Report on Children in Medical Research
https://tukija.fi/documents/1481661/1546647/2003_children.pdf/54924377-820e-4a26-be33-47fcaa64f5f0/2003_children.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Political / Political
Searching for indicator party:
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p.000001: is so wide that it was impossible to take the special characteristics of each type into account. Even though the
p.000001: working group also gave some detailed recommendations, the main purpose of the report is to prompt discussion about
p.000001: ethical questions concerning research conducted on children rather than to give an exhaustive report of all viewpoints
p.000001: on the subject.
p.000001: In the report, the working group decided to emphasise differences associated with different stages of life and
p.000001: development, and the ability of a child or an adolescent to decide whether or not to participate in research. A child
p.000001: or an adolescent should always be party to the decision-making that concerns him/her if possible. This can be promoted
p.000001: by telling the child or adolescent about the research in an understandable way. The number of children recruited
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
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p.000003: children and adolescents.
p.000003: A child needs the protection of adults because of his/her incomplete development. A small child’s ability to evaluate
p.000003: and weigh the health risks and discomfort caused by the research study is limited. The child needs the protection
p.000003: and support of his/her parents or guardian in this evaluation. The child’s possibilities to be party to
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
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p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
p.000006: medical-judicial group, remains a topic for discussion. The line between experimental treatments and clinical research
p.000006: is unclear, but for example ethics committees and drug authorities are more effective at monitoring clinical research
p.000006: than experimental treatments. The follow-up, combination of research data and systematic analysis associated
p.000006: with good clinical research help optimise the treatment and detect any adverse effects as early as possible.
p.000006: It is hard to justify researching similar or parallel medicines on children unless the new parallel
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p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
p.000009: acts as a link between the unit staff and the investigators. By participating in the collection of research samples,
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Health / Drug Dependence
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p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: SUMMARY
p.000001:
p.000001: A considerable proportion of the medical treatment of children is based more on estimates and assumptions than on
p.000001: clinical evidence. Enrolling children into research has been avoided because of the special status of children. The
p.000001: special characteristics of research performed in children are related to the physical size of children and
p.000001: their dependency on adults due to their level of development. While current legislation allows, on certain conditions,
p.000001: a 15-year-old to give independent consent to participate in a research study, a person must be 18 years old before
p.000001: he/she can make an entirely independent decision about participation. Children do not gain the same benefits from
p.000001: pharmaceutical innovations as adults, since so few clinical trials are conducted on children. On the
p.000001: other hand, many trials are conducted on children in some narrow sub- specialties, and both the parents and
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Health / Drug Usage
Searching for indicator influence:
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p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
p.000005: participation in more than one research study at a time should require special grounds and the approval of the head of
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p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
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p.000010: or on-call physician giving the initial information may not necessarily have detailed information about the research
p.000010: unless he/she is part of the research group. The investigator has the most information about the research.
p.000010: However, it is important to discuss whether the interests of the investigator to recruit research subjects make it
p.000010: more difficult for him/her to give neutral information about the research. On the other hand, if the information is
p.000010: given and the consent requested by the child’s treating physician who is acting as the investigator, fear about the
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
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Searching for indicator drug:
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p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
p.000006: medical-judicial group, remains a topic for discussion. The line between experimental treatments and clinical research
p.000006: is unclear, but for example ethics committees and drug authorities are more effective at monitoring clinical research
p.000006: than experimental treatments. The follow-up, combination of research data and systematic analysis associated
p.000006: with good clinical research help optimise the treatment and detect any adverse effects as early as possible.
p.000006: It is hard to justify researching similar or parallel medicines on children unless the new parallel
p.000006: product is expected to be clearly superior to those already on the market. On the other hand, similar medicines that
p.000006: differ with regard to adverse effects or pharmaceutical forms provide more options in the treatment of children. It is
p.000006: impossible to define in general terms how many similar medicines should be available. It is, however, important
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Searching for indicator substance:
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p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
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p.000006: medicinal product is often compared either to a known medicine in the market or to placebo. In clinical research
p.000006: performed in children, the composition of the investigational product is important. Different dosage ? forms are often
p.000006: needed for children, and absorption of the medicine may vary. This may cause problems not only for the investigator but
p.000006: also for the manufacturer of the medicine.
p.000006: Clinical trials on medicinal products have some special characteristics in comparison with other scientific
p.000006: studies. A medicine is either an alien substance to the body or differs quantitatively from substances produced by the
p.000006: body (e.g. hormones), and therefore it may also cause adverse effects. Research on adults can only provide estimations
p.000006: about the incidence of adverse effects on children, since the passage of the medicine in a child’s body and the body’s
p.000006: response to the medicine may be different due to growth and development. Since children cannot be subjected to
p.000006: unnecessary risks, clinical research can be performed on healthy children in exceptional cases only. In
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p.000008: (2001/20/EC) does not appear to allow research in any situations without the consent of the guardian or another legal
p.000008: representative, so the Medical Research Act will be revised during the implementation stage of the directive.
p.000008: Children who have been taken into custody are in a special situation, and should be spared additional
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
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Health / HIV/AIDS
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p.000004: Research studies usually performed on children include vaccine research, which aim at finding preventive
p.000004: vaccines to diseases that commonly occur in children. Although the incidence of many of the most difficult and
p.000004: life-threatening infectious diseases has decreased or the diseases have been
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: entirely eradicated, vaccines are still being developed for, to name a few, chickenpox, diarrhoea, respiratory tract
p.000005: infections and ear infections. Most of the vaccines are directed at young children, but at the moment vaccines are
p.000005: also being developed for adolescents and adults (e.g. HIV and papilloma virus vaccines).
p.000005: In principle, research conducted on children greatly resembles research conducted on adults. When children are
p.000005: participating in research, however, the child’s level of development and ability to cooperate and understand
p.000005: must be taken into account. For example, in tasks that require cooperation from the research subject, such as
p.000005: respiratory research studies on asthma, the child’s ability to act according to directions must be taken into account.
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
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p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
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Searching for indicator aids:
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p.000006: authorisation for use by children. According to various research studies, 20–90 % of the medicines used
p.000006: for children in Europe are not authorised for use by children, or the dosage deviates from the approved
p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
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p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
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Health / Health
Searching for indicator health:
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p.000001: ethical questions concerning research conducted on children rather than to give an exhaustive report of all viewpoints
p.000001: on the subject.
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p.000018:
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p.000003: 3
p.000003:
p.000003: BACKGROUND ON RESEARCH CONDUCTED ON CHILDREN
p.000003:
p.000003: The development of medicine and biology has greatly benefited humankind, particularly during the last century. Life
p.000003: expectancy has improved, many previously fatal diseases have either been eradicated or medicines, vaccines
p.000003: and other preventive procedures have been developed against them. However, even during this time, research
p.000003: contained features that could never be accepted today. At the beginning of the 20th century it was still felt
p.000003: that, if animal studies could not be used for studying a problem, homeless children could be used as research subjects
p.000003: in clinical research; adults were used only as the last resort. Pharmacotherapeutic disasters of the 1950s
p.000003: and 1960s affecting particularly children (e.g. the thalidomide cases and hepatitis vaccine research in the USA) led
p.000003: to the development of the current international treaties and legislation concerning medicines. This history
p.000003: continues to contribute to the fact that people still feel a certain reserve about studying pharmaceuticals in
p.000003: children.
p.000003: Childhood and adolescence are periods of vigorous growth and development. Children are not small adults, and this very
p.000003: growth and development make them mentally and physically different from adults. Scientific research must be conducted
p.000003: on children and adolescents that they could benefit from research-based development of medicine and biology like
p.000003: adults. Such research is the only way to find the best means to monitor and support the normal growth and
p.000003: development of children, as well as diagnose and treat any disturbances in them. Some diseases occur in
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p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
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p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
p.000003: is not in the child’s best interests. It has been our goal to present the various viewpoints in this report on equal
p.000003: terms.
p.000003:
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p.000004: quite specific regulations for the protection of children, but also takes into account the necessity of
p.000004: research. On a national level, clinical research performed in children is controlled by the Medical Research Act
p.000004: (488/1999, later the Research Act). This report mainly refers to national legislation unless the requirements set forth
p.000004: in international documents outweigh those of national regulations.
p.000004:
p.000004:
p.000004: Part I:
p.000004: PERSPECTIVES ON RESEARCH CONDUCTED ON CHILDREN
p.000004:
p.000004: Medical grounds of research conducted on children
p.000004:
p.000004: A child’s organs continue to develop from early foetal period to adulthood. Different organs develop at
p.000004: different rates and at different times. The threshold values of normal development in different age
p.000004: periods, which form the basis of diagnosis and treatment, have to be found with the help of research. Due to
p.000004: ongoing growth and development, the absorption, metabolism and elimination of a medicine, as well as its
p.000004: effect on the target organ and the rest of the body, are different in children than in adults, and
p.000004: they vary on the basis of the child’s age and stage of development.
p.000004: So-called children’s diseases are those which rarely occur in the adult population or which must be treated in early
p.000004: childhood. Typical examples include, for example, several poxes, many infectious diseases occurring in children
p.000004: (such as ear infections), structural defects (anomalies), or CP. Children do, however, have diseases that more
p.000004: commonly occur in adults. These include asthma, chronic intestinal diseases (i.e. coeliacia, Crohn’s disease,
p.000004: ulcerative colitis, migraine and epilepsy). Children with these diseases need treatment just like adults, although
p.000004: there may be differences in the nature of the treatment or the dosage of the medicine.
p.000004: Research studies usually performed on children include vaccine research, which aim at finding preventive
p.000004: vaccines to diseases that commonly occur in children. Although the incidence of many of the most difficult and
p.000004: life-threatening infectious diseases has decreased or the diseases have been
p.000004:
p.000004:
p.000005: 5
p.000005:
p.000005: entirely eradicated, vaccines are still being developed for, to name a few, chickenpox, diarrhoea, respiratory tract
p.000005: infections and ear infections. Most of the vaccines are directed at young children, but at the moment vaccines are
p.000005: also being developed for adolescents and adults (e.g. HIV and papilloma virus vaccines).
p.000005: In principle, research conducted on children greatly resembles research conducted on adults. When children are
p.000005: participating in research, however, the child’s level of development and ability to cooperate and understand
p.000005: must be taken into account. For example, in tasks that require cooperation from the research subject, such as
p.000005: respiratory research studies on asthma, the child’s ability to act according to directions must be taken into account.
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
p.000005: tissue and bone marrow samples or magnetic resonance imaging, x-ray imaging, radionuclide scans and other
p.000005: imaging, the additional stress and risks (e.g. anaesthesia) associated with the procedure must be taken
p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
p.000005: participation in more than one research study at a time should require special grounds and the approval of the head of
p.000005: the unit. The opinions of the other personnel and the parents should also be taken into account in decision-making. In
...
p.000006: needed for children, and absorption of the medicine may vary. This may cause problems not only for the investigator but
p.000006: also for the manufacturer of the medicine.
p.000006: Clinical trials on medicinal products have some special characteristics in comparison with other scientific
p.000006: studies. A medicine is either an alien substance to the body or differs quantitatively from substances produced by the
p.000006: body (e.g. hormones), and therefore it may also cause adverse effects. Research on adults can only provide estimations
p.000006: about the incidence of adverse effects on children, since the passage of the medicine in a child’s body and the body’s
p.000006: response to the medicine may be different due to growth and development. Since children cannot be subjected to
p.000006: unnecessary risks, clinical research can be performed on healthy children in exceptional cases only. In
p.000006: research performed on children, the same principles must be applied to the use of placebo as in
p.000006: research performed on adults. Placebo use in children can sometimes be considered acceptable and, at times, even
p.000006: necessary. For example, if the results of a treatment currently in use are unclear, the use of placebo may be
p.000006: justified.
p.000006: After the requisite studies, new medicines are usually first approved for use by adults. Usually, it is also in the
p.000006: best interests of children that the effect, efficacy and safety have been first evaluated with adults. When the
p.000006: medicine is available in pharmacies or used in hospitals, its use for children is often also possible without
p.000006: authorisation for use by children. According to various research studies, 20–90 % of the medicines used
p.000006: for children in Europe are not authorised for use by children, or the dosage deviates from the approved
p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
p.000006: medical-judicial group, remains a topic for discussion. The line between experimental treatments and clinical research
p.000006: is unclear, but for example ethics committees and drug authorities are more effective at monitoring clinical research
p.000006: than experimental treatments. The follow-up, combination of research data and systematic analysis associated
p.000006: with good clinical research help optimise the treatment and detect any adverse effects as early as possible.
p.000006: It is hard to justify researching similar or parallel medicines on children unless the new parallel
p.000006: product is expected to be clearly superior to those already on the market. On the other hand, similar medicines that
p.000006: differ with regard to adverse effects or pharmaceutical forms provide more options in the treatment of children. It is
p.000006: impossible to define in general terms how many similar medicines should be available. It is, however, important
p.000006: to minimise the number of children enrolled in research while making certain that the research yields, however,
p.000006: sufficient data on the efficacy and safety of the medicine.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Medical research conducted on children and legislation
p.000007: In legislation, children, as well as handicapped adults, are considered a special group in need of
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p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
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p.000007: newborn premature infants into research is facilitated if the parents have
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: already received information on such a situation beforehand. Additional information should be available,
p.000008: preferably in written form, in maternity hospitals and research units. Research that is started without
p.000008: delay can sometimes be of considerable importance to children’s well-being. For example, the hazards of
p.000008: 100 % oxygen in reviving neonates would never have been noticed if a written consent of the parents had been
p.000008: needed before enrolling the children into the research. The current form of the EC Clinical Trials Directive
p.000008: (2001/20/EC) does not appear to allow research in any situations without the consent of the guardian or another legal
p.000008: representative, so the Medical Research Act will be revised during the implementation stage of the directive.
p.000008: Children who have been taken into custody are in a special situation, and should be spared additional
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
...
p.000008: The Medical Research Act allows only minor risk or stress to be caused to an underaged research subject. The problem
p.000008: is the definition of minor risk. Can minor risk be determined with strict classification of procedures, or
p.000008: should it be relative to the situation of the individual patient or to the benefit expected from the research?
p.000008: Collecting five millilitres of blood may be a minor procedure to an adolescent, but it is life-threatening to a
p.000008: premature infant weighing 500 grams. Children also have individual differences. Children who are used to the
p.000008: hospital environment and who know what the procedure entails, may suffer less from minor procedures than
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
...
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
p.000009: acts as a link between the unit staff and the investigators. By participating in the collection of research samples,
p.000009: the research nurse thus frees the staff to treat the patients. Among other things, the research nurse coordinates the
p.000009: studies conducted on the unit, takes care of research documents, writes operating instructions, trains personnel and
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
p.000009: scientific research is time taken from other activities, and as resources become more
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: scarce, conflicts and ethically difficult choices emerge more and more often. The nurse and the doctor
p.000010: treating the child have to weigh the patient’s concrete treatment against the research, as well as to evaluate the
p.000010: quality of their work and factors influencing it. Even when resources are limited, using them for scientific research
p.000010: is necessary in order to gain new knowledge which may improve treatment of patients.
p.000010: Cooperation with the investigator, other research staff and treatment staff is important. It is the
p.000010: investigator’s duty to inform the staff responsible for the child’s treatment about the ongoing research
p.000010: at its various stages regardless of whether the staff form part of the research group or not. Sometimes samples are
p.000010: collected by someone not belonging to the department staff, in which case the child’s personal nurse guarantees
p.000010: the flexibility of the work and looks after the child’s best interests. Successful teamwork and good
p.000010: interaction skills are important also with regard to the development of research compliance. The success of
p.000010: research studies and their flexible conduct also benefit the patient.
p.000010: The genuine voluntariness of the consent is influenced by who gives the information concerning the research, who
p.000010: requests the consent, and how the consent is requested. Nurses often do not have enough information about
p.000010: research-related details, and therefore, asking for the consent should not be left to the nurse. The treating physician
p.000010: or on-call physician giving the initial information may not necessarily have detailed information about the research
p.000010: unless he/she is part of the research group. The investigator has the most information about the research.
p.000010: However, it is important to discuss whether the interests of the investigator to recruit research subjects make it
p.000010: more difficult for him/her to give neutral information about the research. On the other hand, if the information is
p.000010: given and the consent requested by the child’s treating physician who is acting as the investigator, fear about the
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
p.000010: ask questions. The parent information sheet and written consent must state the name of the research and
p.000010: the person conducting the research, contact information of the responsible investigator, and
p.000010: detailed information about the content, benefits, adverse effects, long-term effects, and any unknown risks of the
p.000010: research. The parents must know what they are agreeing to when signing the consent. Whenever possible,
p.000010: enough time should be reserved for giving the consent. The person requesting consent must not put pressure on the
p.000010: parents.
p.000010: When a written consent is given, the parents can always check what they have agreed to and what kind of a research
p.000010: study it is. It is also extremely important for the parents to know how the treatment their child
p.000010: receives during the research differs from the child’s regular treatment, and whether it is possible that
p.000010: their child is randomised into the control group or, if a medicine is being studied, into the placebo group, in which
p.000010: case the child may not receive a certain treatment. If new research-related adverse effects appear later, the
p.000010: parents must be informed. The parents must be
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: able to monitor whether the research is being carried out as described in the information sheet. If extending the
p.000011: research is necessary, a new consent must be requested from the parents.
p.000011: When requesting consent, a negative decision from the parents must be respected. The viewpoint of the parents may be
p.000011: different from the viewpoint of the investigator with regard to the child’s situation. The Medical
p.000011: Research Act and ethics committees require genuine voluntariness from participants in a research study, and the
p.000011: participating children and their parents must have been told that refusal to participate will not affect the child’s
p.000011: regular treatment. Despite this, the parents may give their consent to the child’s participation because they
p.000011: are afraid that refusal will affect the child’s treatment.
p.000011: The parents may consider the request to participate in a research study confusing, and it may also arouse contradictory
p.000011: feelings. Even though the medicine or treatment to be studied might benefit other children in the future, the
p.000011: parents may not necessarily want to add to their own child’s suffering. The parents are worried about the
p.000011: pain and suffering their child experiences. The stress caused by pain or a procedure may cause additional injury, e.g.
p.000011: due to changes in blood pressure. Repeated pain may later lead to pain sensitivity or psychological effects. The
p.000011: parents are also often concerned about whether the chosen research arrangement is necessary or whether the answers to
p.000011: the questions could be found in another way. These matters should be discussed with the parents prior to the signing of
p.000011: the consent form, and again during the study if necessary. Discussion eases the stress associated with making a
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
p.000011: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
p.000011: research. The dosage for many medicines is different in infants aged under one week. In premature infants, the dosage
p.000011: of many medicines is different from the dosage for full-term children. The smaller the patient, the greater is the
p.000011: proportion of water and extracellular space in total body volume. The same applies to skin surface area in proportion
p.000011: to body weight (about six-fold in an infant weighing less than 1000 g in comparison with adults). The
p.000011: functions of the liver and the kidneys are inadequate, and the skin of a very small premature infant is
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
...
p.000012: of blood samples when samples are collected repeatedly.
p.000012: Clinical and therapeutic research should also involve long-term follow-up of neonates participating in the research,
p.000012: since for example the potential adverse effects on growth and development may not be revealed until later,
p.000012: sometimes years after the study. For example, the adverse effects of dexamethasone (a cortisone
p.000012: preparation) treatment, used to mature an infant’s lungs in case of imminent premature birth and after
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
...
p.000012: treatment given to the neonate is important also after the consent has been given.
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Preschool age
p.000013: The organs of a preschool-aged child develop quickly. During this period, the body weight doubles and considerable
p.000013: energy is spent on the development of bones, muscles and nerves. The blood volume of the child no
p.000013: longer sets such strict restrictions to research as it does in the neonatal period, and performing the
p.000013: procedures is technically easier. In many ways, the metabolism of medicines in preschool children is similar
p.000013: to that in older children and thus allows for more adult- type research. On the other hand, the effects of medicines on
p.000013: growth, bones, and metabolism must be taken into consideration in treatment and research alike. Long-term effects may
p.000013: be caused, for example, by steroids (possible growth retardation) and tetracyclines (discoloration of
p.000013: developing teeth).
p.000013: The understanding of a baby or a preschool child regarding the procedures to be performed on him/her
p.000013: increases as the child grows. The child reacts strongly to pain and is often afraid of procedures that
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
p.000013: As a rule, the simpler the procedure, the younger the child who is able to understand the content and the
p.000013: effects of the procedure. The same applies to procedures the child is already familiar with.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: After learning to read, the child also learns to understand information given in written form. Therefore,
p.000014: at this time he/she should also have a separate information sheet, since the information sheet for adults contains
p.000014: not only complicated descriptions of procedures and phrases of foreign derivation but also less meaningful
p.000014: issues from the child’s point of view, such as information about registers and the coding, storing and transfer
p.000014: of data. Information sheets for young school-aged children do not need to fulfil every requirement set by laws
p.000014: and ethical codes about what research subjects should know about the research. A child less than 15 years old also
p.000014: cannot give his/her consent independently, since the consent of at least one guardian is needed in addition to the
p.000014: child’s consent. This is why the guardians should have a separate information sheet, on the basis of which they give
p.000014: their consent.
p.000014: The significance of a child’s expression of his/her wishes becomes greater when the child is better able to understand
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
p.000014: wants to make decisions about his/her own life to a greater extent. Therefore, adolescents should be given the
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
p.000014: legislation, an adolescent can make an independent decision about participating in a research study only at
p.000014: the age of 15 years, and then only in situations when he/she is expected to have direct benefit from the research,
p.000014: many younger adolescents are able to understand the course and significance of the research. The opinions of
...
p.000014: hormonal system, the guardians of the minor must always be informed of the research. This may,
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
p.000014: treatment, research is considered to be different. Although an adolescent from 15 to 18 years of age understands many
p.000014: issues that
p.000014:
p.000015: 15
p.000015:
p.000015: concern him/her, he/she can still be influenced by the opinions of his/her friends, for example. If complications
p.000015: occur in research studies on contraception, for example, the child may be left too much alone with feelings
p.000015: of responsibility and guilt.
p.000015:
p.000015: RECOMMENDATIONS OF THE WORKING GROUP
p.000015: 1. As a rule, the child should not participate in more than one invasive scientific research study at a time. The
p.000015: participation of a child in a clinical research study is always an exception from the main rule set down in
p.000015: law, according to which research should not be performed on children if the same results can be achieved with adult
p.000015: research subjects. Since research data from research performed on children are needed, however, it should
p.000015: be ascertained that the exceptional provisions are not interpreted in such a way that the well- being of individual
p.000015: children is endangered. For this reason, it is the opinion of the working group that, as a rule, a child should not
p.000015: participate in more than one invasive research study at a time. Questionnaire studies have not been taken into
p.000015: account in this case. When requesting consent to participate in a research study, it should always be ascertained
p.000015: that the child is not participating in other research programs at the same time. Since the scope of
p.000015: research studies and the complexity of procedures vary, exceptions to the main rule should be made possible with
p.000015: appropriate grounds. It should also be considered in research units whether different trials and consent procedures
p.000015: can be adapted to each other and combined. The doctor responsible for the unit (and, during on-call hours, the on-call
p.000015: backup person) bears the responsibility for the compatibility of research as well as other treatment given to the
p.000015: children. In outpatient treatment and prevention studies, the child’s personal doctor can evaluate the strain
p.000015: centering on the child and the parents. The doctor in charge of the research is responsible for the
p.000015: well-being of research subjects during the research, as stipulated by the Research Act.
p.000015:
p.000015: 2. The working group proposes that, in the future, more thought should be given to who should provide the necessary
p.000015: information about the research and request the consent needed for the research from the child and the child’s
p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
p.000015: would be if the investigator and the doctor who is treating the child could give the information about the research
p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
p.000015: is important that the research subject or his/her guardian has the opportunity to request additional information
p.000015: about the research from the investigator. Varied and neutral information about the research must be available, on the
p.000015: basis of which a decision about participating or refusing to participate can be reached. It is also important to give
p.000015: the parents enough time to consider their decision, whenever possible.
p.000015:
p.000015: 3. When evaluating the child or adolescent’s level of development, and the consent associated with this,
p.000015: as well as when carrying out the research, the investigators must have sufficient expertise concerning the growth and
p.000015: development of children. In order
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: to ensure a sufficient level of expertise, the working group proposes that special courses in research conducted on
p.000016: children be organised at the Faculties of Medicine. The course could be taken at the stage of specialisation, in
p.000016: association with a doctoral dissertation, or as supplementary education. Ethics committees should have
p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
p.000016: applied in association with research if the risk of injury or stress to the child is equally small.
p.000016:
p.000016: 5. The right of self-determination of minors should be expanded. To ensure that the right of self-determination is
p.000016: realised, it is recommended that a brief summary of the purpose, nature, benefits, risks and adverse effects
p.000016: of the research be made for children who are able to read. If such a summary is not considered necessary, the
p.000016: reasons must be given to the ethics committee. Information about the research can also be given to children who
p.000016: cannot read in the form of fairytales, games and stories. At the pre-planning stage of the research, it is also
p.000016: important to emphasise the significance of oral information and ways to ensure that research-related information is
p.000016: understandable to children of different ages. The resistance of a child younger than school age must also be respected
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000003: in clinical research; adults were used only as the last resort. Pharmacotherapeutic disasters of the 1950s
p.000003: and 1960s affecting particularly children (e.g. the thalidomide cases and hepatitis vaccine research in the USA) led
p.000003: to the development of the current international treaties and legislation concerning medicines. This history
p.000003: continues to contribute to the fact that people still feel a certain reserve about studying pharmaceuticals in
p.000003: children.
p.000003: Childhood and adolescence are periods of vigorous growth and development. Children are not small adults, and this very
p.000003: growth and development make them mentally and physically different from adults. Scientific research must be conducted
p.000003: on children and adolescents that they could benefit from research-based development of medicine and biology like
p.000003: adults. Such research is the only way to find the best means to monitor and support the normal growth and
p.000003: development of children, as well as diagnose and treat any disturbances in them. Some diseases occur in
p.000003: children and adolescents but not in adults. Prevention, diagnosis and treatment of these diseases cannot
...
Health / Motherhood/Family
Searching for indicator family:
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p.000003: and weigh the health risks and discomfort caused by the research study is limited. The child needs the protection
p.000003: and support of his/her parents or guardian in this evaluation. The child’s possibilities to be party to
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
p.000003: and of pain associated with the procedures. It is important that the investigator planning the research
p.000003: study, the person receiving the consent, and other staff participating in the research program think beforehand about
...
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
...
p.000008: needed before enrolling the children into the research. The current form of the EC Clinical Trials Directive
p.000008: (2001/20/EC) does not appear to allow research in any situations without the consent of the guardian or another legal
p.000008: representative, so the Medical Research Act will be revised during the implementation stage of the directive.
p.000008: Children who have been taken into custody are in a special situation, and should be spared additional
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
...
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
...
p.000012: preparation) treatment, used to mature an infant’s lungs in case of imminent premature birth and after
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
...
Health / Physically Ill
Searching for indicator ill:
(return to top)
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
...
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
p.000008: that of children who are not used to the hospital environment. The Medical Research Act states that if the child is
p.000008: able to understand the significance of the procedure to be performed, his/her personal consent is required to perform
p.000008: the research. According to the Medical Research Act, the guardian’s consent is needed in addition to the minor’s
...
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
...
p.000009: studies conducted on the unit, takes care of research documents, writes operating instructions, trains personnel and
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
...
p.000010: given and the consent requested by the child’s treating physician who is acting as the investigator, fear about the
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
...
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
...
Searching for indicator illness:
(return to top)
p.000004: best interests of the child (Article 3.1). Other obligations set forth in this convention include, for example, the
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
p.000004: attainable standard of health, the treatment of illness and rehabilitation services (Article 24).
p.000004: Another important document relating to international law is the Convention on Human Rights and Biomedicine by the
p.000004: Council of Europe (ETS 164), which contains special regulations concerning scientific research in the field of medicine
p.000004: in subjects who are not able to give an informed consent independently. In the last few years, Finland has prepared for
p.000004: the ratification of this convention by bringing its national legislation closer to the convention. The most
p.000004: recent document relating to international law that applies to research in children is Directive 2001/20/EC
...
p.000006: best interests of children that the effect, efficacy and safety have been first evaluated with adults. When the
p.000006: medicine is available in pharmacies or used in hospitals, its use for children is often also possible without
p.000006: authorisation for use by children. According to various research studies, 20–90 % of the medicines used
p.000006: for children in Europe are not authorised for use by children, or the dosage deviates from the approved
p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
...
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
p.000007: another reason, if delay in reaching the decision may cause harm to the child. If the matter is of considerable
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
...
p.000008: hospital environment and who know what the procedure entails, may suffer less from minor procedures than
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
p.000008: cause a great deal of fear towards painful procedures. The concept of minor risk is relative also in
p.000008: research studies where a risk of considerable adverse effects is associated with the treatment of a
p.000008: serious illness. In such cases, minor risk refers to the additional hazard and discomfort that the paediatric
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: patient is subjected to when he/she participates in the research in addition to regular treatment. When
p.000009: evaluating stress caused by the research, the number of additional visits, for example, and the stress caused by
p.000009: travelling and restrictions to normal life must be taken into consideration.
p.000009:
p.000009: Paediatric patients and health-care personnel
p.000009: Doctors, nurses, and other health-care personnel participate in scientific research projects ever more often. In
...
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
...
Health / Terminally Ill
Searching for indicator terminal:
(return to top)
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000004: on the Rights of the Child obligates the signatory countries to take into account as their primary consideration the
p.000004: best interests of the child (Article 3.1). Other obligations set forth in this convention include, for example, the
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
p.000004: attainable standard of health, the treatment of illness and rehabilitation services (Article 24).
p.000004: Another important document relating to international law is the Convention on Human Rights and Biomedicine by the
p.000004: Council of Europe (ETS 164), which contains special regulations concerning scientific research in the field of medicine
p.000004: in subjects who are not able to give an informed consent independently. In the last few years, Finland has prepared for
p.000004: the ratification of this convention by bringing its national legislation closer to the convention. The most
...
p.000007: health. If a minor is able to understand the significance of the research procedure to be performed, a
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
...
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
p.000007: interests and well-being into account in matters concerning the child’s care.
p.000007: But how is one to act if the parents cannot be reached, for example in a case of an accident, or if they are unable to
p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
...
p.000016: suffering must always be minimised. Pain associated with procedures can often be effectively alleviated
p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: LITERATURE
p.000017:
p.000017: Finnish legislation:
p.000017: Medical Research Act (488/1999)
p.000017: Act on the Status and Rights of Patients (785/1992)
p.000017: Act on the Medical Use of Human Organs and Tissues (101/2001) Child Custody and Right of Access Act (361/1983)
p.000017: Child Welfare Act (683/1983)
p.000017: The Constitution of Finland (731/1999) International agreements:
p.000017: United Nations Convention on the Rights of the Child (20th November, 1989)
p.000017: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000017: and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
p.000017: Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and
p.000017: administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
...
Searching for indicator social welfare:
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Social / Child
Searching for indicator child:
(return to top)
p.000001: pharmaceutical innovations as adults, since so few clinical trials are conducted on children. On the
p.000001: other hand, many trials are conducted on children in some narrow sub- specialties, and both the parents and
p.000001: the health-care staff can be confused by repeated requests to participate in various research projects. The emotional
p.000001: stress of the parents and the fear of losing the child in serious situations makes giving a voluntary consent
p.000001: problematic.
p.000001: On 5 June 2001, the National Advisory Board on Health Care Ethics (ETENE) appointed a working group to look for
p.000001: common rules to be applied to scientific research conducted on children. Representatives of paediatric
p.000001: clinical pharmacology, neonatology, nursing, law, and of parents were included in the working group. The
p.000001: members of the working group were: Kalle Hoppu, Docent of Clinical Pharmacology, Medical Director, Poison Information
p.000001: Centre, Helsinki University Central Hospital (HUCH); Sirkku Kiviniitty from KEVYT ry (Parents of Premature Infants
...
p.000001: Ritva Halila, Doctor of Medical Science, Specialist in Paediatrics, National Advisory Board on Health Care Ethics
p.000001: (ETENE). The finished report was extensively circulated for advisory comments and some additions were made on the basis
p.000001: of these comments.
p.000001: The working group assembled eight times. The report of the working group focuses on clinical research of the
p.000001: intervention type, although most issues discussed in the report can also be applied to other research
p.000001: studies, such as research on medical devices, radionuclide and radiology, diagnostics, genetic screening,
p.000001: child psychiatry, and follow-up of normal growth and development. The scope of research studies conducted on children
p.000001: is so wide that it was impossible to take the special characteristics of each type into account. Even though the
p.000001: working group also gave some detailed recommendations, the main purpose of the report is to prompt discussion about
p.000001: ethical questions concerning research conducted on children rather than to give an exhaustive report of all viewpoints
p.000001: on the subject.
p.000001: In the report, the working group decided to emphasise differences associated with different stages of life and
p.000001: development, and the ability of a child or an adolescent to decide whether or not to participate in research. A child
p.000001: or an adolescent should always be party to the decision-making that concerns him/her if possible. This can be promoted
p.000001: by telling the child or adolescent about the research in an understandable way. The number of children recruited
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
...
p.000001: is so wide that it was impossible to take the special characteristics of each type into account. Even though the
p.000001: working group also gave some detailed recommendations, the main purpose of the report is to prompt discussion about
p.000001: ethical questions concerning research conducted on children rather than to give an exhaustive report of all viewpoints
p.000001: on the subject.
p.000001: In the report, the working group decided to emphasise differences associated with different stages of life and
p.000001: development, and the ability of a child or an adolescent to decide whether or not to participate in research. A child
p.000001: or an adolescent should always be party to the decision-making that concerns him/her if possible. This can be promoted
p.000001: by telling the child or adolescent about the research in an understandable way. The number of children recruited
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
...
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
p.000001: child participates in just one research study at a time. Special attention should be paid to the role of the
p.000001: person requesting the consent. For research that includes minor procedures, the consent of just one parent is
p.000001: sufficient. An additional risk of injury or stress associated with the research should be proportional to the
p.000001: child’s individual situation and health benefits expected from the research rather than to a detailed
p.000001: classification of the procedures. It is recommended that researchers in the field receive training about the
p.000001: ethical questions relating to research conducted on children.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000002: 2
p.000002:
p.000002: TABLE OF CONTENTS
p.000002: SUMMARY
p.000002: 2
p.000002: BACKGROUND ON RESEARCH CONDUCTED ON CHILDREN 4
...
p.000003: children and adolescents but not in adults. Prevention, diagnosis and treatment of these diseases cannot
p.000003: be optimised without research conducted on children. Scientific research of diseases occurring in both children and
p.000003: adults is needed in order that, for example, treatments which have been found effective in adults could be applied to
p.000003: children and adolescents.
p.000003: A child needs the protection of adults because of his/her incomplete development. A small child’s ability to evaluate
p.000003: and weigh the health risks and discomfort caused by the research study is limited. The child needs the protection
p.000003: and support of his/her parents or guardian in this evaluation. The child’s possibilities to be party to
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
...
p.000003: adults is needed in order that, for example, treatments which have been found effective in adults could be applied to
p.000003: children and adolescents.
p.000003: A child needs the protection of adults because of his/her incomplete development. A small child’s ability to evaluate
p.000003: and weigh the health risks and discomfort caused by the research study is limited. The child needs the protection
p.000003: and support of his/her parents or guardian in this evaluation. The child’s possibilities to be party to
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
...
p.000003: and weigh the health risks and discomfort caused by the research study is limited. The child needs the protection
p.000003: and support of his/her parents or guardian in this evaluation. The child’s possibilities to be party to
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
p.000003: and of pain associated with the procedures. It is important that the investigator planning the research
p.000003: study, the person receiving the consent, and other staff participating in the research program think beforehand about
p.000003: how the voluntariness of the child’s consent to participate in the research study can be ensured. Ensuring the
...
p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
p.000003: and of pain associated with the procedures. It is important that the investigator planning the research
p.000003: study, the person receiving the consent, and other staff participating in the research program think beforehand about
p.000003: how the voluntariness of the child’s consent to participate in the research study can be ensured. Ensuring the
p.000003: well-being of the child is an obligation for everyone participating in the planning, realisation, and evaluation
p.000003: of the research study. The doctor responsible for the treatment must adhere to the obligation currently set by the Act
p.000003: on the Status and Rights of Patients: to provide the best possible treatment and to avoid all procedures that might put
p.000003: the patient’s health at risk.
...
p.000003: and of pain associated with the procedures. It is important that the investigator planning the research
p.000003: study, the person receiving the consent, and other staff participating in the research program think beforehand about
p.000003: how the voluntariness of the child’s consent to participate in the research study can be ensured. Ensuring the
p.000003: well-being of the child is an obligation for everyone participating in the planning, realisation, and evaluation
p.000003: of the research study. The doctor responsible for the treatment must adhere to the obligation currently set by the Act
p.000003: on the Status and Rights of Patients: to provide the best possible treatment and to avoid all procedures that might put
p.000003: the patient’s health at risk.
p.000003: Ethics committees evaluating clinical research have an obligation to take into account the need of protection of
p.000003: special patient groups. The ethics of research performed in children involve finding a balance between the necessity of
p.000003: the research and the protection of the child. When searching for the right balance, the perspectives of the
p.000003: parents and staff treating the child must be taken into account in addition to medical and legal aspects. It
p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
p.000003: is not in the child’s best interests. It has been our goal to present the various viewpoints in this report on equal
p.000003: terms.
p.000003:
p.000003:
...
p.000003: special patient groups. The ethics of research performed in children involve finding a balance between the necessity of
p.000003: the research and the protection of the child. When searching for the right balance, the perspectives of the
p.000003: parents and staff treating the child must be taken into account in addition to medical and legal aspects. It
p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
p.000003: is not in the child’s best interests. It has been our goal to present the various viewpoints in this report on equal
p.000003: terms.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Creating an atmosphere of trust is of the utmost importance in the treatment of the child as well as in matters
p.000004: relating to research in particular.
p.000004: Children are minors, but they enjoy the same rights as all other population groups. In Finland, this has also been
...
p.000003: parents and staff treating the child must be taken into account in addition to medical and legal aspects. It
p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
p.000003: is not in the child’s best interests. It has been our goal to present the various viewpoints in this report on equal
p.000003: terms.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Creating an atmosphere of trust is of the utmost importance in the treatment of the child as well as in matters
p.000004: relating to research in particular.
p.000004: Children are minors, but they enjoy the same rights as all other population groups. In Finland, this has also been
p.000004: emphasised in the constitution (the Constitution of Finland, 731/1999) § 6 paragraph 3). International agreements on
p.000004: human rights signed by Finland, such as the UN Convention on the Rights of the Child, also give children the
...
p.000003: terms.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Creating an atmosphere of trust is of the utmost importance in the treatment of the child as well as in matters
p.000004: relating to research in particular.
p.000004: Children are minors, but they enjoy the same rights as all other population groups. In Finland, this has also been
p.000004: emphasised in the constitution (the Constitution of Finland, 731/1999) § 6 paragraph 3). International agreements on
p.000004: human rights signed by Finland, such as the UN Convention on the Rights of the Child, also give children the
p.000004: right to the same level of health, health care and rehabilitation enjoyed by other citizens. The UN Convention
p.000004: on the Rights of the Child obligates the signatory countries to take into account as their primary consideration the
p.000004: best interests of the child (Article 3.1). Other obligations set forth in this convention include, for example, the
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
...
p.000004: human rights signed by Finland, such as the UN Convention on the Rights of the Child, also give children the
p.000004: right to the same level of health, health care and rehabilitation enjoyed by other citizens. The UN Convention
p.000004: on the Rights of the Child obligates the signatory countries to take into account as their primary consideration the
p.000004: best interests of the child (Article 3.1). Other obligations set forth in this convention include, for example, the
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
p.000004: attainable standard of health, the treatment of illness and rehabilitation services (Article 24).
p.000004: Another important document relating to international law is the Convention on Human Rights and Biomedicine by the
p.000004: Council of Europe (ETS 164), which contains special regulations concerning scientific research in the field of medicine
...
p.000004: on the Rights of the Child obligates the signatory countries to take into account as their primary consideration the
p.000004: best interests of the child (Article 3.1). Other obligations set forth in this convention include, for example, the
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
p.000004: attainable standard of health, the treatment of illness and rehabilitation services (Article 24).
p.000004: Another important document relating to international law is the Convention on Human Rights and Biomedicine by the
p.000004: Council of Europe (ETS 164), which contains special regulations concerning scientific research in the field of medicine
p.000004: in subjects who are not able to give an informed consent independently. In the last few years, Finland has prepared for
p.000004: the ratification of this convention by bringing its national legislation closer to the convention. The most
...
p.000004: research. On a national level, clinical research performed in children is controlled by the Medical Research Act
p.000004: (488/1999, later the Research Act). This report mainly refers to national legislation unless the requirements set forth
p.000004: in international documents outweigh those of national regulations.
p.000004:
p.000004:
p.000004: Part I:
p.000004: PERSPECTIVES ON RESEARCH CONDUCTED ON CHILDREN
p.000004:
p.000004: Medical grounds of research conducted on children
p.000004:
p.000004: A child’s organs continue to develop from early foetal period to adulthood. Different organs develop at
p.000004: different rates and at different times. The threshold values of normal development in different age
p.000004: periods, which form the basis of diagnosis and treatment, have to be found with the help of research. Due to
p.000004: ongoing growth and development, the absorption, metabolism and elimination of a medicine, as well as its
p.000004: effect on the target organ and the rest of the body, are different in children than in adults, and
p.000004: they vary on the basis of the child’s age and stage of development.
p.000004: So-called children’s diseases are those which rarely occur in the adult population or which must be treated in early
p.000004: childhood. Typical examples include, for example, several poxes, many infectious diseases occurring in children
p.000004: (such as ear infections), structural defects (anomalies), or CP. Children do, however, have diseases that more
p.000004: commonly occur in adults. These include asthma, chronic intestinal diseases (i.e. coeliacia, Crohn’s disease,
...
p.000005: infections and ear infections. Most of the vaccines are directed at young children, but at the moment vaccines are
p.000005: also being developed for adolescents and adults (e.g. HIV and papilloma virus vaccines).
p.000005: In principle, research conducted on children greatly resembles research conducted on adults. When children are
p.000005: participating in research, however, the child’s level of development and ability to cooperate and understand
p.000005: must be taken into account. For example, in tasks that require cooperation from the research subject, such as
p.000005: respiratory research studies on asthma, the child’s ability to act according to directions must be taken into account.
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
...
p.000005: participating in research, however, the child’s level of development and ability to cooperate and understand
p.000005: must be taken into account. For example, in tasks that require cooperation from the research subject, such as
p.000005: respiratory research studies on asthma, the child’s ability to act according to directions must be taken into account.
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
...
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
p.000005: tissue and bone marrow samples or magnetic resonance imaging, x-ray imaging, radionuclide scans and other
p.000005: imaging, the additional stress and risks (e.g. anaesthesia) associated with the procedure must be taken
p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
...
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
p.000005: tissue and bone marrow samples or magnetic resonance imaging, x-ray imaging, radionuclide scans and other
p.000005: imaging, the additional stress and risks (e.g. anaesthesia) associated with the procedure must be taken
p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
...
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
p.000005: tissue and bone marrow samples or magnetic resonance imaging, x-ray imaging, radionuclide scans and other
p.000005: imaging, the additional stress and risks (e.g. anaesthesia) associated with the procedure must be taken
p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
p.000005: participation in more than one research study at a time should require special grounds and the approval of the head of
p.000005: the unit. The opinions of the other personnel and the parents should also be taken into account in decision-making. In
...
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
p.000005: participation in more than one research study at a time should require special grounds and the approval of the head of
p.000005: the unit. The opinions of the other personnel and the parents should also be taken into account in decision-making. In
p.000005: these situations there should also be an evaluation as to what are the times when different research projects can be
p.000005: combined. Doctors responsible for the children’s treatment and other staff members should be informed about
p.000005: the research project before it is launched. In addition, when research permits are being granted, the head of the
p.000005: treatment unit, who is responsible for the availability of unit resources as well as the recruitment
p.000005: effort directed at patients, should be heard. Depending on the study, it should also be considered whether the child’s
p.000005: day care centre or school should be informed of the study. Since participation in a research study is as
p.000005: strictly confidential as all other health care the child receives, contacts and any information sheets, as well as
p.000005: information on the child’s participation in the research, should be conveyed primarily via the child’s parents
p.000005: or guardians, unless other arrangements have been made with them.
p.000005:
p.000005:
p.000006: 6
p.000006:
...
p.000005: the research project before it is launched. In addition, when research permits are being granted, the head of the
p.000005: treatment unit, who is responsible for the availability of unit resources as well as the recruitment
p.000005: effort directed at patients, should be heard. Depending on the study, it should also be considered whether the child’s
p.000005: day care centre or school should be informed of the study. Since participation in a research study is as
p.000005: strictly confidential as all other health care the child receives, contacts and any information sheets, as well as
p.000005: information on the child’s participation in the research, should be conveyed primarily via the child’s parents
p.000005: or guardians, unless other arrangements have been made with them.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Children and clinical trials on medicinal products
p.000006: In clinical trials on medicinal products, an investigational medicinal product is given to the research subjects. This
p.000006: medicinal product is often compared either to a known medicine in the market or to placebo. In clinical research
...
p.000005: effort directed at patients, should be heard. Depending on the study, it should also be considered whether the child’s
p.000005: day care centre or school should be informed of the study. Since participation in a research study is as
p.000005: strictly confidential as all other health care the child receives, contacts and any information sheets, as well as
p.000005: information on the child’s participation in the research, should be conveyed primarily via the child’s parents
p.000005: or guardians, unless other arrangements have been made with them.
p.000005:
p.000005:
p.000006: 6
p.000006:
p.000006: Children and clinical trials on medicinal products
p.000006: In clinical trials on medicinal products, an investigational medicinal product is given to the research subjects. This
p.000006: medicinal product is often compared either to a known medicine in the market or to placebo. In clinical research
p.000006: performed in children, the composition of the investigational product is important. Different dosage ? forms are often
p.000006: needed for children, and absorption of the medicine may vary. This may cause problems not only for the investigator but
p.000006: also for the manufacturer of the medicine.
p.000006: Clinical trials on medicinal products have some special characteristics in comparison with other scientific
p.000006: studies. A medicine is either an alien substance to the body or differs quantitatively from substances produced by the
p.000006: body (e.g. hormones), and therefore it may also cause adverse effects. Research on adults can only provide estimations
p.000006: about the incidence of adverse effects on children, since the passage of the medicine in a child’s body and the body’s
p.000006: response to the medicine may be different due to growth and development. Since children cannot be subjected to
p.000006: unnecessary risks, clinical research can be performed on healthy children in exceptional cases only. In
p.000006: research performed on children, the same principles must be applied to the use of placebo as in
p.000006: research performed on adults. Placebo use in children can sometimes be considered acceptable and, at times, even
...
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
...
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
p.000006: medical-judicial group, remains a topic for discussion. The line between experimental treatments and clinical research
...
p.000007: of children to give an independent informed consent to research procedures. If participation in the
p.000007: research is considered possible, the consent of the parents or guardian and minimisation of
p.000007: research-related risks are, as a general rule, required. Furthermore, children can only be enrolled as
p.000007: research subjects if it is not possible to achieve the same results with adult subjects. The research must
p.000007: also be of direct benefit for the child’s health or of particular benefit to persons of similar age or state of
p.000007: health. If a minor is able to understand the significance of the research procedure to be performed, a
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
...
p.000007: health. If a minor is able to understand the significance of the research procedure to be performed, a
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
...
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
...
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
...
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
...
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
...
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
...
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
...
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
...
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
p.000007: another reason, if delay in reaching the decision may cause harm to the child. If the matter is of considerable
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
...
p.000007: the child’s father to make the decision for the child in a situation where she is unable to give her consent to
p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
p.000007: another reason, if delay in reaching the decision may cause harm to the child. If the matter is of considerable
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
...
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
p.000007: another reason, if delay in reaching the decision may cause harm to the child. If the matter is of considerable
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
...
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
p.000007: interests and well-being into account in matters concerning the child’s care.
p.000007: But how is one to act if the parents cannot be reached, for example in a case of an accident, or if they are unable to
p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
...
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
p.000007: interests and well-being into account in matters concerning the child’s care.
p.000007: But how is one to act if the parents cannot be reached, for example in a case of an accident, or if they are unable to
p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
p.000007: because of the urgency of the matter and the patient’s state of health, and if the procedure is expected to be
p.000007: of immediate benefit to the patient’s health (§ 6 paragraph 1). This regulation can probably be applied to
p.000007: minors whose guardians cannot be reached in time, or if the guardian has, for example, been injured in the same
...
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
p.000007: because of the urgency of the matter and the patient’s state of health, and if the procedure is expected to be
p.000007: of immediate benefit to the patient’s health (§ 6 paragraph 1). This regulation can probably be applied to
p.000007: minors whose guardians cannot be reached in time, or if the guardian has, for example, been injured in the same
p.000007: traffic accident as the child. In these cases the guardians must be informed of the research as soon as possible, and
p.000007: at this or at a later time the guardians can prohibit the child’s participation in the research. This is also the
p.000007: standard approach for emergency research on adults. However, if the research can be performed using other
p.000007: research subjects or waiting for the parents’ consent is possible, this exception should not be applied. Enrolling
p.000007: newborn premature infants into research is facilitated if the parents have
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: already received information on such a situation beforehand. Additional information should be available,
p.000008: preferably in written form, in maternity hospitals and research units. Research that is started without
...
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
...
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
...
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
...
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
...
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
...
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
p.000008: that of children who are not used to the hospital environment. The Medical Research Act states that if the child is
...
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
p.000008: that of children who are not used to the hospital environment. The Medical Research Act states that if the child is
p.000008: able to understand the significance of the procedure to be performed, his/her personal consent is required to perform
p.000008: the research. According to the Medical Research Act, the guardian’s consent is needed in addition to the minor’s
p.000008: consent if the child is less than 15 years old or the research is not expected to produce any direct health benefits to
p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
...
p.000008: able to understand the significance of the procedure to be performed, his/her personal consent is required to perform
p.000008: the research. According to the Medical Research Act, the guardian’s consent is needed in addition to the minor’s
p.000008: consent if the child is less than 15 years old or the research is not expected to produce any direct health benefits to
p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
...
p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
...
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: patient is subjected to when he/she participates in the research in addition to regular treatment. When
p.000009: evaluating stress caused by the research, the number of additional visits, for example, and the stress caused by
p.000009: travelling and restrictions to normal life must be taken into consideration.
p.000009:
p.000009: Paediatric patients and health-care personnel
p.000009: Doctors, nurses, and other health-care personnel participate in scientific research projects ever more often. In
p.000009: clinical trials, the doctor often acts not only as the investigator but also as the child’s treating
p.000009: physician. Similarly, a nurse may be involved in the realisation of the trial as a research nurse and be responsible
p.000009: for the paediatric patient’s care. On the other hand, they may be responsible for the child’s treatment
p.000009: only, or be involved in tasks relating to research only.
p.000009: Scientific research must not interfere with the child’s regular care. Research that requires handling of the child,
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
...
p.000009: clinical trials, the doctor often acts not only as the investigator but also as the child’s treating
p.000009: physician. Similarly, a nurse may be involved in the realisation of the trial as a research nurse and be responsible
p.000009: for the paediatric patient’s care. On the other hand, they may be responsible for the child’s treatment
p.000009: only, or be involved in tasks relating to research only.
p.000009: Scientific research must not interfere with the child’s regular care. Research that requires handling of the child,
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
...
p.000009: physician. Similarly, a nurse may be involved in the realisation of the trial as a research nurse and be responsible
p.000009: for the paediatric patient’s care. On the other hand, they may be responsible for the child’s treatment
p.000009: only, or be involved in tasks relating to research only.
p.000009: Scientific research must not interfere with the child’s regular care. Research that requires handling of the child,
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
...
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
...
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
...
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
...
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
...
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
p.000009: acts as a link between the unit staff and the investigators. By participating in the collection of research samples,
p.000009: the research nurse thus frees the staff to treat the patients. Among other things, the research nurse coordinates the
p.000009: studies conducted on the unit, takes care of research documents, writes operating instructions, trains personnel and
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
...
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
p.000009: acts as a link between the unit staff and the investigators. By participating in the collection of research samples,
p.000009: the research nurse thus frees the staff to treat the patients. Among other things, the research nurse coordinates the
p.000009: studies conducted on the unit, takes care of research documents, writes operating instructions, trains personnel and
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
...
p.000009: assists in the collection and handling of samples. In research studies where the results of measurements may be
p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
p.000009: scientific research is time taken from other activities, and as resources become more
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: scarce, conflicts and ethically difficult choices emerge more and more often. The nurse and the doctor
p.000010: treating the child have to weigh the patient’s concrete treatment against the research, as well as to evaluate the
...
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
p.000009: scientific research is time taken from other activities, and as resources become more
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: scarce, conflicts and ethically difficult choices emerge more and more often. The nurse and the doctor
p.000010: treating the child have to weigh the patient’s concrete treatment against the research, as well as to evaluate the
p.000010: quality of their work and factors influencing it. Even when resources are limited, using them for scientific research
p.000010: is necessary in order to gain new knowledge which may improve treatment of patients.
p.000010: Cooperation with the investigator, other research staff and treatment staff is important. It is the
p.000010: investigator’s duty to inform the staff responsible for the child’s treatment about the ongoing research
p.000010: at its various stages regardless of whether the staff form part of the research group or not. Sometimes samples are
...
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: scarce, conflicts and ethically difficult choices emerge more and more often. The nurse and the doctor
p.000010: treating the child have to weigh the patient’s concrete treatment against the research, as well as to evaluate the
p.000010: quality of their work and factors influencing it. Even when resources are limited, using them for scientific research
p.000010: is necessary in order to gain new knowledge which may improve treatment of patients.
p.000010: Cooperation with the investigator, other research staff and treatment staff is important. It is the
p.000010: investigator’s duty to inform the staff responsible for the child’s treatment about the ongoing research
p.000010: at its various stages regardless of whether the staff form part of the research group or not. Sometimes samples are
p.000010: collected by someone not belonging to the department staff, in which case the child’s personal nurse guarantees
p.000010: the flexibility of the work and looks after the child’s best interests. Successful teamwork and good
p.000010: interaction skills are important also with regard to the development of research compliance. The success of
p.000010: research studies and their flexible conduct also benefit the patient.
p.000010: The genuine voluntariness of the consent is influenced by who gives the information concerning the research, who
p.000010: requests the consent, and how the consent is requested. Nurses often do not have enough information about
...
p.000010: is necessary in order to gain new knowledge which may improve treatment of patients.
p.000010: Cooperation with the investigator, other research staff and treatment staff is important. It is the
p.000010: investigator’s duty to inform the staff responsible for the child’s treatment about the ongoing research
p.000010: at its various stages regardless of whether the staff form part of the research group or not. Sometimes samples are
p.000010: collected by someone not belonging to the department staff, in which case the child’s personal nurse guarantees
p.000010: the flexibility of the work and looks after the child’s best interests. Successful teamwork and good
p.000010: interaction skills are important also with regard to the development of research compliance. The success of
p.000010: research studies and their flexible conduct also benefit the patient.
p.000010: The genuine voluntariness of the consent is influenced by who gives the information concerning the research, who
p.000010: requests the consent, and how the consent is requested. Nurses often do not have enough information about
p.000010: research-related details, and therefore, asking for the consent should not be left to the nurse. The treating physician
p.000010: or on-call physician giving the initial information may not necessarily have detailed information about the research
p.000010: unless he/she is part of the research group. The investigator has the most information about the research.
p.000010: However, it is important to discuss whether the interests of the investigator to recruit research subjects make it
p.000010: more difficult for him/her to give neutral information about the research. On the other hand, if the information is
p.000010: given and the consent requested by the child’s treating physician who is acting as the investigator, fear about the
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
...
p.000010: or on-call physician giving the initial information may not necessarily have detailed information about the research
p.000010: unless he/she is part of the research group. The investigator has the most information about the research.
p.000010: However, it is important to discuss whether the interests of the investigator to recruit research subjects make it
p.000010: more difficult for him/her to give neutral information about the research. On the other hand, if the information is
p.000010: given and the consent requested by the child’s treating physician who is acting as the investigator, fear about the
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
...
p.000010: consequences of refusal on the child’s treatment may influence the voluntariness of the consent in a more direct way.
p.000010:
p.000010: Research on children from the viewpoint of the parents
p.000010: It is always a shock to parents when their child falls seriously ill. The child’s illness, pain, and
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
...
p.000010: suffering are often harder for the parents to accept than a personal illness. When the child is
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
p.000010: ask questions. The parent information sheet and written consent must state the name of the research and
p.000010: the person conducting the research, contact information of the responsible investigator, and
p.000010: detailed information about the content, benefits, adverse effects, long-term effects, and any unknown risks of the
p.000010: research. The parents must know what they are agreeing to when signing the consent. Whenever possible,
p.000010: enough time should be reserved for giving the consent. The person requesting consent must not put pressure on the
p.000010: parents.
p.000010: When a written consent is given, the parents can always check what they have agreed to and what kind of a research
p.000010: study it is. It is also extremely important for the parents to know how the treatment their child
p.000010: receives during the research differs from the child’s regular treatment, and whether it is possible that
p.000010: their child is randomised into the control group or, if a medicine is being studied, into the placebo group, in which
p.000010: case the child may not receive a certain treatment. If new research-related adverse effects appear later, the
p.000010: parents must be informed. The parents must be
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: able to monitor whether the research is being carried out as described in the information sheet. If extending the
...
p.000010: research. The parents must know what they are agreeing to when signing the consent. Whenever possible,
p.000010: enough time should be reserved for giving the consent. The person requesting consent must not put pressure on the
p.000010: parents.
p.000010: When a written consent is given, the parents can always check what they have agreed to and what kind of a research
p.000010: study it is. It is also extremely important for the parents to know how the treatment their child
p.000010: receives during the research differs from the child’s regular treatment, and whether it is possible that
p.000010: their child is randomised into the control group or, if a medicine is being studied, into the placebo group, in which
p.000010: case the child may not receive a certain treatment. If new research-related adverse effects appear later, the
p.000010: parents must be informed. The parents must be
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: able to monitor whether the research is being carried out as described in the information sheet. If extending the
p.000011: research is necessary, a new consent must be requested from the parents.
p.000011: When requesting consent, a negative decision from the parents must be respected. The viewpoint of the parents may be
...
p.000010: parents.
p.000010: When a written consent is given, the parents can always check what they have agreed to and what kind of a research
p.000010: study it is. It is also extremely important for the parents to know how the treatment their child
p.000010: receives during the research differs from the child’s regular treatment, and whether it is possible that
p.000010: their child is randomised into the control group or, if a medicine is being studied, into the placebo group, in which
p.000010: case the child may not receive a certain treatment. If new research-related adverse effects appear later, the
p.000010: parents must be informed. The parents must be
p.000010:
p.000010:
p.000010:
p.000011: 11
p.000011:
p.000011: able to monitor whether the research is being carried out as described in the information sheet. If extending the
p.000011: research is necessary, a new consent must be requested from the parents.
p.000011: When requesting consent, a negative decision from the parents must be respected. The viewpoint of the parents may be
p.000011: different from the viewpoint of the investigator with regard to the child’s situation. The Medical
p.000011: Research Act and ethics committees require genuine voluntariness from participants in a research study, and the
p.000011: participating children and their parents must have been told that refusal to participate will not affect the child’s
p.000011: regular treatment. Despite this, the parents may give their consent to the child’s participation because they
...
p.000011: When requesting consent, a negative decision from the parents must be respected. The viewpoint of the parents may be
p.000011: different from the viewpoint of the investigator with regard to the child’s situation. The Medical
p.000011: Research Act and ethics committees require genuine voluntariness from participants in a research study, and the
p.000011: participating children and their parents must have been told that refusal to participate will not affect the child’s
p.000011: regular treatment. Despite this, the parents may give their consent to the child’s participation because they
p.000011: are afraid that refusal will affect the child’s treatment.
p.000011: The parents may consider the request to participate in a research study confusing, and it may also arouse contradictory
p.000011: feelings. Even though the medicine or treatment to be studied might benefit other children in the future, the
p.000011: parents may not necessarily want to add to their own child’s suffering. The parents are worried about the
...
p.000011: Research Act and ethics committees require genuine voluntariness from participants in a research study, and the
p.000011: participating children and their parents must have been told that refusal to participate will not affect the child’s
p.000011: regular treatment. Despite this, the parents may give their consent to the child’s participation because they
p.000011: are afraid that refusal will affect the child’s treatment.
p.000011: The parents may consider the request to participate in a research study confusing, and it may also arouse contradictory
p.000011: feelings. Even though the medicine or treatment to be studied might benefit other children in the future, the
p.000011: parents may not necessarily want to add to their own child’s suffering. The parents are worried about the
p.000011: pain and suffering their child experiences. The stress caused by pain or a procedure may cause additional injury, e.g.
p.000011: due to changes in blood pressure. Repeated pain may later lead to pain sensitivity or psychological effects. The
p.000011: parents are also often concerned about whether the chosen research arrangement is necessary or whether the answers to
p.000011: the questions could be found in another way. These matters should be discussed with the parents prior to the signing of
p.000011: the consent form, and again during the study if necessary. Discussion eases the stress associated with making a
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
...
p.000011: are afraid that refusal will affect the child’s treatment.
p.000011: The parents may consider the request to participate in a research study confusing, and it may also arouse contradictory
p.000011: feelings. Even though the medicine or treatment to be studied might benefit other children in the future, the
p.000011: parents may not necessarily want to add to their own child’s suffering. The parents are worried about the
p.000011: pain and suffering their child experiences. The stress caused by pain or a procedure may cause additional injury, e.g.
p.000011: due to changes in blood pressure. Repeated pain may later lead to pain sensitivity or psychological effects. The
p.000011: parents are also often concerned about whether the chosen research arrangement is necessary or whether the answers to
p.000011: the questions could be found in another way. These matters should be discussed with the parents prior to the signing of
p.000011: the consent form, and again during the study if necessary. Discussion eases the stress associated with making a
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
p.000011: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
...
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
...
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
...
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
p.000011: research. The dosage for many medicines is different in infants aged under one week. In premature infants, the dosage
...
p.000011: functions of the liver and the kidneys are inadequate, and the skin of a very small premature infant is
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
p.000012: The small blood volume of a neonate places restrictions on the collection of blood samples. If the blood sample
...
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
p.000012: The small blood volume of a neonate places restrictions on the collection of blood samples. If the blood sample
p.000012: collected in association with the trial can amount to no more than one per cent of the total blood volume of the
p.000012: research subject, the largest allowable blood sample from infants weighing 1000 g and 600 g would be approx.
p.000012: 0.9 ml and 0.5 ml, respectively. In the case of small premature infants, blood samples may be needed several times a
p.000012: day to check the child’s condition. For this reason, it is important to agree upon the largest acceptable total volume
p.000012: of blood samples when samples are collected repeatedly.
p.000012: Clinical and therapeutic research should also involve long-term follow-up of neonates participating in the research,
p.000012: since for example the potential adverse effects on growth and development may not be revealed until later,
p.000012: sometimes years after the study. For example, the adverse effects of dexamethasone (a cortisone
p.000012: preparation) treatment, used to mature an infant’s lungs in case of imminent premature birth and after
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
...
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
p.000012: be informed of the research as soon as possible, at which time they have the right to discontinue the
p.000012: child’s participation. To enable parents to make informed decisions in such situations, possibilities should be
p.000012: discussed concerning the distribution of information to maternity clinics and hospital staff about emergency research
p.000012: in neonates. If there is a risk of prematurity, the parents could be informed of a possible research already before
p.000012: delivery. In specialised health-care units treating neonates, information about emergency research could be made
p.000012: available to parents who may need it. In this way, the parents could better prepare themselves for the request for
...
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
p.000012: treatment given to the neonate is important also after the consent has been given.
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Preschool age
p.000013: The organs of a preschool-aged child develop quickly. During this period, the body weight doubles and considerable
p.000013: energy is spent on the development of bones, muscles and nerves. The blood volume of the child no
p.000013: longer sets such strict restrictions to research as it does in the neonatal period, and performing the
p.000013: procedures is technically easier. In many ways, the metabolism of medicines in preschool children is similar
p.000013: to that in older children and thus allows for more adult- type research. On the other hand, the effects of medicines on
p.000013: growth, bones, and metabolism must be taken into consideration in treatment and research alike. Long-term effects may
p.000013: be caused, for example, by steroids (possible growth retardation) and tetracyclines (discoloration of
p.000013: developing teeth).
...
p.000013: procedures is technically easier. In many ways, the metabolism of medicines in preschool children is similar
p.000013: to that in older children and thus allows for more adult- type research. On the other hand, the effects of medicines on
p.000013: growth, bones, and metabolism must be taken into consideration in treatment and research alike. Long-term effects may
p.000013: be caused, for example, by steroids (possible growth retardation) and tetracyclines (discoloration of
p.000013: developing teeth).
p.000013: The understanding of a baby or a preschool child regarding the procedures to be performed on him/her
p.000013: increases as the child grows. The child reacts strongly to pain and is often afraid of procedures that
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
...
p.000013: growth, bones, and metabolism must be taken into consideration in treatment and research alike. Long-term effects may
p.000013: be caused, for example, by steroids (possible growth retardation) and tetracyclines (discoloration of
p.000013: developing teeth).
p.000013: The understanding of a baby or a preschool child regarding the procedures to be performed on him/her
p.000013: increases as the child grows. The child reacts strongly to pain and is often afraid of procedures that
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
...
p.000013: The understanding of a baby or a preschool child regarding the procedures to be performed on him/her
p.000013: increases as the child grows. The child reacts strongly to pain and is often afraid of procedures that
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
...
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
...
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
...
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
...
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
...
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
...
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
...
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
...
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
...
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
...
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
p.000013: As a rule, the simpler the procedure, the younger the child who is able to understand the content and the
p.000013: effects of the procedure. The same applies to procedures the child is already familiar with.
p.000013:
p.000013:
p.000014: 14
p.000014:
...
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
p.000013: As a rule, the simpler the procedure, the younger the child who is able to understand the content and the
p.000013: effects of the procedure. The same applies to procedures the child is already familiar with.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: After learning to read, the child also learns to understand information given in written form. Therefore,
p.000014: at this time he/she should also have a separate information sheet, since the information sheet for adults contains
p.000014: not only complicated descriptions of procedures and phrases of foreign derivation but also less meaningful
...
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
p.000013: As a rule, the simpler the procedure, the younger the child who is able to understand the content and the
p.000013: effects of the procedure. The same applies to procedures the child is already familiar with.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: After learning to read, the child also learns to understand information given in written form. Therefore,
p.000014: at this time he/she should also have a separate information sheet, since the information sheet for adults contains
p.000014: not only complicated descriptions of procedures and phrases of foreign derivation but also less meaningful
p.000014: issues from the child’s point of view, such as information about registers and the coding, storing and transfer
p.000014: of data. Information sheets for young school-aged children do not need to fulfil every requirement set by laws
...
p.000013: effects of the procedure. The same applies to procedures the child is already familiar with.
p.000013:
p.000013:
p.000014: 14
p.000014:
p.000014: After learning to read, the child also learns to understand information given in written form. Therefore,
p.000014: at this time he/she should also have a separate information sheet, since the information sheet for adults contains
p.000014: not only complicated descriptions of procedures and phrases of foreign derivation but also less meaningful
p.000014: issues from the child’s point of view, such as information about registers and the coding, storing and transfer
p.000014: of data. Information sheets for young school-aged children do not need to fulfil every requirement set by laws
p.000014: and ethical codes about what research subjects should know about the research. A child less than 15 years old also
p.000014: cannot give his/her consent independently, since the consent of at least one guardian is needed in addition to the
p.000014: child’s consent. This is why the guardians should have a separate information sheet, on the basis of which they give
p.000014: their consent.
...
p.000014: of data. Information sheets for young school-aged children do not need to fulfil every requirement set by laws
p.000014: and ethical codes about what research subjects should know about the research. A child less than 15 years old also
p.000014: cannot give his/her consent independently, since the consent of at least one guardian is needed in addition to the
p.000014: child’s consent. This is why the guardians should have a separate information sheet, on the basis of which they give
p.000014: their consent.
p.000014: The significance of a child’s expression of his/her wishes becomes greater when the child is better able to understand
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
...
p.000014: cannot give his/her consent independently, since the consent of at least one guardian is needed in addition to the
p.000014: child’s consent. This is why the guardians should have a separate information sheet, on the basis of which they give
p.000014: their consent.
p.000014: The significance of a child’s expression of his/her wishes becomes greater when the child is better able to understand
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
...
p.000014: The significance of a child’s expression of his/her wishes becomes greater when the child is better able to understand
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
p.000014: wants to make decisions about his/her own life to a greater extent. Therefore, adolescents should be given the
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
...
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
p.000014: treatment, research is considered to be different. Although an adolescent from 15 to 18 years of age understands many
p.000014: issues that
p.000014:
p.000015: 15
p.000015:
p.000015: concern him/her, he/she can still be influenced by the opinions of his/her friends, for example. If complications
p.000015: occur in research studies on contraception, for example, the child may be left too much alone with feelings
p.000015: of responsibility and guilt.
p.000015:
p.000015: RECOMMENDATIONS OF THE WORKING GROUP
p.000015: 1. As a rule, the child should not participate in more than one invasive scientific research study at a time. The
p.000015: participation of a child in a clinical research study is always an exception from the main rule set down in
p.000015: law, according to which research should not be performed on children if the same results can be achieved with adult
p.000015: research subjects. Since research data from research performed on children are needed, however, it should
p.000015: be ascertained that the exceptional provisions are not interpreted in such a way that the well- being of individual
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p.000014: issues that
p.000014:
p.000015: 15
p.000015:
p.000015: concern him/her, he/she can still be influenced by the opinions of his/her friends, for example. If complications
p.000015: occur in research studies on contraception, for example, the child may be left too much alone with feelings
p.000015: of responsibility and guilt.
p.000015:
p.000015: RECOMMENDATIONS OF THE WORKING GROUP
p.000015: 1. As a rule, the child should not participate in more than one invasive scientific research study at a time. The
p.000015: participation of a child in a clinical research study is always an exception from the main rule set down in
p.000015: law, according to which research should not be performed on children if the same results can be achieved with adult
p.000015: research subjects. Since research data from research performed on children are needed, however, it should
p.000015: be ascertained that the exceptional provisions are not interpreted in such a way that the well- being of individual
p.000015: children is endangered. For this reason, it is the opinion of the working group that, as a rule, a child should not
p.000015: participate in more than one invasive research study at a time. Questionnaire studies have not been taken into
p.000015: account in this case. When requesting consent to participate in a research study, it should always be ascertained
p.000015: that the child is not participating in other research programs at the same time. Since the scope of
p.000015: research studies and the complexity of procedures vary, exceptions to the main rule should be made possible with
p.000015: appropriate grounds. It should also be considered in research units whether different trials and consent procedures
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p.000015: be ascertained that the exceptional provisions are not interpreted in such a way that the well- being of individual
p.000015: children is endangered. For this reason, it is the opinion of the working group that, as a rule, a child should not
p.000015: participate in more than one invasive research study at a time. Questionnaire studies have not been taken into
p.000015: account in this case. When requesting consent to participate in a research study, it should always be ascertained
p.000015: that the child is not participating in other research programs at the same time. Since the scope of
p.000015: research studies and the complexity of procedures vary, exceptions to the main rule should be made possible with
p.000015: appropriate grounds. It should also be considered in research units whether different trials and consent procedures
p.000015: can be adapted to each other and combined. The doctor responsible for the unit (and, during on-call hours, the on-call
p.000015: backup person) bears the responsibility for the compatibility of research as well as other treatment given to the
p.000015: children. In outpatient treatment and prevention studies, the child’s personal doctor can evaluate the strain
p.000015: centering on the child and the parents. The doctor in charge of the research is responsible for the
p.000015: well-being of research subjects during the research, as stipulated by the Research Act.
p.000015:
p.000015: 2. The working group proposes that, in the future, more thought should be given to who should provide the necessary
p.000015: information about the research and request the consent needed for the research from the child and the child’s
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p.000015: appropriate grounds. It should also be considered in research units whether different trials and consent procedures
p.000015: can be adapted to each other and combined. The doctor responsible for the unit (and, during on-call hours, the on-call
p.000015: backup person) bears the responsibility for the compatibility of research as well as other treatment given to the
p.000015: children. In outpatient treatment and prevention studies, the child’s personal doctor can evaluate the strain
p.000015: centering on the child and the parents. The doctor in charge of the research is responsible for the
p.000015: well-being of research subjects during the research, as stipulated by the Research Act.
p.000015:
p.000015: 2. The working group proposes that, in the future, more thought should be given to who should provide the necessary
p.000015: information about the research and request the consent needed for the research from the child and the child’s
p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
...
p.000015: centering on the child and the parents. The doctor in charge of the research is responsible for the
p.000015: well-being of research subjects during the research, as stipulated by the Research Act.
p.000015:
p.000015: 2. The working group proposes that, in the future, more thought should be given to who should provide the necessary
p.000015: information about the research and request the consent needed for the research from the child and the child’s
p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
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p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
p.000015: would be if the investigator and the doctor who is treating the child could give the information about the research
p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
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p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
p.000015: would be if the investigator and the doctor who is treating the child could give the information about the research
p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
p.000015: is important that the research subject or his/her guardian has the opportunity to request additional information
p.000015: about the research from the investigator. Varied and neutral information about the research must be available, on the
p.000015: basis of which a decision about participating or refusing to participate can be reached. It is also important to give
p.000015: the parents enough time to consider their decision, whenever possible.
p.000015:
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p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
p.000015: is important that the research subject or his/her guardian has the opportunity to request additional information
p.000015: about the research from the investigator. Varied and neutral information about the research must be available, on the
p.000015: basis of which a decision about participating or refusing to participate can be reached. It is also important to give
p.000015: the parents enough time to consider their decision, whenever possible.
p.000015:
p.000015: 3. When evaluating the child or adolescent’s level of development, and the consent associated with this,
p.000015: as well as when carrying out the research, the investigators must have sufficient expertise concerning the growth and
p.000015: development of children. In order
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: to ensure a sufficient level of expertise, the working group proposes that special courses in research conducted on
p.000016: children be organised at the Faculties of Medicine. The course could be taken at the stage of specialisation, in
p.000016: association with a doctoral dissertation, or as supplementary education. Ethics committees should have
p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
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p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
p.000016: applied in association with research if the risk of injury or stress to the child is equally small.
p.000016:
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p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
p.000016: applied in association with research if the risk of injury or stress to the child is equally small.
p.000016:
p.000016: 5. The right of self-determination of minors should be expanded. To ensure that the right of self-determination is
p.000016: realised, it is recommended that a brief summary of the purpose, nature, benefits, risks and adverse effects
p.000016: of the research be made for children who are able to read. If such a summary is not considered necessary, the
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p.000016: reasons must be given to the ethics committee. Information about the research can also be given to children who
p.000016: cannot read in the form of fairytales, games and stories. At the pre-planning stage of the research, it is also
p.000016: important to emphasise the significance of oral information and ways to ensure that research-related information is
p.000016: understandable to children of different ages. The resistance of a child younger than school age must also be respected
p.000016: even if the reaction is based on fear, for example, and is not in accordance with rational behaviour models. If a minor
p.000016: is able to understand the purpose of the research, his/her consent is required before the research can be realised.
p.000016: When implementing the Clinical Trials Directive, the possibility accorded by Finnish law to adolescents over 15
p.000016: years of age to give an independent consent should, at the very least, be maintained, if possible.
p.000016:
p.000016: 6. Any additional research-related risk of injury or stress should be proportional to the child’s individual
p.000016: situation and the health benefits the research is expected to have, rather than to a strict classification
p.000016: of procedures. The Medical Research Act requires that a minor can only be subjected to minimal research-related risk
p.000016: of injury or stress. Such procedures include, for example, collection of a small blood or stool sample,
p.000016: painless imaging that does not involve any additional risks, etc. On the other hand, the risk and injury associated
p.000016: with the collection of blood samples may be considerable, for example, in small premature infants. The child’s
...
p.000016: situation and the health benefits the research is expected to have, rather than to a strict classification
p.000016: of procedures. The Medical Research Act requires that a minor can only be subjected to minimal research-related risk
p.000016: of injury or stress. Such procedures include, for example, collection of a small blood or stool sample,
p.000016: painless imaging that does not involve any additional risks, etc. On the other hand, the risk and injury associated
p.000016: with the collection of blood samples may be considerable, for example, in small premature infants. The child’s
p.000016: suffering must always be minimised. Pain associated with procedures can often be effectively alleviated
p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: LITERATURE
p.000017:
p.000017: Finnish legislation:
p.000017: Medical Research Act (488/1999)
p.000017: Act on the Status and Rights of Patients (785/1992)
p.000017: Act on the Medical Use of Human Organs and Tissues (101/2001) Child Custody and Right of Access Act (361/1983)
p.000017: Child Welfare Act (683/1983)
p.000017: The Constitution of Finland (731/1999) International agreements:
p.000017: United Nations Convention on the Rights of the Child (20th November, 1989)
p.000017: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000017: and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
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p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: LITERATURE
p.000017:
p.000017: Finnish legislation:
p.000017: Medical Research Act (488/1999)
p.000017: Act on the Status and Rights of Patients (785/1992)
p.000017: Act on the Medical Use of Human Organs and Tissues (101/2001) Child Custody and Right of Access Act (361/1983)
p.000017: Child Welfare Act (683/1983)
p.000017: The Constitution of Finland (731/1999) International agreements:
p.000017: United Nations Convention on the Rights of the Child (20th November, 1989)
p.000017: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000017: and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
p.000017: Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and
p.000017: administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.000017: of clinical trials on medicinal products for human use. Official Journal of the European Communities 1
p.000017: May 2001 L121/34-44.
p.000017: Baud O, Foix-Helias L, Kaminski M et al: Antenatal glucocorticoid treatment and cystic periventricular leucomalacia in
p.000017: very premature infants. N Engl J Med 1999 Oct 14;341(16):1190-6
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p.000003: decision-making can, however, be improved by various means. The child’s perspectives and priorities may be different
p.000003: from those of his/her parents or guardian. In some situations, the family may receive considerable financial
p.000003: benefit from participation in research. The benefits may include, for example, free medicines or visits
p.000003: to the outpatient department even though paying actual fees for participation is prohibited by the Medical Research
p.000003: Act. The child, however, may see things differently. The child may be afraid of visiting the doctor or the hospital
p.000003: and of pain associated with the procedures. It is important that the investigator planning the research
p.000003: study, the person receiving the consent, and other staff participating in the research program think beforehand about
p.000003: how the voluntariness of the child’s consent to participate in the research study can be ensured. Ensuring the
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p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
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p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
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p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
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p.000007: research directed at the child.
p.000007: According to the above act, the child’s guardians generally make decisions concerning the child together (§
p.000007: 5) if there are more than one guardian. An exception to this can be made on the basis of travelling, illness, or
p.000007: another reason, if delay in reaching the decision may cause harm to the child. If the matter is of considerable
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
p.000007: interests and well-being into account in matters concerning the child’s care.
p.000007: But how is one to act if the parents cannot be reached, for example in a case of an accident, or if they are unable to
p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
p.000007: because of the urgency of the matter and the patient’s state of health, and if the procedure is expected to be
p.000007: of immediate benefit to the patient’s health (§ 6 paragraph 1). This regulation can probably be applied to
p.000007: minors whose guardians cannot be reached in time, or if the guardian has, for example, been injured in the same
p.000007: traffic accident as the child. In these cases the guardians must be informed of the research as soon as possible, and
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p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
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p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
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p.000009: evaluating stress caused by the research, the number of additional visits, for example, and the stress caused by
p.000009: travelling and restrictions to normal life must be taken into consideration.
p.000009:
p.000009: Paediatric patients and health-care personnel
p.000009: Doctors, nurses, and other health-care personnel participate in scientific research projects ever more often. In
p.000009: clinical trials, the doctor often acts not only as the investigator but also as the child’s treating
p.000009: physician. Similarly, a nurse may be involved in the realisation of the trial as a research nurse and be responsible
p.000009: for the paediatric patient’s care. On the other hand, they may be responsible for the child’s treatment
p.000009: only, or be involved in tasks relating to research only.
p.000009: Scientific research must not interfere with the child’s regular care. Research that requires handling of the child,
p.000009: collection of samples etc. should be accommodated with the child’s other care. When performing the research, the
p.000009: child’s needs and resources should be taken into account whenever possible. Among other things,
p.000009: painlessness and uninterrupted, sufficient periods of rest between procedures should be guaranteed to the child.
p.000009: Examinations must not cause unreasonable stress or additional suffering to the child or anxiety and uncertainty to the
p.000009: parents.
p.000009: The basic task of the treatment staff is to take care of the comprehensive care of the ill child and his/her family.
p.000009: The doctor treating the child is responsible for the realisation of medical treatment. The nurse responsible for the
p.000009: child’s care at a given time acts as the interpreter or advocate for the child and his/her family. Parents’ resources
p.000009: are limited, and worry about the child’s situation may impair their ability to receive information concerning
p.000009: research, the purpose of the research, their participation in it, and the informed consent. The nurse works in
p.000009: cooperation with other personnel treating the child, giving support to the parents without trying to influence their
p.000009: decisions.
p.000009: To the parents, the nurse often represents a more neutral party with regard to the research; a person with whom they
p.000009: can discuss research-related fears and uncertainties without having to consider the effect of their opinions on the
p.000009: medical treatment their child receives. In addition, the nurse often has a different relationship to the child and
p.000009: his/her parents than the treating doctor or the investigator, who often has no part in the clinical treatment of the
p.000009: child.
p.000009: There may be one or more research nurses in units with several ongoing scientific research projects. The research nurse
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p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
p.000009: scientific research is time taken from other activities, and as resources become more
p.000009:
p.000009:
p.000010: 10
p.000010:
p.000010: scarce, conflicts and ethically difficult choices emerge more and more often. The nurse and the doctor
p.000010: treating the child have to weigh the patient’s concrete treatment against the research, as well as to evaluate the
p.000010: quality of their work and factors influencing it. Even when resources are limited, using them for scientific research
p.000010: is necessary in order to gain new knowledge which may improve treatment of patients.
p.000010: Cooperation with the investigator, other research staff and treatment staff is important. It is the
p.000010: investigator’s duty to inform the staff responsible for the child’s treatment about the ongoing research
p.000010: at its various stages regardless of whether the staff form part of the research group or not. Sometimes samples are
p.000010: collected by someone not belonging to the department staff, in which case the child’s personal nurse guarantees
p.000010: the flexibility of the work and looks after the child’s best interests. Successful teamwork and good
p.000010: interaction skills are important also with regard to the development of research compliance. The success of
p.000010: research studies and their flexible conduct also benefit the patient.
p.000010: The genuine voluntariness of the consent is influenced by who gives the information concerning the research, who
p.000010: requests the consent, and how the consent is requested. Nurses often do not have enough information about
p.000010: research-related details, and therefore, asking for the consent should not be left to the nurse. The treating physician
p.000010: or on-call physician giving the initial information may not necessarily have detailed information about the research
p.000010: unless he/she is part of the research group. The investigator has the most information about the research.
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p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
p.000010: ask questions. The parent information sheet and written consent must state the name of the research and
p.000010: the person conducting the research, contact information of the responsible investigator, and
p.000010: detailed information about the content, benefits, adverse effects, long-term effects, and any unknown risks of the
p.000010: research. The parents must know what they are agreeing to when signing the consent. Whenever possible,
p.000010: enough time should be reserved for giving the consent. The person requesting consent must not put pressure on the
p.000010: parents.
p.000010: When a written consent is given, the parents can always check what they have agreed to and what kind of a research
p.000010: study it is. It is also extremely important for the parents to know how the treatment their child
p.000010: receives during the research differs from the child’s regular treatment, and whether it is possible that
p.000010: their child is randomised into the control group or, if a medicine is being studied, into the placebo group, in which
p.000010: case the child may not receive a certain treatment. If new research-related adverse effects appear later, the
p.000010: parents must be informed. The parents must be
p.000010:
p.000010:
p.000010:
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p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
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p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
p.000012: The small blood volume of a neonate places restrictions on the collection of blood samples. If the blood sample
p.000012: collected in association with the trial can amount to no more than one per cent of the total blood volume of the
p.000012: research subject, the largest allowable blood sample from infants weighing 1000 g and 600 g would be approx.
p.000012: 0.9 ml and 0.5 ml, respectively. In the case of small premature infants, blood samples may be needed several times a
p.000012: day to check the child’s condition. For this reason, it is important to agree upon the largest acceptable total volume
p.000012: of blood samples when samples are collected repeatedly.
p.000012: Clinical and therapeutic research should also involve long-term follow-up of neonates participating in the research,
p.000012: since for example the potential adverse effects on growth and development may not be revealed until later,
p.000012: sometimes years after the study. For example, the adverse effects of dexamethasone (a cortisone
p.000012: preparation) treatment, used to mature an infant’s lungs in case of imminent premature birth and after
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
p.000012: be informed of the research as soon as possible, at which time they have the right to discontinue the
p.000012: child’s participation. To enable parents to make informed decisions in such situations, possibilities should be
p.000012: discussed concerning the distribution of information to maternity clinics and hospital staff about emergency research
p.000012: in neonates. If there is a risk of prematurity, the parents could be informed of a possible research already before
p.000012: delivery. In specialised health-care units treating neonates, information about emergency research could be made
p.000012: available to parents who may need it. In this way, the parents could better prepare themselves for the request for
p.000012: their consent and also take care of any consent-related authorisations beforehand.
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
...
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
p.000013: concerning the child’s participation in a research study is made together with the guardians, who are often the best
p.000013: people to interpret the child’s feelings and understand the child’s reactions, whether based on understanding
p.000013: or fear. A preschool child who resists a procedure should not be forced to participate in a research study even if
p.000013: the refusal is based on an emotional reaction. The child’s fears can be eased in many ways, for example by pictures,
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
p.000013: As a rule, the simpler the procedure, the younger the child who is able to understand the content and the
...
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
p.000014: wants to make decisions about his/her own life to a greater extent. Therefore, adolescents should be given the
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
...
p.000014: guardians are not informed of the treatments if he/she forbids it, for example in matters concerning
p.000014: contraception or abortion (Act on the Status and Rights of Patients (785/1992)). On the other hand, if a minor is
p.000014: asked to participate in a clinical trial evaluating the effects of oral contraceptives on a developing
p.000014: hormonal system, the guardians of the minor must always be informed of the research. This may,
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
p.000014: treatment, research is considered to be different. Although an adolescent from 15 to 18 years of age understands many
p.000014: issues that
p.000014:
p.000015: 15
p.000015:
...
...
p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
p.000015: would be if the investigator and the doctor who is treating the child could give the information about the research
p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
...
...
/span> of one guardian is sufficient if the child is to be subjected to a minor<
...
...
p.000016: situation and the health benefits the research is expected to have, rather than to a strict classification
p.000016: of procedures. The Medical Research Act requires that a minor can only be subjected to minimal research-related risk
p.000016: of injury or stress. Such procedures include, for example, collection of a small blood or stool sample,
p.000016: painless imaging that does not involve any additional risks, etc. On the other hand, the risk and injury associated
p.000016: with the collection of blood samples may be considerable, for example, in small premature infants. The child’s
p.000016: suffering must always be minimised. Pain associated with procedures can often be effectively alleviated
p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: LITERATURE
p.000017:
p.000017: Finnish legislation:
p.000017: Medical Research Act (488/1999)
p.000017: Act on the Status and Rights of Patients (785/1992)
p.000017: Act on the Medical Use of Human Organs and Tissues (101/2001) Child Custody and Right of Access Act (361/1983)
p.000017: Child Welfare Act (683/1983)
p.000017: The Constitution of Finland (731/1999) International agreements:
p.000017: United Nations Convention on the Rights of the Child (20th November, 1989)
p.000017: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000017: and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
p.000017: Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and
p.000017: administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.000017: of clinical trials on medicinal products for human use. Official Journal of the European Communities 1
p.000017: May 2001 L121/34-44.
p.000017: Baud O, Foix-Helias L, Kaminski M et al: Antenatal glucocorticoid treatment and cystic periventricular leucomalacia in
p.000017: very premature infants. N Engl J Med 1999 Oct 14;341(16):1190-6
p.000017: Halliday HL, Ehrenkranz RA, Doyle LW: Early postnatal (<96 hours) corticosteroids for preventing chronic
p.000017: lung disease in preterm infants. Cochrane Database Syst Rev 2003;(1):CD001146. Review.
...
Social / Educational
Searching for indicator education:
(return to top)
p.000015: as well as when carrying out the research, the investigators must have sufficient expertise concerning the growth and
p.000015: development of children. In order
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: to ensure a sufficient level of expertise, the working group proposes that special courses in research conducted on
p.000016: children be organised at the Faculties of Medicine. The course could be taken at the stage of specialisation, in
p.000016: association with a doctoral dissertation, or as supplementary education. Ethics committees should have
p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
...
Social / Fetus/Neonate
Searching for indicator capacity:
(return to top)
p.000011: the questions could be found in another way. These matters should be discussed with the parents prior to the signing of
p.000011: the consent form, and again during the study if necessary. Discussion eases the stress associated with making a
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
p.000011: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
...
Social / Gender
Searching for indicator aids:
(return to top)
p.000006: authorisation for use by children. According to various research studies, 20–90 % of the medicines used
p.000006: for children in Europe are not authorised for use by children, or the dosage deviates from the approved
p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
...
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
...
Social / Homeless Persons
Searching for indicator homeless:
(return to top)
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000003: 3
p.000003:
p.000003: BACKGROUND ON RESEARCH CONDUCTED ON CHILDREN
p.000003:
p.000003: The development of medicine and biology has greatly benefited humankind, particularly during the last century. Life
p.000003: expectancy has improved, many previously fatal diseases have either been eradicated or medicines, vaccines
p.000003: and other preventive procedures have been developed against them. However, even during this time, research
p.000003: contained features that could never be accepted today. At the beginning of the 20th century it was still felt
p.000003: that, if animal studies could not be used for studying a problem, homeless children could be used as research subjects
p.000003: in clinical research; adults were used only as the last resort. Pharmacotherapeutic disasters of the 1950s
p.000003: and 1960s affecting particularly children (e.g. the thalidomide cases and hepatitis vaccine research in the USA) led
p.000003: to the development of the current international treaties and legislation concerning medicines. This history
p.000003: continues to contribute to the fact that people still feel a certain reserve about studying pharmaceuticals in
p.000003: children.
p.000003: Childhood and adolescence are periods of vigorous growth and development. Children are not small adults, and this very
...
Searching for indicator neonate:
(return to top)
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
p.000011: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
...
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
p.000011: research. The dosage for many medicines is different in infants aged under one week. In premature infants, the dosage
p.000011: of many medicines is different from the dosage for full-term children. The smaller the patient, the greater is the
p.000011: proportion of water and extracellular space in total body volume. The same applies to skin surface area in proportion
p.000011: to body weight (about six-fold in an infant weighing less than 1000 g in comparison with adults). The
p.000011: functions of the liver and the kidneys are inadequate, and the skin of a very small premature infant is
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
...
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
p.000012: The medicines the mother used during pregnancy, and any problems during pregnancy may have long-term effects on the
p.000012: health of the baby. Via the mother, a neonate may have been involved in a randomised clinical trial as early as
p.000012: in the foetal period. In such a situation, the child generally cannot be enrolled into another randomised
p.000012: clinical trial during the neonatal period.
p.000012: The small blood volume of a neonate places restrictions on the collection of blood samples. If the blood sample
p.000012: collected in association with the trial can amount to no more than one per cent of the total blood volume of the
p.000012: research subject, the largest allowable blood sample from infants weighing 1000 g and 600 g would be approx.
p.000012: 0.9 ml and 0.5 ml, respectively. In the case of small premature infants, blood samples may be needed several times a
p.000012: day to check the child’s condition. For this reason, it is important to agree upon the largest acceptable total volume
p.000012: of blood samples when samples are collected repeatedly.
p.000012: Clinical and therapeutic research should also involve long-term follow-up of neonates participating in the research,
p.000012: since for example the potential adverse effects on growth and development may not be revealed until later,
...
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
p.000012: be informed of the research as soon as possible, at which time they have the right to discontinue the
p.000012: child’s participation. To enable parents to make informed decisions in such situations, possibilities should be
p.000012: discussed concerning the distribution of information to maternity clinics and hospital staff about emergency research
...
p.000012: their consent and also take care of any consent-related authorisations beforehand.
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
p.000012: treatment given to the neonate is important also after the consent has been given.
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Preschool age
p.000013: The organs of a preschool-aged child develop quickly. During this period, the body weight doubles and considerable
p.000013: energy is spent on the development of bones, muscles and nerves. The blood volume of the child no
p.000013: longer sets such strict restrictions to research as it does in the neonatal period, and performing the
p.000013: procedures is technically easier. In many ways, the metabolism of medicines in preschool children is similar
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000006: to minimise the number of children enrolled in research while making certain that the research yields, however,
p.000006: sufficient data on the efficacy and safety of the medicine.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Medical research conducted on children and legislation
p.000007: In legislation, children, as well as handicapped adults, are considered a special group in need of
p.000007: protection, and performing medical research on such groups is restricted. The reason for this is the limited ability
p.000007: of children to give an independent informed consent to research procedures. If participation in the
p.000007: research is considered possible, the consent of the parents or guardian and minimisation of
p.000007: research-related risks are, as a general rule, required. Furthermore, children can only be enrolled as
p.000007: research subjects if it is not possible to achieve the same results with adult subjects. The research must
...
p.000008: the research. According to the Medical Research Act, the guardian’s consent is needed in addition to the minor’s
p.000008: consent if the child is less than 15 years old or the research is not expected to produce any direct health benefits to
p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
...
Social / Infant
Searching for indicator infant:
(return to top)
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
...
p.000008: is the definition of minor risk. Can minor risk be determined with strict classification of procedures, or
p.000008: should it be relative to the situation of the individual patient or to the benefit expected from the research?
p.000008: Collecting five millilitres of blood may be a minor procedure to an adolescent, but it is life-threatening to a
p.000008: premature infant weighing 500 grams. Children also have individual differences. Children who are used to the
p.000008: hospital environment and who know what the procedure entails, may suffer less from minor procedures than
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
p.000008: cause a great deal of fear towards painful procedures. The concept of minor risk is relative also in
...
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
p.000011: research. The dosage for many medicines is different in infants aged under one week. In premature infants, the dosage
p.000011: of many medicines is different from the dosage for full-term children. The smaller the patient, the greater is the
p.000011: proportion of water and extracellular space in total body volume. The same applies to skin surface area in proportion
p.000011: to body weight (about six-fold in an infant weighing less than 1000 g in comparison with adults). The
p.000011: functions of the liver and the kidneys are inadequate, and the skin of a very small premature infant is
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
...
p.000012: 0.9 ml and 0.5 ml, respectively. In the case of small premature infants, blood samples may be needed several times a
p.000012: day to check the child’s condition. For this reason, it is important to agree upon the largest acceptable total volume
p.000012: of blood samples when samples are collected repeatedly.
p.000012: Clinical and therapeutic research should also involve long-term follow-up of neonates participating in the research,
p.000012: since for example the potential adverse effects on growth and development may not be revealed until later,
p.000012: sometimes years after the study. For example, the adverse effects of dexamethasone (a cortisone
p.000012: preparation) treatment, used to mature an infant’s lungs in case of imminent premature birth and after
p.000012: premature birth, were observed only after the medicine had been widely used for several years. It was
p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
...
Social / LGBTQ+ Status
Searching for indicator physically:
(return to top)
p.000003: and 1960s affecting particularly children (e.g. the thalidomide cases and hepatitis vaccine research in the USA) led
p.000003: to the development of the current international treaties and legislation concerning medicines. This history
p.000003: continues to contribute to the fact that people still feel a certain reserve about studying pharmaceuticals in
p.000003: children.
p.000003: Childhood and adolescence are periods of vigorous growth and development. Children are not small adults, and this very
p.000003: growth and development make them mentally and physically different from adults. Scientific research must be conducted
p.000003: on children and adolescents that they could benefit from research-based development of medicine and biology like
p.000003: adults. Such research is the only way to find the best means to monitor and support the normal growth and
p.000003: development of children, as well as diagnose and treat any disturbances in them. Some diseases occur in
p.000003: children and adolescents but not in adults. Prevention, diagnosis and treatment of these diseases cannot
...
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
p.000013: yet developed enough to understand the significance of the research on a rational level, but should the child’s fear be
p.000013: accorded the same significance as an adult’s informed refusal? The final responsibility for evaluating the child’s
p.000013: ability to understand lies with the doctor evaluating the child’s level of development, but in reality, the decision
...
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
p.000014: wants to make decisions about his/her own life to a greater extent. Therefore, adolescents should be given the
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
p.000014: legislation, an adolescent can make an independent decision about participating in a research study only at
p.000014: the age of 15 years, and then only in situations when he/she is expected to have direct benefit from the research,
p.000014: many younger adolescents are able to understand the course and significance of the research. The opinions of
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000010: chronically ill, the parents often experience all crisis-associated emotions, since they must adapt to a new situation,
p.000010: often without a warning.
p.000010: Parents can make good decisions if they have received enough comprehensible information. Parents make a decision
p.000010: concerning the child’s participation in a research study mainly on the basis of the information given by the person
p.000010: requesting the consent. Information sheets and other material must be given to the participants and/or their parents in
p.000010: a language they understand well. Medical terms should be avoided, and there should be enough opportunities to
p.000010: ask questions. The parent information sheet and written consent must state the name of the research and
p.000010: the person conducting the research, contact information of the responsible investigator, and
p.000010: detailed information about the content, benefits, adverse effects, long-term effects, and any unknown risks of the
p.000010: research. The parents must know what they are agreeing to when signing the consent. Whenever possible,
p.000010: enough time should be reserved for giving the consent. The person requesting consent must not put pressure on the
...
Social / Marital Status
Searching for indicator married:
(return to top)
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
p.000007: a child’s guardians to be his/her parents, or persons to whom custody of the child has been entrusted (§ 3).
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
...
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
p.000007: could be given to the child’s parents preferably before the child’s birth, and how the mother could authorise
...
Searching for indicator single:
(return to top)
p.000005: participating in research, however, the child’s level of development and ability to cooperate and understand
p.000005: must be taken into account. For example, in tasks that require cooperation from the research subject, such as
p.000005: respiratory research studies on asthma, the child’s ability to act according to directions must be taken into account.
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.000006: guidelines. If the medicine represents major progress in the treatment of a certain illness, it should
p.000006: be made available for children with this illness as soon as possible. Today’s examples include AIDS medicines
p.000006: which have not been tested with children but which are the only possible medicines for those children who have received
p.000006: the HIV infection from their mothers.
p.000006: Also when treating a critically ill child, a situation may come about in which using a potent medicine
p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
...
Social / Philosophical Differences/Difference of Opinion
Searching for indicator opinion:
(return to top)
p.000015: participation of a child in a clinical research study is always an exception from the main rule set down in
p.000015: law, according to which research should not be performed on children if the same results can be achieved with adult
p.000015: research subjects. Since research data from research performed on children are needed, however, it should
p.000015: be ascertained that the exceptional provisions are not interpreted in such a way that the well- being of individual
p.000015: children is endangered. For this reason, it is the opinion of the working group that, as a rule, a child should not
p.000015: participate in more than one invasive research study at a time. Questionnaire studies have not been taken into
p.000015: account in this case. When requesting consent to participate in a research study, it should always be ascertained
p.000015: that the child is not participating in other research programs at the same time. Since the scope of
p.000015: research studies and the complexity of procedures vary, exceptions to the main rule should be made possible with
p.000015: appropriate grounds. It should also be considered in research units whether different trials and consent procedures
...
Social / Religion
Searching for indicator special:
(return to top)
p.000001: Outi Tammela, Chief Physician of the Neonatal Unit, Tampere University Hospital, Paediatrics Department
p.000001: Ritva Halila, Secretary of the working group, Secretary General, National Advisory Board on Health Care
p.000001: Ethics
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: 1
p.000001:
p.000001: SUMMARY
p.000001:
p.000001: A considerable proportion of the medical treatment of children is based more on estimates and assumptions than on
p.000001: clinical evidence. Enrolling children into research has been avoided because of the special status of children. The
p.000001: special characteristics of research performed in children are related to the physical size of children and
p.000001: their dependency on adults due to their level of development. While current legislation allows, on certain conditions,
p.000001: a 15-year-old to give independent consent to participate in a research study, a person must be 18 years old before
p.000001: he/she can make an entirely independent decision about participation. Children do not gain the same benefits from
p.000001: pharmaceutical innovations as adults, since so few clinical trials are conducted on children. On the
...
p.000001: (ETENE). The finished report was extensively circulated for advisory comments and some additions were made on the basis
p.000001: of these comments.
p.000001: The working group assembled eight times. The report of the working group focuses on clinical research of the
p.000001: intervention type, although most issues discussed in the report can also be applied to other research
p.000001: studies, such as research on medical devices, radionuclide and radiology, diagnostics, genetic screening,
p.000001: child psychiatry, and follow-up of normal growth and development. The scope of research studies conducted on children
p.000001: is so wide that it was impossible to take the special characteristics of each type into account. Even though the
p.000001: working group also gave some detailed recommendations, the main purpose of the report is to prompt discussion about
p.000001: ethical questions concerning research conducted on children rather than to give an exhaustive report of all viewpoints
p.000001: on the subject.
p.000001: In the report, the working group decided to emphasise differences associated with different stages of life and
p.000001: development, and the ability of a child or an adolescent to decide whether or not to participate in research. A child
p.000001: or an adolescent should always be party to the decision-making that concerns him/her if possible. This can be promoted
...
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
p.000001: child participates in just one research study at a time. Special attention should be paid to the role of the
p.000001: person requesting the consent. For research that includes minor procedures, the consent of just one parent is
p.000001: sufficient. An additional risk of injury or stress associated with the research should be proportional to the
p.000001: child’s individual situation and health benefits expected from the research rather than to a detailed
p.000001: classification of the procedures. It is recommended that researchers in the field receive training about the
...
p.000003: well-being of the child is an obligation for everyone participating in the planning, realisation, and evaluation
p.000003: of the research study. The doctor responsible for the treatment must adhere to the obligation currently set by the Act
p.000003: on the Status and Rights of Patients: to provide the best possible treatment and to avoid all procedures that might put
p.000003: the patient’s health at risk.
p.000003: Ethics committees evaluating clinical research have an obligation to take into account the need of protection of
p.000003: special patient groups. The ethics of research performed in children involve finding a balance between the necessity of
p.000003: the research and the protection of the child. When searching for the right balance, the perspectives of the
p.000003: parents and staff treating the child must be taken into account in addition to medical and legal aspects. It
p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
...
p.000004: obligation of the signatory countries to ensure the survival and development of the child to the maximum
p.000004: extent possible (Article 6.2). The convention also recognises the right of the child to have access to the highest
p.000004: attainable standard of health, the treatment of illness and rehabilitation services (Article 24).
p.000004: Another important document relating to international law is the Convention on Human Rights and Biomedicine by the
p.000004: Council of Europe (ETS 164), which contains special regulations concerning scientific research in the field of medicine
p.000004: in subjects who are not able to give an informed consent independently. In the last few years, Finland has prepared for
p.000004: the ratification of this convention by bringing its national legislation closer to the convention. The most
p.000004: recent document relating to international law that applies to research in children is Directive 2001/20/EC
p.000004: of the European Parliament and of the Council (the so-called Clinical Trials Directive). This directive contains
p.000004: quite specific regulations for the protection of children, but also takes into account the necessity of
...
p.000005: In most research studies, various measurements and laboratory samples are required. The child’s size is critical in
p.000005: determining how large a sample overall can be collected. For example, determining the maximum size of a single blood
p.000005: sample and the total volume of samples needed in the research study is important as early as at the planning stage so
p.000005: that blood transfusions would not be needed. One-percent of the child’s blood volume can be considered a reasonable
p.000005: size for a single blood sample. Collecting samples larger than this is justifiable only in special
p.000005: circumstances (e.g. when studying premature infants). Sometimes the child’s treatment necessitates
p.000005: simultaneous collection of several blood samples. The amount of blood lost must be replenished if the amount of
p.000005: samples collected is considerable in proportion to the child’s total blood volume. Samples that are exclusively
p.000005: associated with the research should never be taken in such large amounts that the child needs subsequent
p.000005: blood transfusions. When performing other additional research-related procedures, such as collection of
p.000005: tissue and bone marrow samples or magnetic resonance imaging, x-ray imaging, radionuclide scans and other
p.000005: imaging, the additional stress and risks (e.g. anaesthesia) associated with the procedure must be taken
p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
...
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
p.000005: participation in more than one research study at a time should require special grounds and the approval of the head of
p.000005: the unit. The opinions of the other personnel and the parents should also be taken into account in decision-making. In
p.000005: these situations there should also be an evaluation as to what are the times when different research projects can be
p.000005: combined. Doctors responsible for the children’s treatment and other staff members should be informed about
p.000005: the research project before it is launched. In addition, when research permits are being granted, the head of the
p.000005: treatment unit, who is responsible for the availability of unit resources as well as the recruitment
p.000005: effort directed at patients, should be heard. Depending on the study, it should also be considered whether the child’s
...
p.000005:
p.000006: 6
p.000006:
p.000006: Children and clinical trials on medicinal products
p.000006: In clinical trials on medicinal products, an investigational medicinal product is given to the research subjects. This
p.000006: medicinal product is often compared either to a known medicine in the market or to placebo. In clinical research
p.000006: performed in children, the composition of the investigational product is important. Different dosage ? forms are often
p.000006: needed for children, and absorption of the medicine may vary. This may cause problems not only for the investigator but
p.000006: also for the manufacturer of the medicine.
p.000006: Clinical trials on medicinal products have some special characteristics in comparison with other scientific
p.000006: studies. A medicine is either an alien substance to the body or differs quantitatively from substances produced by the
p.000006: body (e.g. hormones), and therefore it may also cause adverse effects. Research on adults can only provide estimations
p.000006: about the incidence of adverse effects on children, since the passage of the medicine in a child’s body and the body’s
p.000006: response to the medicine may be different due to growth and development. Since children cannot be subjected to
...
p.000006: differ with regard to adverse effects or pharmaceutical forms provide more options in the treatment of children. It is
p.000006: impossible to define in general terms how many similar medicines should be available. It is, however, important
p.000006: to minimise the number of children enrolled in research while making certain that the research yields, however,
p.000006: sufficient data on the efficacy and safety of the medicine.
p.000006:
p.000006:
p.000006:
p.000007: 7
p.000007:
p.000007: Medical research conducted on children and legislation
p.000007: In legislation, children, as well as handicapped adults, are considered a special group in need of
p.000007: protection, and performing medical research on such groups is restricted. The reason for this is the limited ability
p.000007: of children to give an independent informed consent to research procedures. If participation in the
p.000007: research is considered possible, the consent of the parents or guardian and minimisation of
p.000007: research-related risks are, as a general rule, required. Furthermore, children can only be enrolled as
...
p.000008: 100 % oxygen in reviving neonates would never have been noticed if a written consent of the parents had been
p.000008: needed before enrolling the children into the research. The current form of the EC Clinical Trials Directive
p.000008: (2001/20/EC) does not appear to allow research in any situations without the consent of the guardian or another legal
p.000008: representative, so the Medical Research Act will be revised during the implementation stage of the directive.
p.000008: Children who have been taken into custody are in a special situation, and should be spared additional
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
...
p.000011: refusing to let the child participate in a research study. The child’s guardian or guardians give the
p.000011: consent concerning the participation of a neonate in the research, but even the child’s parents may find it difficult
p.000011: to put themselves in the position of the child. Making the decision is often made more difficult by parents’
p.000011: lack of basic information about special characteristics of a neonate’s vital functions.
p.000011: The neonatal period is associated with a process of change and adaptation from intrauterine to
p.000011: extrauterine life. The metabolism of several medicines is influenced by postnatal changes in the
p.000011: circulation and the low content of carrier proteins in the blood, which must be taken into account in clinical
p.000011: research. The dosage for many medicines is different in infants aged under one week. In premature infants, the dosage
p.000011: of many medicines is different from the dosage for full-term children. The smaller the patient, the greater is the
p.000011: proportion of water and extracellular space in total body volume. The same applies to skin surface area in proportion
...
p.000015: basis of which a decision about participating or refusing to participate can be reached. It is also important to give
p.000015: the parents enough time to consider their decision, whenever possible.
p.000015:
p.000015: 3. When evaluating the child or adolescent’s level of development, and the consent associated with this,
p.000015: as well as when carrying out the research, the investigators must have sufficient expertise concerning the growth and
p.000015: development of children. In order
p.000015:
p.000015:
p.000016: 16
p.000016:
p.000016: to ensure a sufficient level of expertise, the working group proposes that special courses in research conducted on
p.000016: children be organised at the Faculties of Medicine. The course could be taken at the stage of specialisation, in
p.000016: association with a doctoral dissertation, or as supplementary education. Ethics committees should have
p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
...
Social / Social
Searching for indicator social:
(return to top)
p.000007: If the child’s parents are married when the child is born, both are considered as the child’s guardians. If the child’s
p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
...
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
...
Social / Student
Searching for indicator student:
(return to top)
p.000001: problematic.
p.000001: On 5 June 2001, the National Advisory Board on Health Care Ethics (ETENE) appointed a working group to look for
p.000001: common rules to be applied to scientific research conducted on children. Representatives of paediatric
p.000001: clinical pharmacology, neonatology, nursing, law, and of parents were included in the working group. The
p.000001: members of the working group were: Kalle Hoppu, Docent of Clinical Pharmacology, Medical Director, Poison Information
p.000001: Centre, Helsinki University Central Hospital (HUCH); Sirkku Kiviniitty from KEVYT ry (Parents of Premature Infants
p.000001: Association); Eija Reen, Healthcare student, Assistant Nurse Manager, Hospital for Children and Adolescents,
p.000001: (HUCH); and Outi Tammela, Docent of Paediatrics, Chief Physician of Neonatology Unit, Tampere University
p.000001: Hospital, Paediatrics Department. Salla Lötjönen, Master of Laws, Master of Arts, National Advisory Board
p.000001: on Research Ethics (TENK), acted as the chairperson of the working group. The secretary of the working group was
p.000001: Ritva Halila, Doctor of Medical Science, Specialist in Paediatrics, National Advisory Board on Health Care Ethics
p.000001: (ETENE). The finished report was extensively circulated for advisory comments and some additions were made on the basis
p.000001: of these comments.
...
Social / Victim of Abuse
Searching for indicator abuse:
(return to top)
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
p.000005: Particularly in departments treating a small number of patients, there are often several
p.000005: simultaneously ongoing clinical research studies that apply to the same patients. There is a need for rules that
p.000005: state how many research programs a child can participate in at the same time. As a general rule,
...
p.000008: (2001/20/EC) does not appear to allow research in any situations without the consent of the guardian or another legal
p.000008: representative, so the Medical Research Act will be revised during the implementation stage of the directive.
p.000008: Children who have been taken into custody are in a special situation, and should be spared additional
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
p.000001: child participates in just one research study at a time. Special attention should be paid to the role of the
p.000001: person requesting the consent. For research that includes minor procedures, the consent of just one parent is
p.000001: sufficient. An additional risk of injury or stress associated with the research should be proportional to the
p.000001: child’s individual situation and health benefits expected from the research rather than to a detailed
p.000001: classification of the procedures. It is recommended that researchers in the field receive training about the
p.000001: ethical questions relating to research conducted on children.
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
p.000001:
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p.000002: 2
p.000002:
p.000002: TABLE OF CONTENTS
p.000002: SUMMARY
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p.000007: research is considered possible, the consent of the parents or guardian and minimisation of
p.000007: research-related risks are, as a general rule, required. Furthermore, children can only be enrolled as
p.000007: research subjects if it is not possible to achieve the same results with adult subjects. The research must
p.000007: also be of direct benefit for the child’s health or of particular benefit to persons of similar age or state of
p.000007: health. If a minor is able to understand the significance of the research procedure to be performed, a
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
...
p.000007: importance to the child’s well-being or future, however, the guardians must make a joint decision unless
p.000007: the best interests of the child requires another approach. This also applies to parents with joint custody who
p.000007: are separated. In routine health care procedures, for example, the consent of one parent is nevertheless considered
p.000007: sufficient. This can also be said to apply to medical research, if the required procedure is minor (e.g. collecting a
p.000007: blood sample). The Child Custody and Right of Access Act (§ 1) requires that the parents must take the child’s best
p.000007: interests and well-being into account in matters concerning the child’s care.
p.000007: But how is one to act if the parents cannot be reached, for example in a case of an accident, or if they are unable to
p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
...
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
p.000008: that of children who are not used to the hospital environment. The Medical Research Act states that if the child is
p.000008: able to understand the significance of the procedure to be performed, his/her personal consent is required to perform
p.000008: the research. According to the Medical Research Act, the guardian’s consent is needed in addition to the minor’s
p.000008: consent if the child is less than 15 years old or the research is not expected to produce any direct health benefits to
p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
p.000008: The Medical Research Act allows only minor risk or stress to be caused to an underaged research subject. The problem
p.000008: is the definition of minor risk. Can minor risk be determined with strict classification of procedures, or
...
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
p.000008: The Medical Research Act allows only minor risk or stress to be caused to an underaged research subject. The problem
p.000008: is the definition of minor risk. Can minor risk be determined with strict classification of procedures, or
p.000008: should it be relative to the situation of the individual patient or to the benefit expected from the research?
p.000008: Collecting five millilitres of blood may be a minor procedure to an adolescent, but it is life-threatening to a
...
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
p.000008: The Medical Research Act allows only minor risk or stress to be caused to an underaged research subject. The problem
p.000008: is the definition of minor risk. Can minor risk be determined with strict classification of procedures, or
p.000008: should it be relative to the situation of the individual patient or to the benefit expected from the research?
p.000008: Collecting five millilitres of blood may be a minor procedure to an adolescent, but it is life-threatening to a
p.000008: premature infant weighing 500 grams. Children also have individual differences. Children who are used to the
p.000008: hospital environment and who know what the procedure entails, may suffer less from minor procedures than
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
...
p.000008: should it be relative to the situation of the individual patient or to the benefit expected from the research?
p.000008: Collecting five millilitres of blood may be a minor procedure to an adolescent, but it is life-threatening to a
p.000008: premature infant weighing 500 grams. Children also have individual differences. Children who are used to the
p.000008: hospital environment and who know what the procedure entails, may suffer less from minor procedures than
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
p.000008: cause a great deal of fear towards painful procedures. The concept of minor risk is relative also in
p.000008: research studies where a risk of considerable adverse effects is associated with the treatment of a
p.000008: serious illness. In such cases, minor risk refers to the additional hazard and discomfort that the paediatric
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: patient is subjected to when he/she participates in the research in addition to regular treatment. When
p.000009: evaluating stress caused by the research, the number of additional visits, for example, and the stress caused by
...
p.000008: children who are not familiar with the procedure. On the other hand, repeatedly painful experiences in the past may
p.000008: cause a great deal of fear towards painful procedures. The concept of minor risk is relative also in
p.000008: research studies where a risk of considerable adverse effects is associated with the treatment of a
p.000008: serious illness. In such cases, minor risk refers to the additional hazard and discomfort that the paediatric
p.000008:
p.000008:
p.000009: 9
p.000009:
p.000009: patient is subjected to when he/she participates in the research in addition to regular treatment. When
p.000009: evaluating stress caused by the research, the number of additional visits, for example, and the stress caused by
p.000009: travelling and restrictions to normal life must be taken into consideration.
p.000009:
p.000009: Paediatric patients and health-care personnel
p.000009: Doctors, nurses, and other health-care personnel participate in scientific research projects ever more often. In
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p.000014: cannot give his/her consent independently, since the consent of at least one guardian is needed in addition to the
p.000014: child’s consent. This is why the guardians should have a separate information sheet, on the basis of which they give
p.000014: their consent.
p.000014: The significance of a child’s expression of his/her wishes becomes greater when the child is better able to understand
p.000014: the significance of the procedure. If a minor understands the significance of the research, his/her written consent
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
...
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
p.000014: legislation, an adolescent can make an independent decision about participating in a research study only at
p.000014: the age of 15 years, and then only in situations when he/she is expected to have direct benefit from the research,
p.000014: many younger adolescents are able to understand the course and significance of the research. The opinions of
p.000014: 15-year-olds, and even younger adolescents who are at a sufficiently high level of development, should be
p.000014: accorded authoritative importance with regard to participation. However, the guardian has the right to receive
p.000014: information about a clinical research study performed on a minor, if necessary.
p.000014: The right of self-determination of children and adolescents should be respected to the greatest extent
p.000014: possible. A teenager should never be forced to participate in a research study against his/her wishes. Youth is
p.000014: associated with rebellion, and adolescents are often more interested in their appearance than their
p.000014: health. The treatment compliance of adolescents is, however, an essential starting point if the research is to
p.000014: succeed. Because puberty is associated with the need to belong in groups, emphasising that the adolescent is in any way
p.000014: different should be avoided in planning the research.
p.000014: When the adolescent approaches maturity, the questions concerning his/her right of self-
p.000014: determination emerge in a more concrete way. The adolescent is treated as an individual, and his/her
p.000014: guardians are not informed of the treatments if he/she forbids it, for example in matters concerning
p.000014: contraception or abortion (Act on the Status and Rights of Patients (785/1992)). On the other hand, if a minor is
p.000014: asked to participate in a clinical trial evaluating the effects of oral contraceptives on a developing
p.000014: hormonal system, the guardians of the minor must always be informed of the research. This may,
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
...
p.000014: different should be avoided in planning the research.
p.000014: When the adolescent approaches maturity, the questions concerning his/her right of self-
p.000014: determination emerge in a more concrete way. The adolescent is treated as an individual, and his/her
p.000014: guardians are not informed of the treatments if he/she forbids it, for example in matters concerning
p.000014: contraception or abortion (Act on the Status and Rights of Patients (785/1992)). On the other hand, if a minor is
p.000014: asked to participate in a clinical trial evaluating the effects of oral contraceptives on a developing
p.000014: hormonal system, the guardians of the minor must always be informed of the research. This may,
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
p.000014: treatment, research is considered to be different. Although an adolescent from 15 to 18 years of age understands many
p.000014: issues that
p.000014:
p.000015: 15
p.000015:
p.000015: concern him/her, he/she can still be influenced by the opinions of his/her friends, for example. If complications
p.000015: occur in research studies on contraception, for example, the child may be left too much alone with feelings
p.000015: of responsibility and guilt.
p.000015:
p.000015: RECOMMENDATIONS OF THE WORKING GROUP
p.000015: 1. As a rule, the child should not participate in more than one invasive scientific research study at a time. The
...
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
p.000016: applied in association with research if the risk of injury or stress to the child is equally small.
p.000016:
p.000016: 5. The right of self-determination of minors should be expanded. To ensure that the right of self-determination is
p.000016: realised, it is recommended that a brief summary of the purpose, nature, benefits, risks and adverse effects
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p.000016: reasons must be given to the ethics committee. Information about the research can also be given to children who
p.000016: cannot read in the form of fairytales, games and stories. At the pre-planning stage of the research, it is also
p.000016: important to emphasise the significance of oral information and ways to ensure that research-related information is
p.000016: understandable to children of different ages. The resistance of a child younger than school age must also be respected
p.000016: even if the reaction is based on fear, for example, and is not in accordance with rational behaviour models. If a minor
p.000016: is able to understand the purpose of the research, his/her consent is required before the research can be realised.
p.000016: When implementing the Clinical Trials Directive, the possibility accorded by Finnish law to adolescents over 15
p.000016: years of age to give an independent consent should, at the very least, be maintained, if possible.
p.000016:
p.000016: 6. Any additional research-related risk of injury or stress should be proportional to the child’s individual
p.000016: situation and the health benefits the research is expected to have, rather than to a strict classification
p.000016: of procedures. The Medical Research Act requires that a minor can only be subjected to minimal research-related risk
p.000016: of injury or stress. Such procedures include, for example, collection of a small blood or stool sample,
p.000016: painless imaging that does not involve any additional risks, etc. On the other hand, the risk and injury associated
p.000016: with the collection of blood samples may be considerable, for example, in small premature infants. The child’s
p.000016: suffering must always be minimised. Pain associated with procedures can often be effectively alleviated
p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
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Searching for indicator minors:
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p.000003: is important to recognise and acknowledge the different interests of the different parties and find a balance
p.000003: between them. The most central principle is that the child should never be enrolled into a trial if participation
p.000003: is not in the child’s best interests. It has been our goal to present the various viewpoints in this report on equal
p.000003: terms.
p.000003:
p.000003:
p.000003:
p.000004: 4
p.000004:
p.000004: Creating an atmosphere of trust is of the utmost importance in the treatment of the child as well as in matters
p.000004: relating to research in particular.
p.000004: Children are minors, but they enjoy the same rights as all other population groups. In Finland, this has also been
p.000004: emphasised in the constitution (the Constitution of Finland, 731/1999) § 6 paragraph 3). International agreements on
p.000004: human rights signed by Finland, such as the UN Convention on the Rights of the Child, also give children the
p.000004: right to the same level of health, health care and rehabilitation enjoyed by other citizens. The UN Convention
p.000004: on the Rights of the Child obligates the signatory countries to take into account as their primary consideration the
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p.000007: give their consent on behalf of the child due to their physical or mental state? The Medical Research Act (488/1999)
p.000007: allows the initiation of research without a written informed consent if the consent cannot be obtained
p.000007: because of the urgency of the matter and the patient’s state of health, and if the procedure is expected to be
p.000007: of immediate benefit to the patient’s health (§ 6 paragraph 1). This regulation can probably be applied to
p.000007: minors whose guardians cannot be reached in time, or if the guardian has, for example, been injured in the same
p.000007: traffic accident as the child. In these cases the guardians must be informed of the research as soon as possible, and
p.000007: at this or at a later time the guardians can prohibit the child’s participation in the research. This is also the
p.000007: standard approach for emergency research on adults. However, if the research can be performed using other
p.000007: research subjects or waiting for the parents’ consent is possible, this exception should not be applied. Enrolling
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p.000008: the child. Only when the child is 15 years old does he/she have the right to make independent decisions
p.000008: concerning participation in research. This right, however, is restricted to research from which direct health benefits
p.000008: can be expected. In addition, the child’s guardians must be informed of the matter. The Act on the Medical Use of Human
p.000008: Organs and Tissues (101/2001) states that, in the case of minors, consent is to be received primarily from their legal
p.000008: representatives. The current form of the EC Clinical Trials Directive does not appear to allow research to be performed
p.000008: without the consent of the guardian or another legal representative even when the minor is over 15 years old. During
p.000008: the implementation stage of the Clinical Trials Directive, the Medical Research Act may have to be revised
p.000008: for this part as well.
...
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
p.000016: applied in association with research if the risk of injury or stress to the child is equally small.
p.000016:
p.000016: 5. The right of self-determination of minors should be expanded. To ensure that the right of self-determination is
p.000016: realised, it is recommended that a brief summary of the purpose, nature, benefits, risks and adverse effects
p.000016: of the research be made for children who are able to read. If such a summary is not considered necessary, the
p.000016: reasons must be given to the ethics committee. Information about the research can also be given to children who
p.000016: cannot read in the form of fairytales, games and stories. At the pre-planning stage of the research, it is also
p.000016: important to emphasise the significance of oral information and ways to ensure that research-related information is
...
Searching for indicator emergency:
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p.000006: or treatment without previous clinical evidence is desired in order to save the child’s life. When is initiation of
p.000006: such a treatment ethically justified? From the perspective of the child needing treatment, it is always preferable if
p.000006: the treatment can be given within the framework of scientific clinical research and not as an individual experiment. It
p.000006: would be good, however, if hospitals had the possibility to ask for an evaluation by a neutral external party on an
p.000006: emergency basis in such cases. Whether this external party would be an ethics committee or a
p.000006: medical-judicial group, remains a topic for discussion. The line between experimental treatments and clinical research
p.000006: is unclear, but for example ethics committees and drug authorities are more effective at monitoring clinical research
p.000006: than experimental treatments. The follow-up, combination of research data and systematic analysis associated
p.000006: with good clinical research help optimise the treatment and detect any adverse effects as early as possible.
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p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
p.000007: initiation of the research requires the consent by the guardian, it is important to consider how more information
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p.000007: of immediate benefit to the patient’s health (§ 6 paragraph 1). This regulation can probably be applied to
p.000007: minors whose guardians cannot be reached in time, or if the guardian has, for example, been injured in the same
p.000007: traffic accident as the child. In these cases the guardians must be informed of the research as soon as possible, and
p.000007: at this or at a later time the guardians can prohibit the child’s participation in the research. This is also the
p.000007: standard approach for emergency research on adults. However, if the research can be performed using other
p.000007: research subjects or waiting for the parents’ consent is possible, this exception should not be applied. Enrolling
p.000007: newborn premature infants into research is facilitated if the parents have
p.000007:
p.000007:
p.000008: 8
p.000008:
p.000008: already received information on such a situation beforehand. Additional information should be available,
p.000008: preferably in written form, in maternity hospitals and research units. Research that is started without
p.000008: delay can sometimes be of considerable importance to children’s well-being. For example, the hazards of
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p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
p.000012: be informed of the research as soon as possible, at which time they have the right to discontinue the
p.000012: child’s participation. To enable parents to make informed decisions in such situations, possibilities should be
p.000012: discussed concerning the distribution of information to maternity clinics and hospital staff about emergency research
p.000012: in neonates. If there is a risk of prematurity, the parents could be informed of a possible research already before
p.000012: delivery. In specialised health-care units treating neonates, information about emergency research could be made
p.000012: available to parents who may need it. In this way, the parents could better prepare themselves for the request for
p.000012: their consent and also take care of any consent-related authorisations beforehand.
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
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p.000012: delivery. In specialised health-care units treating neonates, information about emergency research could be made
p.000012: available to parents who may need it. In this way, the parents could better prepare themselves for the request for
p.000012: their consent and also take care of any consent-related authorisations beforehand.
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
p.000012: treatment given to the neonate is important also after the consent has been given.
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Preschool age
p.000013: The organs of a preschool-aged child develop quickly. During this period, the body weight doubles and considerable
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p.000015: parents. The investigator conducting the research has the best knowledge about the details of the
p.000015: research. The investigator’s neutrality with regard to recruiting research subjects may, however, be made more
p.000015: difficult by his/her research-related interests or the need to recruit the child into the research for other reasons.
p.000015: On the other hand, the physician or nurse treating the child may not know all the details of the research study and may
p.000015: not be able to answer questions the child or the child’s parents wish to ask. In emergency situations, the neutrality
p.000015: of the doctor on call may be jeopardised by the rush and the stress associated with treatment. The ideal situation
p.000015: would be if the investigator and the doctor who is treating the child could give the information about the research
p.000015: together. Additional information can also be given by the research nurse, if there is one in the
p.000015: research unit. However, depending on the circumstances, other methods of action are often needed. It
p.000015: is important that the research subject or his/her guardian has the opportunity to request additional information
p.000015: about the research from the investigator. Varied and neutral information about the research must be available, on the
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Searching for indicator youth:
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p.000014: 15-year-olds, and even younger adolescents who are at a sufficiently high level of development, should be
p.000014: accorded authoritative importance with regard to participation. However, the guardian has the right to receive
p.000014: information about a clinical research study performed on a minor, if necessary.
p.000014: The right of self-determination of children and adolescents should be respected to the greatest extent
p.000014: possible. A teenager should never be forced to participate in a research study against his/her wishes. Youth is
p.000014: associated with rebellion, and adolescents are often more interested in their appearance than their
p.000014: health. The treatment compliance of adolescents is, however, an essential starting point if the research is to
p.000014: succeed. Because puberty is associated with the need to belong in groups, emphasising that the adolescent is in any way
p.000014: different should be avoided in planning the research.
p.000014: When the adolescent approaches maturity, the questions concerning his/her right of self-
p.000014: determination emerge in a more concrete way. The adolescent is treated as an individual, and his/her
p.000014: guardians are not informed of the treatments if he/she forbids it, for example in matters concerning
...
Economic / Economic/Poverty
Searching for indicator poor:
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p.000005: into consideration. It is important to take into account the pain associated with various procedures.
p.000005: Repeated puncturing of the skin should be avoided, and every additional research- related puncture of the
p.000005: skin must be explained not only to the child’s parents or guardian but also to the child, if at all possible.
p.000005: In addition to children being a special group with regard to clinical research, they may have certain additional
p.000005: characteristics that should be taken into account. For example, children with cancer who are in poor condition, or
p.000005: children who have, or whose family members have, substance abuse problems should not be subjected to the
p.000005: additional stress caused by research unless the purpose of the research is to influence the well-being of such
p.000005: children. Particularly in these research studies, acting in the child’s best interests and evaluating on a
p.000005: case-by-case basis are of the utmost importance.
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p.000009: influenced by technical performance, one extra person taking measurements increases the reliability of the results
p.000009: (e.g. head circumference, length).
p.000009: The doctor and nurse treating the child may be faced with several ethical problems in connection with research.
p.000009: Performing scientific research on children may cause feelings of anxiety for the treatment staff as well,
p.000009: especially if the child is very ill or in terminal treatment, or if the prognosis is poor. Questions may arise
p.000009: concerning the purpose and necessity of the research and the giving of false hope. Ethical conflicts concerning
p.000009: clinical research may arise e.g. in cases where placebo is used in clinical research, or in the evaluation of the
p.000009: effects of the medicine in open clinical research studies when the nurse or the doctor knows what medicine
p.000009: the child is receiving and does not consider it the best option for the child in question. Discussing these
p.000009: questions openly in the work community is important.
p.000009: Using limited resources for scientific research can sometimes be felt to be ethically wrong. The time required by
p.000009: scientific research is time taken from other activities, and as resources become more
p.000009:
p.000009:
p.000010: 10
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p.000012: observed that premature infants who had received dexamethasone had a three-fold risk of neurological injury
p.000012: in comparison with premature infants who had received another treatment.
p.000012: Emergencies requiring fast action and decision-making may emerge in particular in the treatment of neonates.
p.000012: Research-based treatment practices must be developed for emergencies as well. The birth of a new family member
p.000012: represents a substantial change in itself, and the parents have to adjust to it. The situation of the parents is
p.000012: particularly fragile if the newborn is ill or in a poor condition. The physical and mental state of the parents,
p.000012: and the mother’s recovery from childbirth or caesarean section should be taken into account when asking for the
p.000012: parents’ consent to a trial to be performed on a neonate. Only in exceptional situations and after thorough
p.000012: deliberation can initiation of the trial without the parents’ consent be considered. The course of action in
p.000012: such situations must be pre- approved by an ethics committee. Also in these situations, the parents must
p.000012: be informed of the research as soon as possible, at which time they have the right to discontinue the
...
Economic / Welfare Recipient
Searching for indicator welfare:
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p.000007: parents are not married when the child is born, only the mother is considered to be the child’s guardian. The father
p.000007: can become the child’s guardian by marrying the mother, by a joint parental agreement validated by the
p.000007: social welfare board, or by a court order (§ 6–9). If a research study needs to be performed in a newborn infant on an
p.000007: emergency basis, the father can give consent for the research only if he is married to the child’s mother, since
p.000007: there has been no time to take action to affirm the father’s role as a guardian. The situation is
p.000007: problematic, as approximately half of the children in Finland are currently born outside of marriage. While the
...
p.000008: hazards and stress. On the other hand, children who have grown up in a family with substance abuse
p.000008: problems, for example, may have special characteristics that are of particular need for further research (e.g. effects
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
...
p.000008: of alcohol use during pregnancy), which may be of considerable benefit to the children themselves. In cases of custody,
p.000008: the right to make decisions about the child’s care, upbringing, supervision and other welfare are normally transferred
p.000008: to the social welfare board (Child Welfare Act (683/1983) § 19 paragraph 1). The right to decide about the child’s
p.000008: participation in clinical trials remains with the child’s parents, unless other arrangements have been
p.000008: made in connection with taking the child into custody or on the basis of a court decision. If the research is for
p.000008: example connected to the child’s care and is in accordance with the purpose of taking the child into custody, the
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
...
p.000008: social welfare board and those responsible for the child’s care are usually in the best position to evaluate what
p.000008: is in the interests of the child. However, when considering the participation of a child who has been taken
p.000008: into custody, it is important to consider on a case-to- case basis who has the best qualifications to oversee the
p.000008: welfare of the child.
p.000008: As the child grows and develops, his/her statutory right of self-determination increases. It is also worth bearing in
p.000008: mind that the ability of chronically ill children to decide about their care is generally better than
p.000008: that of children who are not used to the hospital environment. The Medical Research Act states that if the child is
...
p.000016: topically or by means of anaesthesia. The evaluation of benefits and risks associated with each research study
p.000016: should always be made on a case-by-case basis.
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000016:
p.000017: 17
p.000017:
p.000017: LITERATURE
p.000017:
p.000017: Finnish legislation:
p.000017: Medical Research Act (488/1999)
p.000017: Act on the Status and Rights of Patients (785/1992)
p.000017: Act on the Medical Use of Human Organs and Tissues (101/2001) Child Custody and Right of Access Act (361/1983)
p.000017: Child Welfare Act (683/1983)
p.000017: The Constitution of Finland (731/1999) International agreements:
p.000017: United Nations Convention on the Rights of the Child (20th November, 1989)
p.000017: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology
p.000017: and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
p.000017: Directive 2001/20/EC of the European Parliament and of the Council on the approximation of the laws, regulations and
p.000017: administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct
p.000017: of clinical trials on medicinal products for human use. Official Journal of the European Communities 1
p.000017: May 2001 L121/34-44.
...
General/Other / Diminished Autonomy
Searching for indicator age:
(return to top)
p.000001: by telling the child or adolescent about the research in an understandable way. The number of children recruited
p.000001: should be kept as small as possible, but large enough to enable scientifically valid results. Children may
p.000001: be recruited to a research study only if there can be expectations of a direct benefit to their health or to the health
p.000001: of children having a similar condition or belonging to the same age group. The rule of thumb should be that the
p.000001: child participates in just one research study at a time. Special attention should be paid to the role of the
p.000001: person requesting the consent. For research that includes minor procedures, the consent of just one parent is
p.000001: sufficient. An additional risk of injury or stress associated with the research should be proportional to the
...
p.000002: Medical grounds of research conducted on children 5
p.000002: Children and clinical trials on medicinal products
p.000007: 7
p.000007: Medical research conducted on children and legislation 8
p.000007: Paediatric patients and health-care personnel
p.000010: 10
p.000010: Research on children from the viewpoint of the parents 11
p.000010: Part II: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000012: 12
p.000012: The neonatal period and infancy
p.000012: 12
p.000012: Preschool age
p.000014: 14
p.000014: Pre-pubertal school age
p.000014: 14
p.000014: Pre-puberty and puberty
p.000015: 15
p.000015: RECOMMENDATIONS OF THE WORKING GROUP 16
p.000015: LITERATURE
p.000018: 18
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000003: 3
p.000003:
p.000003: BACKGROUND ON RESEARCH CONDUCTED ON CHILDREN
p.000003:
p.000003: The development of medicine and biology has greatly benefited humankind, particularly during the last century. Life
p.000003: expectancy has improved, many previously fatal diseases have either been eradicated or medicines, vaccines
...
p.000007: 7
p.000007: Medical research conducted on children and legislation 8
p.000007: Paediatric patients and health-care personnel
p.000010: 10
p.000010: Research on children from the viewpoint of the parents 11
p.000010: Part II: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000012: 12
p.000012: The neonatal period and infancy
p.000012: 12
p.000012: Preschool age
p.000014: 14
p.000014: Pre-pubertal school age
p.000014: 14
p.000014: Pre-puberty and puberty
p.000015: 15
p.000015: RECOMMENDATIONS OF THE WORKING GROUP 16
p.000015: LITERATURE
p.000018: 18
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000018:
p.000003: 3
p.000003:
p.000003: BACKGROUND ON RESEARCH CONDUCTED ON CHILDREN
p.000003:
p.000003: The development of medicine and biology has greatly benefited humankind, particularly during the last century. Life
p.000003: expectancy has improved, many previously fatal diseases have either been eradicated or medicines, vaccines
...
p.000004: research. On a national level, clinical research performed in children is controlled by the Medical Research Act
p.000004: (488/1999, later the Research Act). This report mainly refers to national legislation unless the requirements set forth
p.000004: in international documents outweigh those of national regulations.
p.000004:
p.000004:
p.000004: Part I:
p.000004: PERSPECTIVES ON RESEARCH CONDUCTED ON CHILDREN
p.000004:
p.000004: Medical grounds of research conducted on children
p.000004:
p.000004: A child’s organs continue to develop from early foetal period to adulthood. Different organs develop at
p.000004: different rates and at different times. The threshold values of normal development in different age
p.000004: periods, which form the basis of diagnosis and treatment, have to be found with the help of research. Due to
p.000004: ongoing growth and development, the absorption, metabolism and elimination of a medicine, as well as its
p.000004: effect on the target organ and the rest of the body, are different in children than in adults, and
p.000004: they vary on the basis of the child’s age and stage of development.
p.000004: So-called children’s diseases are those which rarely occur in the adult population or which must be treated in early
p.000004: childhood. Typical examples include, for example, several poxes, many infectious diseases occurring in children
p.000004: (such as ear infections), structural defects (anomalies), or CP. Children do, however, have diseases that more
p.000004: commonly occur in adults. These include asthma, chronic intestinal diseases (i.e. coeliacia, Crohn’s disease,
p.000004: ulcerative colitis, migraine and epilepsy). Children with these diseases need treatment just like adults, although
p.000004: there may be differences in the nature of the treatment or the dosage of the medicine.
...
p.000007: research is considered possible, the consent of the parents or guardian and minimisation of
p.000007: research-related risks are, as a general rule, required. Furthermore, children can only be enrolled as
p.000007: research subjects if it is not possible to achieve the same results with adult subjects. The research must
p.000007: also be of direct benefit for the child’s health or of particular benefit to persons of similar age or state of
p.000007: health. If a minor is able to understand the significance of the research procedure to be performed, a
p.000007: written consent from him/her is also required (Medical Research Act § 8, paragraph 1).
p.000007: As a general rule, the guardian(s) of a young child may give the consent for research participation on behalf of the
p.000007: child. Who is considered guardian in the legal sense? The Child Custody and Right of Access Act (361/1983) defines
...
p.000011: pain and suffering their child experiences. The stress caused by pain or a procedure may cause additional injury, e.g.
p.000011: due to changes in blood pressure. Repeated pain may later lead to pain sensitivity or psychological effects. The
p.000011: parents are also often concerned about whether the chosen research arrangement is necessary or whether the answers to
p.000011: the questions could be found in another way. These matters should be discussed with the parents prior to the signing of
p.000011: the consent form, and again during the study if necessary. Discussion eases the stress associated with making a
p.000011: difficult decision.
p.000011:
p.000011:
p.000011:
p.000011: Part II:
p.000011: EFFECT OF AGE AND STAGE OF DEVELOPMENT IN RESEARCH CONDUCTED ON CHILDREN
p.000011: Children can be divided into different age groups according to growth and physical changes, and also according to the
p.000011: capacity for self-determination and to the mental development it is based on.
p.000011:
p.000011: The neonatal period and infancy
p.000011: The ability of a neonate to express his/her feelings and experiences is very limited. The guardians of the child must
p.000011: then consider what is in the best interests of the child, and on that basis, make the decision about agreeing or
...
p.000012: Even if the parents give their consent to emergency research before it is started, receiving new
p.000012: information may be difficult in a state of shock. The parents may have difficulty remembering that they have given
p.000012: their consent to the research at all. Discussing matters relating to the research as well as matters relating to other
p.000012: treatment given to the neonate is important also after the consent has been given.
p.000012:
p.000012:
p.000013: 13
p.000013:
p.000013: Preschool age
p.000013: The organs of a preschool-aged child develop quickly. During this period, the body weight doubles and considerable
p.000013: energy is spent on the development of bones, muscles and nerves. The blood volume of the child no
p.000013: longer sets such strict restrictions to research as it does in the neonatal period, and performing the
p.000013: procedures is technically easier. In many ways, the metabolism of medicines in preschool children is similar
p.000013: to that in older children and thus allows for more adult- type research. On the other hand, the effects of medicines on
...
p.000013: developing teeth).
p.000013: The understanding of a baby or a preschool child regarding the procedures to be performed on him/her
p.000013: increases as the child grows. The child reacts strongly to pain and is often afraid of procedures that
p.000013: cause pain. The child’s right of self-determination should already be respected at an early stage. The child begins to
p.000013: understand matters relating to his/her life as early as the preschool age. The child’s ability to understand speech and
p.000013: causal relationships improves. The child expresses his/her own feelings and sentiments by words, gestures and
p.000013: play, for example, and reacts to treatments and research on the basis of his/her own feelings.
p.000013: Although a preschool child is physically able to resist a procedure, it should be asked if such
p.000013: resistance means that the child refuses to participate in the research entirely. As a rule, a preschool child is not
...
p.000013: games and fairytales, and various means should be used to inform the preschool child about the research and
p.000013: make the research more understandable to him/her. Giving the child time and space also gives him/her an opportunity to
p.000013: make decisions.
p.000013: The principle of respecting the child’s right of self-determination has also been taken into account in legislation.
p.000013: When the Medical Research Act was being prepared, it was planned that even a 5- year-old should have the right to
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
...
p.000013: refuse to participate in a research study. There is no age limit in the final version of the Act, and the right to
p.000013: refuse was proportioned to the child’s age and level of development. The child’s level of development will be
p.000013: evaluated by the doctor giving the information about the research, who will also evaluate whether the
p.000013: consent is informed and voluntary.
p.000013:
p.000013: Pre-pubertal school age
p.000013: Physical growth and development continue rather steadily in school age. In addition to physical growth,
p.000013: the child’s ability to understand, think in abstract terms, and thus take responsibility and make personal decisions
p.000013: increases. The process of becoming independent affects not only the child’s right of self-determination but
p.000013: also the success of the research if the procedures require the collaboration of the child (e.g. swallowing tablets or
p.000013: using medical devices). This should be taken into account when discussing participation in the research with the child.
...
p.000014: is required for participation. Ensuring the child’s continuing willingness to participate and cooperate is
p.000014: important at different stages of the research. If the child refuses to continue to take part in the research, the
p.000014: previously given consent will be cancelled.
p.000014:
p.000014: Pre-puberty and puberty
p.000014: Physical changes occurring in pre-puberty and puberty include pubertal growth spurt, hormonal changes and
p.000014: sexual development. Physically, the adolescent begins to resemble an adult. The most important physiological change
p.000014: occurring in this age group is hormonal in nature. Psychologically, the adolescent starts to become independent and
p.000014: wants to make decisions about his/her own life to a greater extent. Therefore, adolescents should be given the
p.000014: opportunity to decide whether they want to participate in a research study or not. Although, according to current
p.000014: legislation, an adolescent can make an independent decision about participating in a research study only at
p.000014: the age of 15 years, and then only in situations when he/she is expected to have direct benefit from the research,
p.000014: many younger adolescents are able to understand the course and significance of the research. The opinions of
p.000014: 15-year-olds, and even younger adolescents who are at a sufficiently high level of development, should be
p.000014: accorded authoritative importance with regard to participation. However, the guardian has the right to receive
p.000014: information about a clinical research study performed on a minor, if necessary.
p.000014: The right of self-determination of children and adolescents should be respected to the greatest extent
...
p.000014: asked to participate in a clinical trial evaluating the effects of oral contraceptives on a developing
p.000014: hormonal system, the guardians of the minor must always be informed of the research. This may,
p.000014: however, make the recruitment of research subjects considerably more difficult. Although the
p.000014: procedure, i.e. prescribing oral contraceptives to the research subject, is exactly the same as when treating a
p.000014: patient in clinical practice, and although the minor would not face any more substantial risks than in standard
p.000014: treatment, research is considered to be different. Although an adolescent from 15 to 18 years of age understands many
p.000014: issues that
p.000014:
p.000015: 15
p.000015:
p.000015: concern him/her, he/she can still be influenced by the opinions of his/her friends, for example. If complications
p.000015: occur in research studies on contraception, for example, the child may be left too much alone with feelings
p.000015: of responsibility and guilt.
p.000015:
p.000015: RECOMMENDATIONS OF THE WORKING GROUP
p.000015: 1. As a rule, the child should not participate in more than one invasive scientific research study at a time. The
p.000015: participation of a child in a clinical research study is always an exception from the main rule set down in
...
p.000016: children be organised at the Faculties of Medicine. The course could be taken at the stage of specialisation, in
p.000016: association with a doctoral dissertation, or as supplementary education. Ethics committees should have
p.000016: sufficient expertise in paediatrics to evaluate research conducted on children.
p.000016:
p.000016: 4. In routine research procedures, a consent from one guardian is sufficient. If a child or an adolescent under 15
p.000016: years of age is to participate in a research study, the consent of his/her guardian is required. As a
p.000016: rule, the child’s guardians should make the decisions concerning the child together. In practical treatment
p.000016: situations, the consent of one guardian is sufficient if the child is to be subjected to a minor or routine procedure,
p.000016: or if the situation can be considered exceptional as stipulated by law. Similar exceptions should also be
...
p.000016: of the research be made for children who are able to read. If such a summary is not considered necessary, the
p.000016: reasons must be given to the ethics committee. Information about the research can also be given to children who
p.000016: cannot read in the form of fairytales, games and stories. At the pre-planning stage of the research, it is also
p.000016: important to emphasise the significance of oral information and ways to ensure that research-related information is
p.000016: understandable to children of different ages. The resistance of a child younger than school age must also be respected
p.000016: even if the reaction is based on fear, for example, and is not in accordance with rational behaviour models. If a minor
p.000016: is able to understand the purpose of the research, his/her consent is required before the research can be realised.
p.000016: When implementing the Clinical Trials Directive, the possibility accorded by Finnish law to adolescents over 15
p.000016: years of age to give an independent consent should, at the very least, be maintained, if possible.
p.000016:
p.000016: 6. Any additional research-related risk of injury or stress should be proportional to the child’s individual
p.000016: situation and the health benefits the research is expected to have, rather than to a strict classification
p.000016: of procedures. The Medical Research Act requires that a minor can only be subjected to minimal research-related risk
p.000016: of injury or stress. Such procedures include, for example, collection of a small blood or stool sample,
...
General/Other / Other Country
Searching for indicator vulnerability:
(return to top)
p.000011: proportion of water and extracellular space in total body volume. The same applies to skin surface area in proportion
p.000011: to body weight (about six-fold in an infant weighing less than 1000 g in comparison with adults). The
p.000011: functions of the liver and the kidneys are inadequate, and the skin of a very small premature infant is
p.000011: thin and sensitive, thus
p.000011:
p.000011:
p.000011:
p.000012: 12
p.000012:
p.000012: making the collection of a bag urine sample a potentially damaging procedure. The immaturity and vulnerability of the
p.000012: body increases the risk of damage and unexpected adverse effects.
p.000012: A neonate may react strongly to handling, touching, and pain. Moreover, research may interfere with the
p.000012: child’s rhythm of sleeping and being awake. Aids needed for evaluation include tried and proven pain and discomfort
p.000012: indicators. An experienced nurse may be of considerable help in evaluating when it is the appropriate moment
p.000012: for performing a research-related procedure from the child’s point perspective.
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| abuse | Victim of Abuse |
| access | Access to Social Goods |
| age | Diminished Autonomy |
| aids | HIV/AIDS |
| capacity | Fetus/Neonate |
| child | Child |
| children | Child |
| dependency | Drug Dependence |
| drug | Drug Usage |
| education | Educational |
| emergency | Youth/Minors |
| family | Motherhood/Family |
| health | Health |
| hiv | HIV/AIDS |
| homeless | Homeless Persons |
| ill | Physically Ill |
| illness | Physically Ill |
| infant | Infant |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| married | Marital Status |
| mentally | Mentally Disabled |
| minor | Youth/Minors |
| minors | Youth/Minors |
| mothers | Mothers |
| neonate | Homeless Persons |
| opinion | Philosophical Differences/Difference of Opinion |
| party | Political |
| physically | LGBTQ+ Status |
| poor | Economic/Poverty |
| restricted | Incarcerated |
| single | Marital Status |
| social | Social |
| social welfare | Access to Social Goods |
| special | Religion |
| student | Student |
| substance | Drug Usage |
| terminal | Terminally Ill |
| vulnerability | Other Country |
| welfare | Welfare Recipient |
| youth | Youth/Minors |
Indicator Peers (Indicators in Same Vulnerabilty)
| Indicator | Peers |
|---|
| access | ['social welfare'] |
| aids | ['hiv'] |
| child | ['children'] |
| children | ['child'] |
| drug | ['influence', 'substance'] |
| emergency | ['minor', 'minors', 'youth'] |
| hiv | ['aids'] |
| homeless | ['neonate'] |
| ill | ['illness'] |
| illness | ['ill'] |
| influence | ['drug', 'substance'] |
| married | ['single'] |
| minor | ['minors', 'emergency', 'youth'] |
| minors | ['minor', 'emergency', 'youth'] |
| neonate | ['homeless'] |
| single | ['married'] |
| social welfare | ['access'] |
| substance | ['influence', 'drug'] |
| youth | ['minor', 'minors', 'emergency'] |
Trigger Words
consent
developing
ethics
harm
protection
risk
self-determination
sensitive
Applicable Type / Vulnerability / Indicator Overlay for this Input