Ethical Problems Using Children In Clinical Trials
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health care Health care or healthcare is the improvement of health via the prevention, diagnosis, treatment, amelioration or cure of disease, illness, injury, and other physical and mental impairments in people. Health care is delivered by health profe ...
, a
clinical trial Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
is a comparison test of a
medication A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy (pharmacotherapy) is an important part of the medical field and re ...
or other medical treatment (such as a
medical device A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assura ...
), versus a
placebo A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...
(inactive look-alike), other medications or devices, or the standard medical treatment for a patient's condition. To be
ethical Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns ma ...
, researchers must obtain the full and voluntary
informed consent Informed consent is a principle in medical ethics and medical law, that a patient must have sufficient information and understanding before making decisions about their medical care. Pertinent information may include risks and benefits of treatme ...
of participating human subjects. If the subject is unable to consent for him/herself, researchers can seek consent from the subject's legally authorized representative. For a
minor child In law, a minor is someone under a certain age, usually the age of majority, which demarcates an underage individual from legal adulthood. The age of majority depends upon Jurisdiction (area), jurisdiction and application, but it is commonly 18 ...
this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial.


International standards

According to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Good clinical practice Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements ...
, all trials involving unapproved medical treatments are reviewed for ethics before the study begins. These approving groups are typically called
Institutional Review Boards An institutional review board (IRB), also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a committee that applies research ethics by reviewing the methods proposed for research to ens ...
(IRB) in the United States, in Europe they are typically called Independent Ethics Committees (IEC). The IRB or IEC will review not only the protocol of the trial but also the way that subjects are recruited and the consent form that they sign. These groups also examine the incentives given for participation in the trial to ensure that they are not coercive. The
World Medical Association The World Medical Association (WMA) is an international and independent confederation of free professional medical associations representing physicians worldwide. WMA was formally established on September 18, 1947 and has grown to 115 national m ...
's
Declaration of Helsinki The Declaration of Helsinki (DoH, fi, Helsingin julistus, sv, Helsingforsdeklarationen) is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA) ...
requires researchers to take special care with consent involving vulnerable subject populations which have barriers to informed consent. These groups include minors, prisoners, and the mentally ill.


In the United States

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...
(FDA) and
Office for Human Research Protections The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that d ...
regulations require the IRB to make specific "Subpart D" determinations regarding children. To approve the trial, it must meet all of the following conditions: * The trial must involve no more than a minor increase over minimal risk. * The treatments must be appropriate to the condition or to medical care that the child would otherwise receive. * The treatment must either yield "generalizable knowledge" about the specific condition that is vital for understanding or treatment. If not all of those criteria are met, the FDA commissioner or the Secretary of
Department of Health and Human Services The United States Department of Health and Human Services (HHS) is a cabinet-level executive branch department of the U.S. federal government created to protect the health of all Americans and providing essential human services. Its motto is " ...
must then consult appropriate experts and can approve the trial if both: * The study is a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem that specifically affects children. * "Sound ethical principles" are used. In either case, "adequate provisions" must be made to allow the child to decide if they want to participate in the trial. The IRB must ensure that the assent process is appropriate for children. A child cannot legally give informed consent but they must be given the opportunity to decline. A parent or guardian legally consents to the child's participation. Additional safeguards exist for "wards of the state" such as orphans.


Ethical concerns

Since parents often receive compensation for their children's participation in research, there are concerns that the payments received may be coercive and lead them to participate in trials which are not in their child's best interest. The IRB or IEC is expected to evaluate both the consent and assent process to ensure that children are not coerced into participation. They are also expected to evaluate the compensation given to ensure that participants are not coerced by the lure of payment. A particular source of concern is the ethics of enrolling babies in clinical trials aimed to study new analgesic drugs and treatments: some researchers argue that babies should never be given only placebo when exposed to pain during such trials.


Problems for the practice of medicine

Partially because of these issues many drugs that are used in children have never been formally studied in children. Many drugs work differently in children.
Reye's syndrome Reye syndrome is a rapidly worsening encephalopathy, brain disease. Symptoms of Reye syndrome may include vomiting, personality changes, confusion, seizures, and loss of consciousness. While hepatotoxicity, liver toxicity typically occurs in the ...
, for example, is a potentially fatal complication of
aspirin Aspirin, also known as acetylsalicylic acid (ASA), is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce pain, fever, and/or inflammation, and as an antithrombotic. Specific inflammatory conditions which aspirin is used to treat inc ...
therapy in children that is very rare in adults. The 2002 Best Pharmaceuticals for Children Act, allowed the FDA to request
National Institutes of Health The National Institutes of Health, commonly referred to as NIH (with each letter pronounced individually), is the primary agency of the United States government responsible for biomedical and public health research. It was founded in the late ...
-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints.
Patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an enabling disclosure of the invention."A p ...
term extensions were offered to manufacturers that conducted trials of drugs that would be used in children. The Pediatric Research Equity Act of 2003, Congress codified the FDA's authority to mandate manufacturer-sponsored pediatric drug trials for certain drugs as a "last resort" if incentives and publicly funded mechanisms proved inadequate.


Trials in Irish institutions

During the 1960s and 1970s, a series of vaccine trials were undertaken on 123 young children at several residential institutions in
Ireland Ireland ( ; ga, Éire ; Ulster Scots dialect, Ulster-Scots: ) is an island in the Atlantic Ocean, North Atlantic Ocean, in Northwestern Europe, north-western Europe. It is separated from Great Britain to its east by the North Channel (Grea ...
. The trials were conducted under the auspices of researchers at
University College Dublin University College Dublin (commonly referred to as UCD) ( ga, Coláiste na hOllscoile, Baile Átha Cliath) is a public research university in Dublin, Ireland, and a collegiate university, member institution of the National University of Ireland ...
.The Forgotten Children
Irish Independent, 20 Aug 2010
Subsequent investigations by the Irish government, including the
Commission to Inquire into Child Abuse The Commission to Inquire into Child Abuse (CICA) was one of a range of measures introduced by the Irish Government to investigate the extent and effects of abuse on children from 1936 onwards. Commencing its work in 1999, it was commonly known ...
, revealed a broad lack of documentation pertaining to the conduct of the trials at the institutions and the nature of any informed consent, as well as a failure to follow up with the participants.Report of the Inter-Departmental Group on Mother and Baby Homes
, Irish Government Department of Children and Youth Affairs, pp 17-20 The commission's investigations in this area were abruptly halted after legal action was taken by the researchers involved.


See also

*
Clinical trials Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
*
Ethics Ethics or moral philosophy is a branch of philosophy that "involves systematizing, defending, and recommending concepts of right and wrong behavior".''Internet Encyclopedia of Philosophy'' The field of ethics, along with aesthetics, concerns m ...
* Ethics in clinical research *
Human experimentation in the United States Humans (''Homo sapiens'') are the most abundant and widespread species of primate, characterized by bipedalism and exceptional cognitive skills due to a large and complex brain. This has enabled the development of advanced tools, culture, a ...
*
Philosophy of Healthcare The philosophy of healthcare is the study of the ethics, processes, and people which constitute the maintenance of health for human beings. (Although veterinary concerns are worthy to note, the body of thought regarding their methodologies and pr ...
* Pregnant women in clinical research


References

{{DEFAULTSORT:Ethical Problems Using Children In Clinical Trials
Children A child ( : children) is a human being between the stages of birth and puberty, or between the developmental period of infancy and puberty. The legal definition of ''child'' generally refers to a minor, otherwise known as a person younger ...
Clinical research ethics