Appendix 9a - Grady Incentives

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The American Journal of Bioethics
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Money for Research Participation: Does It
Jeopardize Informed Consent?
Christine Grady
Published online: 07 Dec 2010.

To cite this article: Christine Grady (2001) Money for Research Participation: Does It Jeopardize Informed
Consent?, The American Journal of Bioethics, 1:2, 40-44
To link to this article: http://dx.doi.org/10.1162/152651601300169031

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Target Article
Mo ney fo r Research Participatio n

Money for Research Participation:
Does It Jeopardize Informed
Consent?
Christine Grady, National Institutes of Health1

Keywords
undue inducement

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payment
informed consent
coercion

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue in¯ uence capable of distorting the judgment of potential research subjects
and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple in¯ uences leading to decisions, including decisions about research
participation. The concept of undue in¯ uence is explored, as well as the question of whether or not
there is something uniquely distorting about money as opposed to a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time
and contribution that research subjects make.

research participation
ethics of research

—“EARN $30 IN ONE HOUR” (Washington Post 1999b)
—“$$$Skin Ulcer Research Project$$$” (Washington Post 1999a)

Open Peer
Commentary
Jessica Latterman and
Jon F. Merz, p. 45
Jonathan D. Moreno, p. 46
Rebecca Dresser, p. 47
Tod Chambers, p. 48
Mark Kuczewski, p. 49
Trudo Lemmens and
Carl Elliott, p. 51
Nancy King Reame, p. 53
David B. Resnik, p. 54
Jerry Menikoff, p. 56
Harold Y. Vanderpool, p. 58
Caroline Todd, p. 60
Richard E. Ashcroft, p. 62
Erica Heath, p. 63
Laura A. Siminoff, p. 65
Jeanne M. Sears, p. 66
James A. Anderson and
Charles Weijer, p. 67

Advertisements similar to these are increasingly
common in newspapers around the United States,
where, every day, people receive money for their
participation in clinical research designed to test
new drugs or devices or to learn more about human
health and illness. Money is offered to research
subjects as reimbursement for their expenses, compensation or reward for their time and effort, and/
or as an incentive for studies that might otherwise
have difŽculty recruiting. Even though the practice of paying subjects is quite common, attitudes
among investigators, members of Institutional Review Boards (IRBs) and others diverge, with some
defending payment to research subjects as fair and
appropriate and others condemning it as problematic and possibly even offensive or unethical.
Some of those uncomfortable with paying subjects are concerned that payment could jeopardize
informed consent. SpeciŽcally, the concern is that
money is potentially coercive or could cause “undue inducement.” Coercion and undue inducement
are threats to the possibility of voluntary informed
1. The opinions expressed are those of the author and do
not necessarily reect those of the National Institutes of
Health, the Public Health Service, or the Department of
Health and Human Services.

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consent, a tenet of ethical research as described in
guidelines and codes of research ethics. The U.S.
Common Rule for the Protection of Human Subjects (1991) states:
An investigator shall seek consent only under circumstances that provide the prospective subject or
representative sufŽcient opportunity to consider
whether or not to participate and that minimize the
possibility of coercion or undue inuence. (emphasis
added)

The U.S. Food and Drug Administration (FDA)
requires IRBs to “review both the amount of payment and the method and timing of disbursement
to assure that neither are coercive or present undue
inuence” (1998, emphasis added). In this article I
will briey explore the concepts of coercion and
undue inuence as they have been applied to paying research subjects. I argue that the offer of payment to research subjects is not coercive, and that
although in rare circumstances money could possibly constitute an undue inducement, prohibiting
the use of money for research subjects is not the solution.
An individual’s agreement to participate in research after deciding—based on information about
the study—that it is compatible with his or her in-

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Money for Research Participation

terests is an informed consent, widely accepted as
central to the ethical conduct of clinical research.
Informed consent is a process that includes several
elements. In this process a potential research subject who is capable of making decisions is provided
with information about a proposed study in an
amount and manner sufŽcient to promote a thorough understanding of the purpose, risks, beneŽts,
alternatives, and requirements of the study. Given
the information, a subject then voluntarily decides
whether or not he or she wants to participate. Voluntariness is understood, as suggested above, as
free from coercion and undue inuence. Under
what circumstances or conditions might the offer
of money be coercive or unduly inuential and
thereby limit voluntariness?
Although in common usage “coercion” is often
meant to include much more, coercion is, by
deŽnition, the intentional use of a credible and severe threat of harm or force to control another or
compel him or her to do something (Beauchamp
and Childress 1994, 165). Coercion, although certainly possible in research, is not very probable under the current system of checks and balances.
Threatening someone who refuses to participate in
a research study with punishment or retaliation
(for example, by a military ofŽcer, a professor, employer, warden, or even a doctor) would be coercive. Coercion may also occur if someone who refused to participate was threatened with physical
or other harm (e.g., injury or loss of promotion or a
job). However, since the offer of money is not a
threat of punishment or harm, but rather an offer,
it is hard to see how money as payment for research
participation is or could be coercive (Faden and
Beauchamp 1986, ch. 10; Wilkinson and Moore
1997). But what about money as undue inuence?
Undue inuence might be thought of as too
much or excessive inuence. Therefore it is worth
briey considering the nature of inuence more
generally. Most decisions that a person makes, including the decision whether to participate in a research study, are susceptible to multiple inuences.
People usually choose and act in accordance with
their wants and needs, inuenced by their physical,
psychological, social, economic, and cultural experiences and circumstances. Ruth Faden and Tom
Beauchamp in their landmark work, A History and
Theory of Informed Consent, recognize that “inuences come in many forms, and from many sources.
. . . They can vary dramatically in degree of inuence actually exerted” (1986, 256). Some inu-

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ences are strong enough to serve as inducements,
motivations, or stimuli for action.
However, inducements—many of which are
nonmonetary—do not necessarily invalidate or
preclude voluntary choice. We welcome and respond to inducements all of the time in many areas
of life, including selecting employment, making
purchases, and other choices. For example, even if
we are attracted to a job by a higher salary, we still
generally choose a job based on a number of other
factors, including what we feel qualiŽed for, what
would be satisfying, as well as where, with whom,
and what hours we would work. Since human motivation is complex and almost always involves
multiple considerations, there is rarely a single reason for doing something. In the same way, being
attracted to the money offered for research participation does not necessarily negate the possibility of
other inuential motivations and considerations.
Subjects participate in research for multiple reasons. For some subjects money may be one reason
among others. If inducements can be compatible
with voluntary choice, then money, as an inducement, does not inherently obviate or compromise
voluntariness.
Payment for research participation has been objected to, however, not simply because it is an inducement, but because it can be an undue inducement or inuence. In Faden and Beauchamp’s
analysis, inuences exist along a continuum from
controlling to noncontrolling. Control beyond a
certain point is not compatible with voluntary autonomous decision making and action. The control
of inuences found “irresistible” by an individual
might compel unwelcome choices and in this sense
compromise voluntariness (Faden and Beauchamp
1986, 256). These inuences might be regarded as
“undue” or excessively inuential. On this analysis
individuals who Žnd participation in a particular
research study unwelcome yet are unable to refuse
because of the inuence or inducement of money
could be “unduly induced.” Presumably, most subjects attracted to research by money, or subjects
who choose to participate in research partly because of the money, do have the freedom to refuse.
Prospective subjects are reminded of their right to
exercise this freedom in the process of obtaining
informed consent. They are advised that participation is their choice and they have the right to refuse or withdraw at any time without penalty. In
addition, many people who are attracted to research because of the money (including students,

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The American Journal of Bioethics

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people looking for a little extra income, or even the
“professional guinea pig”) generally do have additional options for obtaining money, usually from
other full or part-time unskilled jobs. Perhaps they
select research participation because it has more
exible hours, is time limited, or seems more interesting or easier. In addition, research volunteers
can and do exercise their freedom to refuse when
they decide participating in the particular study is
not in their interests. Perhaps the potential for undue inducement—in the sense that money literally
makes research an offer that one cannot refuse—is a
worry when a person is economically destitute and
truly has no other options for acquiring comparable amounts of money. Even then, do we protect
such people by allowing them to participate in (the
same kind of ) research without receiving money or
by not allowing them to participate at all? In fact,
denying the possibility of Žnancial payment to a
research subject may serve only to eliminate an option—the option of obtaining money through research participation. Careful attention, in the process of obtaining informed consent, to a subject’s
reasons for participating, his or her understanding
and expectations of research, and his or her sense of
freedom to choose to participate or not seems more
appropriate and may be more effective than eliminating the opportunity to receive money. The offer
of money for research participation may actually
expand options for some people, while not restricting their options to do anything else they could
otherwise have done (Wilkinson and Moore 1999).
If a principal concern with respect to undue
inuence is a limited freedom to refuse research
participation because of the lack of other available
money-making options, we ought to be at least as
or more concerned about other inuences on research subjects with other types of need and limited options. These inuences include: the promise
of treatment, albeit investigational, for the desperately ill who have exhausted other treatment options; access to care or medications or other treatment for those who cannot afford these on their
own or have no or inadequate healthcare coverage;
the advice from a trusted physician or healthcare
provider that the study is the best or only hope; or
course credit for student participants. People in
these situations may Žnd research participation extremely difŽcult to resist or refuse. However, as
Wilkinson and Moore (1997) argue, there may be a
distinction between autonomy—understood as the
ability to decide what to do for oneself—and freedom—the presence of more than one acceptable

option. According to their analysis, even people
who are unfree, in that they have no other good options, may still be capable of autonomous consent.
A nonresearch example of this is our acceptance of
individuals’ right to refuse life-sustaining therapy,
based on respect for their autonomy, knowing that,
in many cases, their options are limited to either
accepting the therapy or death. There are few data
on the extent to which research participants feel
free to refuse or withdraw from research within the
context of their often limited options, and the extent to which some actually do agree to participate
in research that compromises their values or interests. Of note is data collected in the Subject Interview Survey by the Advisory Committee on Human Radiation Experiments. They report that
31% of responding patients felt they had no choice
but to participate because of their few medical alternatives (1996, 469). Nevertheless, greater than
98% felt that “the decision to participate had been
theirs to make and that they had not felt pressured
into that decision” (472). Further empirical research would help us to better understand these
issues.
According to the Belmont Report, an inuence
may be undue not only when it is excessive, but also
when it is inappropriate or improper (National
Commission for the Protection of Human Subjects
of Biomedical Behavioral Research 1979). Some
may believe that money, unlike the need for treatment or care, is an inappropriate inuence in decisions about research participation. It is sometimes
argued that since research participants volunteer
with altruistic motives of contributing to science
and society, money has no place in this arrangement. The ethical concern, then, is not simply that
some might Žnd the offer of money irresistible, but
also that money is simply an inappropriate motivating factor for research participation. Money certainly has a reputation for getting people to do
things they otherwise would not do, and, in some
cases, for getting people to do something they
know is wrong. Hence, we see daily newspaper accounts of scandals, bribes, and extortion. Money is
also believed capable of inappropriately distorting
people’s judgments and motivations. The U.S.
OfŽce of Protection from Research Risks (OPRR,
replaced in 2000 by the OfŽce of Human Research
Protections (OHRP)) says that money as a possible
undue inducement for research is problematic because it can impair an individual’s judgment regarding what is at stake in the research or blind
him or her to the potential risks of research partici-

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Money for Research Participation

pation (1993, 3–44). OPRR further notes that offers of money could cause potential participants to
misrepresent something about themselves in order
to gain or maintain enrollment in a study and receive the money. Misrepresentation may not only
jeopardize the participant’s informed consent, but
possibly also his or her well-being as well as the integrity of the study. An individual’s susceptibility
to distorted judgment because of money is relative
to his or her particular circumstances, but importantly also to his or her values, as some people even
in very desperate straits cannot be “bought.” Presumably, however, the larger the sum of money involved, the greater the potential for distorting
judgment or prompting potential participants to
lie or ignore risks. Commentators and common
wisdom have argued that limiting the amount of
payment offered for research participation minimizes the possibility that money will distort judgment and push people towards deception (Levine
1986; Macklin 1981). Payment as recognition of
the research participant’s contribution and calculated according to some regularly applied and locally acceptable standard (per day, visit, or procedure) is likely to be more modest and less likely to
distort judgment than amounts designed solely to
attract subjects and outperform the competition in
terms of recruitment (Dickert and Grady 1999).
Arbitrary or large amounts of money designed simply to entice, to outbid other studies, or to make
up for risk should not be allowed. Modest payment
thought of as remuneration for the participant’s
contribution minimizes the possibility of undue
inducement, because the offer of money is neither
excessive nor inappropriate.
On the other hand, it is not clear that money is
uniquely capable of distorting judgment about the
risks and beneŽts of research. Again, a person with
few or no other treatment options might also be
prompted to conceal something about past medical
history or current behaviors that would otherwise
disqualify him or her from the option he or she
perceives as the best “treatment” or only hope. In
the process of obtaining informed consent, particular care should be taken with people who might be
feeling desperate. In order to assess comprehension
and ensure an adequate voluntary informed consent, reasons for participating should be carefully
assessed, as well as participants’ understanding of
the research risks and beneŽts and the alternatives
available to them. Information about the potential
for therapeutic beneŽt or lack thereof in any particular study should be presented clearly and accu-

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rately. In addition, the threshold of understanding
should be higher for those who are invited to participate in risky, uncomfortable, or even inconvenient research without the prospect of direct
beneŽt to them, whether they be healthy students
looking for a little extra cash or chronically ill and
vulnerable patients dependent on us for their treatment and care.
Some may object that careful evaluation of a research participant’s motivations for participating
and his or her understanding of risks, beneŽts, and
alternatives puts too much additional burden on
the process of obtaining informed consent—a process which is already less than ideal. In my view, by
focusing less on the details and words in written
documents and focusing more time and attention
assuring that research subjects understand and feel
conŽdent that the choice about participation is
theirs, we could improve the reality of informed
consent.
Summary

A decision about whether or not to participate in
research is subject to many inuences, of various
forms and degrees and from different sources.
Money may be one of these inuences, although it
is often just one among several other factors that an
individual will consider in making a decision. In
asking prospective research participants to give informed consent for research participation, it is incumbent upon us not only to provide clear and
honest information about the study and assess how
well they understand the information provided,
but also to assess their reasons for participating and
whether they feel free to refuse. Particular attention should be given to the informed consent of individuals who perceive they have no other choice
because they need the money or the “treatment” or
something else available to them only through the
research. In these cases extra effort to assure that
they understand the nature, risks, beneŽts, alternatives, and requirements of the study is warranted.
In addition, the amount of money offered through
research participation should be standardized and
calculated so that it is more or less comparable to
that available through other similar unskilled
moneymaking opportunities in the relevant community. In these ways the potential that money
will unduly inuence an individual to participate
in a research study against his or her interests, or
with a distorted view of what is at stake, is minimized.
Research participants volunteer and sacriŽce

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The American Journal of Bioethics

their time and effort to generate knowledge that is
helpful to others and society, often with little or
uncertain beneŽt for themselves. Rather than an
undue inducement, money to reimburse research
participants for their expenses and compensate
them in some way for their time and effort may be
a demonstration of respect and appreciation for
these generous individuals. n

Levine, R. 1986. Ethics and regulation of clinical research,
2nd ed. New Haven: Yale University Press.
Macklin, R. 1981. ª Dueº and ª undueº inducements: On
paying money to research subjects. IRB: A Review of Human Subjects Research 3(5):1± 6.
U.S. Department of Health and Human Services. Of® ce of
Protection from Research Risks. 1993. Protecting human
research subjects: IRB guidebook. Washington: GPO.
U.S. Food and Drug Administration. 1998. Payment to research subjects. Guidance for Investigational Review
Boards and clinical investigators. Washington: GPO.

References

Downloaded by [NIH Library] at 13:05 01 May 2014

Advisory Committee on Human Radiation Experiments.
1996. Final report. NY: Oxford University Press.

44 ajob

Beauchamp, T., and J. Childress. 1994. Principles of biomedical ethics, 4th ed. NY: Oxford University Press.

U.S. National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research. 1979.
The Belmont report. Washington: GPO.

Common Rule for the Protection of Human Subjects.
1991. U.S. Code of Federal Regulations. Title 45, pt. 46,
sec. 116.

Washington Post. 1999a. Advertisement, 17 August,
Health section, 4.
Ð

Ð

Dickert, N., and C. Grady. 1999. What’s the price of a research subject? Approaches to payment for research participation. The New England Journal of Medicine 341:198±
203.
Faden, R., and T. Beauchamp. 1986. A history and theory
of informed consent. New York: Oxford University Press.

Ð

. 1999b. Advertisement, 17 August, Health section,

9.

Ð

Wilkinson, M., and A. Moore. 1997. Inducement in research. Bioethics 11:373± 389.
Ð Ð
130.

. 1999. Inducements revisited. Bioethics 13:114±

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