Resources for Patient Families

The information below is designed to help investigators initiate and manage research projects and to encourage collaboration among faculty pursuing pediatric basic and clinical research. This information includes institutional updates, education and reference sources to assist investigators in maintaining the highest scientific and ethical standards in their work.

CDER
Center for Drug Evaluation and Research Web site

ClinicalTrials.gov
The U.S. National Institutes of Health, through its National Library of Medicine, has developed a Web site to provide patients, family members and members of the public current information about clinical research studies.

Declaration of Helsinki
The World Medical Association’s recommendations guiding doctors in biomedical research involving human subjects

FDA
Food and Drug Administration Web site

FDA Science and Research Special Topics
Guidance for Institutional Review Boards and Clinical Investigators

FDA Good Clinical Practice Program
The focal point within the FDA for Good Clinical Practice issues arising in human research trials regulated by the FDA

International Conference on Harmonisation
Guideline for Good Clinical Practice

IRB Guidebook
Institutional Review Board Guidebook by the Office of Human Research Protections

IRB Forum
The Institutional Review Board - Discussion and News Forum

National Institutes of Health
Official Web site for the National Institutes of Health (NIH)

Electronic Research Administration
NIH – Electronic Submission Information (PDF)
NIH – Telephone & Services Directory
NIH – Training Programs

OHRP 
Office for Human Research Protections Web site

45 CFR 46
Department of Health and Human Services Policy on Protection of Human Subjects

21 CFR 312
Investigational New Drug Regulations