2013 - Response to “Human Tissue Intended for Transplantation” [OMB control number 0910-0302, Docket ID FDA-2013-N-0797-0003]

Thank you for the opportunity to provide feedback to “Human Tissue Intended for Transplantation” [OMB control number 0910-0302, Docket ID FDA-2013-N-0797-0003]. This response document will briefly address the ethical and safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products.

Ethical and safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products

Circumcision of male minors, in the absence of a clear and present immediate medical indication, is a controversial practice within the medical profession (KNMG 2010; Smith 2011; Svoboda & Van Howe 2013). Despite this, more than 1.14 million circumcision procedures were performed on male infants in U.S. hospitals in the year 2010 (AHRQ 2013). Foreskins excised from minors in the absence of a clear and present immediate medical indication, almost invariably present in a normal healthy state, and as such their excision and preservation contributes little to the study of the pathology of disease.

Products derived from foreskins excised en masse from minors in the absence of clear and present immediate medical indications, are frequently utilised in the commercial medical product, and more especially cosmetics industries (Advanced Healing 2011; Ballantyne 2009; Business Standard 2013; LifeCell 2012; Organogenesis 2011; Pitman 2008; SkinMedica 2011). As observed by the U.S. Department of Health and Human Services Office of Human Research Protections, “Changing technology in the field of genomics has dramatically increased the amount and nature of information about individuals that can be obtained from their DNA” (OHRP 2011). Valid concerns therefore exist for the future privacy of children whose healthy tissues are likely to be acquired by commercial interests in the cosmetic and medical product industries - and may be retained indefinitely - due to presently unforeseeable technological advances in the field of genomics.

Doubts exist about the appropriateness of utilising products derived from foreskin and other healthy tissue excised from minors, in the cosmetic and medical product industries, on the basis of exculpatory consent forms signed by parents and legal guardians of minors, and whether it is appropriate for parents and legal guardians to give explicit consent for these purposes.

The provision of information to parents on circumcision consent forms about the storage, transfer, processing, sale or any other use of excised healthy foreskins is unstudied. However, a survey conducted by Schaefer et al (2011) of consent forms from U.S. in vitro fertilization clinics and the provision of information to egg donors of the potential for embryonic research using donated eggs, concluded that “egg donors in the United States, including some who may have a moral objection to research and stem cell research, are not being informed that embryos created with their donated eggs may in fact be used for these purposes”, suggesting the possibility that incomplete information is also being provided to parents about the use of foreskin and other healthy tissue excised from minors. Similarly, information about the original source of human skins cells used in cosmetic and medical products, has been ominously absent from the websites of some manufacturers who utilise foreskin-derived ingredients in their products (LifeCell 2012; SkinMedica 2011).

Cellulitis and osteomyelitis have been reported as complications in several studies drawn from the clinical literature for FDA regulated skin-substitute products incorporating foreskin-derived ingredients (AHRQ 2012). Further, as observed by Dr Ron Moy, a dermatologist at the David Geffen School of Medicine at the University of California, Los Angeles, foreskin cells can potentially carry viruses, and although foreskin fibroblasts may be screened for contamination, there is "no test that's perfect" (Ballantyne 2009).

Action Required

Future regulatory and policy decisions must address the ethical issues concerning the privacy of children whose healthy tissues are likely to be acquired by commercial interests in the cosmetic and medical product industries [due to presently unforeseeable technological advances in the field of genomics]; the extent to which parents and legal guardians can give consent for the use of foreskin and other healthy tissue excised from minors in the in the cosmetic and medical product industries; and the provision of information to parents and guardians in exculpatory consent forms. In the interim, safety concerns associated with utilitising foreskin-derived ingredients in medical and cosmetic products, mandate that full and complete disclosure in the proposed information collection activity take precedence over manufacturers professed concerns for increased regulatory and administrative 'burden'.

References

Advanced Healing (2011) Dermagraph Active Living Cells Overview Link http://www.dermagraft.com/about/overview/ Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jhakjim

AHRQ (2013) Most Frequent Procedures Performed in U.S. Hospitals, 2010 Statistical Brief #149 prepared by Pfuntner, A (Truven Health Analytics), Wier, LM (Truven Health Analytics), Stocks, C (AHRQ) February 2013 Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.hcup-us.ahrq.gov/reports/statbriefs/sb149.jsp Accessed: 2013-07-10. Archived by WebCite at http://www.webcitation.org/6I0JloBRv

AHRQ (2012) Skin Substitutes for Treating Chronic Wounds Technology Assessment Report Project ID: HCPR0610 prepared by David L. Snyder, Ph.D. (ECRI Institute EPC), Nancy Sullivan, B.A. (ECRI Institute EPC), Karen M. Schoelles, M.D., S.M., F.A.C.P. (ECRI Institute EPC) 18 December 2012 Agency for Healthcare Research and Quality, Rockville, MD Full-text available at http://www.ahrq.gov/research/findings/ta/skinsubs/HCPR0610_skinsubst-final.pdf

Ballantyne, C (2009) A Cut above the Rest?: Wrinkle Treatment Uses Babies' Foreskins Scientific American 12 February 2009 [Epub] Full-text available at http://www.scientificamerican.com/article.cfm?id=a-cut-above-the-rest-wrin Accessed: 2012-01-18. Archived by WebCite at http://www.webcitation.org/64mLMhvCA

Business Standard (2013) Circumcised foreskins may provide new baldness treatment Business Standard website 21 October 2013 Full-text available at http://www.business-standard.com/article/pti-stories/circumcised-foreskins-may-provide-new-baldness-treatment-113102100652_1.html Accessed: 2013-12-27. Archived by WebCite at http://www.webcitation.org/6MAiVH64J

KNMG (2010) Non-theraputic circumcision of male minors Royal Dutch Medical Association Full-text available at http://knmg.artsennet.nl/web/file?uuid=579e836d-ea83-410f-9889-feb7eda87cd5&owner=a8a9ce0e-f42b-47a5-960e-be08025b7b04&contentid=77976

LifeCell (2012) AlloDerm Tissue Matrix defined Full-text available at http://www.lifecell.com/alloderm-regenerative-tissue-matrix/95/ Accessed: 2012-01-18. Archived by WebCite at http://www.webcitation.org/64mqrqxmQ

OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered Office of Human Research Protections website Full-text available at http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jh4cWek

Organogenesis (2011) Apligraf: How Is It Made? Link http://www.apligraf.com/professional/what_is_apligraf/how_is_it_made/ Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jhpT91Q

Pitman, S (2008) Babies’ foreskin dubbed as new anti-aging treatment Cosmetic Design Full-text available at http://www.cosmeticsdesign.com/Formulation-Science/Babies-foreskin-dubbed-as-new-anti-aging-treatment Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64ji8mqbP

Schaefer GO, Sinaii N, Grady C (2011) Informing egg donors of the potential for embryonic research: a survey of consent forms from U.S. in vitro fertilization clinics Fertil Steril. 2011 Dec 22. [Epub ahead of print] Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22196714

SkinMedica (2011) Key Ingredients Link http://www.skinmedica.com/skin-care-products/skin-rejuvenation/tns-recovery-complex#tab2 Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jiK7Gdx

Smith JF (2011) The professional imperative for obstetrician-gynecologists to discontinue newborn male circumcision Am J Perinatol. 2011 Feb;28(2):125-8. Epub 2010 Aug 10 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed?term=20700861

Svoboda JS, Van Howe RS (2013) Out of step: fatal flaws in the latest AAP policy report on neonatal circumcision J Med Ethics. 2013 Mar 18. [Epub ahead of print] Abstract available at https://www.ncbi.nlm.nih.gov/pubmed/23508208

2013-06-10 HHS OIG - "The Vietnam Administration for HIV/AIDS Control Did Not Always Manage the President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-06-11-00057)"

Summary:

Through its Global HIV/AIDS Program, CDC implemented the President's Emergency Plan for AIDS Relief (PEPFAR), working with ministries of health and other in-country partners to combat HIV/AIDS by strengthening health systems and building sustainable HIV/AIDS programs in more than 75 countries. CDC awarded PEPFAR funds totaling $15 million and a carryover amount of $4.2 million to the Vietnam Administration for HIV/AIDS Control, the Ministry of Health (the Ministry), for the budget period September 30, 2009, through September 29, 2010.
Our audit found that the Ministry did not always manage PEPFAR funds or meet program goals in accordance with award requirements. With respect to financial management, the Ministry did not return $18,000 in interest income to CDC through the Payment Management System. In addition, $30,000 of the $434,000 in financial transactions that we reviewed was used to pay potentially unallowable value-added taxes (VAT) on purchases. Also, the Ministry did not ensure that all of the provinces obtained the tax identification (tax ID) required to receive a VAT refund or record adjustments to the general ledger account in a timely manner.
We recommended that the Ministry (1) return $18,000 in interest income to CDC, (2) work with CDC to resolve whether the $30,000 of VAT was an allowable expenditure under the cooperative agreement, (3) ensure that all provinces receive a tax ID and apply for a VAT refund, (4) record financial transactions timely, and (5) strengthen its internal controls. The Ministry generally agreed with our recommendations.

Archived URL: http://www.webcitation.org/6byIRKlZH

2013-06-24 Uganda Picks - "Mbale Residents Flee Forceful Circumcision"

Excerpt:

If you are an adult male who has been planning to visit Mbale anytime this week, then you might as well postpone your visit unless you want to be circumcised in the streets. The youth in Mbale are on the run following the forceful circumcision campaign that started last week.
The operation is being spearheaded by the Mbale male Bagisu youth against their colleagues that have not been circumcised. Business in the town has been affected as the uncircumcised have begun fleeing lest they be injured and ruthlessly circumcised.

Archived URL: http://www.webcitation.org/6HgAOPB1e

2013-07-22 The Star (Kenya) - "Met to get cash, food prizes for circumcision"

Excerpt:

Kenya National Male Circumcision task force and players in the Voluntary Medical Male Circumcision have launched a pilot study to lure men within 24-49 years to circumcision. The  initiative is aimed at circumcising male adults. 
The awareness will start at greater Nyando before being rolled out to other parts of the region. The initiative will also provide food incentives, cash and shopping vouchers to families of those willing to be circumcised to entice more men  to be circumcised.

Archived URL: http://www.webcitation.org/6IMrKH0CD

2013-11-10 ZimEye - "Zimbabwe Buys Into Controversial Israeli Style Circumcision"

Excerpt:

At at time when government is struggling to provide bath and drink water for women in maternity wards across the country, the Ministry of Health and Child Care (MoHCC) has embarked on an expensive and controversial Israeli style pilot programme to circumcise young boys a few days after being born under the hope of stopping the spread of HIV AIDS.
...
The ministry’s program will see over 500 babies between the ages of 10 and 60 days in Harare being circumcised voluntarily at the government’s own expense.
The state media reports that the programme is meant to assist Government in determining the best age at which to start conducting male circumcision, which is said to reduce the likelihood of contracting HIV by approximately 60percent albeit amid protest from other independent practitioners that this is untrue.

Archived URL: http://www.webcitation.org/6LvHdFdC2

2013 - Response to “PEPFAR Program Expenditures” [Form Number: DS-4213, OMB Control Number: 1405-0208]

Thank you for the opportunity to provide feedback to “PEPFAR Program Expenditures” [Form Number: DS-4213, OMB Control Number: 1405-0208]. This response document will briefly address concerns about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; concerns about adverse consequences of PEPFAR program areas; and concerns about the absence of oversight of the activities of PEPFAR funding recipients.

Ethical, Legal and Methodological Flaws with Past Research informing present PEPFAR Program Areas

In 2011 and 2012, the Department of Health and Human Services Office of Inspector General [OIG] published a series of audit reports revealing that throughout fiscal years 2000-2010, the National Institute of Allergy and Infections Diseases [NIAID], did not comply with the time and amount requirements specified in appropriations statutes, in awarding several federal contracts to commercial partners, committing the federal government to tens of millions of dollars of expenditure ahead of appropriation of funds from Congress (OIG 2011a; OIG 2011b; OIG 2011c; OIG 2011d; OIG 2012a; OIG 2012b). During this time, NIAID also funded and sponsored research conducted abroad, that would be unlikely to receive ethical approval to be conducted in the United States, incorporating the excision of healthy tissue from subjects in the absence of a clear and present immediate medical indication, specifically ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 ['the African circumcision trials'] (NIH 2008; NIH 2007), the methodology, conclusions, ethics and legality of which have been questioned in the professional medical literature (Boyle & Hill 2011; Green et al 2010). In the years following publication of the African circumcision trials, regulatory agencies under the aegis of the Department of Health and Human Services have moved to strengthen protections afforded human research subjects and to increase the rigor with which trials conducted abroad are assessed as a basis for seeking approval of new drugs and medical devices in the U.S. market (FDA 2012; OHRP 2011), although concerns continue to be raised about the capability of National Institutes of Health [NIH] Data and Safety Monitoring Boards to ensure the safety of study subjects and validity and integrity of the data for clinical trials (OIG 2013a).

Adverse Consequences of PEPFAR Program Funding Areas

Despite the concerns identified above, the results of the African circumcision trials continue to be used to justify the en masse circumcision of men in Africa using PEPFAR funds and to justify the circumcision of boys and male infants - both in the United States and abroad - in the absence of clear and present immediate medical indications, and in the latter instance, with the tacit endorsement of U.S. government agencies in receipt of PEPFAR program funding (CDC 2011; Llewellyn 2012). In the wake of PEPFAR funding for mass circumcision programs in Africa, human rights organisations and local media in the region have reported coercion of men and boys to be circumcised (AFP 2012; Ahlberg & Njoroge 2013; Aluru 2013; Amnesty International 2013; Chibaya 2013a; Chibaya 2013b; Chirombo 2013; Dube 2012; Echwala 2013; Handable 2013; Hatyoka 2013; Langa 2012; Layoo 2013; Mbanje 2013; Mhlanga 2012; News24 2013; Ngwega 2012; Okwii 2013; Onyango 2012; Otieno 2013; Towindo 2012) and misdirection of limited medical resources from other priority areas to male circumcision (AHN 2012; Gonzalez 2012; ZimEye 2013).

Absence of Oversight

On the 15 June 2011, the OIG published a report critical of the Centers for Disease Control and Prevention's [CDC's] failure to oversee recipientss use of PEPFAR funds, concluding that the “lack of required documentation demonstrates that CDC has not exercised proper stewardship over Federal PEPFAR funds because it did not consistently follow departmental and other Federal requirements in monitoring PEPFAR recipients” (OIG 2011e). Further investigations by the OIG have also revealed specific failures of the CDC to monitor recipients use of PEPFAR funds in Namibia (OIG 2013c; OIG 2013d) and South Africa (OIG 2013b; OIG 2013e; OIG 2013f; OIG 2013g). In 2013, the OIG also published a report critical of the CDC's failure to oversee use of PEPFAR funds by the Vietnam Administration for HIV/AIDS Control (OIG 2013h), suggesting the possibility that more systemic problems may exist within the CDC, impacting the agency's ability to effectively oversee the activities of grantees in receipt of federal funds, and that this is not specific to difficulty with oversight of grantees in the African region.

Conclusion

Valid concerns exist about the ethical, legal and methodological flaws with past research informing aspects of present PEPFAR program areas; adverse consequences of PEPFAR program areas; and the absence of oversight of the activities of PEPFAR funding recipients. It is therefore imperative that full and complete disclosure and oversight in the proposed information collection activity take precedence over the CDC's and PEPFAR funding recipients' professed concerns for increased regulatory and administrative 'burden'.

References

AFP (2012) US urges circumcision for soldiers to fight HIV in Africa Yahoo! Health http://health.yahoo.net/news/s/afp/us-urges-circumcision-for-soldiers-to-fight-hiv-in-africa Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68Trj7ABp

Ahlberg BM, Njoroge KM (2013) 'Not men enough to rule!': politicization of ethnicities and forcible circumcision of Luo men during the postelection violence in Kenya Ethn Health. 2013 Oct;18(5):454-68. doi: 10.1080/13557858.2013.772326. Epub 2013 Jun 11 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/23758644

AHN (2012) HIV services in western refugee camps overwhelmed Gant Daily 29 March 2012 http://gantdaily.com/2012/03/29/hiv-services-in-western-refugee-camps-overwhelmed/

Aluru L (2013) Siaya County seeks forced male ‘cut’ law 2 October 2013 Standard Digital News http://www.standardmedia.co.ke/?articleID=2000094743&story_title=Kenya-county-seeks-forced-male-cut-law Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6LtnVPjiW

Amnesty International (2013) Kenya’s ICC trials Amnesty International website 16 September 2013 Amnesty International website http://www.amnesty.org/en/news/kenya-s-icc-trials-2013-09-16 Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6LtoCK3gQ

Boyle GJ, Hill G (2011) Sub-Saharan African randomised clinical trials into male circumcision and HIV transmission: methodological, ethical and legal concerns J Law Med. 2011 Dec;19(2):316-34 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/22320006

CDC (2011) Trends in In-Hospital Newborn Male Circumcision - United States 1999-2010 Prepared by Xinjian Zhang, PhD, Sanjyot Shinde, PhD, Peter H Kilmarx, MD, Robert T Chen, MD, Div of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention; Shanna Cox, MSPH, Lee Warner, PhD, Div of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion; Maria Owings, PhD, Div of Healthcare Statistics, National Center for Health Statistics; Charbel El Bcheraoui, PhD, EIS Officer, CDC. Morbidity and Mortality Weekly Report (MMWR) Full-text available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6034a4.htm?s_cid=mm6034a4_w

Chibaya, M (2013a) Resistance hinders circumcision programme The Standard Full-text available at http://www.thestandard.co.zw/2013/05/19/resistance-hinders-circumcision-programme/ Archived by WebCite at http://www.webcitation.org/6Ltky3cRF

Chibaya, M (2013b) Winky D tackles circumcision controversy New Zimbabwe 21 October 2013 Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6LtoaHGyi

Chirombo, S (2013) Malawi: Kasungu Registers Low Turnout for Male Circumcision allAfrica.com 5 July 2013 Accessed: 2013-07-08. Archived by WebCite at http://www.webcitation.org/6HxNQ2VYn

Dube, C (2012) F/town adult males spurn circumcision The Monitor 21 May 2012 http://www.mmegi.bw/index.php?sid=1&aid=370&dir=2012/May/Monday21 Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68TqWHbxL

Echwala, E (2013) Zimbabwe's circumcision drive fails to take off IRIN News 9 July 2013 http://www.irinnews.org/report/98379/zimbabwe-s-circumcision-drive-fails-to-take-off Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6Ltn5kJBC

FDA (2012) FDA's HSP/BIMO Initiative Accomplishments: Update May 2012 Food and Drug Administration Full-text available at http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm305275.htm Accessed: 2012-06-10. Archived by WebCite at http://www.webcitation.org/68JLjWhEP

Gonzalez L L (2012) Africa: Less Global Funds, More Problems allAfrica 10 May 2012 Full-text available at http://allafrica.com/stories/201205110671.html

Green LW, Travis JW, McAllister RG, Peterson KW, Vardanyan AN, Craig A (2010) Male circumcision and HIV prevention insufficient evidence and neglected external validity Am J Prev Med. 2010 Nov;39(5):479-82 Abstract available at http://www.ncbi.nlm.nih.gov/pubmed/20965388

Handable, N (2013) Zambia: Women Should Encourage Their Partners allAfrica.com http://allafrica.com/stories/201211201412.html Accessed: 2013-12-16. Archived by WebCite at http://www.webcitation.org/6LvIDW2pt

Hatyoka, B (2013) ‘Sensitise subjects on male circumcision’ Times of Zambia 22 May 2013 Accessed: 2013-12-15. Archived by WebCite at http://www.webcitation.org/6LtlPFBWm

Langa, V (2012) 175 MPs to be circumcised News Day 18 May 2012 http://www.newsday.co.zw/article/2012-05-18-175-mps-to-be-circumcised/ Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68Tqz9L2u

Layoo, R (2013) Former inmates decry forced circumcision Daily Monitor http://www.monitor.co.ug/News/National/Former-inmates-decry--forced-circumcision/-/688334/2110502/-/1wm3ydz/-/index.html Accessed: 2013-12-16. Archived by WebCite at http://www.webcitation.org/6Ltvm2Hi9

Llewellyn, E (2012) Infant Circumcision: A Tipping Point for HIV Prevention USAID Frontlines May/June 2012 Full-text available at http://transition.usaid.gov/press/frontlines/fl_may12/FL_may12_U5_SWAZILAND.html Accessed: 2012-06-17. Archived by WebCite at http://www.webcitation.org/68U9lv9vt

Mbanje, P (2013) Zimbabwe government takes circumcision into the classroom The Standard http://www.thestandard.co.zw/2013/12/08/zimbabwe-government-takes-circumcision-classroom/ Accessed: 2013-12-16. Archived by WebCite at http://www.webcitation.org/6LtvSfy7N

Mhlanga, P (2012) Govt sharpens knives for forced circumcision NewsDay 1 December 2012 Full-text available at http://www.newsday.co.zw/2012/12/01/govt-sharpens-knives-for-forced-circumcision/

News24 (2013) Minister urges MPs to get circumcised News24 website http://www.news24.com/SouthAfrica/Politics/Minister-urges-MPs-to-get-circumcised-20131022 Archived by WebCite at http://www.webcitation.org/6Ltunawpb

NIH (2008) Male Circumcision and HIV Rates in Kenya ClinicalTrials.gov website 28 May 2008 Full-text available at http://www.clinicaltrials.gov/ct2/show/NCT00059371

NIH (2007) Male Circumcision for HIV Prevention in Rakai, Uganda ClinicalTrials.gov website 23 August 2007 Full-text available at http://www.clinicaltrials.gov/ct2/show/NCT00425984

Ngwega, N (2012) Tanzania: Handeni Promotes Male Circumcision to Curb HIV Spread allAfrica.com 11 February 2012 Full-text available at http://allafrica.com/stories/201302110873.html

OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered Office of Human Research Protections website Full-text available at http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Accessed: 2012-01-16. Archived by WebCite at http://www.webcitation.org/64jh4cWek

OIG (2011a) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2006-00015C With NexBio, Inc. (A-03-10-03119) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003119.pdf

OIG (2011b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN272-2008-00013C with the EMMES Corporation (A-03-10-03115) Health and Human Services Office of Inspector General website 31 October 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003115.pdf

OIG (2011c) 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) on the Health and Human Services Office of Inspector General website 10 July 2011 Available at http://oig.hhs.gov/oas/reports/region3/31003120.pdf

OIG (2011d) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-3-0052 With Avecia Biologics Limited (A-03-10-03117) Health and Human Services Office of Inspector General website 21 September 2011 Full-text available at http://oig.hhs.gov/oas/reports/region3/31003117.pdf

OIG (2011e) Review of the Centers for Disease Control and Prevention’s Oversight of the President’s Emergency Plan for AIDS Relief Funds for Fiscal Years 2007 Through 2009 (A-04-10-04006) Health and Human Services Office of Inspector General website 15 June 2011 Full-text available at http://oig.hhs.gov/oas/reports/region4/41004006.pdf

OIG (2012a) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2005-00022C With PPD Development, LP (Audit A-03-10-03118) Health and Human Services Office of Inspector General website 14 September 2012 Full-text available at https://oig.hhs.gov/oas/reports/region3/31003118.pdf

OIG (2012b) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-30068 With PPD Development, LP (Audit A-03-10-03116) Health and Human Services Office of Inspector General website 14 September 2012 Full-text available at https://oig.hhs.gov/oas/reports/region3/31003116.pdf

OIG (2013a) Data and Safety Monitoring Boards in NIH Clinical Trials: Meeting Guidance, But Facing Some Issues (Report OEI-12-11-00070) Health and Human Services Office of Inspector General website 28 June 2013 Full-text available at https://oig.hhs.gov/oei/reports/oei-12-11-00070.pdf

OIG (2013c) The Centers for Disease Control and Prevention's Namibia Office Did Not Always Properly Monitor Recipients' Use of the President's Emergency Plan for AIDS Relief Funds Audit (A-04-12-04020) Health and Human Services Office of Inspector General website 19 November 2012 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204020.pdf

OIG (2013d) The Republic of Namibia, Ministry of Health and Social Services, Did Not Always Manage the President’s Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-04-12-04019) Health and Human Services Office of Inspector General website 19 November 2012 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204019.pdf

OIG (2013b) The Centers for Disease Control and Prevention's South Africa Office Did Not Always Properly Monitor Recipients' Use of the President's Emergency Plan for AIDS Relief Funds (Audit A-04-12-04022) Health and Human Services Office of Inspector General website 12 February 2013 Full-text available at https://oig.hhs.gov/oas/reports/region4/41204022.pdf

OIG (2013e) National Health Laboratory Service Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00024) Health and Human Services Office of Inspector General website 15 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200024.pdf

OIG (2013f) The South African National Department of Health Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00022) Health and Human Services Office of Inspector General website 23 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200022.pdf

OIG (2013g) Aurum Institute for Health Research Did Not Always Manage President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-05-12-00021) Health and Human Services Office of Inspector General website 23 August 2013 Full-text available at http://oig.hhs.gov/oas/reports/region5/51200021.pdf

OIG (2013h) The Vietnam Administration for HIV/AIDS Control Did Not Always Manage the President's Emergency Plan for AIDS Relief Funds or Meet Program Goals in Accordance With Award Requirements (Audit A-06-11-00057)  Health and Human Services Office of Inspector General website 10 June 2013 Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2013-06-10-hhs-oig-vietnam.html

Okwii, E (2013) Mbale Residents Flee Forceful Circumcision Uganda Picks 24 June 2013 Accessed: 2015-10-02. Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2013-06-24-uganda-picks-mbale-residents.html

Onyango, H (2012) Kenya: The Cut for Boys to Tame HIV allAfrica Accessed: 2015-10-02. Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2012-05-10-allafricacom-kenya-cut-for.html

Otieno, S (2013) Met to get cash, food prizes for circumcision The Star 22 July 2013 Accessed: 2015-10-02. Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2013-07-22-star-kenya-met-to-get-cash.html

Towindo, L (2012) Were we fooled? The Sunday Mail 13 July 2012  Accessed: 2015-10-01. Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2012-07-13-sunday-mail-zimbabwe-were-we.html

ZimEye (2013) Zimbabwe Buys Into Controversial Israeli Style Circumcision ZimEye Accessed: 2015-10-01. Archived by Bodily Autonomy Watch at http://bodilyautonomywatch.blogspot.com/2015/10/2013-11-10-zimeye-zimbabwe-buys-into.html