 | This article has multiple issues. Please helpimprove it or discuss these issues on thetalk page.(Learn how and when to remove these messages) (Learn how and when to remove this message)
|
| Regulation of therapeutic goods in the United States |
|---|
 |
| Prescription drugs Over-the-counter drugs |
International coordination |
Non-governmental organizations |
Inhealth care, aclinical trial is a comparison test of amedication or other medical treatment (such as amedical device), versus aplacebo (inactive look-alike), other medications or devices, or the standard medical treatment for a patient's condition.
To beethical, researchers must obtain the full and voluntaryinformed consent 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 aminor child this is typically a parent or guardian since as under the age of 18 cannot legally give consent to participate in a clinical trial.
According toInternational Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human UseGood clinical practice, all trials involving unapproved medical treatments are reviewed for ethics before the study begins. These approving groups are typically calledInstitutional Review Boards (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.
TheWorld Medical Association'sDeclaration of Helsinki requires researchers to take special care with consent involving vulnerable subject populations which have barriers to informed consent. These groups includeminors, prisoners, and the mentally ill.
U.S. Food and Drug Administration (FDA) andOffice for Human Research Protections regulations require the IRB to make specific "Subpart D" determinations[1] regarding children. To approve the trial, it must meet all of the following conditions:
If not all of those criteria are met, the FDA commissioner or the Secretary ofDepartment of Health and Human Services must then consult appropriate experts and can approve the trial if both:
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.
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.[2] 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.[3]
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, for example, is a potentially fatal complication ofaspirin therapy in children that is very rare in adults.
The 2002 Best Pharmaceuticals for Children Act, allowed the FDA to requestNational Institutes of Health-sponsored testing for pediatric drug testing, although these requests are subject to NIH funding constraints.Patent 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.[4]
During the 1960s and 1970s, a series of vaccine trials were undertaken on 123 young children at several residential institutions inIreland. The trials were conducted under the auspices of researchers atUniversity College Dublin.[5] Subsequent investigations by the Irish government, including theCommission to Inquire into Child Abuse, 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.[6] The commission's investigations in this area were abruptly halted after legal action was taken by the researchers involved.[5]
