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CONSENT FOR PARTICIPATION IN NON-CLINICAL RESEARCH – THE LEGAL BASIS
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1.1
The legal concept of consent
Consent is a recognised legal concept. 'Assent' is not. Consent may be
implied (by actions, lack of actions, words or deeds) rather than explicit,
therefore does not need to be given in writing. However, for an opt-out
system to qualify as implied consent there must have been an effective
communication between the researcher and the person who is being asked
to consent.
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2.1
Consent and the child
In the following section references to a 'child' refer to a person who is under
18. Parental responsibility is a legally defined term - see appendix 1.
2.2
A child may be competent to give consent on his/her own behalf. There is
no fixed age of competence and the 'Gillick' competence test applies. This
requires an assessment of the child’s capability to understand the
information about the research and any potential consequences of taking
part in the research. NB: It is always open to a parent to take the issue to
court and a court can then do whatever is in the child's best interests, be it
to consent or refuse.
2.3
Where a competent child has given consent only a court could override that
consent. Where a competent child has withheld consent a person with
parental responsibility in respect of that child, or a court, can override a
refusal.
2.4
In the absence of a decision from a competent child consent may be given
instead by a person with parental responsibility in respect of that child.
2.5
Consent may be given or withheld on behalf of a non-competent child only
by a person with parental responsibility in respect of that child or a court.
2.6
In many cases consent given by only one person with parental responsibility
is legally sufficient; however this will depend on the nature of the research.
In a treatment/clinical research situation, for example, it might well be
that a court would require both parents' consent. This may also apply to
highly sensitive research such as into sexual abuse. NB: Whatever the strict
legal position, there will be situations where it would be ethically and
pragmatically advisable (if only to avoid problems between estranged
parents and/or the child concerned) to get both parents' consent (provided
the non-resident parent does have parental responsibility) even though that
of the resident parent would suffice in law.
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Consent and Mental Capacity in Adults
The Mental Capacity Act 2005 provides that every adult has the right to
make his or her own decisions and must be assumed to have capacity to do
so unless it is proved otherwise. In addition individuals must be supported
to make their own decisions – a person must be given all practicable help
before anyone treats them as not being able to make their own decisions.
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Any act done or decision made under the Act for or on behalf of a person
who lacks capacity must be done in their best interests and anything done
for or on behalf of a person who lacks capacity should consider options that
are less restrictive of their basic rights and freedoms if they are as effective
as the proposed option.
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4.1
4.2
4.3
Consent required in law for research (excluding clinical trials)
Human rights/common law
Where the research requires intervention because the research participant
has to undertake some specific experience (e.g. to undergo a procedure, to
undertake tasks in an experimental setting, to attend an interview or to
complete a questionnaire) consent for participation in the activity is
normally required.
Data Protection
Whether or not consent is required to collect information for research
purposes about a living individual will be determined by the Data Protection
Act 1998. The type of information being collected is significant. The Data
Protection Act permits the collection and processing of non-sensitive
personal data for research purposes, both with or without consent but, in
the absence of consent, a balance of legitimate interests must be applied.
Where the research involves use of sensitive personal data, as defined in s2
of the Data Protection Act 1998 (see appendix 2), the Act states that any
consent relied upon must be explicit - this means a positive agreement and
not opt out or implied consent. However, the Act does permit collection
and processing of sensitive personal data without explicit consent but only
on one of the following conditions:

where the research is for necessary medical purposes and carried out
by a health professional or someone with an equivalent duty of
confidence

where the research is necessary in order to meet equal opportunity
monitoring obligations

where the research is justifiable on the grounds that it is in the
substantial public interest, must not be used as a basis to take
decisions about or measures against that individual, and must not be
likely to cause significant damage or distress to anyone.
or
or
4.4
4.5
Under the Data Protection Act for consent to be valid it must be fully
informed and freely given.
Those Lacking Mental Capacity
The Mental Capacity Act 2005 introduces the concept of ‘intrusive
research’. Intrusive research is defined as research which, if carried out on
a person with mental capacity, would be unlawful without his/her consent.
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4.6
The Act provides that such research involving, or in relation to, a person
[adult] lacking capacity may be lawfully carried out if an “appropriate
body” (this currently is an NHS Research Ethics Committee) agrees that the
research is safe, relates to the person’s condition and cannot be done as
effectively using people who have mental capacity. The research must
produce a benefit to the person that outweighs any risk or burden.
Alternatively, if it is to derive new scientific knowledge it must be of
minimal risk to the person and be carried out with minimal intrusion or
interference with their rights.
4.7
Carers or nominated third parties must be consulted and agree that the
person would want to join an approved research project. If the person
shows any signs of resistance or indicates in any way that he or she does not
wish to take part, the person must be withdrawn from the project
immediately.
4.8
4.9
Use of Human Tissue
The Human Tissue Act 2004 makes ‘informed consent’ the fundamental
principle underpinning the lawful storage and use of human bodies, body
parts, organs and tissue and the removal of material from the bodies of
deceased persons. It introduces regulation of the storage of human material
for education, training and research. Human tissue covers a wide range of
materials and includes, inter alia, saliva.
Tissue from the living may be stored for use and/or used without consent
for research purposes, provided that:

the research is ethically approved by a research ethics authority (this
currently is an NHS Research Ethics Committee)
and

the tissue is anonymised such that the researcher is not in possession of
the information identifying the person from whose body the material
has come and is not likely to come into possession of it. (This does not
mean that samples must be permanently and irrevocably unlinked.)
NB: Fetal tissue - The law does not distinguish between fetal tissue and
other tissue from the living – fetal tissue is regarded as the mother’s
tissue, however, it is recommended that consent is always gained (from the
mother) for the examination, storage of use of fetal tissue. It is considered
good practice that wherever practicable, consent should also be obtained
for the use in research of non-fetal products of conception.
4.10
In other circumstances informed consent is required before tissue from the
living may be stored or used for research and teaching purposes.
4.11
Informed consent is also required for the removal, storage and use of human
tissue from the deceased for educational and research purposes, unless
part of an investigation under the authority of the coroner or in connection
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with a criminal investigation or following a criminal conviction. The Act sets
out from whom informed consent is required in the case of the deceased.
4.12
The Act does not define ‘informed consent’ but the associated guidance
refers to the clinical trials definition, which is ‘a process by which a subject
voluntarily confirms his or her willingness to participate in a particular
trial, after having been informed of all aspects of the trial that are
relevant to the subject's decision to participate. Informed consent is
documented by means of a written, signed and dated informed consent
form.’
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Opt out or implied consent scenarios.
5.1
The ‘nil response’ scenario
In this type of scenario researchers write to the participant or the person
with parental responsibility stating that they intend to collect information
from the participant unless he/she or person with parental responsibility
contacts them to object. This is a high risk method in that it is possible for
the researchers to be challenged on the grounds that the information was
never received and there is often no evidence that can be produced to show
that it was.
5.2
In scenarios where this type of opt out 'consent' is proposed for the
collection of non-sensitive personal data it is also worth applying the
legitimate interests balance test in order that the research could be
justified under the Data Protection Act on a non-consent basis should this
prove necessary.
5.3
This opt out method would not constitute explicit consent in relation to the
collection and use of sensitive personal data, therefore research involving
sensitive personal data would either have to be justifiable on one of the
other permitted grounds (as described in para 4.3 above) or the
methodology changed so that the participant provides some positive
evidence of agreement (opt in) which would constitute explicit consent.
5.4
This opt out method is unlikely to suffice for the purposes of getting
informed consent under the Human Tissue Act 2004.
The ‘tick the box’ scenario
5.5
In this type of scenario data is already being actively collected for one
purpose and at the same time potential participants are informed that their
data will also be used for research purposes but they may positively indicate
(for example by ticking the box) if they do not wish for this to happen. This
is the standard method of opt out in marketing situations. This is less risky
than the above situation as participants are more actively engaged in
deciding whether to opt out and there is evidence of receipt of the
communication.
5.6
This opt out method would not constitute explicit consent in relation to the
collection and use of sensitive personal data, therefore research involving
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sensitive personal data would either have to be justifiable on one of the
other permitted grounds (as described in para 4.3 above) or the
methodology changed so that the participant provides some positive
evidence of agreement (opt in) which would constitute explicit consent.
5.7
It is debatable as to whether this opt out method would suffice for the
purposes of getting informed consent under the Human Tissue Act 2004.
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6.1
Significance of consent
Whether research should be conducted on the basis of consent is an ethical
issue as well as a legal one but the legal basis must be clarified in any given
project. It is important that researchers and Ethics Committees understand
whether or not the chosen methodology will deliver the type of consent that
is legally valid in any given project. This analysis will need to include
accurate identification of whether the data is covered by the Data
Protection Act, and if so, whether it is sensitive according to the Data
Protection Act (and therefore which grounds under the Act researchers are
relying on), whether any human tissue is being collected and whether
consent is required under the Human Tissue Act, whether consent is
necessary under the Mental Capacity Act and if so, from whom?
6.2
Without this explicit analysis researchers may not be able to give clear and
accurate information to participants about whether they are relying on
participants’ consent, or on the participants’ parent(‘s) consent, or on noone’s consent and what should happen if the participants wish to withdraw
from the study.
6.3
Research conducted on an unlawful basis leaves the University at risk from
litigation, loss of reputation and potential loss of future research income.
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APPENDIX 1
SENSITIVE PERSONAL DATA (from section 2 of the Data Protection Act 1998)
“sensitive personal data” means personal data (i.e. information relating to a living
identifiable individual) consisting of information as to
 the racial or ethnic origin of the data subject,
 the data subject’s political opinions,
 the data subject’s religious beliefs or other beliefs of a similar nature,
 whether the data subject is a member of a trade union (within the meaning of
the Trade Union and Labour Relations (Consolidation) Act 1992),
 the data subject’s physical or mental health or condition,
 the data subject’s sexual life,
 the commission or alleged commission by the data subject of any offence,
 any proceedings for any offence committed or alleged to have been
committed by the data subject, the disposal of such proceedings or the
sentence of any court in such proceedings.
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APPENDIX 2
PARENTAL RESPONSIBILITY (from sections 2, 3 and 4 of the Children Act 1989, as
amended by s111 of the Adoption and Children Act 2002).
“parental responsibility” means all the rights, duties, powers, responsibilities and
authority which by law a parent of a child has in relation to the child and his
property
Persons with parental responsibility:
• Natural mother
• Natural father if:
married to natural mother at birth of child, or
subsequently married to natural mother, or
(if not married to natural mother) registered as father from 1st
December 2003, or
Has acquired parental responsibility by court order or by agreement with
the mother
• Adoptive parents
• Where the Court has so decided (care orders, residence orders in favour of
third parties (eg grandparents) etc)
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APPENDIX 3
CONSENT FOR USE OF MATERIAL FROM THE DECEASED (from the Human Tissue
Act 2004)
Tissue from the Deceased – adults
Where an adult has, whilst alive and competent, given consent for the use or
storage of tissue for research or teaching purposes, then that consent is sufficient
for the activity to be lawful. The consent required for anatomical examination of
a deceased person’s body must be written down and witnessed.
Tissue from the deceased – nominated representatives
If a deceased adult has neither consented to nor specifically refused any particular
donation or removal, storage or use of their body or tissue those close to them
should be asked whether a nominated representative was appointed to take those
decisions.
A nominated representative cannot give consent for anatomical examination, but
may consent to other teaching or research purposes.
More information on nominated representatives and other persons with ‘qualifying
relationships’ and the power to give consent can be found in the Human Tissue
Authority - Code of Practice on Consent.
Tissue from the deceased – children
As with adults, where a child has, whilst alive and competent, given consent for
the use or storage of tissue for research or teaching purposes, then that consent is
sufficient for the activity to be lawful. The consent required for anatomical
examination of a deceased child’s body must be written down and witnessed.
It will however still be essential to discuss this with the child’s family and to take
their views and wishes into account before deciding how to proceed.
If a child did not make a decision, or was not competent to make a decision, the
Act makes it clear that the appropriate consent will be that of the person with
parental responsibility for the child (as defined by the Children Act 1989 as
amended).
For more information on consent from others in respect of deceased children see
the Human Tissue Authority - Code of Practice on Consent.
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