|
|
| Line 1: |
Line 1: |
| − | [[Image:NIH.jpg|right|thumb]] | + | #REDIRECT [[National Institutes of Health]] |
| − | The U.S. National Institutes of Health (NIAID, FIC, NIHCD, NCI) funded the three major RCTs being used by the [[WHO]] to endorse circumcision as HIV prevention<ref name='DOC%252525252525252525252525252525202008'>{{REFweb
| |
| − | | quote=...funding from the United States National Institutes of Health to conduct randomized controlled trials (RCTs) in Africa.
| |
| − | | url=http://www.doctorsopposingcircumcision.org/info/HIVStatement.html
| |
| − | | title=The Use of Male Circumcision to Prevent HIV Infection
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=Doctors Opposing Circumcision
| |
| − | | work=
| |
| − | | date=2008
| |
| − | | accessdate=2011-03-05
| |
| − | }}</ref>. They continue to fund further "research" and promotion of circumcision as HIV prevention in Africa.
| |
| − | | |
| − | == 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>Auvert B, Taljaard D, Lagarde E, Sobngwi-Tambekou J, Sitta R, et al. (2005) Randomized, controlled intervention trial of male circumcision for reduction of HIV infection risk: The ANRS 1265 trial. PLoS Med 2:e298. [http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020298 Full Text]</ref>, one in Kenya under the supervision of North American circumcision proponent [[Robert C. Bailey]] and [[Stephen Moses]]<ref>Bailey RC, Moses S, Parker CB, et al. Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet 2007;369:643-56. [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>Gray RH. Kigozi G, Serwadda D, et al. Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet 2007;369:557-66.</ref>.
| |
| − | | |
| − | == Other projects ==
| |
| − | | |
| − | The NIH fund other projects for the "research" and promotion of circumcision, such as the Center for Infectious Disease Research in Zambia, who in turn are collaborating with the University of Alabama, Birmingham to conduct a "study" an the "Feasibility, Acceptability, and Safety of Neonatal Male Circumcision in Lusaka, Zambia."
| |
| − | | |
| − | == 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).
| |
| − | | |
| − | You may also be interested to know that NIAID-supported research has found that medical circumcision can help heterosexual men significantly reduce their risk of acquiring two other sexually transmitted infections—herpes simplex virus type 2 (HSV2), the cause of genital herpes, and human papillomavirus (HPV), which can cause penile and cervical cancer and genital warts. (see http://www.niaid.nih.gov/about/whoWeAre/Documents/scienceadvances2009.pdf).
| |
| − | | |
| − | You are correct that in 1999, the American Academy of Pediatrics (AAP) changed from a neutral stance on circumcision to a position that the data then available were insufficient to recommend routine neonatal male circumcision. However, AAP has convened a panel to reconsider its circumcision policy in light of additional data now available. You may wish to review the most recent data that support revision of the AAP policy in the following review article, which is available from your nearest medical library: Tobian, AA et. al. “Male circumcision for the prevention of acquisition and transmission of sexually transmitted infections: the case for neonatal circumcision.” Arch Pediatr Adolesc Med. 2010 Jan;164(1):78-84.
| |
| − | | |
| − | This article also evaluates the evidence that circumcision decreases bacterial vaginosis, T vaginalis infection, and genital ulcer disease in heterosexual men’s female partners. Additionally, it discusses the plausibility of a biological basis for why male circumcision would reduce viral sexually transmitted diseases.
| |
| − | | |
| − | As to the ethics of the Zambian study, we do not believe that it violates the basic human rights of its participants. Parents must make choices for their children when they are unable to consent for themselves. Although there may be controversy over the question of whether parents can give proxy consent to non-therapeutic interventions, especially if they carry risks, there is no controversy over whether parents can give proxy consent to therapeutic interventions such as vaccines or appendectomies. The randomized clinical trial data provides assurance that male circumcision is therapeutic, unlike female circumcision. You may be interested in the position of the WHO which states that female circumcision can be very harmful and that there are not any health benefits derived from the procedure (http://www.who.int/mediacentre/factsheets/fs241/en/).
| |
| − | | |
| − | We can assure you that safeguards are in place for all NIH-supported research involving people. For instance, local committees--called Institutional Review Boards (IRBs) and Research Ethics Committees (RECs)--are required to review research to assure that the rights and welfare of study participants are protected. This review includes the equitable selection of participants, maintenance of privacy and confidentiality, minimizing coercion or undue influence, and ensuring appropriate safeguards in vulnerable participants. Committee members have knowledge of the local research context and cultural considerations. In addition, research is often conducted in adult populations to obtain safety data prior to acquiring data in vulnerable population such as children. In the case of Zambia, the Zambian Ministry of Health (MOH) oversees research. It is the MOH’‘s role to consider the ethical and public health implications of research studies within their purview. As such, the Zambian MOH is responsible for approving and implementing the WHO recommendations regarding male circumcision for HIV prevention in that country and have made the decision to do so. Since the Zambian Ministry of Health and the local IRB/REC have reviewed and approved the research study in question, the local ethical and public health issues, in their opinion, have been addressed.
| |
| − | | |
| − | We appreciate your concerns and hope that this information helps clarify the rationale for circumcision as an important component of HIV prevention.
| |
| − | | |
| − | Sincerely,
| |
| − | | |
| − | Correspondence Specialist<br>
| |
| − | Legislative Affairs and Correspondence Management Branch<br>
| |
| − | Office of Communications and Government Relations<br>
| |
| − | National Institute of Allergy and Infectious Diseases
| |
| − | | Author=
| |
| − | | Source=
| |
| − | }}
| |
| − | | |
| − | == 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
| |
| − | | quote=
| |
| − | | url=http://projectreporter.nih.gov/project_info_description.cfm?icde=0&aid=7495232
| |
| − | | title=Project Information 1R01HD057785-01A1
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=
| |
| − | | accessdate=2011-12-07
| |
| − | }}</ref>.
| |
| − | | |
| − | | |
| − | == Office of Inspector General (OIG) investigations of NIAID commercial partnerships ==
| |
| − | | |
| − | On the 10 June 2011, the OIG published it's results from an audit of a contract between the National Institute of Allergy and Infectious Diseases (NIAID) and the University of California at San Francisco, which read in part:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003120.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-15416 With the University of California at San Francisco Audit (A-03-10-03120)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=June 2011
| |
| − | | accessdate=2011-06-25
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | 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
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003117.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-3-0052 With Avecia Biologics Limited
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=September 2011
| |
| − | | accessdate=2011-10-09
| |
| − | }}</ref><ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003119.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2006-00015C With NexBio, Inc.
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=September 2011
| |
| − | | accessdate=2011-10-09
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | ...
| |
| − | | |
| − | 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.)
| |
| − | }}
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | ...
| |
| − | | |
| − | NIAID funded only $19.8 million of the $49.8 million Contract obligation with fiscal year 2006 appropriations. NIAID obligated a total of $20.0 million in violation of the bona fide needs rule: $10.0 million of fiscal year 2007 appropriated funds and $10.0 million of fiscal year 2009 appropriated funds. NIAID planned to obligate future-year appropriated funds as well. 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 is awarded), NIAID was required to record the full amount of the Contract using fiscal year 2006 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.) NIAID complied with the purpose requirements of appropriations statutes.
| |
| − | | |
| − | We recommended that NIAID (1) deobligate $10.0 million of fiscal year 2007 funds and $10.0 million of fiscal year 2009 funds, (2) record the remaining $30.0 million of the $49.8 million Contract obligation against fiscal year 2006 funds, and (3) report an Antideficiency Act violation if fiscal year 2006 funds are not available.
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | On the 31 October 2011, the OIG published it's results from an audit of a contract between NIAID and the EMMES Corporation, which read in part:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003115.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN272-2008-00013C with the EMMES Corporation (A-03-10-03115)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=October 2011
| |
| − | | accessdate=2011-09-11
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | Furthermore, although NIAID estimated that it would require $6.8 million for program year 1, at the time of our audit, it had expended only $4.9 million. NIAID may not use the remaining funds for costs incurred in subsequent program years. Rather, NIAID will need to deobligate an additional $1.9 million ($6.8 million less $4.9 million) of fiscal year 2008 appropriations if it is determined that they are no longer needed during their period of availability. NIAID funded the Contract in compliance with the purpose requirements of appropriations statutes.
| |
| − | | |
| − | ...
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | On the 14 September 2012, the OIG published it's results from two separate audits of NIAID contracts with PPD Development, LP. The reports read in part:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003118.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2005-00022C With PPD Development, LP (Audit A-03-10-03118)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=September 2012
| |
| − | | accessdate=2012-09-26
| |
| − | }}</ref><ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003116.pdf
| |
| − | | title=Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-30068 With PPD Development, LP (Audit A-03-10-03116)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=September 2012
| |
| − | | accessdate=2011-09-26
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | NIAID violated the Antideficiency Act by obligating funds in advance of an appropriation and may have violated the Antideficiency Act by obligating significantly less of appropriate fiscal year funds in program years 2 and 4 than required by either the Contract estimate or the actual expenditures incurred. Similarly, NIAID may have obligated less of fiscal years 2010 and 2011 funds than required for program years 6 and 7. NIAID funded the Contract in compliance with the purpose requirements of the appropriations statutes.
| |
| − | | |
| − | We recommended that NIAID (1) record expenditures for each program year against the appropriate fiscal year appropriations; (2) resolve its bona fide needs violations; (3) report an Antideficiency Act violation for obligating fiscal year 2005 funds in advance of an appropriation, if not previously reported; (4) report an Antideficiency Act violation if NIAID does not have $16.5 million (estimated) of fiscal year 2008 funds, $6.9 million of current fiscal year funds, and, if needed, appropriate fiscal years 2010 and 2011 funds for expenditures recorded after our review, if not previously reported; and (5) report, in accordance with 31 U.S.C. § 1554, any adjustment to the Contract using current fiscal year appropriations.
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | == Office of Inspector General (OIG) investigations of NICHD commercial partnerships ==
| |
| − | | |
| − | On the 17 October 2011, the OIG published it's results from an audit of a contract between the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and Westat, Inc., which read in part:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003106.pdf
| |
| − | | title=Appropriations Funding for Eunice Kennedy Shriver National Institute of Child Health and Human Development Contract HHSN275-03-3345 With Westat, Inc. Audit (A-03-10-03106)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=October 2011
| |
| − | | accessdate=2011-11-20
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | Background information:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003106.pdf
| |
| − | | title=Appropriations Funding for Eunice Kennedy Shriver National Institute of Child Health and Human Development Contract HHSN275-03-3345 With Westat, Inc. Audit (A-03-10-03106)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=October 2011
| |
| − | | accessdate=2011-11-20
| |
| − | }}</ref>
| |
| − | | |
| − | {{Citation
| |
| − | | Title=
| |
| − | | Text=On November 1, 2002, NICHD awarded contract HHSN275-03-3345 (the Contract), totaling $164.7 million, to Westat, Inc. (Westat), in Rockville, Maryland. The Contract required Westat to establish an international pediatric and perinatal HIV studies network-coordinating center to maintain, coordinate, and manage a network of clinical centers. These clinical centers, under subcontracts with Westat, conducted research on the treatment, prevention, diagnosis, epidemiology, and natural history of HIV infection and disease in pediatric, adolescent, and maternal patient populations.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | == Office of Inspector General (OIG) investigations of NIDA commercial partnerships ==
| |
| − | | |
| − | On the 26 October 2011, the OIG published it's results from an audit of a contract between the National Institute on Drug Abuse (NIDA) and Charles River Laboratories, Inc., which read in part:<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oas/reports/region3/31003104.pdf
| |
| − | | title=Appropriations Funding for National Institute on Drug Abuse Contract HHSN271-2007-00009C with Charles River Laboratories, Inc. (A-03-10-03104)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=October 2011
| |
| − | | accessdate=2011-11-22
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | ...
| |
| − | | |
| − | NIDA violated both the bona fide needs rule and the Antideficiency Act by obligating funds in advance of an appropriation. The initial contract action obligated funds only for program year 1 (July 9, 2007, through July 8, 2008). However, NIDA twice modified the contract to obligate fiscal year 2007 funds through July 8, 2010, and May 1, 2011, respectively. Because the Contract was for severable services, NIDA should have obligated only those fiscal year 2007 funds needed for program year 1.
| |
| − | | |
| − | Additionally, NIDA 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, NIDA must resolve these violations by deobligating $14.9 million ($20.2 million less $5.3 million) of fiscal year 2007 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 NIDA does not have adequate fiscal year funds available, it will violate the Antideficiency Act for these fiscal years as well.
| |
| − | | |
| − | Furthermore, although NIDA estimated that it would require $5.3 million for program year 1 and $5.2 million for program year 2, at the time of our audit, it had expended only $5.0 million and $4.4 million program years 1 and 2, respectively. NIDA may not use the remaining funds for costs incurred in subsequent program years. Rather, NIDA will need to deobligate an additional $0.3 million ($5.3 million less $5.0 million) of fiscal year 2007 appropriations and $0.8 million ($5.2 million less $4.4 million) of fiscal year 2008 appropriations if it is determined that they are no longer needed during their period of availability.
| |
| − | | |
| − | Our audit also determined that the NIH Office of Financial Management erroneously paid an invoice for $111,000 against the Contract. NIDA funded the Contract in compliance with the purpose requirements of appropriations statutes.
| |
| − | | |
| − | We recommended that NIDA:
| |
| − | | |
| − | (1) Record the correct obligation for each program year against the appropriate fiscal year appropriations,
| |
| − | | |
| − | (2) Record expenditures for each program year against the appropriate fiscal year appropriations,
| |
| − | | |
| − | (3) Report an Antideficiency Act violation for expending fiscal year 2007 funds in advance of an appropriation,
| |
| − | | |
| − | (4) Report an Antideficiency Act violation if adequate fiscal year 2009 and subsequent year funds are unavailable to cover obligations for subsequent program years,
| |
| − | | |
| − | (5) Return funds that were not required for program years 1 and 2, and
| |
| − | | |
| − | (6) Reverse the expenditure to the Contract for the $111,000 erroneous payment and charge the correct contract accordingly.
| |
| − | | |
| − | In written comments on our draft report, 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. NIH said that HHS would report the Antideficiency Act violation and stated that the NIH Office of Financial Management corrected the erroneously paid invoice by reversing the $111,000 payment.
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | == Office of Inspector General (OIG) investigation of the NIH's administration of the CTSA program ==
| |
| − | | |
| − | On the 20 December 2011, the OIG published a report critical of the NIH's administration of the Clinical and Translational Science Awards (CTSA) program.<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://oig.hhs.gov/oei/reports/oei-07-09-00300.pdf
| |
| − | | title=NIH Administration of the Clinical and Translational Science Awards Program (Report OEI-07-09-00300)
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=December 2011
| |
| − | | accessdate=2011-12-22
| |
| − | }}</ref> The report read in part:
| |
| − | | |
| − | {{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.
| |
| − | | |
| − | CTSA program staff documented a comparison of accomplishments to research objectives for only 1 of 38 awardees throughout our review period. Although reviews for six awardees' files mentioned an inability to fulfill goals, only one file included a note from CTSA program staff regarding resolution. Also, most progress reports and half of financial status reports were late, yet the files contained no evidence that CTSA program staff took action to address timeliness of reports. CTSA program staff did not maintain files in accordance with HHS policy. Finally, no files contained evidence that CTSA program staff provided substantial involvement to awardees in accordance with Federal requirements and NIH policy.
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | == Weird science ==
| |
| − | | |
| − | "NIH video reveals the science behind yoga"<ref>{{REFweb
| |
| − | | quote=
| |
| − | | url=http://www.nih.gov/news/health/aug2012/nccam-01.htm
| |
| − | | title=NIH video reveals the science behind yoga
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=August 2012
| |
| − | | accessdate=2012-08-02
| |
| − | }}</ref>
| |
| − | | |
| − | {{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).
| |
| − | | |
| − | ...
| |
| − | | |
| − | The video, available at http://nccam.nih.gov/video/yoga, highlights the work of two respected researchers in the field of yoga. George Salem, Ph.D., at the University of Southern California, uses innovative technology to examine how older adults use their muscles and joints in certain yoga postures. Karen Sherman, Ph.D., M.P.H, at Group Health Research Institute in Seattle, focuses on how yoga may be a beneficial complementary health practice for people with chronic low-back pain.
| |
| − | | |
| − | 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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | == 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
| |
| − | | quote=
| |
| − | | url=http://www.niaid.nih.gov/news/newsreleases/2011/Pages/HVAD2011.aspx?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+aidsgovnews+%28AIDS.gov+News+and+Events%29
| |
| − | | title=National HIV Vaccine Awareness Day May 18, 2011 Statement of Anthony S. Fauci, M.D. Director, National Institute of Allergy and Infectious Diseases National Institutes of Health
| |
| − | | last=
| |
| − | | first=
| |
| − | | publisher=
| |
| − | | work=
| |
| − | | date=May 2011
| |
| − | | accessdate=2011-06-25
| |
| − | }}</ref>
| |
| − | | |
| − | {{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.
| |
| − | | Author=
| |
| − | }}
| |
| − | | |
| − | {{REF}}
| |
| − | | |
| − | [[Category:Institutions]]
| |
| − | [[Category:Circumcision in Africa]]
| |
| − | [[Category:CircLeaks]]
| |
| − | | |
| − | [[Category:From IntactWiki]]
| |
