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

2011 - Written Evidence in response to Health Committee Public Health Inquiry

SUMMARY:

There has been a concerted effort in the professional literature, from a small cabal within the medical fraternity, to argue the case for reinstating non-therapeutic circumcision at the expense of the NHS, frequently using professed concern for the well-being of boys of certain ethnic or religious backgrounds receiving circumcision in non-medical settings, as a pretext.
Recently, there has been a string of mainstream media items favourable to male circumcision, which amount to nothing less than a marketing campaign to motivate parents to have their sons circumcised. Many of these articles draw upon established marketing concepts (in turn derived from insights of behavoiural science), most notably, the use of “experts”.  In the context of promoting circumcision to parents, such “experts” generally include medical practitioners who work at private circumcision clinics and religious officials.
Regardless of whether it is performed in a medical or non-medical setting, a significant number of boys subjected to the practice of circumcision will later fulfill the DSM-IV criteria for a diagnosis of Post-Traumatic Stress Disorder.
Circumcision removes the most sexually sensitive parts of a boy’s penis, including the foreskin, the frenulum, and the ridged band of nerves. The male foreskin is also designed to protect the glans of the penis throughout a man’s life, ensuring that the internal mucosal tissue remains moist and sensitive (much the same way that a woman’s clitoral hood protects the clitoris). In addition, the foreskin acts as a natural gliding mechanism to reduce chafing and dryness during intercourse.
The British Medical Association advises against routine male circumcision, and no national medical association in the world recommends that boys be forcefully circumcised for preventive health reasons.
There has been little incentive for the medical profession to investigate the long-term affects on men's sexual and psychological health and well-being, but the growth of groups such as NORM-UK (an organisation registered with the Charities Commissioners for England and Wales), suggests that a substantial number of men genuinely resent being circumcised.
It is imperative that Department of Health and Public Health England  mandate that all staff, contractors, agencies, facilities and departments under their auspices, including GPs and GP practices: Must not offer among their services the harmful male genital mutilation known as circumcision; Must not permit on their premises individuals or organisations promoting the harmful male genital mutilation known as circumcision; Must not be refer patients explicitly for the harmful male genital mutilation known as circumcision; Must not be employed or associated with any facility offering the harmful male genital mutilation known as circumcision; Must not allow their facilities to be used for the harmful male genital mutilation known as circumcision.; and Must not stock or allow on their premises literature or other material promoting the harmful male genital mutilation known as circumcision.
Given the dearth of research in this area, it would be appropriate for the Department of Health and Public Health England to partner with registered charities such as NORM-UK and to create incentives for medical researchers to investigate the long-term affects of circumcision on men's sexual and psychological health and well-being.

1.    There has been a concerted effort in the professional literature, from a small cabal within the medical fraternity, to argue the case for reinstating non-therapeutic circumcision at the expense of the NHS, frequently using professed concern for the well-being of boys of certain ethnic or religious backgrounds receiving circumcision in non-medical settings, as a pretext [1], a call loudly echoed in sections of the mainstream media [2]. Regardless of whether it is performed in a medical or non-medical setting, a significant number of boys subjected to the practice of circumcision will later fulfill the DSM-IV criteria for a diagnosis of Post-Traumatic Stress Disorder [3]. Further, circumcision removes the most sexually sensitive parts of a boy’s penis, including the foreskin, the frenulum, and the ridged band of nerves [4]. The male foreskin is also designed to protect the glans of the penis throughout a man’s life, ensuring that the internal mucosal tissue remains moist and sensitive (much the same way that a woman’s clitoral hood protects the clitoris). In addition, the foreskin acts as a natural gliding mechanism to reduce chafing and dryness during intercourse [5].

2.    Recently, there has been a string of mainstream media items favourable to male circumcision, which amount to nothing less than a marketing campaign to motivate parents to have their sons circumcised [2,6,7,8]. Many of these articles draw upon established marketing concepts (in turn derived from insights of behavoiural science), most notably, the use of “experts”. An “expert”, in a marketing context, is an individual who, because of their occupation, or perceived experience, is uniquely placed to lend credence to the product or service that an advertisement promotes [9]. In the context of promoting circumcision to parents, such “experts” generally include medical practitioners who work at private circumcision clinics [6,8] and religious officials [7]. Following complaints from the public, the Press Complaints Commission has reached resolutions noting the inappropriate implication in media items that religious officials are qualified to offer medical advice in regard to circumcision, the minimisation of the inherent risks of circumcision as a medical procedure, and the implication that circumcision is of minimal discomfort through the impression that it is legitimate practice to conduct the procedure without anaesthesia [10,11]. Both the hospital and doctor (who is also a Consultant Urological Surgeon at Royal Liverpool University Hospital NHS Trust) featured in a recent episode of the Channel 4 television series Embarrassing Bodies [8], linked to the video on the Channel 4 website from their respective web-pages [12,13], effectively by-passing the General Medical Council Guidelines about how medical practitioners should promote and publish information about their services [14]. It is unsurprising that such symbiotic relationships should form between private doctors seeking to promote their practice and mainstream media outlets who want to appease advertisers by keeping such a high-profile controversial social issue alive, since advertising is the force which has historically sustained all commercial media [15].

3.    The British Medical Association advises against routine male circumcision [16], and no national medical association in the world recommends that boys be forcefully circumcised for preventive health reasons. The Royal Dutch Medical Association's very up-to-date policy on circumcision states that "KNMG is calling upon doctors to actively and insistently inform parents who are considering the procedure of the absence of medical benefits and the danger of complications", and that there is a good case for making it illegal [17]. Female genital mutilation has been illegal for a number of years now [18]. There has been little incentive for the medical profession to investigate the long-term affects on men's sexual and psychological health and well-being, but the growth of groups such as NORM-UK (an organisation registered with the Charities Commissioners for England and Wales), suggests that a substantial number of men genuinely resent being circumcised [19].

4.    A recent statement from the British Association of Paediatric Urologists on behalf of the British Association of Paediatric Surgeons and The Association of Paediatric Anaesthetists admitted that some doctor's under it's charge “have been willing to provide non therapeutic circumcision without charge rather than risk the procedure being carried out in unhygienic conditions.” [20]. In it's statement on the law and ethics of male circumcision, the British Medical Association has concluded that “it is for society to decide what limits should be imposed on parental choices.” [16].

5.    It is therefore imperative that Department of Health and Public Health England  mandate that all staff, contractors, agencies, facilities and departments under their auspices, including GPs and GP practices: Must not offer among their services the harmful male genital mutilation known as circumcision; Must not permit on their premises individuals or organisations promoting the harmful male genital mutilation known as circumcision; Must not be refer patients explicitly for the harmful male genital mutilation known as circumcision; Must not be employed or associated with any facility offering the harmful male genital mutilation known as circumcision; Must not allow their facilities to be used for the harmful male genital mutilation known as circumcision.; and Must not stock or allow on their premises literature or other material promoting the harmful male genital mutilation known as circumcision.

6.    To best develop and enhance the availability, accessibility and utility of public health information and intelligence regarding the harmful male genital mutilation known as circumcision, it is imperative that the Department of Health and Public Health England establish a central information store of the harm caused by male circumcision, which will form the basis for establishing a dictate that staff, contractors, agencies, facilities and departments under it's auspices, including GPs and GP practices, will not perform nor refer patients for circumcision; and to make use of the insights of behavioural science to research and implement strategies which discourage parents from subjecting their sons to the harmful male genital mutilation known as circumcision, without lending to it's prestige by implying that it is a practice worthy of it's own policy statement or the subject of a legitimate 'debate'.

7.    To counteract the mainstream media marketing of circumcision to parents, it is appropriate that the Department of Health and Public Health England mandate that staff, contractors, agencies, facilities and departments under it's auspices, including GPs and GP practices, will not perform nor refer patients for circumcision; and should use the insights of behavioural science to research and implement strategies which discourage parents from subjecting their sons to the harmful male genital mutilation known as circumcision, without lending to it's prestige by implying that it is a practice worthy of it's own policy statement or the subject of a legitimate 'debate'.

8.    It would be appropriate to invite appropriately registered charity organisations such as NORM-UK to partner with the Department of Health and Public Health England to contribute to compiling and improving the use of public health evidence to counteract the mainstream media marketing of circumcision to parents and discourage parents from subjecting their sons to the harmful male genital mutilation known as circumcision, without lending to it's prestige by implying that it is a practice worthy of it's own policy statement or the subject of a legitimate 'debate'.

9.    Given questions raised about the professional conduct of some medical practitioners with regard to the continuing practice of male circumcision, whatever system of voluntary regulation may be implemented, it is appropriate that the Department of Health and Public Health England mandate that staff, contractors, agencies, facilities and departments under their auspices, including GPs, GP practices and other public health specialists, will not perform nor refer patients for the harmful male genital mutilation known as circumcision.

10.    Given the dearth of research in this area, it would be appropriate for the Department of Health and Public Health England to create incentives for medical researchers to investigate the long-term affects of circumcision on men's sexual and psychological health and well-being.

11.    Links/References:
    1. Paranthaman K., Bagaria, J & O'Moore, E. (2010) The need for commissioning circumcision services for non-therapeutic indications in the NHS: lessons from an incident investigation in Oxford J Public Health first published online July 14, 2010 http://jpubhealth.oxfordjournals.org/content/early/2010/07/14/pubmed.fdq053.full
    2. Campbell, D. (2010) NHS urged to offer circumcisions to avoid botched operations in The Guardian Sunday 11 July 2010 http://www.guardian.co.uk/society/2010/jul/11/doctors-urge-circumcision-on-nhs

    3. Samuel Ramos and Gregory J. Boyle. Ritual and Medical Circumcision among Filipino boys: Evidence of Post-traumatic Stress Disorder Humanities & Social Sciences papers (2000). Available at: http://epublications.bond.edu.au/cgi/viewcontent.cgi?article=1120&context=hss_pubs

    4. Morris L. Sorrells, James L. Snyder, Mark D. Reiss, Christopher Eden, Marilyn F. Milos, Norma Wilcox, Robert S. Van Howe Fine-touch pressure thresholds in the adult penis British Journal of Urology International, Volume 99 Issue 4 Page 864 – 869 April 2007 http://www.nocirc.org/touch-test/bju_6685.pdf

    5. Taylor, J.P., A.P. Lockwood and A.J.Taylor The prepuce: Specialized mucosa of the penis and its loss to circumcision Journal of Urology (1996), 77, 291-295 http://www.cirp.org/library/anatomy/taylor/

    6. Renton, A. (2010) It protects men (and women) against fatal diseases and sexual infections. So, should all boys be circumcised? in TheDaily Mail http://www.dailymail.co.uk/health/article-1199472/It-protects-men-women-fatal-diseases-sexual-infections-So-boys-circumcised.html

    7. Rich, B. (2010) To snip or not to snip? in The Guardian http://www.guardian.co.uk/lifeandstyle/2010/oct/30/circumcision-jewish-son-ben-rich

    8. Channel 4 (2011) Embarrassing Bodies Series 4 Episode 4 http://www.channel4.com/programmes/embarrassing-bodies/episode-guide/series-4/episode-4

    9. Schiffman, L Bednell, D O’Cass, A Paladino, A Kanuk, L (2005) Consumer Behaviour 3rd Edition Pearson Education Australia, Australia: Frenchs Forest

    10. Press Complaints Commission (2011) Parkes vs The Guardian http://www.pcc.org.uk/news/index.html?article=NjkxNg==

    11. Press Complaints Commission (2010) Warren vs Daily Mail http://www.pcc.org.uk/news/index.html?article=NjIyNA==

    12. http://www.spirehealthcare.com/Liverpool/Our-Facilities-Treatments-and-Consultants/Our-Treatments/Adult-circumcision/

    13. http://www.spirehealthcare.com/Liverpool/Our-Facilities-Treatments-and-Consultants/Our-Consultants/Mr-P-Cornford/

    14. General Medical Council (2011) Good Medical Practice: Providing and publishing information about your services http://www.gmc-uk.org/guidance/good_medical_practice/probity_information_about_services.asp

    15. Cunningham, S & Turner, G (2002) The Media & Communications in Australia Allen & Unwin, Australia

    16. British Medical Association. The law and ethics of male circumcision: guidance for doctors. London: BMA, 2006 http://www.bma.org.uk/ethics/consent_and_capacity/malecircumcision2006.jsp

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

    18. LASSL (2004)4: Female Genital Mutilation Act 2003, DoH, published 27.2.2004

    19. http://www.norm-uk.org/

    20. British Association of Paediatric Urologists (2007) MANAGEMENT OF FORESKIN CONDITIONS Statement from the British Association of Paediatric Urologists on behalf of the British Association of Paediatric Surgeons and The Association of Paediatric Anaesthetists. http://www.apagbi.org.uk/sites/apagbi.org.uk/files/circumcision2007.pdf

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