The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

What Is “Minimal Risk” For Research with Children?

Conducting clinical research with children is necessary to ensure that children are prescribed safe and effective medications.  However, children are legally prohibited and ethically unable to consent to clinical research.  As a result, clinical research with children requires more careful ethical analysis and oversight.

According to federal regulation, clinical research with children is generally acceptable if it involves only minimal risk, and satisfies certain other ethical criteria.  Research that subjects children to greater than minimal risk may only be approved under certain specified circumstances, such as when the research offers the prospect of direct benefit to the participant.

So the question is – how do we define minimal risk? 

Federal regulation of human subject research protections defines minimal risk as no greater than the degree or likelihood of harm a child would face during everyday life or during a routine physical or psychological exam. 

However, the regulations do not specify the circumstances of the child who serves as a comparator in the definition.  What kind of neighborhood does the child live in?  Does the child have a chronic health problem, like severe allergies, that requires frequent tests and exams?  It is easy to see how, depending on the circumstances of the child referred to in the regulation, the procedures that qualify as minimal risk could vary dramatically. 

Several national committees, including the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1977, the National Human Research Protections Advisory Committee in 2001, and the Secretary’s Advisory Committee on Human Research Protections in 2005, have added more specificity to the interpretation of “minimal risk.” 

According to these national commissions’ interpretation, minimal risk should be no greater than the risk a healthy child, living in a safe environment encounters daily or during a routine medical exam.  This interpretation brings more clarity to what qualifies as minimal risk.  The Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) accepted this interpretation in its recent report, Safeguarding Children: Pediatric Medical Countermeasure Research.

Blood draws are generally considered minimal risk.  The most common side effect from a blood draw is pain from the needle stick; other effects are rare, and even the discomfort is short-lived and mild.  However, research that involves many blood draws over a short period, and might deplete blood volume, might be more than minimal risk.

Another way to determine whether a procedure is minimal risk is to assess what conditions might result.  For example, conditions such as redness or moderate soreness at an injection sight are minor and considered minimal risk.  However, fever or malaise that results in missed days of school is greater than minimal risk. 

Procedures that might have severe and lasting effects are not generally considered minimal risk.  Some examples include skin biopsies, bronchoscopies, and lumbar punctures.

The more specific definition of minimal risk can help to clarify federal human subject research protection regulations.  Using the refined consensus interpretation of minimal risk, established by several national committees and accepted by the Bioethics Commission, is central to reviewing and approving ethical pediatric research.

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About blog.Bioethics.gov

This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

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