Freedom of Information (FOIA) Resources

This section of our web site provides several resources:

1. The indices of CIRCARE's collection of documents released under the Freedom of Information Act (FOIA), the Access to Information Act (ATI), or acquired from litigation related to questionable, potentially unethical, affirmatively unethical, noxious, and lethal research on human subjects.
2. Resources for finding information previously released under FOIA.
3. Practical suggestions for requesting records under FOIA along with addresses of federal agencies likely to be of interest in human research protections.

We've collected thousands of documents showing what can happen to research subjects when there are no laws to protect them. If the endless catalogue of injury and violations is alarming, more alarming is the monotonous regularity with which they occur. We're working on a searchable online database for our FOIA documents in the hope that public disclosure will have a salutary educational effect and raise public awareness of the need for a comprehensive National Human Research Protections Act. In the interim, please browse the indices below or use search the search form at the top of this page.

How to Use the Freedom of Information Act

Tips For Making Requests for Records /Information Under the Freedom of Information Act Including correspondence addresses for FOIA requests from the Food and Drug Administration (FDA), the Office For Human Research Protections (OHRP), and the National Institutes of Health (NIH).

Finding Information Already in the Public Domain

Previous Disclosures Under the Freedom of Information Act Where to find information released by the Food and Drug Administration (FDA), the Office For Human Research Protections (OHRP), and the National Institutes of Health (NIH), and information about financial relationships (e.g., lobbying, corporation, taxes, and charitable organizations).

U.S. Food and Drug Administration (FDA) We've alphabetized and organized FDA warning letters by recipient and type of research (drug, medical device, pediatric study, clinical investigators, IRBs, sponsors, and CROs) to make it easier to locate useful information from the FDA web site.

FDA Warning Letters to Institutional Review Boards (IRBs)
FDA Warning Letters to Clinical Investigators (A – E)
FDA Warning Letters to Clinical Investigators (F – L)
FDA Warning Letters to Clinical Investigators (M – R)
FDA Warning Letters to Clinical Investigators (S – Z)
FDA Warning Letters to Sponsors and Contract Research Organizations (CROs)
Form FDA 483s Notices of Inspectional Findings
Early Cases of Clinical Investigator Misconduct in FDA-Regulated Research
Consent Forms
NDA 20-823 Novartis Exelon

Physician Discipline

State Medical and Osteopathic Licensing Boards
State Medical Board Orders: Physician Conduct in Research and Related Issues

EmpowerPlus Research

EmpowerPlus Research Introduction
EmpowerPlus Research 1: Alberta Science and Research Authority Funding, Drug Manufacture, Trademarks, and Corporations
EmpowerPlus Research 2: University of Calgary ATI Records; Health Canada Clinical Trials License Application
EmpowerPlus Research 3: Clinical Trials, Ethical Approval, Funding, Consent Forms, and Publications
EmpowerPlus Research 4: Health Canada ATI Disclosures ATI File Number A-2001-0845/ms
EmpowerPlus Research 5: Health Canada ATI Disclosures ATI File Number A-2002-00199/ms
EmpowerPlus Research 6: EmpowerPlus Visits The Parliament of Canada
EmpowerPlus Research 7: Health Canada Litigation, Warnings/Advisories, Health Canada Health Hazard Evaluation, Media Articles, and Press Releases
Truehope Nutritional Support Ltd., Synergy Group of Canada, Empowerplus® — Health Canada ATIP A200800462
EmpowerPlus Research Document Index (No discussion. Just the documents identified by ATIP number, institution, and date.)

Miscellaneous FDA Correspondence, IRB, and Clinical Trial Documents

TGN1412 Tegenero AG Clinical Trial
Index of Documents Disclosed Under FOIA by UCLA re: Research on Induced Malaria for HIV/AIDS
Index of FOIA Documents Related to Henry Heimlich M.D. and Induced Malaria Research
Index of Miscellaneous Documents Awaiting Final Organization / Great Lakes College of Clinical Medicine IRB (Studies, IRB documents, and correspondence with FDA, and more.)

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Last Updated: 2012-08-12

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