).

Condorcet’s account of the stages in a decision

process has been virtually forgotten, and it does not

seem to have been referred to in modern decision

theory. However, it is an insightful theory. In par-

ticular, it is unfortunate that his distinction between

the first and second discussions has been lost in later

accounts of decision processes. From the viewpoint

of democratic theory, it is important to observe that

in democratic decision-making, all three stages

should be democratic. Popular voting over decision

alternatives developed by an elite does not constitute

a full democracy.

As already indicated, the notion of informed

consent refers only to the last of the three decision

stages. The potential research subject in a medical

experiment does not take part in the development

of the experimental procedure. He or she only

decides whether or not to be a subject in an

experiment developed by others. Similarly, a pa-

tient giving informed consent to a surgical opera-

tion makes a choice between the therapy options

proposed by medical professionals. In these cases,

the restriction of the person’s involvement to the

third and last stage of the decision does not seem to

be inappropriate. It would not be realistic for pa-

tients to take part in the preliminary discussions in

which the treatment alternatives are developed.

Against this background, the application of in-

formed consent in medicine can be seen as a way to

ensure a high quality of the third step when par-

ticipation in steps 1 and 2 is undesirable or

impossible to achieve.

152 Sven Ove Hansson

This feature of the term ‘‘informed consent’’ is

corroborated by the observation that we tend to

use it only when referring to persons with little or

no influence over what alternatives they can choose

between. Consider the case of a rich investor who

orders an investigation of several investment alter-

natives, carefully studies the experts’ advice and

then authorizes them to implement one of these

alternatives. It would be strange to say that he has

given informed consent to how his money is used.

True, he is well-informed and he has consented,

but he has also done much more, namely had a

decisive influence over the whole decision-making

process. The term informed consent would be

more appropriate in the case of a small saver

who authorizes a bank official to do as the latter

proposes.

From a democratic point of view, the aims of

public participation in engineering, planning, or

business decisions refer to the decision process as a

whole, not just to its last stage. If we want for

instance traffic planning to be democratic, the

influence of citizens should not be restricted to a

choice whether or not to consent to a proposal

developed by professionals. The public should have

the opportunity to take active part in the whole

decision-making process. This includes the first

open-ended discussion in which means and ends,

advantages and disadvantages of different solutions

are discussed. It also includes the second stage, in

which major alternatives for the future decision are

formed, in part through a process of coalition

formation. If citizens do not enter the process until

its third and last stage, no amount of quality at this

stage can compensate for their lack of influence at

the earlier stages.

Some proponents of the extended uses of

informed consent seem to be less concerned with

involving citizens in the full process of decision-

making than with obtaining a carte blanche from the

public for projects and proposals developed by an

elite. Hence John Simmons wrote:

‘‘Community groups have in recent years success-

fully used zoning and other local regulations, as

well as physical opposition (e.g., in the form of

sitdowns or sabotage), to stall or defeat locally

unacceptable land uses. In the face of such resis-

tance, it is desirable (and sometimes even neces-

sary) to draw forth the consent of such groups to

proposed land uses.’’ (Simmons, 1987, p. 6)

In a democratic society, it is not sufficient to find

ways to ‘‘draw forth’’ acceptance of the ready-made

plans and proposals of an elite. Instead, public par-

ticipation on equal terms should be sought in all

phases of decision-making. Attempts to apply the

notion of informed consent to collective decision-

making are counterproductive from this point of

view.

Individual arrangements

The argumentation in the two previous sections

refers to the application of informed consent to sit-

uations involving collective interests and collective

decision-making. It is much more sensible to extend

its uses from the traditional areas to new areas in

which agreements with individual persons are at

focus. There are at least two such areas in business

ethics, namely a company’s relations with its cus-

tomers and with its employees (Fisher, 2001).

It is generally recognized that the seller of a

product or service has an obligation to provide the

prospective buyer with correct and reasonably

complete information about the product, including

information about its shortcomings. Without this

information, the buyer cannot make an informed

decision on whether or not to buy. This duty to

inform is not unlike the physician’s duty to inform

about side-effects of a treatment and about alterna-

tive treatment options. The seller also has an obli-

gation to refrain from using manipulative techniques

that would endanger the buyer’s ability to make a

well-considered, autonomous decision. The physi-

cian has a corresponding obligation. In addition, the

physician has a more far-reaching obligation, not

shared by the seller, namely to make sure as far as

possible that the consent obtained from the patient is

autonomous also in relation to third parties such as

family members. (Another important difference is

that in addition to the requirements of informed

consent, the physician is required to only offer

treatments that are in the patient’s best interest.)

A company recruiting new employees typically

has information about the position that the

prospective employee does not have, including

Informed consent out of context 153

information about occupational health and safety. A

strong case can be made that the company has a

moral obligation to provide the job applicant with

full and truthful information so that she can make a

well-informed decision on whether or not to accept

a job offer. There is an obvious analogy between

information about occupational risks and about the

risks associated for instance with participation in a

medical experiment. However, there are also

important differences. In particular, standard

research ethics does not allow agreements in which

an experimental subject is paid to accept risk-taking

she would otherwise not accept (Grunberg and

Cefalu, 2003). This principle cannot easily be

transferred to the employment context.

Hence, both in the selling and the employment

case a weakened form of the informed consent cri-

terion can be used to describe dealings that a com-

pany has with individual persons. This is a much

more promising extension of the use of this notion

than the attempted extensions to collective

arrangements for which it is not suitable.

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Department of Philosophy and the History of Technology

Royal Institute of Technology

Teknikringen 78,

100 44, Stockholm,

Sweden

E-mail: soh@infra.kth.se

154 Sven Ove Hansson