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== Three RCTs in Africa ==
The NIH funded the three major RCTs being used by the WHO to endorse circumcision as HIV prevention: One in Orange Farm, South Africa under the supervision of French circumcision proponent [[Bertran Auvert]]<ref>{{REFjournal |last=Auvert |first=B, . |last2=Taljaard |first2=D, . |last3=Lagarde |first3=E, . |last4=Sobngwi-Tambekou |first4=J, |last5=Sitta |first5=R, et al. ( |etal=yes |date=2005) |title=Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 trial. |journal=PLoS Med |volume=2: |issue=e298. [ |url=http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020298 Full Text] |DOI=10.1371/journal.pmed.0020298}}</ref>, one in Kenya under the supervision of North American circumcision proponent [[Robert C. Bailey]] and [[Stephen Moses]]<ref>{{REFjournal |last=Bailey RC, |first=R.C. |last2=Moses |first2=S, . |last3=Parker CB, et al |first3=C.B. |etal=yes |title=Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. |journal=Lancet |date=2007; |volume=369: |pages=643-56. [656 |url=http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(07)60312-2/abstract Abstract]}}</ref>, and one in Uganda under the supervision of North American circumcision proponent [[Ronald H. Gray]]<ref>{{REFjournal |last=Gray RH |first=R. H. |last2=Kigozi |first2=G, . |last3=Serwadda |first3=D, et al. |etal=yes |title=Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. |journal=Lancet |date=2007; |volume=369: |pages=557-66.566}}</ref>.
== Other Projects ==
== Response from NIH ==
{{Citation
| Title=When inquired about their involvement, an intactivist received this response | Text=This is in response to your email dated June 30, 2010, to Dr. Francis S. Collins, M.D., Ph.D., Director of the National Institutes of Health (NIH), concerning clinical trial #NCT01115335l, “Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia,” and the premise upon which it was designed. That is, that circumcision prevents the transmission of HIV infection. Your email has been forwarded to the National Institute of Allergy and Infectious Diseases (NIAID), the NIH component with primary responsibility for research on HIV/AIDS.
The World Health Organization/Joint United Nations Program on HIV/AIDS has concluded that the research evidence that male circumcision is efficacious in reducing sexual transmission of HIV from women to men is compelling, and that it has been proven beyond reasonable doubt. (http://data.unaids.org/pub/Report/2007/mc_recommendations_en.pdf) Their report and additional information is available on male circumcision for HIV prevention at www.malecircumcision.org. This Web site/clearinghouse is a service of the World Health Organization (WHO), the Joint United Nations Programme on HIV/AIDS (UNAIDS), the AIDS Vaccine Advocacy Coalition (AVAC), and Family Health International (FHI).
Office of Communications and Government Relations<br>
'National Institute of Allergy and Infectious Diseases'
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== NICHD funded studies ==
The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is presently funding a five-year (2009-2013), $465,108 'study' entitled "HIV PREVALENCE, SEXUAL BEHAVIOR, AND ATTITUDES TOWARD CIRCUMCISION AMONG COLOMBIA" (sic) with the stated aim of investigating "individual, social, and structural influences on HIV risk and serostatus among men who have sex with men (MSM) in Bogota, Colombia...Moreover, it will evaluate the protection against HIV afforded by circumcision among MSM in Colombia"<ref>[{{REFweb |url=http://projectreporter.nih.gov/project_info_description.cfm?icde=0&aid=7495232 |title=Project Information 1R01HD057785-01A1]}}</ref>.
== Office of Inspector General (OIG) investigations of NIAID commercial partnerships ==
{{Citation
| Title= | Text=NIAID initially funded only $35.3 million of the $134.8 million Contract obligation with fiscal year 2001 appropriations. NIAID obligated a total of $99.5 million in violation of the bona fide needs rule: $19.5 million of fiscal year 2002 appropriated funds, $22.4 million of fiscal year 2003 appropriated funds, $23.4 million of fiscal year 2004 appropriated funds, $22.7 million of fiscal year 2005 appropriated funds, and $11.5 million of fiscal year 2006 appropriated funds. In addition, when it awarded a fiscal year 2007 Contract modification for nonseverable services, NIAID initially funded only $40.3 million of the $220.5 million contract obligation with fiscal year 2007 appropriations. Because the Contract was a nonseverable service contract, which represents a single undertaking and provides for a single outcome, NIAID was required to record the full amount of the Contract using fiscal year 2001 or fiscal year 2007 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. NIAID complied with the purpose requirements of appropriations statutes.
...
In written comments on our draft report, NIH agreed that an Antideficiency Act violation had occurred but did not concur with our findings and recommendations regarding the characterization of the Contract as a nonseverable service contract. While the Contract may contain severable elements, we maintain that, on balance, the Contract is nonseverable. We determined that the Contract was overall nonseverable based on the language describing the tasks included in the statement of work.
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On the 21 September 2011, the OIG published it's results from two separate audits of NIAID contracts with Avecia Biologics Limited and NexBio, Inc. The reports read in part:<ref>{{REFweb
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{{Citation
| Title= | Text=Our review found that during fiscal years 2003 through 2009, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time and amount requirements specified in appropriations statutes in administering contract N01-AI-3-0052 (the Contract) with Avecia Biologics Limited.
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NIAID funded only $40.0 million of the $71.3 million initial Contract obligation with fiscal year 2003 appropriations. NIAID obligated a total of $31.3 million in violation of the bona fide needs rule: $26.0 million of fiscal year 2004 appropriated funds and $5.3 million of fiscal year 2005 appropriated funds. Because the Contract was for nonseverable services, NIAID was required to record the full amount of the Contract using fiscal year 2003 appropriated funds. By not doing so, NIAID potentially violated the Antideficiency Act. (When services are severable they are continuing and recurring and chargeable to the fiscal year in which the services are provided.)
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{{Citation
| Title= | Text=Our review found that during fiscal years 2006 through 2009, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time requirements and may not have complied with the amount requirements specified in appropriations statutes in administering contract HHSN266-2006-00015C (the Contract) with NexBio, Inc.
...
NIH concurred with the findings that the Contract is nonseverable and that it should have been funded at the time the Contract was awarded. NIH said that the Department of Health and Human Services would report the violation as required. NIH did not address our recommendations to correct the improper funding for the first 4 years of the Contract.
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{{Citation
| Title= | Text=NIAID violated both the bona fide needs rule and the Antideficiency Act by obligating funds in advance of an appropriation. The initial contract action obligated fiscal year 2008 funds for a period of approximately 14 months (March 1, 2008, through April 30, 2009). Subsequent modifications obligated fiscal year 2008 and 2009 funds through May 31, 2011. Because the Contract was for severable services, NIAID should have obligated only those fiscal year 2008 funds needed for program year 1 and only those fiscal year 2009 funds needed for program year 2.
Additionally, NIAID violated the bona fide needs rule by obligating more funds than it needed for program year 1 and using those funds to pay for costs incurred after program year 1. Using the program year estimates provided in the Contract as evidence of the bona fide need, NIAID must resolve these violations by deobligating $16.9 million ($23.7 million less $6.8 million) of fiscal year 2008 funds that were obligated in excess of the agency's bona fide need for program year 1 and obligating the appropriate fiscal year funds for the program years in which the services were provided. If NIAID does not have adequate fiscal year funds available, it will violate the Antideficiency Act for these fiscal years as well.
NIH did not address our recommendations to correct the improper funding for the first 2 program years of the Contract. Until NIH makes these adjustments, HHS cannot report the correct amount of its Antideficiency Act violation. Therefore, we continue to recommend that NIH record the correct Contract obligations and expenditures against the correct fiscal year funds.
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{{Citation
| Title= | Text=During fiscal years 2005 through 2008, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time and amount requirements specified in appropriations statutes in administering contract HHSN266-2005-00022C (the Contract) with PPD Development, LP. An agency may obligate appropriations for goods and services when (1) the purpose of the obligation or expenditure is authorized, (2) the obligation occurs within the time limits for which the appropriation is available, and (3) the obligation and expenditure are within the amounts provided by Congress. Federal statutes specify that a fiscal year appropriation may be obligated only to meet a legitimate, or bona fide, need arising in or continuing to exist in the appropriation's period of availability. The Antideficiency Act prohibits an agency from obligating or expending funds in advance of or in excess of an appropriation unless specifically authorized by law.
NIAID violated the bona fide needs rule when it recorded expenditures against the wrong fiscal years. NIAID recorded expenditures for each program year against funds obligated for 1 or more previous program years. NIAID may not use funds remaining from any program year for costs incurred in subsequent program years and should record expenditures for each program year against the appropriate fiscal year appropriations. Because it recorded expenditures on a first-in-first-out basis against inappropriate fiscal year funds, NIAID failed to identify and properly obligate funds for its bona fide need in any program year.
NIH concurred with the findings and agreed that the Contract is severable and should have been funded with the appropriation that was current when the services were performed. HHS reported the Antideficiency Act violation as required by 31 U.S.C. § 1351. However, NIH did not concur with our recommendations to correct the improper funding for the Contract. NIH stated that the Contract had expired and was being closed.
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{{Citation
| Title= | Text=During fiscal years 2003 through 2008, NIH's National Institute of Allergy and Infectious Diseases (NIAID) did not comply with the time and amount requirements specified in appropriations statutes in administering contract N01-AI-30068 (the Contract) with PPD Development, LP. An agency may obligate appropriations for goods and services when (1) the purpose of the obligation or expenditure is authorized, (2) the obligation occurs within the time limits for which the appropriation is available, and (3) the obligation and expenditure are within the amounts provided by Congress. Federal statutes specify that a fiscal year appropriation may be obligated only to meet a legitimate, or bona fide, need arising in or continuing to exist in the appropriation's period of availability. The Antideficiency Act prohibits an agency from obligating or expending funds in advance of or in excess of an appropriation unless specifically authorized by law.
NIAID violated the bona fide needs rule when it recorded expenditures against the wrong fiscal years. NIAID failed to deobligate the unneeded fiscal year 2003 funds remaining from program year 1. Instead, NIAID inappropriately used the remaining fiscal year 2003 funds for program year 2 expenditures. Subsequently, NIAID recorded expenditures for each program year against funds obligated for 1 or more previous program years. Because it recorded expenditures on a first-in-first-out basis against inappropriate fiscal year funds, NIAID failed to identify and properly obligate funds for its bona fide need in succeeding program years. In addition, NIAID violated the Antideficiency Act by obligating funds in advance of an appropriation. NIAID funded the Contract in compliance with the purpose requirements of the appropriations statutes.
NIH concurred with the findings and agreed that the Contract is severable and should have been funded with the appropriation that was current when the services were performed. HHS reported the Antideficiency Act violation as required by 31 U.S.C. § 1351. However, NIH did not concur with our recommendations to correct the improper funding for the Contract. NIH stated that the Contract had expired and was being closed.
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{{Citation
| Title= | Text=Our review found that during fiscal years 2003 through 2007, NIH's Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) did not comply with the time and amount requirements specified in appropriations statutes in administering contract HHSN275-03-3345 (the Contract) with Westat, Inc. (Westat). An agency may obligate appropriations for goods and services when (1) the purpose of the obligation or expenditure is authorized, (2) the obligation occurs within the time limits for which the appropriation is available, and (3) the obligation and expenditure are within the amounts provided by Congress. Federal statutes specify that a fiscal year appropriation may be obligated only to meet a legitimate, or bona fide, need arising in or continuing to exist in the appropriation's period of availability. The Antideficiency Act prohibits an agency from obligating or expending funds in advance of or in excess of an appropriation unless specifically authorized by law.
NICHD initially funded only $31.0 million of the $164.7 million contract obligation with fiscal year 2003 appropriations. NICHD obligated a total of $133.7 million in violation of the bona fide needs rule: $33.2 million of fiscal year 2004 appropriated funds, $33.3 million of fiscal year 2005 appropriated funds, $33.5 million of fiscal year 2006 appropriated funds, and $33.7 million of fiscal year 2007 appropriated funds. Because the Contract was a nonseverable service contract (a single undertaking that provides for a single outcome chargeable to the fiscal year in which the contract was awarded), NICHD was required to record the full amount of the Contract using fiscal year 2003 appropriated funds. By not doing so, NICHD potentially violated the Antideficiency Act. (When services are severable, they are continuing and recurring and chargeable to the fiscal year in which the services are provided.) NICHD complied with the purpose requirements of appropriations statutes.
We recommended that NICHD (1) deobligate $33.2 million of fiscal year 2004 funds and $33.3 million of fiscal year 2005 funds and return the canceled funds to the Treasury; (2) deobligate $33.5 million of fiscal year 2006 funds and $33.7 million of fiscal year 2007 funds; (3) record the remaining $133.7 million of the $164.7 million contract obligation against current fiscal year appropriations; (4) report an Antideficiency Act violation if sufficient current year appropriations are not available; and (5) report, in accordance with 31 U.S.C. § 1554, the adjustment to the Contract using current fiscal year appropriations. NIH agreed that a bona fide needs violation had occurred and admitted violating the Antideficiency Act but disagreed with our characterization of the Contract as a nonseverable service contract. While the statement of work may contain severable elements, we maintain that, on balance, the Contract is nonseverable.
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{{Citation
| Title=| Text=Our review found that during fiscal years 2007 through 2009, NIH's National Institute on Drug Abuse (NIDA) did not comply with the time and amount requirements specified in appropriations statutes in administering contract HHSN271-2007-00009C (the Contract) with Charles River Laboratories, Inc.
[...]
NIH did not address our recommendations to correct the improper funding for the first 3 program years of the Contract. Until NIH makes these adjustments, HHS cannot report the correct amount of its Antideficiency Act violation. Therefore, we continue to recommend that NIH record the correct Contract obligations and expenditures against the correct fiscal year funds.
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{{Citation
| Title= | Text=For all 38 Clinical and Translational Science Awards (CTSA) cooperative agreements awarded from 2006 through 2008, CTSA program staff did not document awardees' progress in compliance with NIH policy.
CTSA program staff must ensure that awardees submit annual progress reports and financial status reports, determine whether awardee progress remains satisfactory before awardees receive continued funding, and maintain official files in accordance with Department of Health and Human Services (HHS) policy. Additionally, under cooperative agreements, CTSA program staff provide assistance to awardees above and beyond the levels usually required for program stewardship of grants. This level of stewardship is known as substantial involvement. CTSA program staff assign NIH Project Scientists to awardees to provide this substantial involvement through technical assistance, advice, and coordination. Names of substantially involved staff and an annual summary of staff involvement should be documented in the official files.
We recommend that NIH ensure that CTSA program staff (1) document their monitoring of awardee progress; (2) ensure timely submission of required reports; (3) maintain official files in accordance with Federal policy; and (4) as required for cooperative agreements, provide substantial involvement to CTSA awardees. NIH concurred with our recommendations.
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== Weird Science science ==
"NIH video reveals the science behind yoga"<ref>{{REFweb
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{{Citation
| Title= | Text=A video featuring research on how yoga works, the safety of yoga and whether yoga can help treat certain health problems is being released by the National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health (NIH).
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This is the second installment in NCCAM's The Science of Mind and Body Therapies video series. The first video, Tai Chi and Qi Gong for Health and Well-Being, was released in September 2010.
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== Continuing advocating for more circumcision ==
From a National HIV Vaccine Awareness Day statement dated 18 May 2011 by Anthony S. Fauci, M.D., Director of NIAID (emphasis added):<ref>{{REFweb
|last=Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health
{{Citation
| Title= | Text=To speed the pace at which promising HIV vaccine candidates become viable for evaluation in large clinical trials, NIAID is exploring the use of innovative or adaptive clinical trial designs that let scientists quickly modify ongoing trials in response to data acquired during the study. Such flexibility in trial design will allow the research community to maximize efficiencies in studying vaccine candidates.
[...]
No matter how effective a preventive HIV vaccine is, however, we will need to evaluate and administer it in combination with other biomedical and behavioral HIV prevention tools. No single HIV prevention strategy will control and ultimately end the HIV/AIDS pandemic. That is why it is important for NIAID to continue supporting promising research on vaginal and rectal microbicides, pre-exposure prophylaxis (PrEP) and expanded HIV testing with linkage to care. That is also why public health workers will continue to advocate and implement scientifically proven HIV prevention strategies such as condom use, medically supervised adult <strong>male circumcision</strong>, harm-reduction strategies for injection drug users and the prevention of mother-to-child transmission of HIV.
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