Ethics of peds countermeasure research discussed

Ethics of peds countermeasure research discussed
Pediatric research on medical countermeasures should present no more than minimal risk to participants, and should follow a specific framework if there is a minor increase over minimal risk, according to a perspective piece published online March 19 in the New England Journal of Medicine.

(HealthDay)—Pediatric research on medical countermeasures should present no more than minimal risk to participants, and should follow a specific framework if there is a minor increase over minimal risk, according to a perspective piece published online March 19 in the New England Journal of Medicine.

Amy Gutmann, Ph.D., from the Presidential Commission for the Study of in Washington, D.C., discusses the ethical considerations pertaining to pediatric research on medical countermeasures designed for use in response to chemical, biologic, radiologic, or nuclear attacks.

Gutmann notes that pre-event research can be considered ethical if it presents no more than minimal risk to participants and poses no significant threat to the child's health or well-being. A minor increase over minimal risk is only acceptable if research is likely to yield generalizable knowledge about participants' specific condition or under exceptional circumstances. A framework for ethical considerations of research includes specific circumstances; for example, that the research is of vital importance for addressing a serious problem. A rigorous set of five categories of conditions was developed to ensure that research adheres to 'sound ethical principles.' In addition, informed and developmentally appropriate assent by children are necessary. Different ethical and apply to post-event research which directly benefits participants, but should be limited to minimal risk if possible.

"Sound science must always respect our to protect children from unnecessary risks," Gutmann writes. "Medical countermeasure research warrants an ongoing national conversation to ensure an unwavering commitment to safeguard all children both from unacceptable risks in research and through research promoting their health and well-being."

More information: Full Text

add to favorites email to friend print save as pdf

Related Stories

Panel debates bioterrorism protection for children

May 17, 2012

(AP) -- The Obama administration is asking a presidential commission to help decide an ethical quandary: Should the anthrax vaccine and other treatments being stockpiled in case of a bioterror attack be tested in children?

Ethical oversight needed for social network health research

Mar 12, 2013

Participant-led research, such as studies conducted via social networks, are increasingly common and have several advantages over more standard research but there are some concerns about their ethical oversight, according ...

New ethical guidelines needed for dementia research

Mar 29, 2010

How do we handle the ethical dilemmas of research on adults who can't give their informed consent? In a recent article in the journal Bioethics, ethicist Stefan Eriksson proposes a new approach to the dilemma of including dement ...

Recommended for you

PCV13 recommended for 6- to 18-year-olds at high risk

6 hours ago

(HealthDay)—Pneumococcal conjugate vaccine 13 (PCV13) should be administered to certain children aged 6 through 18 years who are at high risk of invasive pneumococcal disease (IPD), according to a policy ...

Brain abnormality found in group of SIDS cases

Nov 25, 2014

More than 40 percent of infants in a group who died of sudden infant death syndrome (SIDS) were found to have an abnormality in a key part of the brain, researchers report. The abnormality affects the hippocampus, ...

Eczema cases rising among US children

Nov 24, 2014

(HealthDay)—A growing number of children are being diagnosed with the allergic skin condition eczema—but it can usually be eased with topical treatments, according to a new report.

Adult-sized ATVs deadly for kids, report shows

Nov 24, 2014

(HealthDay)—Santa might think twice about giving kids an all-terrain vehicle this year. Riding ATVs poses high risks of injury or death for children and teens, with dangers differing by age, a new U.S. ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.