BioSocieties (2006), 1, 251262 London School of Economics and Political Science

doi:10.1017/S1745855206060029

Im not Really Read up on Genetics:

Biobanks and the Social Context of
Informed Consent
Michael Barr
BIOS Centre, London School of Economics, Houghton Street, London WC2A 2AE, UK
E-mail: m.t.barr@lse.ac.uk

Abstract
It is widely recognized that traditional informed consent requirements are highly problematic in the
context of population-based genetic research. This article is based on a qualitative study that
describes and analyses the consenting procedures and perceptions of donors to the North Cumbria
Community Genetics Project (NCCGP), a DNA bank in northwest England. The NCCGP collected
placenta and cord tissue, as well as maternal blood samples and health and lifestyle information,
in order to conduct genetic epidemiological studies. The findings show that the nature of the sample (i.e. afterbirth) significantly impacted donors decision to donate. The antenatal context also
influenced the way the request was framed to potential donors, who had a limited understanding
of the aims of the biobank. However, the article concludes that a lack of understanding on the
part of donors is not necessarily an ethical problem and that efforts to re-think informed consent
guidelines may benefit from paying greater attention to the factors that motivate people to donate
in the first place.
keywords Antenatal context, Biobanks, Consent, Donation, NCCGP

Recently there has been much discussion about the need to re-evaluate research ethics and to
question the primacy of informed consent. Critics contend that consent is problematic for
several reasons including: (a) it relies on an unitary version of rationality and reifies the principle of autonomy at the cost of insights from care and feminist schools of thought; (b) it
fails to appreciate how patients make decisions in relation to their wider relationships,
wants and expectations; and (c) it was developed as a direct result of the Holocaust and
thus cannot serve as the primary standard of ethical conduct in a genetic era that deemphasizes individual rights in favour of community and solidarity (Chadwick and Berg,
2001; Corrigan, 2003; DeVries and Subedi, 1998; Hoffmaster, 2001; Rhodes, 2005). Of
course, nearly all commentators agree that consent is important and necessary to help
Michael Barr works in the BIOS Centre at the London School of Economics and Political Science. His interests
include the history of biomedical ethics and the social and ethical implications of genome-based antidepressants. Previously, he worked for five years in China and in Egypt as an English teacher. He did his undergraduate work in
international relations and earned his MA in theology and PhD in philosophy from the University of Durham while
working as a research assistant at the PEALS Institute at the University of Newcastle. He has published on the history of medical ethics education in Britain, the relationship between rights and obligations in relation to informed
consent and research ethics, and the social and ethics aspects of genetic epidemiology and the pharmacogenomics
of depression.

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protect against coercion and deception; and there is similar agreement that consent is not a
sufficient ethical requirement, since merely consenting to an act (say cannibalism) does not
make it right.
There are also good philosophical reasons why consent is a problematic concept. As
Onora ONeills work has highlighted, consent is a propositional attitudethat is, one
inevitably gives consent to a description of a proposal for treatment or research. It is
assumed that in consenting to a description of a procedure, research subjects also consent
to the logical consequences of its being done, but this is not necessarily the case. The person
giving consent may fail to see any further than the specific description to which they have
agreed. I may consent to act A but not be aware of As causal links to B, so in effect cannot
say that I consented to B. ONeill uses the case of Alder Hey to illustrate this point. Some
parents consented to the removal of tissue from their children post mortem but they did
not, they later argued, consent to the removal and storage of whole organs. Of course
organs consist of tissue but, in technical terms, the parents were not incorrect. In other
words, consent lacks transitivity such that it cannot be assumed that implied consent will
spread from one proposition to another or to its consequences, no matter how obvious
they may seem (ONeill, 2002, 2003).
One key area that illustrates this problem and has prompted a re-evaluation of
informed consent is human biobanking. Biobanks (sometimes called DNA banks or genetic
databases) aim to better understand disease causation by combining genetic, lifestyle and
environmental information with medical health records. Biobanks present a particular
challenge to consent requirements. Since samples can be immortalized and stored indefinitely, it is often impossible to anticipate future sample uses. At issue, then, is how investigators can achieve informed consent in a context of unspecified future studies, which
entail unknown risks and unknown benefits (Beskow et al., 2001). Attempts to address
these problems are often framed in terms of heavily detailed consent forms and adherence
to a well-established protocol of institutional safeguards to help ensure public trust
(Petersen, 2005).
This article addresses the issue of informed consent in DNA banking by using the North
Cumbria Community Genetics Project (NCCGP) as a case study. After describing the
consenting procedures of the NCCGP, I provide data from a qualitative study of NCCGP
team members and donors. My focus is on the nature of genetic donation in relation to
the NCCGP, and on how the context of the request to donate impacted donors views
and understandings of the biobank. I end with discussion of how donors views of donation
may be incorporated into wider debates on the limitations of informed consent.

The North Cumbria Community Genetics Project

The NCCGP was a collaboration between the University of Newcastle upon Tyne and
Westlakes Research Institute in northern England. From January 1996 until April 2003,
the NCCGP collected blood and tissue samples from the umbilical cord of newborn babies,
maternal blood samples (from 1999) and personal health information derived from
questionnaires (Chase et al., 1998). With nearly 10,000 samples in the bank, the NCCGP
provides a resource of DNA samples for other researchers to use in genetic epidemiological

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studies (which so far include studies on heart disease, cancer and prenatal viability, neurodegenerative disease and gene repair of damaged DNA).
The NCCGP had a highly successful uptake rate for the collection of afterbirth samples.
Nearly 90 percent of the pregnant women approached agreed to provide umbilical cord
samples and maternal blood specimens (Chase et al., 2000). However, only 60 percent of
those who were asked to donate also completed the mothers questionnaire, a health and
lifestyle form for the woman and her partner, as well as giving a biological sample.
Pregnant women in West Cumbria were recruited to the DNA bank and given consent
forms by their community midwife. To help ensure a high uptake rate, the NCCGP also
employed a midwife who served as a liaison between the DNA bank managers and community midwives. The consent form cited studies likely to be performed (i.e. studies on diabetes, heart disease and asthma); it stressed that the NCCGP was purely a research study
and stated that information would NEVER (original emphasis) be available for life assurance, mortgage applications, police records, identification of parents, [or] AIDS/HIV testing. It also indicated that feedback of results would not be given and that donors could
withdraw from the project at any time without their medical care or legal rights being
affected (NCCGP, 2001).
Prior to the collection of the first samples, organizers of the NCCGP adopted several
measures to help ensure ethical and public acceptability of the DNA bank. In 1995, the
NCCGP team held two public consultations. Turn-out for these events was very low, despite
what team members considered to be extensive advertising. Nonetheless, the NCCGP was
subsequently approved by the West Cumbria Local Research Ethics Committee and each
study that uses NCCGP samples must be approved by a similar research ethics committee.
In addition, because of the unique nature of the project and the lack of published guidelines, NCCGP team members formed their own Ethics Advisory Group (Chase et al.,
1998: 414).
The study reported here involved semi-structured interviews with forty-three donors to
the NCCGP, seven women who were asked to donate but refused, seven NCCGP research
team members, two members of the NCCGPs Ethics Advisory Group, ten community
midwives (conducted in two groups), and three members of local community groups that
opposed the NCCGP because of its financial ties to British Nuclear Fuels, which operate a
nuclear reprocessing plant in near-by Sellafield. The central focus of the study was on the
nature of participation and non-participation, issues which have been addressed elsewhere
(Haimes and Whong-Barr, 2004a, 2004b).1

Donating to the NCCGP

Cord and placenta tissue as a source of donation
Interview data with donors and biobank managers shows that the nature of the sample was
a key factor in the NCCGPs high participation rate. The NCCGPs consent form states that
1 The study of participation in the NCCGP was funded by the Wellcome Trust and approved by the local research
ethics committee. Interview schedules were devised in consultation with the projects own advisory group. Interviews were transcribed by the University of Newcastle Data Preparation Service. NVivo 2.0 software was used to
assist with category building and to help identify analytical themes.

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the material, which they collect from the umbilical cord was normally thrown away. As
one team member explained:
[We] wanted to identify a source of DNA thats normally just discarded.. . . I feel that
thats a very strong reason why the NCCGP is so successful.. . . It is no use to them
unless they want to have a placenta casserole, which very few people do. (T351)
Donors also expressed a similar attitude towards the afterbirth. One woman said, Once
you get to that stage, you have got your baby and whatever else comes out, you know, you
are never wanting to see it again (M003). Another expressed the view that the afterbirth
wasnt something that I was particularly attached to (M008). Others replied that, the placenta means nothing to me (M009), or that its just waste, isnt it? (M013), or it was of
no use to me (M029).
In contrast to views of afterbirth as a source of donation, women said that a different
sample type, such a cheek swab or blood sample from the child, would have necessitated
greater thought before agreeing to donate. There was a view that no harm could be done
by taking a non-invasive sample but that it would probably have been a harder decision
had the request not involved waste material (M036).
The NCCGP team was of the same opinion that more invasive samples would have been
harder to consent for:
The only trouble with that is whether people would be willing to take part in a
research project for asthma that involved their child having a needle stuck in them.
[It] might dramatically alter their level of cooperation, and if you did, it would
weaken the data set dramatically.. . . That was the whole point of the exercise and
at very low cost weve got DNA from those kids. (T234)
It is clear, however, that in order to get DNA from those kids, the NCCGP had to ask
community midwives to serve a dual function, to assist in their role as an instrument of
care for the mother-to-be and to help ensure success of the project by getting consent for
the removal and storage of samples (Kennedy, 2002).2

Antenatal care and the request to donate

The request for consent was usually made during the first hour-long antenatal appointmenta time when women receive a large amount of information and midwives have
much to cover, including family medical history and lifestyle questions, routine urine or
blood work, and general explanations of what lies ahead. Thus, it is not surprising that during the NCCGP consenting process, midwives said that they usually spent about 30 seconds discussing the NCCGP (CMW02). For midwives, requesting samples for the
biobank was:
. . . only a very very small portion of our care and after this weve got so many other
things to talk about because they are having diagnostic tests on their own baby and
2 For more on power and politics in maternal care, see Solinger (2005), DeVries et al. (2001), Parens and Asch
(2000).

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weve got a lot to cover. So Ive got to be honest, after the first interview I dont really
bring it up again unless they come back to me with any questions. (CMW01)
As one mother said, The midwives didnt provide much additional information because for
them, the primary concern was helping myself . . . they said heres a leaflet if you have any
questions ask next time you come (M060).
Many women confirmed that their midwife didnt go into great detail but had just
asked if the afterbirth could be taken away and be tested for genetics (M002). However,
only a few interviewees complained that their midwife could have been better informed.
One mother who did want more information said, She was very nice and she answered
what she could instead of pretending, but I would have rather have more, you know,
what are the people, what sort of research, what immediate impact on all that research,
you know, just wanted to know where is it going? (M010). Despite her reservations,
however, this person consented to donating her afterbirth.
Despite not receiving much information about the biobank, interviewees believed donating to the NCCGP was an easy decision to make. Donors also tended to ask their midwife
very few questions about the nature of the project or the use of their sample. As one donor
put it, What does another test matter really? Its just a case of us really signing the form
(M012). Another agreed, Its basically why not? I couldnt think of any good reason why
not really (M034).
One reason many women felt it was an easy decision concerns their wider views and
experiences with medical research. Several were aware that they themselves had benefited
from research done previously and this influenced their own decisions.
. . . because we had had the IVF treatment, you think, Well, if they hadnt done a lot
of research about that then, you know . . . I think that was the main reason why we
agreed that we would donate. We thought that anything that helps, you know helps
with cancer or anything like that. And there was no harm to me or the baby so we
thought, well, yes, its a good idea. (M013)
Another respondent expressed a similar view that not a lot was involved in donating,
especially in comparison to the potential good medical research could bring.
My understanding of what the Cumbria Genetics Project is about, its something that
is worth doing. My contribution to it is very small for me, its not as if it was an
ongoing thing, its not as if Im being asked to do something every week or every
year, its a one-off thing, it was a one-off donation but really, you know it didnt
impinge on me at all. Im glad to have the opportunity to be involved in something
like this because I think its important but its not something that preys on my
mind. I just think if you dont have medical research you dont move forward. (M008)
This woman then went on to compare what was asked of her for the NCCGP with a project
that her husband contributed to as a child when his mother agreed to have him be a guinea
pig for the measles vaccineand at the end of the day what we did in giving a sample and
afterbirth was nothing compared to actually having your child vaccinated with a vaccine
that was, well it would have been through a lot of trials but was still, you know, at the
forefront. (M008)

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Only one donor expressed regret at her decision and explicitly tied her feelings to the
antenatal context and the limited information she had been offered.
It could be pressure from the midwife who may say something like, Oh, flaming
donate! The placenta, it doesnt really matter, it just gets thrown in the bin anyway.
Do you know what I mean? Making the issue seem very small and insignificant. It
would be the way that its actually put over when you have an antenatal visit or
whatever.. . . I dont know, at the time I said yes. I wished I hadnt have done, I
must admit. I really wished that I had more information and that I was better
informed and I wish I wasnt put on the spot to make that decision because I dont
think that I was in the right frame of mind to make the right decision. (M040)
The above quote illustrates how donors decisions can be influenced by the way in which
information is presented to them. In other words, information that is factually identical can
be framed in different ways, either positively or negatively, which can result in whether people envision a loss or benefit to their own interests (Marteau, 1989). In this case, afterbirth
was described as waste materialthat is, as having no lasting or redeeming value beyond
the point of birth.3 But such material carries significant and lasting value in the context of
DNA bankinga point, as described below, which was lost on donors, in part, it seems,
because of the way in which the NCCGP framed the donation and in part because of the
timing and manner of the request.

Perceptions and understandings of the NCCGP4

It is not surprising that, since little was said about the biobank, women ended up with a limited understanding of the aims of the NCCGP as well as of the uses and storage of their sample. For the most part, written forms provided the only detailed source of information for
donors.
Maybe I read it wrong but I thought they were doing it individually, your placenta
individually, to see how theyve worked during the pregnancy. Is that what they are
doing? To tell you the truth, I just thought I would do it and whatever, see what happened when. (M042)
I just thought it would help to look for, I dont know, a cure or something. I dont
know. (M046)
I dont know a lot about it, Im not really read up in genetics or anything at all. I
cant remember [what it was for]. (M007)
How they put it to me was, when you have the baby, your placenta can be sort of
sent away and you know they sort of look into it for different things, different

3 Of course, for some, the placenta is valuable. One NCCGP donor had opted to keep her afterbirth frozen until she
could get a tree to plant over it, a practice not uncommon in some cultures.
4 In this section I focus on the views of women who agreed to donate to the NCCGP. Perceptions and understandings of non-participants were frequently shaped by the involvement of British Nuclear Fuels Limited (BNFL) in the
initial funding of the NCCGP. BNFL operate a nuclear reprocessing plant at Sellafield, Cumbria, which has been
associated with allegations about the effects of excessive radiation causing a higher than average incidence of
childhood leukaemia. The concern, seemingly unfounded, was that NCCGP research would not be independent
since the nuclear industry has a vested interest in the results.

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studies.. . . They didnt really go into a lot of details, they just said they would take it
away for studies. (M043)
One NCCGP team member expressed various reasons for the lack of
understanding:
A lot of the women who are approached, dont have much of a deep understanding
of genetics in general and scientists in general. They have more pressing concerns
of where the next meals coming from and other more pressing concerns, probably
violence, poverty, illiteracy. (T351)5
Donors also possessed a limited grasp of the future status of their sample. When asked if
they thought it was a good idea or not for their children to have the right to re-consent
when they turn 16, many respondents said they did not know that their samples would be
stored for so long. According to one participant, Its something I havent really thought
about. I dont know. I wasnt aware of that, you see. What kind of studies do they do
then? (M016). Many others replied along similar lines, [I] did not know they kept them
that long. Do they keep them that long? (M021). A number of women also expressed doubt
that theyd remember to tell their child about the donation, which raises the issue of
the adequacy of proxy consent as a means of protecting childrens rights (Helgesson,
2005). The NCCGP team has committed itself to allowing child donors to withdraw their
consent at the age of 16, but, at present, it is unclear if NCCGP will ever re-contact
children.6
A common perception among donors was that the research would somehow benefit
themselves or their family: They would monitor my sample for the next 20 years and maybe
connect it if I got breast cancer, or if Jenny had anything, to link it back to her genetics
(M045).
On this point, interviews with team members revealed that, early in the project, a few
participants had started phoning researchers to ask about their results and to see if
anything untoward had been found. NCCGP managers quickly realized that any possibility
of providing any sort of feedback to women was untenable, except in very rare and clear-cut
cases where a direct and immediate intervention could save a life (for more on this issue, see
Richards et al., 2003). However, donors still held the perception that the biobank may
benefit someone close to themthat the project was for family illnesses and/or social
and medical disease within West Cumbria (M012).
To briefly re-cap, from the findings presented above, it is evident that donors to the
DNA bank were informed of the NCCGPs aims and details in the briefest of terms and
asked few questions about the database. To some degree, this is due to the fact that the
request to donate was made as part of routine antenatal care and not in a special appointment designed to thoroughly inform subjects about the bank. However, most felt that the
5 In fact the issue of illiteracy amongst potential donors was cited several times by NCCGP team members. This is
interesting, not least because the team was seemingly comfortable with relying on written consent forms as the
primary means of distributing information about the DNA bank.
6 The NCCGP has hopes of re-contacting children in relation to two specific studies, one on childhood obesity and
another on eczema, but their plans have to be approved since the original consent form stated that families would
not be re-contacted. My own view is that the NCCGP ought to systematically re-contact child donors, since it is
increasingly recognized that children are capable of making their own reasoned judgements about whether or not
to participate in medical research. See Williamson et al. (2004).

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decision to donate was a relatively easy one to make since it required little effort and was
non-invasive. In the remainder of the article I seek to reflect on these findings and their
implications for how to achieve genuine consent.

Discussion: re-thinking informed consent for medical research

It would be tempting to argue that, because of the poor understanding women had of the
NCCGPs aims, there must have been a serious ethical flaw in the operating procedures of
the biobank. But a lack of understanding in and of itself does not make the NCCGP ethically problematic. As I discuss below, there is increasing evidence that potential donors
are able to reach decisions without reference to exhaustive protocols and without wanting
or needing to comprehend the full details of a study.
Arguably, that donors could not recite the aims, uses and procedures of the NCCGP
reflects the fact that the request to donate to a DNA bank is only one small and quite forgettable part of leading a busy life. We all, at one time or another, make decisions and sign
forms without reading the fine print or being fully cognizant of what we are agreeing to.
Nor is it necessarily the case that, if a participant has a limited understanding of a project,
then more and better information is required. We all, at one time or another, make decisions
and sign forms without wanting to know the fine print of what we are agreeing to. It is a
legitimate choice for a research participant to not want to be informedthe trick for investigators is to know when people are consciously rejecting information or when the communicative process is flawed such that participants are acting with only partial knowledge
(Helgesson et al., 2005).
Consent forms are obviously an important and necessary ingredient of ethical protection
since, as we have seen in the NCCGP, the communicative process between participant and
researcher can be flawed or subject to external pressures of time and personal relations. But
the data presented here confirms the view that many research participants in fact pay little
attention to the details of a study and are seemingly not bothered by their lack of knowledge. Although some respondents in the study had wished that their midwife had been
more informed, the fact is that all relevant information about the NCCGP was contained
in the consent form they had signed (and kept a copy of). Donors either did not take notice
of this information or else had read it, accepted it and forgotten it. Nor did many women
ask the NCCGP for copies of the Further Information Leaflet, which was cited on consent
forms and readily available on request by post or phone. Perhaps it is the case that donors
were too preoccupied with the success of their pregnancy to inquire about the biobank. Yet
interview data clearly shows that a majority of participants were highly attentive to issues
surrounding the health of their baby, and since they perceived, rightly or not, that in
some way their donation would help someone close to them, it seems reasonable to claim
that, if donors had been concerned or curious enough to know more, they would have
inquired.7
7 Elsewhere, in considerable detail, I have addressed issues surrounding the gift relationship, altruism and
their implications for informed consent. See Barr (forthcoming), for a defence of the drive to reshape current ethical frameworks to encompass greater appreciation of the reciprocity that exists between the benefits of medical
research and the obligation to participate in such research.

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It is clear that NCCGP participants decided to donate quickly and easily and in relation
to their own particular circumstances; that is, their judgements were inevitably contextdependent. Many donated because they or a member of their family had previously benefited from medical research, or because they had calculated that the cost of so doing was
small. Some of those who had refused to donate did so because someone they knew had
died of leukaemia and they were suspicious of the role of BNFL in funding the biobank.
The point is that people decide, it seems, based on their own specific life stories, needs
and experience. In other words, people do not seem to make decisions based on the fine
details of how information will be kept private, the studys costs, what international collaborators are involved, or at what temperature their placenta will be kept. In her recent work
on genetic donation, Helen Busby has argued that many participants feel that genetic
research was now very much on the agenda and could be seen as an indicator of good modern science, and so in a sense was not particularly novel, troubling or noteworthy (Busby,
2004: 47). Data from NCCGP donors supports this view.
These findings are also confirmed by the work of Klaus Hoeyer, who evaluated a biobank in northern Sweden. He found that, out of twenty-one persons who received information sheets on the project they were donating to, only eight claimed to have actually read
them. Yet donors did not feel that they had an insufficient understanding of the biobank
and, when asked about their reasons for donating, many people echoed the rather simplesounding sentiment that research is good. Importantly, Hoeyer also found that donors
did not reason independent of the context. In this case, donors relationships with the nurses
who requested samples and their views of the wider Swedish biomedical establishment led
them to make what seemed like fairly quick judgements. Hoeyer also argues that the history
of the Swedish welfare state has helped to create a narrative of progress which contributes
to a climate of acceptability of scientific research (Hoeyer, 2003).
That donors decide quickly and seem to be inarticulate is not to say that their decisions
are not reasoneda lack of detailed explanations does not mean a lack of considered judgement. For example, during the interviews, many responded to my questions by saying It just
seemed right to donate; I just trusted what the doctors said; I couldnt see any reason not
to donate. When encouraged to expand upon these answers about why it just seemed right
to act and think in the way they did, many donors were not able to articulate any clear reasons (apart from those who had benefited directly from previous medical research, such as
IVF). For an interviewer, this can be as fascinating as it is frustrating. I wanted to acquire
the most interesting data possible and such responses seemed, at first, to be rather unsatisfactory explanations of peoples motivations. Although I succeeded in getting respondents to
talk at length, I often failed to elicit more expansive answers on this specific point. However, I began to realize that, far from being the result of a lack of reasoning or care about
the matter in hand, this sort of response was in fact evidence of the embedded nature of
that reasoningsuch that not only was it difficult to extract, it was also difficult to articulate in the first place.
If donation is akin in some way to an act of intuitiondifficult to justify but not devoid
of reasonthen this carries implications for informed consent guidelines. Curiously, much
of the current preoccupation with informed consent is about maximizing and enhancing
participants understandings. A common technique, especially in the United States but
increasingly in Britain, has been to focus on the content and language of consent forms

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(Beskow et al., 2001; Deschenes et al., 2001). This approach is designed to exhaust the
disclosure element of consent requirements, which requires researchers to inform subjects
of all relevant facts of the proposed study. For example, in its recent report on epidemiological research, the Centres for Disease Control and Prevention concluded that the best way
of protecting subjects interests is by making forms as thorough as possible regarding the
details of a study (Khoury, 2001).
The result, of course, is legalistic and bureaucratic forms that are pages long and seem
more like contracts than documents of explanation and education. Critics rightly argue
that focusing too heavily on the language of forms, in the hope that it will improve understanding, seems to be more for the protection of the interests of researchers, Institutional
Review Boards, and Research Ethics Committees, than those of the subject (Annas, 2001).
Such an approach to consent is perhaps a consequence of the so-called audit society, in
which institutions are monitored for accountability by external review (Power, 1997). Or
perhaps it is the result of a consumer-driven culture: In a world where medicine has become
a good to be consumed, where patients are customers to be wooed, informed consent
becomes the disclosure of the contents on the back of the box (Wolpe, 1998: 49). In either
case, the danger, in my view, is that concentrating on the language of forms runs the risk of
turning consent into a sufficient ethical justification, which it is not.
Instead of focusing on consent as the ultimate protection of donors interests, I follow
ONeills view that ethically acceptable consent for tissue donation ought to adhere to three
main standards. These include: making clear and easy the possibility of refusal to donate;
subjecting studies to scrutiny by an independent body that includes lay representation, to
ensure the research is ethically warranted and medically important; and maintaining standards of anonymization of data that are plain and verifiable (ONeill, 2002). Although
the NCCGP was an early forerunner of todays biobank collections and was established
in the mid 1990s, before most current guidelines were developed, it still met all three of
these standards.
ONeill writes:
Donors and relatives, like patients, may find that being confronted with the full detail
of research protocols provides excess, unassimilable information, to which they can
hardly hope to give genuinely informed consent.. . . [T]here is a good deal of evidence
from other areas of life that insisting on consent to every detail may not be the most
serious or convincing way of seeking genuine consent. (ONeill, 2002: 157)
Arguably, most people, even when not ill or in a clinical setting, have little time to read all
the fine print details on things such as insurance policies or financial transactions. Thus,
asking them to constantly keep up with the details of medical projects may not only be
unrealistic, it may, ironically, undermine trust in the service of an audit culture.

Conclusion
At the beginning of the article, I indicated that consent is propositional by nature: that is,
when one consents to an act, one may be oblivious to the effects of the action one has agreed
to. Thus, donors limited comprehension suggests that it is not reasonable to seek consent

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for every detail of a medical project. Nor is it the case that consent is always improved by
trying to ensure that it is given to more specific propositions: more specific consent is not
necessarily better consent (ONeill, 2002).
The notion that only a particular individual can make wise deliberations about a particular request in a particular time and place may seem fairly obvious. Yet it runs counter to
recent bioethical obsession with informed consent. How much should be disclosed on the
consent form? What should the layout of the form look like? Who should be asked for consent and how often? Evidence from donors own accounts suggests that many are content to
donate without knowing much at all.
In other words, the process of informed consent is embedded in a whole series of social
processesincluding, crucially, beliefs about the role of medicine, health and technology in
everyday life. By focusing exclusively on the who and how of consent, and on the language
of consent forms, we may be in danger of losing the plotof mistakenly seeing the act of
consent as a one-off event somehow abstracted from other considerations of why and
wherefore. Perhaps it would prove helpful to pay closer attention the act of donation itself
and the belief patterns underpinning it.

Acknowledgements
I would like to gratefully acknowledge support from the Wellcome Trust Biomedical Ethics
Division for funding the study of participation in the NCCGP. I would also like to thank
Erica Haimes for her comments on an earlier draft of this article.

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