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Guidance
Institutional:
Advertisements for Recruiting Subjects (PDF)
- Example Advertisement for Recruiting (PDF)
Approval Periods (PDF)
Involvement of Prisoners in Behavioral Research (PDF)
Magnetic Resonance Imaging (MRI Scan) (PDF)
Pregnant Subjects Withdrawn From Clinical Studies (DOC)
Research Involving Examination of Medical Records (PDF)
Screening of Research Participants (PDF)
- Script for Screening Research Participants (DOC)
Social Security Number Collection in Research (PDF)
Stamping Documents (PDF)
Federal:
FDA: Guidance on Investigator Responsibilities (PDF)
FDA: Guidance on Protecting the Righs and Safety of Study Subjects (PDF)
DHHS-OHRP Information and Guidance
FDA Information and Guidance
Institutional Review Board Guidebook (OHRR)
Certificates of Confidentiality Kiosk NIH Office of Extramural Research
Contacts for Certificates of Confidentiality
Contacts for Certificates of Confidentiality - Frequently asked questions
NIH Policy on Children in Research Projects
Office of Biotechnology Activities
Belmont Report
Nuremberg Code
Declaration of Helsinki
Definitions of Terms in Clinical Trials (PDF)
Glossary of Human Subjects Terminology
http://research.ucdavis.edu/home.cfm?id=OVC,1,1081,1433,1064
NIH Definitions
http://clinicaltrials.gov/ct/info/glossary
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