Science & Research
-
Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
Background
Guidance documents included under the umbrella title of FDA Information Sheets represent the agency's current thinking on protection of human subjects in research. The date following the title of each document represents the most recent update for that subject. Many documents were last updated prior to the enactment of good guidance practice requirements. As further updates become necessary, reformatting of some documents may therefore be necessary. While most will still be included under the umbrella of Information Sheets, some may be accessible separately after update.
-
General
- Frequently Asked Questions
(1998) - IRB Information Sheets--Research and Review (Updated 9/98) -- Cooperative Research
(1998) - Non-local IRB Review
(1998) - Sponsor - Investigator - IRB Interrelationship
(1998) - Foreign Clinical Studies, Acceptance of
(2001) - Charging for Investigational Products
(1998) - Recruiting Study Subjects
(1998) - Payment to Research Subjects
(1998) - Screening Tests Prior to Study Enrollment
(1998) - Informed Consent, A Guide to
(1998) - Use of Investigational Products When Subjects Enter a Second Institution
(1998) Exception from Informed Consent Requirements for Emergency Research (PDF - 309KB)
(2011)- "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices
(1998) - IRB Continuing Review After Clinical Investigation Approval, Guidance for IRBs, Clinical Investigators, and Sponsors (PDF - 145KB)
(2012)
-
-
Drugs and Biologics
- Emergency Use of an Investigational Drug or Biologic
(1998) - Treatment Use of Investigational Drugs
(1998) - Waiver of IRB Requirements for Drug and Biological Product Studies (PDF - 35KB)
(2006) - Drug Study Designs
(1998) - Evaluation of Gender Differences
(1998) - Frequently Asked Questions – Statement of Investigator (Form FDA 1572) (PDF - 105KB)
(2010)
-
-
-
-
-
-
-
