Children in Medical ResearchChildren in Medical Research

We are We are reluctantreluctant to use children in to use children in research because (1) they are less research because (1) they are less able than adults to protect able than adults to protect themselves, and (2) there is a themselves, and (2) there is a greater possibility of long-term greater possibility of long-term physical and psychological harm.physical and psychological harm.

But we But we mustmust use children because use children because (1) there are biological differences (1) there are biological differences between children and adults, and (2) between children and adults, and (2) some problems are some problems are uniqueunique to to children.children.

““Vulnerable” subjects: children, Vulnerable” subjects: children, prisoners, pregnant individuals, those prisoners, pregnant individuals, those with dementia or mental disability.with dementia or mental disability.

Well-known example of research Well-known example of research involving children: case at Willowbrook involving children: case at Willowbrook State Hospital (NY, 1954-1970)State Hospital (NY, 1954-1970)Facts of the case (to be presented in Facts of the case (to be presented in class).class).

In In defendingdefending the research at the research at Willowbrook, Drs. Krugman, Giles, Willowbrook, Drs. Krugman, Giles, and Hammond made these points:and Hammond made these points:

Children used as subjects were not Children used as subjects were not made worse off than they otherwise made worse off than they otherwise would have been.would have been.

Children benefited.Children benefited. Parental consent was obtained.Parental consent was obtained.

Criticisms of the Willowbrook research:Criticisms of the Willowbrook research:

1.1. Even if the children “benefited,” the Even if the children “benefited,” the research was nontherapeutic.research was nontherapeutic.

2.2. Parental consent was not freely Parental consent was not freely given.given.

3.3. Mentally retarded children should not Mentally retarded children should not be used as subjects if competent be used as subjects if competent adults could be used.adults could be used.

4. Researchers took advantage of the 4. Researchers took advantage of the children who were in an already bad children who were in an already bad situation. The only reason they were situation. The only reason they were not made worse off by participating not made worse off by participating is because the status quo was so is because the status quo was so bad. The researchers bad. The researchers exploitedexploited the the children.children.

ResponseResponse to the fourth objection: to the fourth objection: Critics are being too Critics are being too idealisticidealistic. .

Researchers are gaining important Researchers are gaining important knowledge that will help everyone, knowledge that will help everyone, especially individuals in the group especially individuals in the group from which the subjects are from which the subjects are procured. [procured. [UtilitarianUtilitarian justification] justification]

The same issues raised by criticism The same issues raised by criticism (4) of the Willowbrook study were (4) of the Willowbrook study were present in the Tuskegee Syphilis present in the Tuskegee Syphilis Study. Some said that since the men Study. Some said that since the men could not afford standard treatment could not afford standard treatment anyway, the researchers were not anyway, the researchers were not making them worse off.making them worse off.

This same issue is being raised by This same issue is being raised by research in research in developingdeveloping countries. countries.

Example: In one study, a drug for Example: In one study, a drug for preventing transmission of HIV from preventing transmission of HIV from a pregnant pt to her fetus was being a pregnant pt to her fetus was being tested. The control group received a tested. The control group received a placebo, even though a drug known placebo, even though a drug known to be effective in reducing such to be effective in reducing such transmission was available (though transmission was available (though notnot in the country where the study in the country where the study was done).was done).

Example: In a study in Uganda, Example: In a study in Uganda, researchers were examining researchers were examining transmission of HIV in heterosexual transmission of HIV in heterosexual partners (where one is +). No partners (where one is +). No treatment was given to the HIV+ treatment was given to the HIV+ person. The justification: subjects person. The justification: subjects would not have received the would not have received the treatment if they were not in the treatment if they were not in the study.study.

Concerning research in developing Concerning research in developing countries: If persons are knowingly countries: If persons are knowingly made worse off by their participation, made worse off by their participation, then the protocol is ethically then the protocol is ethically problematic.problematic.

But if no one is knowingly made But if no one is knowingly made worse off by participating, there is a worse off by participating, there is a disagreement about this research.disagreement about this research.

DefendersDefenders of the research: of the research: Nobody is made worse off knowingly Nobody is made worse off knowingly

by participating in the study.by participating in the study. Those randomized to the Those randomized to the

experimental group are apt to be experimental group are apt to be better off.better off.

The research is likely to produce The research is likely to produce knowledge that will help many.knowledge that will help many.

CriticsCritics of the research: of the research: It is It is exploitativeexploitative (taking advantage of (taking advantage of

people who are in dire straits).people who are in dire straits). Because of literacy problems, there Because of literacy problems, there

are doubts about informed consent.are doubts about informed consent. There are doubts about whether There are doubts about whether

consent is freely given.consent is freely given.

Critics say that when HCPs encounter Critics say that when HCPs encounter persons who have serious health persons who have serious health problems, they have a problems, they have a role-relatedrole-related obligation to provide them with help. obligation to provide them with help. In this research, those randomized to In this research, those randomized to the control group are being betrayed.the control group are being betrayed.

Another criticism: If people from Another criticism: If people from North America and Europe want to North America and Europe want to benefit from this research (as they benefit from this research (as they probably will), they should be willing probably will), they should be willing to bear their share of the burdens by to bear their share of the burdens by participating in it.participating in it.

To quell criticisms, some drug To quell criticisms, some drug companies have made a companies have made a commitment to make newly tested commitment to make newly tested drugs (if effective) available to all drugs (if effective) available to all persons who need them in the persons who need them in the countries where the research was countries where the research was conducted.conducted.

For how long? Is this enforceable?For how long? Is this enforceable?