Special Protections for Vulnerable People

Special Protections for Vulnerable People Involved in a Clinical Trial
At PritzkerOlsen, P.A. , we are concerned about the current climate in clinical research. Recent deaths associated with clinical research at the University of Pennsylvania and Johns Hopkins have brought attention to the possible risks and dangers of participating in clinical trials. Children and other vulnerable people are particularly at risk.

If you or your child has been seriously harmed due to participation in a clinical trial, contact PritzkerOlsen, P.A.Call us toll-free at 1-888-377-8900, email us at info@pritzkerlaw.com, or fill out our online consultation form. We want to help you during this time when you are hurting so deeply, confused, and not knowing where to turn. We will listen and care.

Senior Partner Fred Pritzker has more than 30 years of experience giving his all for his clients. In recognition of his successes and outstanding legal skills, he has been named a Super Lawyer and has been selected for inclusion in the current edition of The Best Lawyers in America.

Below is information on federal regulations that are meant to protect children and other vulnerable people participating in clinical research.

Participation of Children in Clinical Research
Both the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) have regulations (45 CFR 46, Subpart D and 21 CFR 50) outlining the requirements for participation of children in clinical trials. By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.

For children to be involved in a clinical trial, the clinical trial decision makers must consider the potential benefits, risks, and discomforts of the research to children and assess the justification for their inclusion in the research. In assessing the risks and potential benefits, they should consider the circumstances of the children to be enrolled in the study, for example their health status, age, and ability to understand what is involved in the research. They should also consider the potential benefits to subjects, other children with the same disease or condition, or society as a whole.

Participation of Pregnant Women in Clinical Research
Recognizing the special issues surrounding research on pregnant women, HHS regulations (45 CFR 46, Subpart B) outlines considerations that must be made before a pregnant woman may participate in a clinical trial. Researchers must consider the risks to the unborn child. Possible benefits of research must outweigh these risks.

Participation of Prisoners in Clinical Research
The federal government has recognized that prisoners may be under constraints because of their incarceration to participate as subjects in research. HHS regulations on prisoner involvement in clinical trials (45 CFR 46, Subpart C) require that participation in a clinical trial be voluntary, not coerced.

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