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" Protecting the health and informed consent rights of children since 1982. "

 

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November 23, 2002

 

AAP Provides Form for Non-Vaccinators

Smallpox Vaccine For Children

 

A news alert from Pediatric News discusses the new form that pediatricians

are using for non-vaccinators. The article says, " The consent form confirms

that the physician and the parent have discussed a particular vaccine and

the types of diseases it prevents. By signing the form, parents are

acknowledging that they understand the purpose of the recommended vaccine,

its risks and benefits, and the consequences of nonvaccination. "

 

To obtain a copy of the " Refusal to Vaccinate " form, go to

www.cispimmunize.org/pro/pdf/RefusalToVaccinate.pdf, or call 888-227-1770.

 

The November, 2002 issue of Pediatric News is available online at

http://www.epediatricnews.com/

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Smallpox Trials on Children: Comments Needed

 

(October 31, 2002) The Office for Human Research Protections (OHRP) and the

Food and Drug Administration (FDA) are soliciting public review and comment

on a proposed research protocol entitled " A Multicenter, Randomized Dose

Response Study of the Safety, Clinical and Immune Responses of Dryvax

Administered to Children 2 to 5 Years of Age " as announced in Federal

Register Vol. 67, No. 211 Thursday October 31, 2002 Page 66403, available

for review on the OHRP website at:

<http://ohrp.osophs.dhhs.gov/dpanel/fr1031.pdf>. This proposed research

would include children as research subjects. Experts in relevant disciplines

have reviewed the protocol, but prior to the Secretary, HHS, and

Commissioner, FDA, making a final determination on whether this clinical

investigation may proceed, public review and comment are hereby solicited

pursuant to HHS regulations at 45 CFR 46.407 and FDA regulations at 21 CFR

50.54. Materials are available for review on the OHRP website at:

http://ohrp.osophs.dhhs.gov/dpanel/dpindex.htm. Public comment on the

proposed research protocol should be submitted to:

http://www.fda.gov/dockets/ecomments. Received comments may be viewed on

the FDA website at:

http://www.fda.gov/ohrms/dockets/dockets/02n0466/02n0466.htm

 

 

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News is a free service of the National Vaccine Information

Center and is supported through membership donations. Learn more about

vaccines, diseases and how to protect your informed

consent rights http://www.909shot.com

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