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State and federal agencies are usually happy to comply with FOIA requests, although we should point out that our collective experience has been mixed, ranging from cheerful friendly responses within a week to surly delayed responses taking years to complete. Refusal to release records is rare, but interminable waits are not. Private organizations tend to vary wildly in their policies. Based on our experience we offer information, suggestions, and tips to increase the likelihood your FOIA request will produce useful, complete information in a timely fashion. We also suggest what to avoid and why.
• Make sure the information you want hasn't been released already.
Federal agencies can legitimately refuse to send you information they've already released. By law the agencies are required to have
Reading Rooms
where documents released under FOIA are collected. Reading Rooms often have an online equivalent – look for the
Electronic Reading Room
or
EFOIA
on government web sites, and check carefully to make sure the information you want isn't already available. The FDA web site maintains an excellent collection online, as does the Securities and Exchange Commission. See if the information you want is already indexed and linked on our web site. Check the following pages at CIRCARE:
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
(External) Office For Human Research Protections / Determination Letters
If you're reasonably sure the records you want haven't already been disclosed, your next step is to figure out where the records are and how to request copies of them.
• Send your request to the correct person or office.
An agency or institution is under no obligation to comply with FOIA requests sent to the wrong office or employee. Check the web site or telephone and ask for the name and address of the person to whom FOIA requests should be sent. In our experience most, but not all, organizations will re-direct your request to the correct office or tell you how do this.
• Make sure your request is legible.
• Type your correspondence if possible.
• Use standard business format for addressing.
• Include your full address, daytime telephone number, and email address. Provide a fax number if possible.
• Clearly indicate your letter is a request under the Freedom of Information Act. Include a sentence above the salutation like
Request for Information Under the Freedom of Information Actin bold-face or underlined text.
FOIA officers are human beings and often swamped with requests and hampered by arcane filing systems. To the extent your request is intelligible and provides contact information in the event clarification is necessary, you'll minimize delay.
• Write a civil business-like letter avoiding language that could be interpreted as libelous or threatening.
Requests for records under the Freedom of Information Act are themselves subject to disclosure under the act. These are generally referred to as
reverse FOIA
requests.
Do not make accusations or statements in a FOIA request that essentially or actually libel an individual or organization. If you're angry or upset, put the request aside for a few days or ask a trusted friend to read it before you send it. Re-read your letter of request before sending it. If you would be embarassed (or worse) if the request was made public, considering editing it.
• Indicate the amount of money you're willing to pay and ask to be contacted if (or when) the cost of your request is more than this. Generally speaking, a FOIA request for a single record might indicate the requester is willing to pay up to $25; a request for multiple records (e.g.,
All records related to Sam's Widgets, Inc. between 1990 and 2006) might indicate you're willing to paying up to $250, depending upon the number of records and their size. Federal agencies charge nonprofit organizations and consumers lower fees, so don't forget to indicate this where applicable.
You should expect to pay reasonable fees for copying and the time it takes staff to locate records. If you make a request that's likely to include several hundred pages of records, decide how much you can afford to pay and ask the agency or organization to contact you when (or if) charges reach this amount. Some federal agencies will do this automatically when fees hit $250; others don't. If cost is a concern it's safer to specify in advance how much you're willing to pay. Costs range from nothing to thousands of dollars, and as a rule federal agencies charge less than private organizations. In fact some federal agencies don't charge anything for requests totaling less than a certain amount ($10, for example) because such requests cost more to bill than can be recouped in fees.
While uncommon, it's not unheard of for an institution to try to dissuade FOIA requests with outrageous fees. If you receive an estimate so astronomical that no private citizen could realistically afford to pay it, inspect the estimate carefully. How many pages are there? How many hours will it take to locate the information and what is the hourly rate for this? Is this a standard fee at the institution or agency? Find the per-page copying fee — is it appropriate? Most agencies and institutions allow
reasonable
charges for copying. Keep in mind that
reasonable
may be significantly more than you pay for copying at your local office supply store. Do these charges add up? What is the institutional FOIA policy? Can you appeal FOIA charges at a later date? If, after considering these things and asking for clarification, you still find the price out of reach, there are several options. Consider how to pare down your request by figuring out which, if any, of the records requested are likely to be refused or disclosed with so many redactions as to amount to non-disclosure. In theory an institution
could
present you with a bill for several hundred blank pages of redacted records. If you genuinely believe an institution is using FOIA charges to prevent disclosure of something particularly messy, it's probably time to seek help from state or federal regulatory agencies, the media, or your elected representatives.
• Describe the information you want.
• Specify the information you're requesting by identifying or describing the records you want.
• Identify the record(s) you're requesting by name whenever possible.
The single most important thing to keep in mind when making a FOIA request is that the Freedom of Information Act pertains to records , rather than to information per se. To get information under FOIA, you have to request records that contain the information you want. Identifying records is easier said than done, and often requires familiarity with a specific industry, agency, and applicable regulations. Agencies and private institutions comply with FOIA requests by releasing records, and to a lesser extent, by answering specific questions. Ideally FOIA requests should identify records (documents) wanted. If you ask questions, make sure they are likely to elicit factual answers.
For example, a request asking
Why did you conduct this ghastly clinical trial
is likely to yield unhelpful information (
Because the
IRB
approved it
may be factually accurate, but useless). Such a request might be rejected because it does not ask for records or documents. A request for institutional review board meeting minutes, complete study protocol, consent form, associated attachments, including all versions of same, study budget, annual reviews, and all correspondence between the investigator and
IRB
is a comprehensive description of records related to the study you're interested in. Whether or not an institution would release any or all of these records is anyone's guess. If you want as much information as possible, include a request for
All correspondence in any media reasonably related to X.
State laws differ in terms of what information can be released. Generally speaking, it's easier to get information under FOIA from federal agencies than from private institutions.
Federal agencies are generally very helpful about identifying records and explaing which records can be disclosed. When you're uncertain about what records exist or the names of records, call and ask before making your request. Federal agencies publish FOIA policies and related information on their web sites, and there is often a telephone number for questions about FOIA requests. In any case you should briefly consult the FOIA policy of an agency or institution before you make a request.
• Expect some redactions and refusals.
Agencies and institutions are legally prohibited from disclosing certain information, or disclosing it without permission from the relevant parties. Broadly speaking, you won't get proprietary information or anything that could be considered a trade secret, educational records, information related to an open investigation, personal or financial information (including salaries, personnel records, medical records, and social security numbers), unrelated third-party information, or information submitted to agencies in confidence.
• Find out what records (if any) were refused, and why.
To make sure you know about any records that were withheld and the basis upon which they were withheld, include a sentence in your request like
If the agency decides to withhold any record(s) or redact any information from the record(s), please identify the legal basis you assert for each such decision.
• Read between the lines.
A response indicating that
No records exist responsive to your request
is disappointing, but
differs
from a response in which an agency or institution refuses to disclose multiple records requested or parts thereof. If you submitted a comprehensive request for records related to a particular study (see above), the latter response suggests the study at least went through
IRB
review and approval, while the former suggests serious non-compliance. To whatever extent possible, you should try to figure out what records
should
exist in terms of applicable federal regulations before you make a FOIA request.
In the Addresses section below we list records you might want to ask for in FOIA requests related to research. Once an agency receives your request, you'll receive a letter indicating this and assigning your request a case number. You'll usually get this letter several weeks after you file a FOIA request, but don't get too excited because it's often many weeks weeks if not months until you receive the actual records. If you feel you've waited too long, send a letter of inquiry. If this doesn't get results, send a second letter with copies to your senator and congressional representative if you've made a request to a government agency. Include the FOIA case number assigned to your request in all correspondence. If this fails, you're left with the option of filing a lawsuit. The costs involved make such litigation impossible for most individuals.
• Consider using a professional FOIA service.
Several companies offer FOIA retrieval services for a flat fee, and some offer free consultations. If time is short and cost isn't a major constraint, professional help can be a good choice. One such company is linked on our
Previous FOIA Disclosures page
(e.g., FOI Services Inc., because their web site has useful resources); you can find other providers by searching the web for
FOIA services.
The Reporters Committee for Freedom of the Press (RCFP) has an on-line FOI letter generator that asks for basic information and produces a letter to download and print.
RCFP FOI Letter Generator: (External) http://www.rcfp.org/foi_letter/generate.php
Below is a simple model letter for making a request under the Freedom of Information Act. There is no single best model for writing FOIA requests and you shouldn't feel obligated to follow our model.
CIRCARE sample FOIA request (Microsoft Word file): http://www.circare.org/FOIA/samplefoiarequest.doc
To download free viewers for Microsoft Access®, Excel®, Powerpoint®, and Word® files follow this link to (External) Microsoft Office® OnlineCIRCARE sample FOIA request (PDF file): http://www.circare.org/FOIA/samplefoiarequest.pdf
Office For Human Research Protections (OHRP)
Ms. Darlene Christian
PHS FOIA Office, Parklawn Building, Room 17A-46
5600 Fishers Lane
Rockville, MD 20857
Telephone: (301) 443-5252
Fax: (301) 443-0925
U.S. Food and Drug Administration (FDA)
Food and Drug Administration Staff
Division of Freedom of Information (DFOI)
5600 Fishers Lane, Parklawn (PKLN) Building
HFI-35, Room 12A-16
Rockville, MD 20857
Telephone: (301) 827-6500
Fax: (301) 443-1726
Confirm fax receipt / fax problems: (301) 443-2414
(External) FDA FOIA Handbook: A Handbook for Requesting Information and Records from FDA
new alert 2008-03-15: FDA Freedom of Information Act (FOIA) main page: (External) http://www.fda.gov/foi/default.htm
FDA FOIA Contacts: (External) http://www.fda.gov/foi/contacts/default.htm
Form FDA 483 Notice of Inspectional Findings. A list of violations and objectionable conditions provided to sponsors, investigators, institutional review boards (IRBs), and organizations after inspection.
Form FDA 483 example: Form FDA 483 Issued to Alkis Togias M.D., Johns Hopkins Asthma & Allergy Clinic. 2001-06-28. Available from (External) http://www.fda.gov/ora/frequent/483s/JohnHopkins483.html
FDA Establishment Inspection Reports (EIRs). Narrative report of inspectional findings. Copies of records made during FDA inspections are included in the List of Exhibits at the end of
EIRs
. If you want records in an EIR's List of Exhibits, indicate you want the
Establishment Inspection Report and all records in the List of Exhibits.
FDA EIR example: FDA Establishment Inspection Report (EIR), Great Lakes College of Clinical Medicine IRB. 1999-12-01. Available from http://www.circare.org/foia2/glccm_fdaeir19991201.pdf
Hint: Form FDA 483s are relatively short, perhaps two to five pages. FDA EIRs are long detailed reports (35 to 100 pages). The fee you're charged for a FOIA request may include per-page copying fees so try to decide how much information you really need.
FDA Warning Letters.
A Warning Letter is an informal advisory, to a firm or clinical investigator, communicating the Agency's position on a matter but does not commit FDA to taking enforcement action. A Warning Letter is issued for significant regulatory violations that require prompt and adequate corrective actions.
FDA Center for Drug Evaluation and Research, Division of Scientific Investigations. Accessed 2006-03-19 from (External)
http://www.fda.gov/cder/Offices/DSI/enforcement.htm
Hint: For FDA warning letters issued after November, 1996 see the CIRCARE indices (above) of alphabetized warning letters issued to clinical investigators, institutional review boards (IRBs), sponsors and contract research organizations (CROs).
To find dates and results of FDA inspections of clinical investigators in drug studies use the FDA Center for Drug Evaluation and Research (CDER) Clinical Investigator Inspection List search or download the data file. To find FDA inspections of clinical investigators in biologic studies (cell and tissue-derived products, vaccines, products tested in gene transfer research, etc.), consult the FDA Center for Biologic Research and Evaluation Clinical (CBER) Investigator Inspection List.
Help! I still don't know what records to ask for.
To find documents and records created by FDA related to inspection, compliance, and enforcement activities, try the following:
Browse the FDA Office of Regulatory Affairs Investigations Operations Manual (2004): (External) http://www.fda.gov/ora/inspect_ref/iom/iomtc.html In particular chapters 5,
Establishment Inspections,and 9,Investigations,to get an idea of what information FDA collects.Consult the FDA Investigations Operations Manual's
List of Exhibitsto find the name of specific FDA forms on which information gathered during inspection is recorded: (External) http://www.fda.gov/ora/inspect_ref/iom/Contents/exhibits_toc.htm
To locate documents and records submitted to FDA, try the following, keeping in mind that not all of them are subject to disclosure under FOIA:
NIH FOIA requests are handled by the coordinator(s) of the NIH institute or center that funded (or sponsored) the research. Consult the list of names and addresses of NIH Freedom of Information Office Coordinators and send your request to the NIH FOIA coordinator for the NIH institute or center that funded the research in which you're interested: (External) http://www.nih.gov/icd/od/foia/coord.htm
NIH FOIA requests will be processed more quickly if you include the complete study title, grant award identification number(s), and the name of the principal investigator and institution.
Use the NIH CRISP database to find grant award identification numbers and titles of studies: (External) http://crisp.cit.nih.gov/
If you don't know which institute or center funded the research, you should be able to find this information by searching for the name of the principal investigator in the NIH CRISP database: (External) http://crisp.cit.nih.gov/
Hint: If you have little or no information, set the default search options to
all
and select the last five years as the search period.
Try searching for the principal investigator or her institution in the annual listing of NIH Extramural Awards by State & Foreign Site: (External) http://grants1.nih.gov/grants/award/state/state.htm
If you know the study title, try searching the NIH Guide: (External) http://grants1.nih.gov/grants/guide/index.html
You may be able to find information by searching ClinicalTrials.gov: (External) http://www.clinicaltrials.gov/ct/screen/SimpleSearch
You can find clinical trials sponsored by NIH using ClinicalTrials.gov Focused Search. Click the box for NIH in the
Supported Byfield: (External) http://www.clinicaltrials.gov/ct/screen/AdvancedSearchYou can browse clinical trials by NIH center or institute: (External) http://www.clinicaltrials.gov/ct/screen/BrowseAny?path=%2Fbrowse%2Fby-sponsor%2FNIH&recruiting=true
Hint: To find clinical trials that are completed or no longer recruiting subjects, check the box labeled
Include trials that are no longer recruiting patients.
Also useful are:
If all else fails, contact the NIH FOIA coordinator for the most likely NIH institute or center to check before you send a request.
Indicate in your request whether or not you're willing to accept records in electronic form.
Grant applications (also called
PHS 398 forms
), study protocols, consent forms, and grant award records.
Hint: Specify that you want the
final version of the study protocol
in case changes were required.
Rosters of reviewers for Study Sections or Special Emphasis Panels.
Reviewer rosters for permanent Study Sections and current (e.g., 30 days) Special Emphasis panels are published by the NIH Center for Scientific Review: (External) http://www.csr.nih.gov/Committees/rosterindex.asp
Last Updated: 2008-04-15
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