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Ealth STUDY NUMBER: STUDY TITLE: PRINCIPAL INVESTIGATOR: Effects of Single Dose of in Attention Deficit Hyperactivity Disorder: A functional magnetic resonance study Latest IRB Review: New Protocol Latest Amendment Approved:N/A Standard Parent of Healthy Child Page 1 of 8 INTRODUCTION We invite you and your child to take part in a research study at the National Institutes of Health (NIH). First, we want you to know that: Taking part in NIH research is entirely volunt.

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Because your child is a minor, you may be legally required to give informed consent allowing them to participate. Your child may also need to give their assent after having the trial explained to them in an age-appropriate manner.

PEDIATRIC RESEARCH EQUITY ACT3 The Pediatric Research Equity Act amends the federal Food, Drug, and Cosmetic Act to authorize the FDA to require pediatric studies of drugs or biologics when other approaches are insufficient to ensure that the products are safe and effective for use in children.

Clinical trials help provide reliable evidence needed when studying medical products to diagnose, prevent, treat, and sometimes even cure, childhood diseases. Children who participate in these research studies may also potentially benefit from the medical products under investigation.

Key issues Many pharmaceutical agents are used off-label in children without guidance to clinicians for dosage initiation or adjustment. The lack of dosing guidance stems from ethical, pharmacological, statistical and economic challenges to studying pharmaceutical agents in children.

For research that is FDA-regulated, a waiver of documentation of consent may be granted only: When the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside the research context.

Children should become a part of any studies that directly involve things that will have an impact on their life. A child's voice is just as important as the voice of the adults in their lives and the voice of the researcher.

Requirements for parental permission serve the ethical obligation of investigators to respect and protect vulnerable individuals. Provisions for involving children in discussions about research participation and seeking their assent, when appropriate, attest to respect for children's developing autonomy.

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines pediatric patients as persons aged 21 or younger at the time of their diagnosis or treatment. Pediatric subpopulations are further categorized as follows: Neonates - from birth through the first 28 days of life. Infants - 29 days to less than 2 years.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232