Journal of Research in Nursing

2015, Vol. 20(6) 435–446

Research involving people ! The Author(s) 2015
Reprints and permissions:

with a learning disability – sagepub.co.uk/journalsPermissions.nav

DOI: 10.1177/1744987115591867
jrn.sagepub.com
methodological challenges
and ethical considerations
Lesley Goldsmith
School of Nursing and Midwifery, Faculty of Health and Human Sciences, University of Plymouth, UK

Heather Skirton
Faculty of Health and Human Sciences, University of Plymouth, UK

Abstract
The aims of the original study referred to in this paper were to explore the information needs of
people with learning disabilities with respect to consent for genomic tests, and to identify ways of
facilitating informed consent for such tests. In this research methods review paper, we consider
the ethical issues involved in recruitment for our study and describe the process of recruiting
vulnerable participants via gatekeepers. We discuss the ethical issues under the themes ‘freedom
from coercion’, ‘disclosure of information’ and ‘competence’. In conclusion, we acknowledge the
paradox that exists in learning disability research: the importance of protecting members of a
vulnerable group against the need to include people with a learning disability in order to gather
the best possible evidence. However, a focus on wider inclusion will result in a more robust body
of knowledge concerning the health and welfare of people with learning disabilities.

Keywords
ethics, informed consent, learning disability, recruitment, research

Introduction
In any population a proportion of individuals will have a learning disability. In the United
Kingdom (UK) this figure is over 2% (Emerson et al., 2012). Those who have a learning
disability may be more likely to suffer social inequalities, and adults with learning disabilities
are particularly vulnerable to a lack of respect for their human rights (Joint Committee on

Corresponding author:
Heather Skirton, School of Nursing and Midwifery, Faculty of Health and Human Sciences, University of Plymouth,
Drake Circus, Plymouth PL4 8AA, UK.
Email: [email protected]
436 Journal of Research in Nursing 20(6)

Human Rights, 2008). People with learning disability (PWLD) are thus considered to be
vulnerable, or can be vulnerable in certain circumstances when the appropriate support is
not in place or their needs are not fully understood. Additional measures may therefore be
needed to ensure they receive equitable treatment. People with a learning disability should be
treated ‘with the same dignity and respect as any other member of the community’
(Department of Health, 2009: 6).
Involving PWLD in healthcare research has posed both ethical and practical challenges.
Historical examples of problems that have arisen in the practice of research on vulnerable
populations include experimentation on disabled people in Germany by the Nazis in the
1940s (Weindling, 2011) and research into infectious hepatitis on children with learning
disabilities at Willowbrook Hospital in the United States in the 1970s (Robinson and
Unruh, 2011). However, efforts to avoid abuse and perceived obstacles in obtaining
consent may result in lack of inclusion of PWLD in research. Issues raised include doubt
about capacity to consent to participate, problems arising from the use of institutional care
(which may influence the person’s experience of making decisions), as well as the tendency of
PWLD to acquiesce to the wishes of others and the unequal power relationship between
researcher and participant, both of which may make them more susceptible to coercion
(Dalton and McVilly, 2004; Iacono, 2006). Iacono (2006) considered that ethics
committees were becoming more conservative in their approach to granting approval for
research involving PWLD in order to avoid risking their exploitation and potential harm.
However, it is possible that by adopting this approach, they may actually be discriminating
against PWLD (Iacono, 2006). It has been suggested that researchers should focus on
including participants with learning disabilities (McClimens and Allmark, 2011). Indeed,
excluding PWLD from research may both deny them the right to choose to take part and
have their opinions heard as well as result in incomplete research evidence (Feldman et al.,
2014). Adults with learning disabilities want to engage in research (McDonald et al., 2013),
and with training and support they may be able to participate as well as enjoy the benefits
such as increased self-esteem and intellectual stimulation that research can offer (Inglis and
Cook, 2011).
We undertook research to explore the needs of PWLD with regard to informed consent
for genomic testing, which is increasingly being used in mainstream clinical practice (Centers
for Disease Control and Prevention, 2013). The ethical principle of justice (Beauchamp and
Childress, 2009) makes it imperative that these advances in clinical care should be available
to PWLD as part of the general population. Obtaining informed consent for any type of
biomedical test can be challenging and there may be a need for additional safeguards if the
patient has a learning disability (Ministry of Justice 2007). In this review paper, we discuss
the process used to recruit and support PWLD who were involved as participants in a study.

Consent and capacity

In the majority of research studies involving human subjects, informed consent of the
participants is a fundamental component. The requirements for informed consent are
adequate disclosure of information, freedom from coercion and capacity (or competence)
to consent (Beauchamp and Childress, 2009). The legal standards for capacity demand that
the person can understand relevant information, appreciate the current situation and its
consequences, manipulate information rationally and communicate their choice; although
legislation differs between countries, the principles remain those of understanding,
Goldsmith and Skirton 437

Does the person have an impairment of the mind or brain, or is there some sort of disturbance affecting the way their
mind or brain works? Does that impairment or disturbance mean that the person is unable to make the decision in
question at the time it needs to be made?

If there is an impairment likely to render the person unable to make any decision at a particular time, then the following
criteria need to be fulfilled before capacity can be confirmed –

1. Does the person have a general understanding of what decision they need to make and why they need to make
it?

2. Does the person have a general understanding of the likely consequences of making, or not making, this
decision?

3. Is the person able to understand, retain, use and weigh up the information relevant to this decision?

4. Can the person communicate their decision (by talking, using sign language or any other means)?

Figure 1. The two-stage test of capacity (Ministry of Justice, 2007).

appreciation, reasoning and choice (e.g., National Health and Medical Research Council
et al., 2007; United States Department of Health and Human Services, 2009). In England
and Wales, the Mental Capacity Act (Department of Health, 2005) has formalised common
law relating to capacity, and the Code of Practice outlines a two-stage test of capacity
(Figure 1).
Research in England and Wales is subject to the requirements of the Mental Capacity Act
(Department of Health, 2005), which demands that researchers should assume capacity
unless proven otherwise. This may involve presenting information in a format tailored to
the individual’s communication needs. Potential participants should also receive support to
enable them to make the decision whether or not to participate. It is the responsibility of the
researcher to decide whether a potential participant has capacity to give their own consent to
take part in research, with appropriate consultation with their care professionals. If
recruiting participants who do not have capacity, researchers have to fulfil certain criteria
(Section 31 of the Mental Capacity Act) (Department of Health, 2005). We will not elaborate
on these here, as in our study we recruited only participants who had capacity to consent
using the procedure described later in this paper. If the potential participant is judged to
have capacity to consent, the usual criteria for valid consent described above apply.

The study
Aims
The aims of the original study were to explore the information needs of PWLD with respect
to consent for genetic tests, and to identify ways of facilitating informed consent for those
tests (Goldsmith et al., 2013). As the project evolved, the focus moved from the specific topic
of genetic testing towards a greater emphasis on consent and capacity and the implications of
both for the recruitment process and the outcome of the study.
438 Journal of Research in Nursing 20(6)

We present here the methodological and ethical issues that arose, particularly during the
recruitment process and when obtaining consent from potential participants. We relate the
challenges we faced to the three elements which constitute valid consent – freedom from
coercion, disclosure of information and competence (Cameron and Murphy, 2007; General
Medical Council, 2010).
Ethics approval for the study was received from the South West 5 National Health Service
(NHS) Ethics Committee. We used a focused ethnographic approach (Roper and Shapira,
2000), and data collection from PWLD involved observations of a blood test procedure and
semi-structured interviews.

Recruitment
During recruitment, we needed to ensure that there was no element of coercion involved.
For this reason, we did not recruit directly, but identified gatekeepers (Nind, 2008)
working in the field who could assist in finding suitable participants. Gatekeepers were
provided with the inclusion criteria for participants with learning disabilities, which were:
being aged 18 years or over and able to consent to participate in research, not affected by
any acute physical health problems or under the care of mental health services, and
requiring a routine blood test.

Consent and capacity of potential participants

Having determined the necessary participant information for the study, we had to ensure
that it was in an accessible format for participants with a range of intellectual abilities and
communication impairments. We compiled information sheets and consent forms using large
font text, simple language and short sentences combined with images and photographs
where appropriate. Input from several speech therapists with experience of learning
disability was sought and utilised. The information sheets were tested with a group of
three young adults with learning disabilities (who did not participate in the study).
We utilised a two-step process of recruitment: participants were initially nominated by
gatekeepers as being likely to have capacity to consent to research; a consent interview then
followed, with capacity being confirmed (or otherwise) by a supporter. This process was
explained to the gatekeepers, with reassurance that there was minimal risk of harm to the
participant. By visiting the settings where the gatekeepers worked, the first author made
herself familiar to both staff and potential participants; she felt that she had gained the trust
of those concerned and established some degree of rapport (Cameron and Murphy, 2007).
However, initially some gatekeepers were reluctant to take part because of their own
concerns about the individual’s freedom of choice. For example, one gatekeeper
commented that the person he supported would do anything asked of her by her carer.
After participants had been nominated, a consent interview was arranged. In line with the
Mental Capacity Act (2005), consent was also confirmed immediately prior to data
collection.
Across the two phases, 21 potential participants were involved; of these, 15 consented to
one or both phases of the study (Table 1). However, our experience showed that participants
were excluded for three reasons. These were 1) they declined to participate (n ¼ 3), 2) they
were assessed as not having capacity (n ¼ 3) or 3) access was denied by the general
practitioner (n ¼ 2).
Goldsmith and Skirton 439

Table 1. Record of recruitment of potential participants.

Consented to and completed Phases 1 and 2 6

Consented to Phase 1 (observation in general practice) and Phase 2 (interview) but could not 2
complete Phase 1 due to lack of access to general practice
Consented to Phases 1 and 2 but could not complete Phase 1 as no blood test due within time 3
frame of study
Could not consent to Phase 1 (assessed as not having capacity) but consented to and completed 1
Phase 2
Consented and completed Phase 2 only 2
Consented to Phase 1 but did not participate 1
Were assessed as not having capacity to consent to research studya 3
Received invitation letter but declined to participate 3
a
Two of these participants were nominated by one gatekeeper (a GP) but ruled out by second gatekeeper (provider
of care).

By using gatekeepers to recruit participants with learning disabilities, it was necessary to

become familiar with local learning disability services. Gatekeepers were identified from
local providers of care, a self-advocacy group and general practice.

The phases of the study

For the first phase of data collection (observation of a blood test in general practice), six
participants were recruited. This stage was particularly challenging, as there was a
requirement for the participant to be scheduled for a routine blood test in primary care.
There was potential for misunderstanding in this case, with some gatekeepers assuming that
we were asking participants to have an additional blood test. In addition to relying on
gatekeepers to identify suitable participants, we then had to approach each potential
participant’s general practice for permission to conduct the observations. The aim was to
recruit a maximum variation sample in order to observe people with a range of intellectual
abilities and observe the communication between healthcare professional, patient and carer.
Two of the six participants had a carer present in the consulting room.
Data collection for the second phase was undertaken via semi-structured interviews;
recruitment took place in a range of contexts that included residential care establishments
and specialist day services. Participants who had already taken part were approached again,
and the same consent process followed. We also recruited participants who had not been
observed in the first phase, but who had experience of having a blood test.

Consent interviews
Prior to the consent interviews, potential participants were asked to nominate a supporter,
such as a relative, friend or carer, to be present. Consent interviews were then arranged at a
place familiar to the participant. Participants were given an information sheet in accessible
format and a verbal explanation of the study, and were given the opportunity to ask
questions. The researcher then asked potential participants to feed back the information
to her in their own words. Using her own experience and taking into account the
observations of the supporter with regard to the participant’s understanding of the
440 Journal of Research in Nursing 20(6)

research information, the researcher was able to make a decision as to whether or not the
participant had capacity to consent to the research.
In phase 1 we conducted four consent interviews: three participants gave valid consent,
with capacity being confirmed by the supporter; a fourth participant was considered by both
the researcher and the supporter not to have capacity to consent to research and was
therefore not recruited to the study. However, this participant was on the list of service-
users nominated by learning disability nurses as having capacity. As a non-healthcare
professional, the researcher’s first impression was that this particular service-user would
have capacity to consent to the research. Interestingly, this participant was subsequently
suggested by a different gatekeeper for the interview phase of the study, and at the second
consent interview she was assessed as having capacity to be interviewed.
Making a decision on a person’s capacity to make a decision is always specific to the
decision to be made (e.g. consenting to a particular phase of the study), and also specific to
the time the assessment is made. As mentioned earlier, consent was always confirmed
immediately prior to collecting data.
Having succeeded in recruiting a small number of participants, it was encouraging to
listen to their enthusiasm for participation: ‘It’s good to help people’ (PPT B). As the
participants in the centre became familiar with the researcher during her visits, she was
greeted in a very friendly manner. On an individual level, the researcher also felt that she
was viewed as a friend rather than as a researcher; the participants seemed to be expressing
pride in the fact they were helping her. In view of the willingness of potential participants to
take part and their enthusiasm, it was disappointing that two participants could not
participate in the observation phase due to access being refused by their general practice.
The reason for this was not offered; the participants had consented to have their blood test
consultation observed and recorded, but this was subsequently not permitted by the
practitioners involved. Those PWLD who did participate, without exception, approached
both the observation and the interview willingly and showed an interest in the research.

Discussion
We discuss the challenges and dilemmas we experienced under the themes ‘freedom from
coercion’, ‘disclosure of information’ and ‘competence’.

Freedom from coercion

Coercion, defined as persuading (an unwilling person) to do something by using force or
threats, is perhaps too strong a word to use when applied to obtaining consent from a
research participant in the context of our study. However, consent has to be voluntary
and so when recruiting potential participants with learning disabilities, this element of
valid consent needs to be considered carefully for several reasons.
First, participants will have varying experience of decision-making in their everyday lives.
This could be related to their residential status, as it has been suggested that living
environment has an effect on self-determination and choice. Wehmeyer and Bolding
(1999) found evidence to show that adults with learning disabilities who lived or worked
in community settings made more choices for themselves and had greater autonomy than
those who were segregated. Research also suggests that those living in smaller residences
with fewer staff and fewer other residents had more opportunity to make choices (Stancliffe,
Goldsmith and Skirton 441

1997). The above evidence would suggest that PWLD living independently with support, and
thus comparatively integrated into the community, would develop a greater degree of
self-determination and control over many of their everyday decisions. When recruiting, we
therefore aimed for a maximum variation sample in terms of residential status, from those
living at home with parents to those living alone in accommodation with minimal support.
Second, coercion involves the use of power by one individual over another, and the
concept of coercion is a difficult one in this context; the researcher was recruiting people
who may have had little experience of decision-making and also a tendency to acquiesce to
carers and other professionals. Evidence has shown that PWLD have higher levels of
acquiescence than those without (Clare and Gudjonsson, 1993; Keywood and Flynn,
2006; Murphy and Clare, 1995). Acquiescence can be a problem when there is a power or
status difference between researcher and respondent, and in general, PWLD demonstrate an
exaggerated acquiescence bias (i.e. the tendency to say ‘yes’) when being interviewed (Heal
and Sigelman, 1995). We were not convinced by the argument that potential participants
were less likely to be coerced by gatekeepers than by a researcher. Problems expressed by
‘intermediaries’ (gatekeepers) have included the time taken to recruit effectively, confusion
about the role of gatekeeper, worries about bias and, of interest in relation to our study,
concerns that they could be seen to coerce potential participants to take part (Nicholson
et al., 2013). Reinforcing the findings from that study, Carlson (2013) describes the risk of
coercion where there is a perceived power imbalance, such as when staff are used as
gatekeepers. Fisher et al. (2006) consider that ‘adults with mental retardation are
more vulnerable than others to acquiescing to requests to please the investigator’. We
consider that the original views expressed earlier by the gatekeeper were pertinent and
that the members of staff were in a more powerful position than the researcher would be,
as they had the potential to influence the everyday life of the participant. However, it was
reassuring that several of the potential participants nominated by gatekeepers subsequently
expressed their desire not to participate. Cameron and Murphy (2007) suggest that it is useful
to record these decisions to demonstrate lack of coercion in the recruitment process.
Each participant was keen for the researcher to know that they wanted to help, and this
led us to reflect that they may have been partly motivated by a desire for friendship, as it
is well documented that PWLD do not have the same opportunities or social skills to
make friendships as those without learning disability (Chappell, 1994; Fish et al., 2006). It
is especially important, therefore, for the researcher to ensure that the participants
understand not only the role of researcher and participant, but also that contact will
cease at the end of the study.
Finally, although frustrating for the researcher, we consider that this ‘failure’ to recruit
can be viewed as demonstrating the rigour of the recruitment process and supports the
decision to use a two-stage process for consent.

Disclosure of information
The provision of appropriate information is essential when obtaining informed consent.
However, deciding what or how much is appropriate is not simple. The code of practice
for the Mental Capacity Act (2005) states that it is sometimes sufficient to give a broad
explanation using simple language, but also stresses that information needs to be
appropriate to the needs and circumstances of the person making the decision and that
too much detail may be confusing to some people (Ministry of Justice, 2007). There is a
442 Journal of Research in Nursing 20(6)

body of knowledge to guide the production of accessible information, for example, the use of
simple language, short sentences and large, simple font, together with pictures if appropriate
(Mencap, 2005; Social Care Institute for Excellence, 2005). Testing the participant
information sheets with young adults with learning disabilities confirmed that the most
important element was the verbal explanation, supported by accessible written
information. Carlson (2013) stresses the importance of effective and appropriate
information throughout the whole research process – in recruitment, consent procedures
and data collection; this implies an inclusive approach to research involving PWLD.

Competence (capacity)
The nature of capacity and its assessment. The process of recruiting illustrated to us how
easy it is to assume understanding in a person who has good verbal skills and appears
articulate. This phenomenon applies particularly to certain groups of PWLD, whose
communication abilities may be well ahead of their overall cognitive profile (Bellugi
et al., 2001). Research is an abstract concept, and it has been shown that PWLD are
more capable of understanding ‘concrete’ facts than abstract ones. It is likely, therefore,
that some potential participants would have had capacity to consent to a simple blood
test, but not to participation in research. There is evidence that participants with a
learning disability find it easier to understand the procedures involved in research than
the purpose of research (Fisher et al., 2006); Inglis and Cook (2011) found that with
appropriate training, a group of men with learning disabilities were able to enjoy the
benefits and opportunities that participatory research offered.

Lack of capacity – the implications

The consequences of choosing to conduct research with participants with mild to moderate
learning disability rather than severe or profound, and having a rigorous method to ensure
valid consent to participate, may have had unforeseen consequences. McClimens and
Allmark (2011) suggest the need for a redefining of consent in the context of learning
disability research in which researchers should be ‘less troubled about whether or not an
individual has capacity to consent and more concerned that we have not wronged them’
(McClimens and Allmark, 2011: 637). Most of the participants we recruited were relatively
independent – travelling independently around the city and living alone with support or in
shared housing (receiving varying levels of support). We have concerns that by ensuring
capacity to consent to research, this may have resulted in exclusion of a group of service-
users who could have contributed useful data.

Implications for research practice

Having completed the study, we reflected on what effect our choice of participants had on
the data. We decided to include only people who were likely to have capacity, that is, those
with mild to moderate learning disability. This tendency to focus on participants with
learning disability who can be included, in the face of the challenges involved in including
those with a greater degree of learning disability, is described by McClimens and Allmark
(2011). This caused us to reflect on how the results would have been affected if we had
involved participants with profound or severe learning disabilities.
Goldsmith and Skirton 443

Second, we used gatekeepers to introduce us to participants, which caused delay in

recruitment and the possibility that suitable participants were excluded. Gatekeepers may
be biased in their selection of participants due to being over-protective, thus denying some
people the opportunity to make the choice for themselves. As researchers we should be
aware of the fact that gatekeepers may have a different agenda from researchers, and that
this may contribute to PWLD being denied the opportunity to participate (Wiles et al.,
2007). There is some evidence that higher research participation among PWLD occurs
where the researcher can make direct contact with the potential participant to present the
opportunity, rather than relying on gatekeepers (Cleaver et al., 2010). It is worth considering
whether direct contact by the researcher could be construed as coercion; we think this is
unlikely in view of the low risk nature of this qualitative study, which would fit within the
governance guidelines for research ethics committees in England (Department of Health
Research and Development Directorate (England), 2011) that demand that the research is
worthwhile and the risks minimal.
When considering the ethical dilemmas of recruiting people with intellectual disabilities to
research, researchers need to reflect on the difference between therapeutic research (e.g.
clinical trials) and non-therapeutic research. We consider that the benefits of participation
(e.g. enjoyment of the interview process, interest in research and altruistic motivation)
outweighed the risks, and provided people with mild to moderate intellectual disabilities
the opportunity to make the decision to participate for themselves.

Conclusions
Having acknowledged the limitations of our recruitment strategy, on reflection we would
suggest that it is essential to recruit a maximum variation sample for this type of study, and
to do this would necessitate the inclusion of people whose capacity might be in doubt. The
Mental Capacity Act Code of Practice includes clear criteria about the inclusion of people
lacking capacity in a research project. The research must be linked either to an ‘impairing
condition that affects the person who lacks capacity, or to the treatment of that condition’
(Ministry of Justice, 2007: 206). There also have to be reasonable grounds to believe that the
research would be less effective if these people were excluded, and that researchers have
consulted carers and followed other requirements of the Act. As our research did not fulfil
these criteria, it would not have been appropriate to recruit people who lacked capacity. This
would mean that their views would not be heard. However, on the other hand, the Code of
Practice states that research that explores wider issues, such as capacity to make a decision,
may be undertaken (Ministry of Justice, 2007: 204). In both the United States (United States
Department of Health and Human Services, 2009) and Australia (National Health and
Medical Research Council et al., 2007), it is possible to waive informed consent if the
research poses a minimal risk and could not otherwise be conducted. The situation for
researchers is therefore somewhat unclear.
If research can be considered low risk and has the potential to be of benefit to the
population of PWLD, we would therefore recommend widening the inclusion criteria to
allow a wider range of participants with learning disability to engage in research. Numbers
of people who lack capacity due to intellectual disabilities or conditions such as dementia are
increasing due to overall improvements in healthcare. However, as they are often the group
most in need of health and social care, they should not be prevented from participating in
research, to ensure that their needs are met (Calveley, 2012). McVilly and Dalton (2006)
444 Journal of Research in Nursing 20(6)

suggest that considering the opportunity to participate in research as a human rights issue is
a way of ensuring that the needs and dignity of PWLD are not overlooked. It is hoped that a
less stringent approach to recruitment of PWLD should result in a more robust body of
knowledge concerning the health and welfare of those people.

Key points for policy, practice and/or research

. Researchers involved in learning disability research should consider recruiting a
maximum variation sample in terms of learning disability and, where appropriate to
the research question, include people who lack capacity.
. If using gatekeepers for recruitment, researchers should ensure that the aims of the
study and the inclusion criteria are clear.
. When conducting research of a low risk such as qualitative interviews or focus groups,
researchers should consider recruiting participants directly.
. Researchers should consider the potential benefits to be gained by people with learning
disabilities engaging in research and be prepared to justify this, if needed, when seeking
ethical approval.

Declaration of conflicting interests

None declared.

Funding
This research received no specific grant from any funding agency in the public, commercial, or not-for-
profit sectors.

References
Beauchamp TL and Childress JF (2009) Principles Chappell AL (1994) A question of friendship: Community care
of Biomedical Ethics. New York: Oxford University and the relationships of people with learning difficulties.
Press. Disability and Society 9: 419.
Bellugi U, Lichtenberger L, Jones W, et al. (2001) The Clare ICH and Gudjonsson GH (1993) Interrogative
neurocognitive profile of Williams syndrome: A complex suggestibility, confabulation, and acquiescence in people
pattern of strengths and weaknesses. In: Bellugi U and St. with mild learning disabilities (mental handicap):
George M (eds) Journey from Cognition to Brain to Gene: Implications for reliability during police interrogations.
Perspectives from Williams Syndrome. Cambridge, MA: The British Journal of Clinical Psychology 32: 295–301.
MIT Press, pp. 8–10. Cleaver S, Ouellette-Kuntz H and Sakar A (2010) Participation
Calveley J (2012) Including adults with intellectual disabilities in intellectual disability research: A review of 20 years of
who lack capacity to consent in research. Nursing Ethics studies. Journal of Intellectual Disability Research 54:
19(4): 558–567. 187–193.
Cameron L and Murphy J (2007) Obtaining consent to Dalton AJ and McVilly KR (2004) Ethics guidelines for
participate in research: The issues involved in including international, multicenter research involving people with
people with a range of learning and communication intellectual disabilities. Journal of Policy and Practice in
disabilities. British Journal of Learning Disabilities 35: Intellectual Disabilities 1: 57–70.
113–120. Department of Health (2005) The Mental Capacity Act 2005.
Carlson L (2013) Research ethics and intellectual disability: Available at: http://webarchive.nationalarchives.gov.uk/þ/
Broadening the debates. Yale Journal of Biology and www.dh.gov.uk/en/SocialCare/Deliveringadultsocialcare/
Medicine 86: 303–314. MentalCapacity/MentalCapacityAct2005/index.htm
Centers for Disease Control and Prevention (2013) Public (accessed 3 March 2015).
health genomics. Available at: http://www.cdc.gov/ Department of Health (2009) Valuing people now: A new
genomics/about/welcome.htm (accessed 23 March 2015). three-year strategy for people with learning disabilities.
Goldsmith and Skirton 445

Available at: http://webarchive.nationalarchives.gov.uk/ people with intellectual disability as participants in research.

20130107105354/http://www.dh.gov.uk/en/ (accessed 3 Journal of Intellectual and Developmental Disability 31:
March 2015). 186–188.
Department of Health Research and Development Directorate Mencap (2005) Make it clear. Available at: http://
(England) (2011) Governance arrangements for research ethics www.mencap.org.uk/document.asp?id¼1579 (accessed 23
committees: A harmonised edition. Available at: https:// March 2015).
www.gov.uk/government/publications/health-research- Ministry of Justice (2007) Mental Capacity Act 2005. Code of
ethics-committees-governance-arrangements (accessed 3 practice. Available at: http://www.justice.gov.uk/docs/mca-
March 2015).
cp.pdf (accessed 13 March 2015).
Emerson E, Hatton C, Robertson J, et al. (2012) Improving
Murphy GH and Clare ICH (1995) Adults’ capacity to make
health and lives: Learning disabilities observatory. People
decisions affecting the person: Psychologist’s contribution.
with learning disabilities in England 2012. Available at:
In: Bull R and Carson D (eds) Handbook of Psychology in
https://www.improvinghealthandlives.org.uk/numbers/
Legal Contexts. Chichester: John Wiley.
howmany/ (accessed 15 August 2014)
National Health and Medical Research Council, Australian
Feldman MA, Bosett J, Collet C, et al. (2014) Where are
Research Council and Australian Vice-Chancellors’
persons with intellectual disabilities in medical research? A
survey of published clinical trials. Journal of Intellectual Committee (2007) National statement on ethical conduct in
Disability Research 58: 800–809. human research. Available at: http://www.nhmrc.gov.au/
_files_nhmrc/publications/attachments/e72.pdf (accessed 13
Fish TR, Rabidoux P, Ober J, et al. (2006) Community literacy March 2015).
and friendship model for people with intellectual disabilities.
Mental Retardation 44: 443–446. Nicholson L, Colyer M and Cooper S-A (2013) Recruitment to
intellectual disability research: A qualitative study. Journal of
Fisher CB, Cea CD, Davidson PW, et al. (2006) Capacity of
Intellectual Disability Research 57: 647–656.
persons with mental retardation to consent to participate in
randomized clinical trials. American Journal of Psychiatry Nind M (2008) Conducting qualitative research with people
163: 1813–1820. with learning, communication and other disabilities:
General Medical Council (2010) Good practice in research and methodological challenges. Available at: http://
consent to research. Available at: www.gmc-uk.org/ eprints.ncrm.ac.uk/491/ (accessed 3 March 2015).
guidance/research_guidance (accessed 27 January 2011). Robinson WM and Unruh BT (2011) The hepatitis
Goldsmith L, Woodward V, Jackson L, et al. (2013) Informed experiments at the Willowbrook State School. In: Emanuel
consent for blood tests in people with a learning disability. EJ, Grady CC, Crouch RA, et al. (eds) The Oxford Textbook
Journal of Advanced Nursing 69: 1966–1976. of Clinical Research Ethics. New York: Oxford University
Press.
Heal LW and Sigelman CK (1995) Response biases in
interviews of individuals with limited mental ability. Journal Roper JM and Shapira J (2000) Ethnography in Nursing
of Intellectual Disability Research 39: 331–340. Research. Thousand Oaks: SAGE.
Iacono T (2006) Ethical challenges and complexities of Social Care Institute for Excellence (2005) How to produce
including people with intellectual disability as participants in information in an accessible way. Available at: http://
research. Journal of Intellectual and Developmental Disability www.scie.org.uk/publications/misc/accessguidelines
31: 173–179. publications.pdf (accessed 13 November 2012).
Inglis P and Cook T (2011) Ten top tips for effectively Stancliffe RJ (1997) Community living-unit size, staff presence,
involving people with a learning disability in research. and residents’ choice-making. Mental Retardation 35: 1–9.
Journal of Learning Disabilities and Offending Behaviour 2: United States Department of Health and Human Services.
98–104. (2009) Code of federal regulations. Human subjects research.
Joint Committee on Human Rights (2008) A life like any Available at: http://www.hhs.gov/ohrp/humansubjects/
other? Human rights of adults with learning disabilities. guidance/45cfr46.html#46.116 (accessed 31 March 2015).
Available at: http://www.publications.parliament.uk/pa/ Wehmeyer ML and Bolding N (1999) Self-determination
jt200708/jtselect/jtrights/40/4002.htm (accessed 3 March across living and working environments: A matched samples
2015). study of adults with mental retardation. Mental Retardation
Keywood K and Flynn M (2006) Healthcare decision-making 37: 353–363.
by adults with learning disabilities: Ongoing agendas, future Weindling PJ (2011) The Nazi medical experiments.
challenges. Psychiatry 5: 360–362. In: Emanuel EJ, Grady CC, Crouch RA, et al. (eds) The
McClimens A and Allmark P (2011) A problem with inclusion Oxford Textbook of Clinical Research Ethics. New York:
in learning disability research. Nursing Ethics 18: 633–639. Oxford University Press.
McDonald KE, Kidney CA and Patka M (2013) ‘You need to Wiles R, Crow G, Charles V, et al. (2007) Informed consent
let your voice be heard’: Research participants’ views on and the research process: Following rules or striking
research. Journal of Intellectual Disability Research 57: balances? Sociological Research Online 12. Available at:
216–225. http://www.socresonline.org.uk/12/2/wiles.html (accessed 28
McVilly KR and Dalton AJ (2006) Commentary on Iacono March 2015).
(2006): Ethical challenges and complexities of including

Lesley Goldsmith is a researcher with a particular interest in learning disability and direct-to-
consumer genetic testing. Her PhD was on the topic of informed consent for
pharmacogenomic testing in people with a learning disability. She has subsequently
worked as a Research Fellow on the Applied Health Genetics Team at Plymouth
446 Journal of Research in Nursing 20(6)

University, involved in research on direct-to-consumer genetic testing, and prenatal genetic

testing and screening.

Heather Skirton is Professor of Applied Health Genetics at Plymouth University. She has a
clinical background in nursing and midwifery and is a registered genetic counsellor. Her
research, resulting in over 140 peer-reviewed papers, focusses on improvement of health
services for families with genetic conditions, prenatal genetic testing and screening, and
development of professional competence in genetics.