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Special Section: Open Forum
Does Informed Consent Have an Expiry Date?
A Critical Reappraisal of Informed Consent
as a Process
GERT HELGESSON and STEFAN ERIKSSON
Informed consent is central to modern research ethics.
1
Informed consent
procedures have mainly been justified in terms of respect for autonomy, the core
idea being that it should be every competent individual’s right to decide for
herself whether or not to participate in scientific studies.
2
A number of conditions
are normally raised with regard to morally valid informed consent. These include
that potential research subjects get adequate information, understand those
aspects that are relevant to them, and, based on that information, make
a voluntary decision whether or not to participate.
3
These conditions are meant
to guarantee that participation is genuinely the individual’s own choice and is
coherent with his or her authentic interests.
4
Informed consent is a moral requirement meant to ensure the voluntary and
informed participation of subjects in research. It should, thus, not be understood
as a contract committing the subject to an agreement once it is signed, but as
a one-sided declaration that, until further notice, the consenting person agrees to
the actions described in the supplied information and stated on the consent form.
As soon as the person disagrees to further participation, for whatever reason, the
consent is revoked. The person should then be excluded from the study.
5
In
practice, researchers cannot act on decisions to withdraw consent unless they
know about them. In clinical studies, there are normally many occasions to
communicate such decisions. In other kinds of research, such as longitudinal
screening studies, quite some time may pass between contacts; much biobank
research and register-based research does not involve any contacts between
researcher and research subject.
Not only must participation remain voluntary, research subjects must also
remain adequately informed. If there is new information about the study after it
has been running for some time, arguably this information should be conveyed to
the subjects for consideration.
In neither of these aspects—voluntariness and information—is informed
consent just a single event at which the research subject is informed and consents
to participation, but rather an ongoing process not ending until the study is over.
6
Whether the original informed consent remains morally valid depends on
whether the participant is still adequately informed and still consents. In the
light of this, it has been suggested that informed consent has an expiry date
beyond which it is no longer valid unless renewed, both regarding information
supplied and the very act of consenting.
7
For instance, Wendler and Rackoff
argue that ‘‘accepting individuals’ initial agreement for the duration of their
research participation, no matter how long it lasts, is likely to result in individuals
Cambridge Quarterly of Healthcare Ethics (2011), 20, 85–92.
ÓCambridge University Press 2011.
doi:10.1017/S0963180110000642 85
participating in research that is no longer consistent with their preferences and
interests.’’
8
Although these ideas have some immediate appeal, they need to be further
analyzed. Should information be given at several occasions in long-term studies?
Should consent be renewed? Is it reasonable to talk about an expiry date for
morally valid informed consent? These issues are explored in this paper.
Continuous Consent
In research involving competent participants, informed consent is obtained
before inclusion as part of the recruitment process. Unless the study has a series
of separate stages, which might be the case, for instance, in longitudinal screenings
and long-term follow-ups of interventions, consent from research subjects is
normally obtained only once. It is assumed to be valid from then on unless
something happens that might be relevant for the participant’s continued consent.
Afirst sense in which informed consent is a process is, thus, that a subject’s consent
is constantly active and continues over time as long as he or she truly agrees to
continued participation. Consent is, in this sense, a process and is informed to the
extent that the conditions for informed consent are fulfilled (which might require
an ongoing information process; we return to this below).
Another sense in which informed consent can be said to be a process is that
participants are asked for new consent (i.e., asked to explicitly consent to
participation again) one or several times during the project. That such procedures
should be in place for studies that run for an extended period has been argued by
several writers, for instance Geller et al. and Wendler and Rackoff.
9
For such
a procedure to be justified, there must, however, be some uncertainty regarding
the validity of the original consent or of its present relevance, because otherwise
obtaining new consent would be a mere repetition and doing so might have
negative effects, such as confusing research subjects, causing dropout, or
intruding on subjects’ privacy. Asking for new consent might, for instance, cause
study participants to wonder if the original consent form is lost and what that
might imply about the reliability of the study and research team. It may also
inadvertently convey the impression that there are good reasons to question the
present validity of the original consent. Furthermore, participants may prefer not
to have any contacts with the researchers except for those required for participa-
tion in the study.
10
What, then, would justify questioning the present relevance of the initial
consent? The uncertainty that may justify this can, in principle, concern one of the
following three kinds of changes potentially relevant to the participant’s
continued participation: (1) changes in the study, (2) changes in the participant’s
health, and (3) changes in the participant’s preferences.
11
Changes in Preferences
To start with the latter, participants may change their attitude toward partici-
pating. They themselves might change as persons, or newly accessed information
might change their view of the study. If they therefore want to withdraw their
previous consent, they need to inform the research team or hospital staff
administering the study. This is what normally can be expected to happen.
Gert Helgesson and Stefan Eriksson
86
However, this may occasionally be difficult for some study participants, perhaps
because they are participating in a clinical study and fear that their withdrawal
will affect their treatment. If there are clear indications that a research subject no
longer wants to remain in the study but hesitates to say so, the research team or
others administering the study should kindly and carefully ask about this.
However, it does not seem reasonable as a general strategy that researchers
should ask about potentially changed preferences unless there is some clear
indication, for the reasons listed above (dropout, false impressions, privacy). Yet
this is what Wendler and Rackoff suggest, with the following motivation:
[T]he more time that elapses between individuals’ last agreement to
participate and their present participation, the greater the possibility
that the prior decision no longer reflects their current preferences and
interests.... As the interval between the most recent expression of
agreement and present research participation increases, the possibility
that subjects’ interests have changed becomes sufficiently great that
investigators should solicit ‘‘reaffirmation’’ of their continued willing-
ness to participate.... [I]nvestigators should explicitly remind subjects
that they are in research and are free to withdraw, and actively assess
their willingness to continue to participate.
12
Wendler and Rackoff state that they do not suggest that new formal consent
should be obtained at these occasions and underline that no consent form should
be signed. Yet they obviously propose something more than observations of
whether there are indications that someone wants to withdraw. It is hard to see
how research subjects can distinguish such active assessments from attempts to
obtain new consent. The distinction drawn by Wendler and Rackoff is unknown
to the subjects, and the components of the procedure are essentially the same.
Therefore, the risk remains that research participants get confused and even feel
encouraged to drop out. This risk becomes even greater as Wendler and Rackoff
suggest that reaffirmation of consent should be solicited approximately six times
a year, even if no material changes in the study or in the participant’s health
conditions have occurred!
13
They write: ‘‘Asking subjects to reaffirm their
willingness to participate every day, or even every week, may inadvertently
convey the impression that significant changes in the protocol or the subject’s
conditions have occurred,’’
14
yet they do not acknowledge the risk that this might
happen also if active assessment is performed once every two months. We
strongly question this. Instead of making sure that participation reflects current
preferences and interests, active assessment of the kind proposed may rather
result in subjects getting confused and unsure about their participation.
Furthermore, if you ask a competent person about something and then
repeatedly ask the same thing, the implication of your action is that you do
not trust the person to be competent after all. Thus, it seems that underlying this
approach to defend the autonomy of research subjects is actually a paternalistic
attitude—research subjects need to be taken care of because they cannot take care
of themselves. Besides, to communicate to research subjects that they have to
carefully and repeatedly reassess their involvement in research risks conveying
the impression that the researchers cannot be fully trusted. Active reassessment
may, thus, in our view, undermine trust in research, because the implicit message
from the researchers seems to be that ‘‘We can’t trust you, and you can’t trust us.’’
Does Informed Consent Have an Expiry Date?
87
Changes in the Study
Changes in the study could be either unforeseen events, such as unexpected side
effects of a tested drug, or modifications of the study protocol. The research team
might, for instance, want to carry out additional tests or analyses or modify the
original aims of the study. Unless research subjects are informed and get the
chance to take a stance whether or not to remain in the study, arguably, valid
informed consent is no longer in place. New informed consent can seem to be
imperative in such circumstances.
It is, however, worth distinguishing between changes of different magnitude.
15
Clearly some changes can be so minor as to be irrelevant to anyone’s decision to
remain in the study, such as adding a few new questions in a survey, changes of
analyzing laboratories or specific techniques by which to analyze or store
biological samples, or replacement of retiring personnel. Other changes are more
relevant to research subjects, yet not likely to affect their willingness to par-
ticipate. Discoveries of a minor side effect, such as a rash that lasts a short while
or the addition of some new analyses that are in line with initial research aims are
two examples. Some changes, finally, are both substantial and significant enough
to be likely to be relevant to participants’ willingness to remain in the study, such
as the discovery of serious side effects or radical changes in the purpose
of research.
16
Substantial and significant changes regarding research purpose,
requirements for participation, risks, or potential benefits (to the extent such have
been implied) require both new personally addressed information and some
active inquiry regarding participants’ willingness to remain in the study.
However, only such changes justify this, because, if there are costs tied to the
process, then a minimum requirement for applying it is that there are also some
expected benefits.
Prentice et al. seem to disagree. For them, one of the potentially important
changes may be ‘‘a change in a participant’s ongoing knowledge of his own
circumstances and options.’’
17
They therefore suggest a model of systematic
periodic assessment, where participants have to answer study-related questions
in order to establish that they still fulfill requirements of valid informed consent.
Prentice et al. argue in support of their model that ‘‘the justification for ongoing
participation in research depends substantially on subjects’ continued knowledge
of at least some protocol-related information.’’
18
We agree with their basic
requirements that research subjects must know throughout the study that they
participate in research and that participation is voluntary and can be terminated
without penalty at any time: these are preconditions for voluntary participation.
However, that research subjects should remain aware of these aspects of research
participation is one thing; periodic assessment of their understanding is another.
Prentice et al. suggest periodic assessment and protocol review in order to find
those that need closer monitoring. But if research participants have been clearly
informed about how to withdraw and there are no substantial and significant
changes to the study, then repeatedly checking if their knowledge about the
study is accurate or asking if they still ‘‘really consent’’ implies a paternalistic
outlook. It not only involves overly intrusive routines for making sure that
participation rests on an autonomous choice but also implies that the participants
are not allowed to decide how much information to process and care to
remember.
19
This seems to disrespect the autonomy of the many in an effort to
Gert Helgesson and Stefan Eriksson
88
strengthen it for the few. Would it not be better to have a procedure in place for
informing subjects further about the study if they so wish and leave it to them to
decide whether to ponder the continuing validity of their original informed
consent?
Changes in the Health Status of Research Subjects
Changes in participants’ health can be highly relevant to their willingness to
participate. For instance, a change in the severity of a cancer prognosis might
motivate the patient to reconsider participation. As long as participants are
informed about such changes and have the opportunity to discuss them with
their doctor, they can consider their implications without the involvement of the
research team. If important health changes are discovered in the process of
clinical research, such as a considerable decrease in CD4 cells for HIV patients,
this should be reported back to the research subject.
20
If this information leads the
person to reconsider participation, this should be duly noted.
New Consent or Openness about the Right to Withdraw?
While rejecting too far-reaching suggestions, we have identified some situations
where consent procedures should be a process: research subjects should be given
a special opportunity to reconsider their participation as the study, their health,
or their preferences change in significant ways. Saying this is, however, not the
same thing as saying that they should be asked to reconsent or that researchers
should solicit their ongoing consent. There are other options that, if handled
correctly, equally well respect autonomy while avoiding the negative aspects of
soliciting new consent.
Nothing about autonomy and its connection to informed consent implies
that asking for new explicit affirmation would be preferable to gently
reminding participants of the unconditional option to withdraw from the
study at any time. Respecting autonomy implies respecting the individual’s
choice about participation. If the person has once chosen to participate, this
choice should be respected until further notice. Rather than focusing on
obtaining new consent, the proper thing to do is to be observant regarding
whether the person has changed her mind. Taking the original consent at face
value and inviting participants to reflect on whether it still stands is more
respectful to the person than asking for new consent, as if the original one was
notgoodenough.Wewanttostressthatitwouldbeamistaketothinkthat
a person’s autonomy is better respected by repeatedly asking for consent than
by just being attentive to whether the person wants to opt out. On the contrary,
asking over and over for new explicit statements of the initial consent is
disrespectful.
The general conclusion this boils down to is that procedures intended to ensure
valid informed consent must not be such that they do not show proper respect for
the autonomy of research subjects—the autonomy, that is, that informed consent
procedures are there to protect. Procedures that include repeated soliciting of
consent to participation in a study are highly questionable in this respect—unless
they are explicitly asked for by research subjects.
Does Informed Consent Have an Expiry Date?
89
Continuous Information
Informed consent understood as a process relates, to a considerable extent, to the
handling of information to participants in scientific studies. This can be un-
derstood in various ways. A first interpretation concerns that participants should
continuously be informed about events in the project. Whether or not research
subjects should be informed depends on the magnitude of the change. A rule of
thumb, suggested by Wendler and Rackoff, is that you do not have to convey
a certain piece of information when the study is running if it would not have
been relevant for the initial informed consent.
21
Information that is clearly
relevant to research subjects’ continuous participation, on the other hand, should
be conveyed to them. Information of less importance can still be made available
to them, as long as the informing does not risk becoming intrusive. A convenient
way for the research team to reach nonwarded subjects is to use a study website
where they can present updated information about the study. Keeping partic-
ipants updated might increase their interest in the study and their willingness to
remain in it.
According to a second interpretation, informed consent as a process refers to
procedures intended to enhance participants’ understanding of central aspects of
the study, an understanding that for various reasons might be limited at first.
Allmark and Mason discussed a study investigating the use of whole-body
cooling of neonates with perinatal asphyxia (lack of oxygen during birth), where
parents were not only informed when they were recruited but also at a later
stage. Initial problems with understanding side effects were markedly reduced
after the follow-up discussion.
22
For certain studies, procedures intended to
enhance understanding underway can certainly be helpful. It is preferable that
these follow-ups are integrated with other study-related events, such as occasions
when new study information is given, checkups, sample collections, or inter-
views.
Athird interpretation of informed consent as a process in relation to study
information is that there should be repeated controls of the understanding
participants have of the study, with new information efforts if the results are
judged to be too poor. Can this be justified?
There can indeed be situations where participation involves considerable risks
and it therefore is very important that participants understand the study
information. For instance, in certain clinical cancer trials the negative side effects
may be partly unknown or known to be considerable. In such situations, it seems
particularly important that participants understand the risks and not only the
expected (or hoped for) benefits. Generally, the greater the risks of participating
are, the more important it is that research subjects really do understand the study
information. If there are strong indications that participants do not understand
crucial information about requirements for participation, the right to withdraw,
risks, or potential benefits, this might call for new information efforts in order to
decrease the risk that participation rests on mistaken assumptions.
If there are no special indications that participants do not understand central
aspects of the study and the study involves limited risk, then controls of research
participants’ understanding should normally not be carried out. We thus disagree
with Prentice et al., who suggest that participants’ understanding should be
regularly assessed regardless of any such indication.
23
They argue that research
Gert Helgesson and Stefan Eriksson
90
subjects should keep in mind what the purpose or goal of the study is as well as
risks and benefits of participating. Subjects also ‘‘need to recalculate that ratio to
make sure it is still in their favor.’’
24
One sense in which informed consent need not
be a process, we suggest, is that subjects must have a vivid understanding of the
study as long as it runs. For instance, they may forget information they once
understood because they feel they do not need to remember it. When they enrolled
in the study, they processed the study information and decided that participation
was OK for them; now they do what is asked of them as long as they think it is
acceptable and does not take too much of their time. Participants can, thus, have
a limited present understanding of the study and still participate autonomously.
People may not bother to try and grasp every piece of information given to
them or care whether they remember most of it a few months later. They are
perfectly rational in so doing. They do not have to reach the standards set by
scientific belief-formation; they need to use their abilities to the extent that this
enables them to go on living their lives purposively. The research team must,
accordingly, be careful not to overload participants with information, or else they
might decide to drop out.
25
It is essential that relevant study information is made
available but not forced on research subjects. The duty to inform is not generally
tied to a corresponding duty to remain informed.
26
The consent given is not
rendered invalid just because there are knowledge differences between research-
ers and research subjects.
Concluding Remarks
Informed consent was originally perceived as an important means to protect
research subjects from undue risks. In later years, ethical review boards have
shouldered much of this responsibility. What mainly remains for informed
consent procedures is to protect the autonomy of research participants. The
natural way to do this seems to be to let research subjects decide about things that
mainly concern themselves. Checking their understanding over and over and
repeatedly asking for new consent are not only misdirected efforts, if routinely
applied, but also an expression of paternalism.
Notes
1. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. Oxford: Oxford University
Press; 1986.
2. Beauchamp T, Childress J. Principles of Biomedical Ethics (6th ed). New York: Oxford University
Press; 2009; Brock D. Informed consent. In Brock D. Life and Death. Philosophical Essays in Biomedical
Ethics. Cambridge, UK: Cambridge University Press; 1993:21–54; Kihlbom U. Autonomy and
negatively informed consent. Journal of Medical Ethics 2008;34:146–9; Laurie G. Genetic Privacy:
A Challenge to Medico-legal Norms. Cambridge, UK: Cambridge University Press; 2002.
3. See note 2, Beauchamp, Childress 2009 and Kihlbom 2008.
4. Wendler D, Rackoff J. Consent for continuing research participation: What is it and when should it
be obtained? IRB: Ethics & Human Research 2002;24(3):1–6; see note 2, Kihlbom 2008.
5. Helgesson G, Johnsson L. The right to withdraw consent to research on biobank samples. Medicine,
Health Care and Philosophy 2005;8:315–21; World Medical Association. Declaration of Helsinki. The
59th General Assembly, Seoul, October 2008; see note 2, Beauchamp, Childress 2009; see note 4,
Wendler, Rackoff 2002.
6. Geller G, Strauss M, Bernhard BA, Holtzman NA. Decoding informed consent: Insights from
women regarding cancer susceptibility testing. Hastings Center Report 1997;27(2):28–33; Kuczewski
MG, Marshall P. The decision dynamics of clinical research; the context and process of informed
Does Informed Consent Have an Expiry Date?
91
consent. Medical Care 2002;40(Suppl):V45–54; Getz KA. Informed consent process: A survey of
subjects assesses strengths and weaknesses. Applied Clinical Trials 2002;11:30–6; see note 4,
Wendler, Rackoff 2002.
7. Prentice KJ, Appelbaum PS, Conley RR, Carpenter WT. Maintaining informed consent validity
during lengthy research protocols. IRB: Ethics & Human Research 2007;29(6):1–6; see note 4,
Wendler, Rackoff 2002; see note 6, Geller et al. 1997.
8. See note 4, Wendler, Rackoff 2002:5.
9. See note 4, Wendler, Rackoff 2002; see note 6, Geller et al. 1997.
10. Eriksson S, Helgesson G. Keep people informed or leave them alone? A suggested tool for
identifying research participants who rightly want only limited information. Journal of Medical
Ethics 2005;31:674–78; see note 4, Wendler, Rackoff 2002.
11. See note 4, Wendler, Rackoff 2002.
12. See note 4, Wendler, Rackoff 2002:4.
13. See note 4, Wendler, Rackoff 2002.
14. See note 4, Wendler, Rackoff 2002:4–5.
15. See note 4, Wendler, Rackoff 2002.
16. See note 4, Wendler, Rackoff 2002.
17. See note 7, Prentice et al. 2007:2.
18. See note 7, Prentice et al. 2007:1.
19. See note 10, Eriksson, Helgesson 2005.
20. The issue of whether or not to report research results back to research subjects is complicated. It
seems reasonable in some kinds of studies and not so in others. We cannot discuss this in detail
here, but suggest the following general principle: If research is conducted in a clinical setting, then
participating patients will most likely perceive research as part of clinical procedures (which, in
a sense, it is). In such situations, research results should be reported back if they can be expected to
be relevant to the treatment and care of the patient. If research is not conducted in a clinical
setting, as when research is carried out on previously collected biobank samples, then results
should not be reported back. Exceptions to the latter principle should be considered if
consequences otherwise would be dire to those concerned. In principle, research and treatment
of patients are different activities and should be treated as such when research subjects could be
expected to perceive the difference (the last condition is important for the sake of people’s trust in
both research and healthcare).
21. See note 4, Wendler, Rackoff 2002.
22. Allmark P, Mason S. Improving the quality of consent to randomised controlled trials by using
continuous consent and clinician training in the consent process. Journal of Medical Ethics
2006;32:439–43.
23. See note 7, Prentice et al. 2007:2.
24. See note 7, Prentice et al. 2007:3.
25. Swartling U, Helgesson G. Self-assessed understanding as a tool for evaluating consent:
Reflections on a longitudinal study. Journal of Medical Ethics 2008;34:557–62; see note 10,
Eriksson, Helgesson 2005.
26. Chamot E, Charvet AI, Perneger TV. Variability in women’s desire for information about
mammography screening: Implications for informed consent. European Journal of Cancer
Prevention 2005;14:413–8; O’Neill O. Some limits of informed consent. Journal of Medical Ethics
2003;29:4–7; see note 10, Eriksson, Helgesson 2005; see note 25, Swartling, Helgesson 2008.
Gert Helgesson and Stefan Eriksson
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