WE SEEM TO HAVE FORGOTTEN ABOUT THE 40 OTHER DELIBERATE INFECTION STUDIES DONE IN THE US - IS ME/CFS/RETROVIRUS FAMILY ONE OF THEM??? "Forty similar deliberate-infection studies were conducted in [/COLOR]the United States during that period, Collins said." U.S. apologizes for 1940s STD study in Guatemala WASHINGTON (AP) American scientists deliberately infected prisoners and patients in a mental hospital in Guatemala with syphilis 60 years ago, a recently unearthed experiment that prompted U.S. officials to apologize Friday and declare outrage over "such reprehensible research." The U.S. government-funded experiment, which ran from 1946 to 1948, was discovered by a Wellesley College medical historian. It apparently was conducted to test whether penicillin, then relatively new, could prevent infection with sexually transmitted diseases. The study came up with no useful information and was hidden for decades. Two members of President Barack Obama's Cabinet apologized to the Guatemalan government for the tests, and the White House press secretary, Robert Gibbs, said the medical experimentation was "shocking, it's tragic, it's reprehensible." Obama telephoned Guatemalan President Alvaro Colon to apologize personally. The government researcher who led the work in Guatemala also was involved in this country's infamous Tuskegee experiment, where from 1932 to 1972 scientists tracked 600 black men in Alabama who had syphilis but did not know it, without ever offering them treatment. "We are outraged that such reprehensible research could have occurred under the guise of public health," Secretary of State Hillary Rodham Clinton and Health and Human Services Secretary Kathleen Sebelius said Friday. Strict regulations today make clear that it is unethical to experiment on people without their consent and require special steps for any work with such vulnerable populations as prisoners. But such regulations did not exist in the 1940s. Guatemalan Embassy official Fernando de la Cerda said his country had known nothing about the experiment until Clinton called to apologize Thursday night. "We appreciate this gesture from the USA., acknowledging the mistake and apologizing," he said. "This must not affect the bilateral relationship." Strict today's regulations make clear that it is unethical to experiment on people without their consent and require special steps for any work with such vulnerable populations as prisoners. But such regulations did not exist in the 1940s. The U.S. government ordered two independent investigations to uncover exactly what happened in Guatemala and to make sure current bioethics rules are adequate. They will be led by the prestigious Institute of Medicine and the Presidential Commission for the Study of Bioethical Issues. The U.S. government ordered two independent investigations to uncover exactly what happened in Guatemala and to make sure current bioethics rules are adequate. They will be led by the prestigious Institute of Medicine and the Presidential Commission for the Study of Bioethical Issues. While deliberately trying to infect people with serious diseases is abhorrent today, the Guatemalan experiment is not the only example from what National Institutes of Health Director Dr. Francis Collins on Friday called "a dark chapter in the history of medicine." Forty similar deliberate-infection studies were conducted in the United States during that period, Collins said. In Guatemala, 696 men and women were exposed to syphilis or in some cases gonorrhea, through jail visits by prostitutes or, when that did not infect enough people, by deliberately inoculating them, reported Wellesley College historian Susan Reverby. Those who were infected were offered penicillin, but it was not clear how many were infected and how many were treated successfully. She reported that the United States had gained permission from Guatemalan officials to conduct the study, but did not inform the experimental subjects. Reverby's work was reported first by NBC News. She uncovered the records of Dr. John Cutler, a prominent government scientist of the 1940s, while researching the Tuskegee experiment for a recent book. She posted on her website a copy of an article about the findings that is to be published in January in an academic journal. A speech she gave on her findings last spring alerted government health officials to her findings, resulting in Friday's apology. The revelation of abuses by a U.S. medical research program is only the latest chapter in the United States' troubled history with the impoverished Central American nation, which has a per capita gross domestic product about half that of the rest of Central America and the Caribbean. The U.S. helped topple the democratically elected president Jacobo Arbenz in 1954 and backed several hard-line governments during a 36-year civil war that ended in 1996 and cost 200,000 lives. Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. ----------------------------------------------------------------------------------------- "The U.S. government ordered two independent investigations to uncover exactly what happened in Guatemala and to make sure current bioethics rules are adequate. They will be led by the prestigious Institute of Medicine and the Presidential Commission for the Study of Bioethical Issues. The U.S. government ordered two independent investigations to uncover exactly what happened in Guatemala and to make sure current bioethics rules are adequate. They will be led by the prestigious Institute of Medicine and the Presidential Commission for the Study of Bioethical Issues. While deliberately trying to infect people with serious diseases is abhorrent today, the Guatemalan experiment is not the only example from what National Institutes of Health Director Dr. Francis Collins on Friday called "a dark chapter in the history of medicine." Forty similar deliberate-infection studies were conducted in the United States during that period, Collins said. "... She uncovered the records of Dr. John Cutler, a prominent government scientist of the 1940s, while researching the Tuskegee experiment for a recent book." NIHinfo@od.nih.gov http://www.nih.gov/icd/od/foia/ Freedom of Information Act Office The NIH FOIA Staff welcomes you to the NIH FOIA Home Page. We hope you will find this site informative and that it will give you a better understanding of NIH's public information programs. We will continue to improve this site to bring you current program information. NIH FOIA Staff Susan R. Cornell, Freedom of Information Officer and Chief FOIA Liaison, NIH Connie A. Wivel, Senior FOIA Specialist and FOIA Requester Service Center Contact, NIH Brenda J. Butler, FOIA Specialist, NIH ^ top Welcome The NIH FOIA office generally handles three different categories of requests: requests for information maintained by the Office of the Director, NIH requests that involve trans NIH issues or initiatives unless a specific IC has responsibility requests for information that will not be released because it is protected by one or more of the FOIA's nine exemptions or three exclusions While all requests may be sent to the NIH FOIA Office, each of NIH's separate Institutes and Centers has its own FOIA Coordinator. Requesters should direct requests for information about a specific NIH component to that component. A list of the FOIA Coordinators for each component is available at this site for your convenience. Background/Overview The Freedom of Information Act ("FOIA"), 5 U.S.C. 552, provides individuals with a right to access to records in the possession of the federal government. The government may withhold information pursuant to the nine exemptions and three exclusions contained in the Act. The Electronic FOIA ("E-FOIA") Amendments which President Clinton signed into law in 1996, amended the law in several ways, including: extend from 10 to 20 business days (excluding holidays) the time agencies must respond to requests for information; require agencies to make reasonable efforts to make records available in formats desired by requesters; require agencies to submit the NIH FOIA Annual Report by fiscal year; require agencies to make the reports available to the public by computer telecommunications or other electronic means; require agencies to list their major information systems, record locator systems, and a reference guide or guide for obtaining information; and require agencies to establish electronic reading rooms that include agency policies, staff manuals, opinions made in the adjudication of cases, and an index of records released by FOIA that are likely to become the subject of subsequent FOIA requests. these amendments have to be implemented by specific dates. Guide for Submitting FOIA Requests Before submitting FOIA requests, individuals should ensure that the information they seek is not already in the public domain. Each of NIH's components has information available in both published format and electronically. A search of the NIH Home Page can assist requesters in locating information and lists of available publications. Such a search can also help requesters identify the component(s) most likely to have responsive documents so FOIA requests can be sent to the appropriate component for response. A list of the NIH Institutes and Centers is available at this site to assist you. A list of the FOIA Coordinators for each component also is available at this site for your convenience. FOIA requesters interested in obtaining information on federally funded biomedical research projects should consult the Computer Retrieval of Information on Scientific Projects (CRISP) database. This will enable requesters to identify the grant number and the component funding the research in their FOIA request. In 1999 the Office of Management and Budget issued final revisions to Circular A110 to provide for access to data produced under grants awarded by the National Institutes of Health and other federal awarding agencies. To the extent you are interested in requesting data produced under a National Institutes of Health grant pursuant to the provisions of Office of Management and Budget (OMB) Revised Circular A110, please understand that the provisions of Revised Circular A110 apply to data: first produced under a new or competing continuing grant awarded after the Department of Health and Human Services amended 45 C.F.R. 74 to incorporate the changes mandated by the Revised Circular (April 17, 2000); and cited publicly and officially by the Federal Government in support of an agency action that has the force and effect of law. In addition, if the data you request are already available to the public through an archive or other source, we will not process your request under the FOIA. In that situation, we will refer you to the archive or other source. More information regarding NIH implementation of Revised Circular A110 may be found at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. With all FOIA requests, if the information you are interested in is not in the public domain, please follow the suggestions listed below when preparing your FOIA request: identify the records requested (be as specific as possible, i.e., describe the subject matter of the records, and, if known, indicate the dates of the records, the places where they originated, and the names of the originating persons or offices); state that the records are requested under the Freedom of Information Act; include daytime telephone numbers in case additional information is needed before answering requests; and forward all requests either to the appropriate FOIA Coordinator or to the NIH FOIA Office by one of the methods listed below: if you are requesting data produced under an NIH grant, include the following information in your request: the federal regulation or administrative order that cited the data being requested; the publication and/or reference cited in the federal regulation; the grant number under which the data were produced (this information can be obtained from the CRISP database; a description of the data sought; and a statement that the data are being requested under OMB Revised Circular A110. Mail the request (mark the outside of the envelope, "FOIA Request") either to the appropriate FOIA Coordinator or to the NIH FOIA Office: Freedom of Information Office, NIH Building 31, Room 5B35 9000 Rockville Pike Bethesda, MD 20892 OR Fax the request to the FOIA Office at (301) 402-4541. If the requester knows which component has responsive documents, the FOIA request should be sent directly to the FOIA Coordinator for that component. A list of the FOIA Coordinators for NIH components and their addresses is included at this site. Individuals with questions concerning their requests may contact the FOIA Coordinator to whom they sent their request or the NIH FOIA Office at 301-496-5633. Requesters may also contact the appropriate FOIA Requester Service Center or FOIA Public Liaison with questions or for a status update of their request. Requests for Grants and Contract documents: If you are requesting a copy of a funded grant application or an awarded contract with associated documents, you should understand that NIH routinely redacts certain information from those documents before we release them. More information about these routine redactions can be found at this site. Just click on the type of document that interests you: grants or contracts. ^ top Guide for Submitting FOIA Appeals FOIA requesters may appeal the denial of information within 30 days of receipt of letters from the agency. Appeals should state the following information: the reasons why the requested information should be released under the Act; and why the denial may be in error. FOIA requesters should attach copies of their original requests and response letters to all appeals, clearly mark the letters and the outside envelopes, "FOIA Appeal, " and mail appeals to the following address: Deputy Assistant Secretary for Public Affairs (Media) U.S. Department of Health and Human Services Parklawn Building, Room 17-66 5600 Fishers Lane Rockville, MD 20857 ^ top Fees The Freedom of Information Act provides for the agency to recover part of the cost associated with responding to a request. The Department Regulations set out the specific rules for fees and for requesting a fee waiver or a reduction in fees. Some general principles apply to all requests such as: if you are going to request a fee waiver or a reduction in fees, you must do so when you file your initial request for documents. you may be charged for search time even if we do not locate any documents responsive to your request or if the documents we locate are denied to you under one of the FOIA's exemptions. there will not be a charge if the cost of responding to your request is less than $25. If a determination is made that fees will be charged, the following fee schedule will be used to calculate the exact cost of search and review time: if the work is performed by an agency employee Grade 1-8, you will be charged $5.75 for each 15 minutes worked. if the work is performed by an agency employee Grade 9-14, you will be charged $11.50 for each 15 minutes worked. if the work is performed by an agency employee Grade 15 or above, you will be charged $20.75 for each 15 minutes worked. In addition, if you are requesting data produced under a NIH grant under the provisions of OMB Revised Circular A110, you will be charged a reasonable fee equaling the full incremental cost of obtaining the data. This fee will reflect the costs incurred by NIH, the grantee institution and the grantee investigator. These fees will be in addition to any fees assessed by NIH under the FOIA. ^ top FOIA Requester Service Centers and FOIA Public Liaisons Requesters may have questions or want to know the status of their request. All questions about a pending request, including those for a status may be directed to the FOIA Coordinator to whom the request was submitted. In addition, NIH and each of its components has a FOIA Requester Service Center available to answer questions or to provide a status regarding a pending request. For more efficient service, questions and inquiries should be directed to the Service Center contact for the NIH component to which the request was submitted. A complete listing of the FOIA Requester Service Center contacts is available at this site. If, after contacting the appropriate FOIA Requester Service Center, a requester wants more information about a request, NIH and each component also has a FOIA Public Liaison who is available to provide information regarding FOIA requests. The listing of the FOIA Public Liaisons is included with the listing of FOIA Requester Service Center contacts. ^ top Exemptions The Freedom of Information Act provides that the agency will provide access to identifiable documents within our possession unless one of nine exemptions or three exclusions applies. The exact language of the exemptions can be found in the Freedom of Information Act. Additional guidance on the exemptions and how they apply to certain documents can be found in the Department Regulations implementing the FOIA. ^ top NIH Reading Rooms On-Site Reading Room The NIH On-Site Reading Room (RR) contains a variety of documents that come from several of the Institutes and Centers at the NIH. The documents are indexed with an identifying number to assist users in locating the document(s) of interest. The Index of Documents is available at this site for your convenience. Documents cited with an asterisk (*) are available for viewing in the RR, which is located in Building 31, Room 5B-35. The hours of operation are 10:00 a.m. to 4:00 p.m., Monday through Friday (closed on Federal holidays). A copy machine is available for users to duplicate documents of particular interest. Documents without an asterisk are presently stored off-site and can be retrieved for viewing upon specific request. Please contact the FOI Office to make arrangements to view one or more of these documents.