weighing risks and benefits

Weighing Risks and Benefits Sven Ove Hansson

ABSTRACT: It is almost universally acknowledged that riskshave to be weighed against benefits, but there are different

ways to perform the weighing. In conventional risk analysis,collectivist risk-weighing is the standard. This means that anoption is accepted if the sum of all individual benefits out-

weighs the sum of all individual risks. In practices originatingin clinical medicine, such as ethical appraisals of clinical trials,individualist risk-weighing is the standard. This implies a muchstricter criterion for risk acceptance, namely that the risk to

which each individual is exposed should be outweighed bybenefits for that same individual. The different choices of risk-weighing methods in different policy areas seem to have

emerged from traditional thought patterns and social relations,rather than from explicit deliberations on possible justifica-tions for the alternative ways to weigh risks against benefits. It

is not obvious how the prevalent differences in risk-weighingpractices can be reconstructed in terms of consistent underly-ing principles of preventive health or social priority-setting.

1. The basic risk-weighing principle

The world that we live in is not free of risks, and

neither can we make it so. Some risks have to be

accepted in order to obtain benefits that would

otherwise be inaccessible. It seems undeniable that

risks have to be weighed against benefits. A risk

should only be taken if it brings with it some benefit

that makes it worth taking. We can express this

intuition as follows:

The basic risk-weighing principle:A risk is acceptable if and only if it is outweighed by agreater benefit.

This principle corresponds to common, and generally

accepted, patterns of argumentation about risks, both

in private and public life. Going back into a burning

building may be worth the risk if the purpose is to

save a sleeping child, but it should not be done in

order to recover a left-behind wallet. The risk is the

same in the two cases, but the expected gain is

incomparably higher in the first case.

However, although the basic risk-weighing princi-

ple captures important aspects of our intuitions about

risk acceptance, it is insufficiently specified. There are

different ways to weigh risks against benefits, and

different variants of risk-weighing have been chosen

in different policy areas. It is the purpose of the

present contribution to clarify the nature of these

variants. Before they are introduced, a few more

general comments are in order about the basic risk-

weighing principle.

First, as it stands the principle is insufficiently

decision-guiding. The major reason for this is that it

only requires a positive net benefit, and does not

differentiate between alternative risk-taking actions

that differ widely in the size of the net benefit. (Net

benefit¼ benefits minus risks.) For an example, sup-

pose that we have a choice between two life-saving

drugs for patients with a certain condition. The two

drugs are equally efficient, and the only known dif-

ference between them is that one of them gives rise to

cirrhosis in 1 out of 100 patients, whereas the other

has that side effect in 1 out of 5000 patients.

According to the above formulation of the basic risk-

weighing principle, both drugs are acceptable. This is

contrary to common moral intuitions and to well-

established ethical practices in clinical medicine.

Obviously, only the drug with the lowest risk of cir-

rhosis should be used.

It is a relatively easy matter to adjust the basic risk-

weighing principle so that it guides choices between

different alternatives, rather than determining the

acceptability of isolated alternatives. The most obvi-

ous way to do this is to require that one chooses one

of the alternatives that have the highest net benefit.

Other choice-guiding criteria are also possible. It is

for instance possible to construct the set of allowable

alternatives so that it includes not only the alterna-

tives with maximal net benefit but also those

with near-maximal net benefit (with some suitable

Topoi 23: 145–152, 2004.� 2004 Kluwer Academic Publishers. Printed in the Netherlands.

definition of near-maximality).1 For our present

purposes, the choice of an optimization/satisficing

method can be left open. Therefore, the basic risk-

weighing principle will not be reformulated along any

of these lines. Instead, the following reformulation

will be used, that is intended to keep this choice open:

The basic risk-weighing principle, revised:A risk is acceptable to the extent that it is outweighed by a

greater benefit.

Secondly, the terms ‘‘risk’’ and ‘‘benefit’’ exhibit a

strange asymmetry. Whereas ‘‘risk’’ denotes disad-

vantages that may or may not materialize, ‘‘benefit’’

denotes advantages of which one is sure. It would be

more symmetric to weigh risks against chances or

benefits against harms.

There are cases in which one chooses between

combinations of risks and benefits, but also cases with

a choice between combinations of risks and chances.

Investment decisions involve the weighing of risks

against chances, i.e. both advantages and disadvan-

tages are uncertain. The same applies to clinical

treatment decisions in which the available therapies

have significant risks.

The general problem that should be addressed is

not the weighing of uncertain negative effects (risks)

against certain positive effects (benefits). Instead, it is

the weighing of certain and uncertain negative effects

(harms and risks) against certain and uncertain po-

sitive effects (benefits and chances). Hence, good

arguments can be made in favour of terminological

reform. However, the traditional risk-benefit termi-

nology is entrenched and not easily changed. It will be

used here, with the understanding that it refers to the

general case just described.

Thirdly, the basic risk-weighing principle has a

strong consequentialist bias. Weighing is not easily

accommodated in deontological or rights-based eth-

ics, and terms such as ‘‘risk’’, ‘‘benefit’’ (and for that

matter ‘‘harm’’ and ‘‘chance’’) give a strong indica-

tion that actions are evaluated according to their

consequences. Generally speaking, consequentialism

should not be taken for granted in discussions of risk

(Hansson, 2003). However, in an investigation of risk-

weighing it is methodologically convenient to accept

the consequentialism inherent in the basic risk-

weighing principle as a starting-point. Its weaknesses

should be uncovered in the analysis.

2. Collectivist or individualist risk-weighing

The weighing of risks against benefits is a central

feature in a large number of social practices. A closer

study will reveal that it is performed in fundamen-

tally different ways in different application areas. The

crucial difference concerns whether or not benefits

for one person are allowed to outweigh harms to

another person. We can call this the issue of inter-

personal compensability. It has unfortunately often

been conflated with the related but distinct issue of

interpersonal comparability. Even if it can be estab-

lished that a benefit is greater than a harm, the

benefit need not cancel out the harm in the same

unproblematic way as a loss is (presumably) can-

celled out by a gain in the calculations of an inves-

tor.2 The fact that a certain loss for Ms. Black is

smaller than a certain gain for Mr. White does not

suffice to make it allowable for Mr. White, or anyone

else, to perform an action that leads to this particular

combination of a loss for Ms. Black and a gain for

Mr. White. For that conclusion to follow, another

premise must be added, namely the premise of

interpersonal compensability.3 Interpersonal compa-

rability does not imply interpersonal compensability,

but they are nevertheless closely related since the

former is a necessary prerequisite for making the

latter operative.

If full interpersonal compensability is assumed,

then the basic risk-weighing principle can be specified

as follows:4

The collectivist risk-weighing principle:An option is acceptable to the extent that the sum of all

individual risks that it gives rise to is outweighed by the sumof all individual benefits that it gives rise to.

If on the other hand interpersonal incompensability is

assumed, then we can instead specify the risk-weigh-

ing principle in the following way:

The individualist risk-weighing principle:An option is acceptable to the extent that the risk to whicheach individual is exposed is outweighed by benefits for that

same individual.

Clearly, intermediate standpoints are possible,

that allow for partial rather than complete compen-

sability.

146 SVEN OVE HANSSONSVEN OVE HANSSON

The practical consequences of how the basic risk-

weighing principle is specified can be illustrated with

two examples. For the first of these, suppose that

your physician considers including you in a group of

patients who will receive a new, experimental treat-

ment. Such a treatment clearly involves risks and

benefits that have to be weighed against each other.

This can be done according to either the collectivist or

the individualist risk-weighing principle. First, sup-

pose that the physician employs the collectivist risk-

weighing principle. Then she will consider it justified

to include you in the study if the risk is outweighed by

the total social benefit, which includes the expected

gains from the study for future patients. This may of

course be the case even if the risks to which you are

exposed are not outweighed by the expected gains to

you personally. Next, suppose that she instead makes

use of the individualist risk-weighing principle. Then

she will not propose that you participate unless she

believes that the risks to which you will be exposed

are outweighed by advantages for you personally

(primarily in the form of chances of improved health

due to the experimental treatment).

In the second example it has been proposed to site

a chemical factory in your neighbourhood. Some of

your neighbours protest against these plans, claiming

that pollutants from the factory will cause unaccept-

able risks for themselves and their children. Again, it

makes a large difference if the collectivist or the

individualist risk-weighing principle is used to ap-

praise the situation. According to the collectivist

principle, it is justified to build the factory if the total

social benefits that it brings about outweigh the

totality of the risks that it gives rise to. Arguably, the

factory contributes to economic growth and therefore

to the welfare of every inhabitant in the country.

Although these gains are very small, they are attained

by a very large number of persons, and they may

therefore outweigh the risks that the neighbours are

exposed to. In contrast, the individualist risk-weigh-

ing principle requires that each and every concerned

individual obtains benefits from the factory that are

outweighed by the risks to which she is exposed.5

As these examples show, the choice between col-

lectivist and individualist risk-weighing can have a

large impact on policy outcomes. In the following two

sections, we are going to have a closer look at policy

areas that are dominated by each of these risk-

weighing methodologies.

3. Risk analysis

The dominant systematic approach to risk is the

discipline of risk analysis. Modern risk analysis grew

out of the various reactions that public opposition to

new technologies gave rise to in the 1960s (Otway,

1987; Hansson, 1993). Some of the earliest studies in

the field aimed at determining a level of ‘‘acceptable

risk’’ that should be accepted irrespective of the

associated benefits. However, with the exception of a

marginal discourse on ‘‘de minimis risk’’,6 this ap-

proach is now defunct. Today, the weighing of risks

against benefits is conceived as a central task in risk

analysis.

Risks and benefits are different types of entities,

and not immediately comparable. The practices that

are used in risk-benefit analysis to achieve compara-

bility can be summarized as two technical procedures.

First, uncertain outcomes are weighed according to

their probabilities, so that for instance a risk of one in

50 that a person will die is counted as the death of

0.02 persons. In other words, risks are assessed

according to their statistical expectation values.7 (It is

also common to use the word ‘‘risk’’ to denote the

expectation value, i.e. the product of the probability

of an event and a measure of the magnitude of the

harm that it gives rise to.) A proponent of that

methodology recently motivated it as follows:

The only meaningful way to evaluate the riskiness of atechnology is through probabilistic risk analysis (PRA). APRA gives an estimate of the number of expected health

impacts-e.g., the number of induced deaths-of the tech-nology, which then allows comparisons to be made with thehealth impacts of competing technologies so a rational

judgment can be made of their relative acceptability. Noonly is that procedure attractive from the standpoint ofscientific logic, but it is easily understood by the public.

(Cohen, 2003, p. 909)

Secondly, monetary values are assigned to all out-

comes, including deaths, so that an overall value can

be calculated for each alternative under consider-

ation. Various methods to convert lives to monetary

values have been deviced, making use of expected

earnings, actual sums paid to save lives, willingness to

pay for reduced risks of death, etc.8 Through the

combination of these two procedures – probabilistic

weighing and conversion to money – full compara-

bility of risks and benefits is obtained, in a technical

WEIGHING RISKS AND BENEFITSWEIGHING RISKS AND BENEFITS 147

sense. It is implicitly (and seemingly unreflectingly)

taken for granted that comparability implies com-

pensability.

Much of the early work in risk analysis was fo-

cused on chemicals and on nuclear technology, the

same risk factors that public opposition targeted on.

Today, risk analysis employing collectivist risk-

weighing is applied to a wide category of social areas,

such as the health impacts of air pollution (Pandey

and Nathwani, 2003) and radioactive waste reposi-

tories (Cohen, 2003), the effectiveness of airbag

regulation (Thompson et al., 2002) and accident-

preventive measures in road construction (Usher,

1985), and the effectiveness of efforts to detect

asteroids or comets that could strike the earth

(Gerrard, 2000), just to mention a few examples.

Risk analysis is a large and ramified discipline that

includes a multitude of methodologies. However, the

discipline is strongly dominated by standard risk-

benefit analysis with its adherence to full compensa-

bility and to collectivist risk-weighing. This domi-

nance can be seen for instance in risk-analytical

approaches to issues such as uncertainty and justice.

Treatments of uncertainty in risk analysis usually take

the form of determining a distribution of ‘‘risk val-

ues’’ (see for instance von Stackelberg et al., 2002).

Discussions of justice tend to focus on the distribu-

tion of the aggregate expectation value (‘‘risk’’)

among population strata. This means that collectivist

risk-weighing is the starting-point, to which consid-

erations of justice are added.

The dominance of collectivist risk-weighing can

also be seen from prevalent attitudes to the so-called

NIMBY (not in my backyard) phenomenon. By

NIMBY is meant that a person or group or persons

protest against the siting in their neighbourhood of a

facility that will be disadvantageous to themselves but

advantageous to society as a whole. Risk analysts

who condemn NIMBY reactions seem to take it for

granted that collective risk-weighing is justified in the

cases in question.9

4. Medical risk assessment

One of the most well-developed practices that makes

consistent use of individualist risk-weighing is re-

search ethics as applied to clinical trials. In a clinical

trial, each patient is randomly assigned to one of

several groups that receive different treatments. The

standard approach to medical research ethics, as

codified in the Helsinki declaration and the practices

with which it is connected, sets up two conditions for

the inclusion of a patient in a clinical trial. The first of

these is the patient’s informed consent.10 The second

is a state of genuine uncertainty on whether or not

participation in the trial is better for the patient than

the standard treatment that she would otherwise re-

ceive. The latter requirement is of particular interest

in the present context. A common way to express it is

that there should be equipoise or uncertainty between

the different treatments.11 By this is meant a state of

knowledge in which there are no compelling reasons

to choose one treatment over the other. There should

be ‘‘credible doubts’’ about the ‘‘relative net thera-

peutic advantage’’ of the two interventions, and no

third intervention should be available that is prefer-

able to at least one of them (London, 2001). These

doubts constitute the justification for assigning the

patient randomly to one of the treatments.

Different views have been expressed on whose

assessment of the evidence should determine whether

or not equipoise holds: the individual physician, the

individual patient, the medical community, or some

larger community that includes patients and perhaps

others (London, 2001; Sackett, 2001). Some authors

claim that equipoise refers to the state of mind of the

individual physician who is uncertain about which

treatment is best for the patient. However, it would

then be difficult if not impossible to conclude that a

physician ever errs in enrolling a patient in a trial. So

long as the physician claims that he or she was uncer-

tain, he or she cannot be said to be wrong even if this

uncertainty was due to ignorance (Weijer et al., 2000).

Amore promising proposal is that equipoise should be

determined in relation to competent medical practice,

i.e., practice that is within the bounds of the standard

of care. Clinical trials can then be performed if there is

disagreement in the community of competent medical

professionals about which treatment is best.12 A fur-

ther proposal is to allow for equipoise in a wider group

of decision-makers, that includes both physicians and

patients (Karlawish andLantos, 1997). Amajor reason

for extending decision-making on clinical trials to non-

experts is that the choice between treatments is in part a

value issue that should not be delegated to experts.

(The choice between lumpectomy and radical mastec-

tomy is one of many examples of this.)


However, irrespective of how equipoise is deter-

mined, it refers to the balance between risks and

benefits (or risks and chances) for the individual pa-

tient. Hence, the standard ethical approach to clinical

trials adheres strictly to the individualist risk-weigh-

ing principle. This is particularly interesting in view of

the fact that clinical trials are performed for the sake

of future patients, rather than the patients partici-

pating in the trials. It is difficult to see how a physi-

cian searching for the best treatment for an individual

patient could end up recommending that the choice of

a treatment should be made by a randomizing device.

The use of individualist risk-weighing as an inclusion

criterion can be seen as a corrective, intended to en-

sure that the interests of individual patients are not

sacrificed in studies that are primarily undertaken for

the benefit of a wider collective.

According to the received ethical approach to

clinical trials, both equipoise and informed consent

are required. The latter cannot replace the former. In

other words, current principles of medical ethics do

not allow a person to sacrifice her own interests by

taking part in a clinical trial that is beneficial to a

wider community but known to be to some extent

harmful to herself. This is in stark contrast to the

collectivist risk-weighing that dominates the practice

of risk analysis as described in Section 3. To mention

just one example, critics of NIMBY reactions require

that potential neighbours of a contested facility sac-

rifice their own interests by consenting to a siting that

is beneficial to a wider community but potentially

harmful to themselves.

Proposals have been made to reform the received

ethical criteria for clinical trials. Fears have been

expressed that the current approach may prevent

some of the clinical trials that are necessary for

medical progress. This, it is argued, can be avoided by

giving some weight to ‘‘utilitarian’’ considerations,

i.e., to the expected benefits for non-participating

patients who will receive improved treatment due to

the new knowledge obtained in the trial (Gifford,

1995; Longwood, 1983). However, there is strong

resistance to such proposals in the medical ethics

community, partly for historical reasons. Modern

medical research ethics largely originated as a ‘‘pro-

test movement’’ against dangerous experiments per-

formed by physicians on their patients, justifying

them with reference to expected benefits for future

patients.

Some authors have claimed that altruistic motives

for participation in a clinical trial should be accepted

(Amdur and Biddle, 2001; Veach, 2002). Appeal to

altruism has precedents in other medical practices.

Patients are routinely advised to complete an antibi-

otics regimen in order not to contribute to the

development of resistant microorganisms, even if it

would be marginally better for their own wellbeing to

end the cure. Patients with contagious diseases are

advised to take various measures to protect others

from contracting the disease. The effect of accepting

altruism in clinical trials would be that (some) vol-

untary risk-taking for the benefit of future patients

would be accepted.

In addition to clinical trials there are other areas of

risk discourse in which the individualist mode of risk-

weighing is strictly adhered to. Dietary advice is one

of these areas. As one example of this, although fish is

generally speaking healthy food, contaminants in fish

caught in certain waters give reason to recommend

limits in fish consumption. Such recommendations

are based on the positive and negative health effects

on the individual (and in the case of pregnant or

breast-feeding women, on corresponding effects on

the child) (Knuth et al., 2003). It would be regarded

as inappropriate to include other factors in these

deliberations, such as the effects of diminished fish

consumption on employment in the fishing industry

or on regional economics.

5. A hybrid risk-weighing principle

The collectivist and individualist risk-weighing prin-

ciples are not the only ways in which the basic risk-

weighing principle can be specified. A third variant

should be mentioned, that corresponds to patterns of

thought that dominate in certain social areas.

The hybrid risk-weighing principle:

An option is acceptable to the extent that the risk to whicheach individual is exposed is outweighed by the totality ofbenefits.

The hybrid principle measures benefits on the collec-

tive level and risks on the individual level. Suppose

for instance that we apply the hybrid principle to risks

in space exploration. Then the accepted individual

risk level in a space operation will be determined on


the basis of the overall benefits of the operation. Just

as the collectivist principle, the hybrid principle fo-

cuses on total benefits rather than on benefits for the

individual person. However, just like the individualist

principle, it focuses on risk levels for individuals ra-

ther than on total (aggregated) risk. Contrary to the

collectivist principle, neither the hybrid nor the indi-

vidualist principle allows for higher individual risk

levels if the number of exposed persons is propor-

tionately reduced.

The hybrid principle has some intuitive appeal, but

it has the conceptual disadvantage of stretching the

meaning of ‘‘weigh’’. It may therefore be more accu-

rate to express it as follows:

The hybrid risk-weighing principle, revised:

An option is acceptable to the extent that the risk to whicheach individual is exposed is reasonable against the back-ground of the totality of benefits.

A major application area for the hybrid risk-

weighing principle is the setting of occupational

exposure limits. These are maximal allowed exposures

for individual workers (irrespective of the number of

exposed persons). In practice, most if not all of these

values are based on a compromise with technical and

economic feasibility, that is assessed on an aggregated

social level. However, there is an unfortunate tradi-

tion in this area of incorrectly announcing the out-

come of such compromises as values based exclusively

on medical or scientific information (Hansson,

1998).13

In radiation protection two regulatory methods are

combined in order to limit exposures. One of these is

an individual exposure limit of the same type as in

occupational hygiene. The other consists in limiting

the total exposure to radiation according to the

ALARA principle (as low as reasonably achievable).

The individual exposure limit is essentially based on

hybrid risk-weighing, whereas the ALARA principle

is based on collectivist risk-weighing. Judging by

ongoing debates in leading radiation protection cir-

cles, the system will probably be changed in the

direction of a greater emphasis on individual expo-

sure limits and a corresponding de-emphasis on col-

lective exposure.14

One more area should be mentioned in which hy-

brid risk-weighing takes place, namely the use of

healthy volunteers in medical experiments. In phar-

macological research, drugs are often administered to

healthy volunteers from whom blood samples and

other measurements are obtained in order to deter-

mine the metabolism and pharmacokinetics of the

drug. Participation in such experiments cannot be

based on equipoise, since participants typically have

no personal medical gain from them. Instead, par-

ticipation is based on (altruistic) informed consent to

accept (small) individual risks in order to contribute

to expected advantages to humanity.

6. Conclusion

We have found that the basic risk-weighing principle,

the idea that risks should be weighed against benefits,

can be applied in widely different ways, as expressed

in the collectivist, individualist, and hybrid variants of

the principle. The choice between these variants has

large effects on policy outcomes.

We have also seen that different variants of the

principle dominate in different policy areas. These

differences seem to have emerged from traditional

thought patterns and social relations in the respective

areas, rather than from explicit deliberations on pos-

sible justifications for the different ways to weigh risks

against benefits. Hence, the individualist risk-weighing

principle has a strong standing in social practices that

have their origins in the physician-patient relation-

ship. This is not surprising, given the strong emphasis

in medical ethics on the physician’s role as a trustee for

the patient’s medical welfare. (Beauchamp and Chil-

dress, 2001, p. 312). However, the effect is that indi-

vidual risk-weighing dominates in those areas of

preventive health that have grown out of medical

practices, whereas collective risk-weighing dominates

in many other areas. The health effects of chemical

substances in the atmosphere are in general evaluated

in terms of collectivist risk-weighing, whereas those of

substances in food are evaluated in terms of individ-

ualist risk-weighing.15 It is not obvious how differ-

ences such as this can be reconstructed with reference

to consistent underlying principles of preventive

health or social priority-setting.

The different ways to weigh risks all have their

advantages and disadvantages. With individualist

risk-weighing we avoid sacrificing individuals for the

sake of collective goals. It is precisely in order to

avoid such sacrifices that this type of weighing is used


in medical research ethics. On the other hand, there

are social settings in which the individualist risk-

weighing principle will lead to stalemates and allow

minorities to prevent social progress (Hansson, 2003).

Hybrid risk-weighing can be seen as an attempt to

combine some of the advantages of collective risk-

weighing with some of those of the individualist ap-

proach. However, there may also be other ways to

obtain such a compromise.

We clearly need open-minded studies and discus-

sions on how risk-weighing is and should be per-

formed. The mechanisms that have led to the choice

of different risk-weighing methods in different social

contexts should be investigated. Possible motivations

for using different methods in different policy areas

should be critically assessed. Not least, it is an

important task to develop new methods of risk-

weighing, in particular in the form of reasonable and

principled compromises between the two extreme

positions that now dominate the field, namely those

represented by the collectivist and the individualist

risk-weighing principles.

Notes

1 Both the optimizing and the satisficing criterion providechoice-guidance even in the unfortunate cases in which all

options have a negative net benefit. This is an improvementover the original formulation of the basic risk-weighingprinciple.2 The unreflecting acceptance of interpersonal compensabil-ity can be seen as an instance of what I have elsewhere calledthe ‘‘tuxedo syndrome’’, i.e. the tendency to abstract from the

complex features of most real-world decision problems thatdistinguish them from dealings at the roulette table (S. O.Hansson, submitted for publication).3 Compensability does not either necessarily hold in all

intrapersonal cases, i.e. cases in which the gains and lossespertain to one and the same person. Even if the sum of the(negative) value of losing a toe and the (positive) value of

obtaining a certain sum of money is exactly zero, a transactionleading to these two changes of one’s condition need not be anunproblematic zero-sum affair.4 An assumption of methodological individualism is madehere, i.e. it is assumed that all positive and negative effects ofan option are decomposable into effects on specific individuals.Hence, the possibility of irreducibly collective or impersonal

harms and benefits is not taken into account.5 These benefits may of course include compensations fromthe company (Hansson and Peterson, 2001).6 For an overview of de minimis arguments, see Peterson(2002).

7 For appraisals of this technique, see Hansson (1993) andHansson (2001).8 For a critical appraisal, see Mishan (1985).9 For a critical discussion of how the NIMBY concept is usedin the risk literature, see Luloff et al. (1998).10 Certain exceptions are allowed for research that can only

be performed on patients unable to give informed consent.11 The term ‘‘equipoise’’ is more common in North America,and the term ‘‘uncertainty principle’’ in Europe (Weijer et al.,2000; Sackett, 2000a). Some authors use the two terms in

parallel with different meanings. Hence, Rolleston (2001) andothers use the term ‘‘clinical equipoise’’ for the criterion thatshould be used by a research ethics board when deciding

whether to allow a clinical trial, whereas they use the term‘‘uncertainty principle’’ for the criterion to be applied by aphysician when deciding whether or not to enter patients into a

trial.12 Gifford, 1995; Weijer and Glass, 2002; Weijer et al., 2000;Shapiro et al., 2000; Sackett, 2000b.13 In this context it may be of some interest to note that therole of physicians was very limited in the pioneering years ofoccupational exposure limits. The first TLV (threshold limitvalues) committee of the American Conference of Govern-

mental Industrial Hygienists was formed in the 1940s bychemists, and contained no single physician. As late as in 1966the Industrial Medical Association publicly complained that

only 4 out of the 12 members of the TLV committee had amedical education (Golz et al., 1966; Ziem and Castleman,1989).14 For an overview and critical appraisal of this discussion,see Wikman (in press).15 As noted above, the effects of occupational exposure is

evaluated according to the hybrid risk-weighing principle.

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