- NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects:
http://grants.nih.gov/grants/guide/notice-files/not98-024.html - Guidance for Industry - Guidance for Human Somatic Cell Therapy and Gene Therapy:
http://www.fda.gov/cber/gdlns/somgene.pdf - Reporting forms for AE and SAE for INDs and IDEs. Additionally, Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements:
http://www.fda.gov/medwatch/getforms.htm - NIH web site about Certificates of Confidentiality:
http://grants2.nih.gov/grants/policy/coc/index.htm - The Food and Drug Administration (FDA):
http://www.fda.gov - National Center for Research Resources (NCRR):
http://www.ncrr.nih.gov - National Institutes of Health:
http://www.nih.gov - Office of Research Integrity:
http://ori.dhhs.gov - HIPAA - Office of the Secretary; Standards for Privacy of Individually Identifiable Health Information; Proposed Rule [HIPAA; 45 CFR Parts 160 and 164]:
http://www.hhs.gov/ocr/hipaa - NIH guidelines on inclusion of women and minorities as subjects in clinical research (August 2, 2000):
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html
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