This is a response to the document "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" [regulations.gov Docket ID: HHS-OPHS-2011-0005] ( http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-0001 ).
The deadline for submissions is 26 October 2011.
This submission can be made by anybody from any country around the world.
Download and save the document from the following link (Click 'Download Now', Wait for the counter to reach zero and click 'Download file now'):
Go to the following regulations.gov submission page:
Enter your name in the appropriate fields (Optional). Click browse under '3. UPLOAD FILE(S)' to upload the saved document from your harddisk. Click 'Submit'.
Please leave a reply so that I may gauge the number of submissions made (and to keep this post prominent until the deadline).
In case anyone has trouble with the above 4shared link, the full text of the response is below, which you can copy and paste into the word processor or text editor of your choice, and save to your harddisk to upload to regulations.gov:
Response to "Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators" [regulations.gov Docket ID: HHS-OPHS-2011-0005]
Thank you for the opportunity to provide feedback to “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators” [regulations.gov Docket ID: HHS-OPHS-2011-0005]. This response shall briefly address a few of the issues identified in the document “Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered” (OHRP 2011).
Issue 1: There are no specific data security protections for IRB-reviewed research: regulations require IRBs to determine, for each study, “when appropriate [that] there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”.
The management of subject data is increasingly being outsourced and commercialised by federal agencies. Examples involving the National Institute of Allergy and Infectious Diseases [NIAID] include Contract N01-AI-15416 With the University of California at San Francisco (OIG 2011a), Contract N01-AI-3-0052 With Avecia Biologics Limited (OIG 2011b) and Contract HHSN266-2006-00015C With NexBio, Inc. (OIG 2011c). In 2011, following an investigation by the U.S. Department of Health and Human Services [HHS] Office for Civil Rights [OCR], the University of California agreed to settle potential violations of the Health Insurance Portability and Accountability Act of 1996 [HIPAA] Privacy and Security Rules, after it was uncovered that between 2005-2008, unauthorized employees had repeatedly looked at the electronic protected health information of numerous patients (HHS 2011). It is therefore imperative that the HIPAA Privacy and Security Rules be adopted and applied to federal agency commercial partners, with the same applicable penalties for breaches of patient/subject privacy.
Issue 2: Research using existing biospecimens (clinical or from prior research) can be done without consent by stripping the specimens of identifiers.
Circumcision of male minors, in the absence of a clear and present immediate medical indication, is a controversial practice within the medical profession (Smith 2011). 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. Further, the most promising advances in the field of stem cell research, are to be found in stem cell lines derived from adult sources including dental pulp stem cells (Authur et al 2008), uterine stem cells (Bock 2011) and bone marrow stem cells (Wada et al 2011), rather than stem cell lines derived from the excised healthy foreskins of minors.
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; Organogenesis 2011; Pitman 2008; SkinMedica 2011). As observed by the OHRP (2011) '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'. 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.
It is therefore inappropriate to ask or permit the parent or legal guardian of a minor, to authorise the storage, transfer, processing, sale or any other use of foreskin or other healthy tissue excised from minors in the absence of a clear and present immediate medical indication.
Issue 3: Federal protections only apply to studies that are funded by certain federal agencies (Common Rule agencies), or to clinical investigations that involve products regulated by the FDA.
As observed by the OHRP (2011) 'Many have called for legislation to extend the Common Rule protections to all research with human subjects conducted in the U.S., regardless of funding source'. Increasingly however, federal agencies are funding and sponsoring research conducted abroad, that would be unlikely to receive ethical approval to be conducted in the U.S. Specific examples include NIAIDs sponsorship and funding of ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 (Bailey et al 2007; Gray et al 2007). It is therefore imperative that federal protections be extended to all studies conducted by recipients of federal agency funds, or that are in any way sponsored by federal agencies, whether conducted in the U.S. or abroad.
Issue 5: Current provisions of the Common Rule provide only basic information about the elements of informed consent and how consent documents should be written. Many consent forms are too long and hard to understand, and fail to include some of the most important information.
Increasingly, federal agencies are funding and sponsoring research incorporating the excision of healthy tissue from subjects in the absence of a clear and present immediate medical indication. Specific examples include NIAIDs sponsorship and funding of ClinicalTrials.gov registered trials NCT00059371 and NCT00425984 (Bailey et al 2007; Gray et al 2007). Consent forms for these trials failed to include then known information, from the professional medical literature, about the importance to mens sexual health of the foreskin and other tissues removed by circumcision (Taylor 1996).
Of concern, is the results of the above trials are increasingly being used to justify the en masse circumcision of male minors in the absence of clear and present immediate medical indications (Kim 2011).
Research incorporating the excision of healthy tissue from subjects in the absence of a clear and present immediate medical indication, must be limited to consenting adult subjects and consent forms must contain full and complete information, drawn from the professional medical literature, about the biological functions of the tissue to be excised, with clear stipulations in any published conclusions or media releases arising from such studies, that any results obtained are applicable only to populations and patients of the same demographic characteristics as the trial subjects, in “real world” settings which have similar variables to the study settings.
Issue 19: One of the six exempt categories applies to research involving the use of existing data, documents, records, and pathological or diagnostic specimens, but only if the sources are publicly available or if the information is recorded by researchers in such a manner that subjects cannot be identified, directly or through identifiers linked to them.
See reply to Issue 2, above.
Advanced Healing (2011) Dermagraph Active Living Cells Overview Link archived at http://liveweb.archive.org/http://www.dermagraft.com/about/overview/ Retrieved 25 September 2011
Arthur A, Rychkov G, Shi S, Koblar SA, Gronthos S (2008) Adult human dental pulp stem cells differentiate toward functionally active neurons under appropriate environmental cues in Stem Cells. 2008 Jul;26(7):1787-95. Epub 2008 May 22 Abstract archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed/18499892 Retrieved 25 September 2011
Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF, Campbell RT, Ndinya-Achola JO (2007) Male circumcision for HIV prevention in young men in Kisumu, Kenya: a randomised controlled trial. Lancet369(9562),643–656 Abstract archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed/17321310 Retrieved 02 October 2011
Bock, R (2011) Uterine stem cells used to treat diabetes in mice in NIH News Article archived at http://liveweb.archive.org/http://www.nih.gov/news/health/aug2011/nichd-30.htm Retrieved 25 September 2011
Gray RH, Kigozi G, Serwadda D, Makumbi F, Watya S, Nalugoda F, Kiwanuka N, Moulton LH, Chaudhary MA, Chen MZ, Sewankambo NK, Wabwire-Mangen F, Bacon MC, Williams CF, Opendi P, Reynolds SJ, Laeyendecker O, Quinn TC, Wawer MJ (2007) Male circumcision for HIV prevention in men in Rakai, Uganda: a randomised trial. Lancet369(9562),657–666 Abstract archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed/17321311 Retrieved at 02 October 2011
HHS (2011) University of California settles HIPAA Privacy and Security case involving UCLA Health System facilities HHS Press Office published 7 July 2011 website Archived at http://liveweb.archive.org/http://www.hhs.gov/news/press/2011pres/07/20110707a.html Retrieved 02 October 2011
Kim, A (2011) Botswana’s Infant Circumcision Campaign in PRI's The World Article archived at http://liveweb.archive.org/http://www.theworld.org/2011/10/botswana-infant-circumcision-campaign/ Retrieved 11 October 2011
Organogenesis (2011) Apligraf: How Is It Made? Link archived at http://liveweb.archive.org/http://www.apligraf.com/professional/what_is_apligraf/how_is_it_made/ Retrieved 25 September 2011
OHRP (2011) Regulatory Changes in ANPRM Comparison of Existing Rules with Some of the Changes Being Considered in Office of Human Research Protections website archived at http://liveweb.archive.org/http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html Retrieved 25 September 2011
OIG (2011a) 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 published 10 July 2011 Available at http://oig.hhs.gov/oas/reports/region3/31003120.pdf
OIG (2011b)Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract N01-AI-3-0052 With Avecia Biologics Limited (A-03-10-03117) on the Health and Human Services Office of Inspector General website published 21 September Available at http://oig.hhs.gov/oas/reports/region3/31003117.pdf
OIG (2011c) Appropriations Funding for National Institute of Allergy and Infectious Diseases Contract HHSN266-2006-00015C With NexBio, Inc. (A-03-10-03119) on the Health and Human Services Office of Inspector General website published 21 September Available at http://oig.hhs.gov/oas/reports/region3/31003119.pdf
Pitman, S (2008) Babies’ foreskin dubbed as new anti-aging treatment in Cosmetic Design Article archived at http://liveweb.archive.org/http://www.cosmeticsdesign.com/Formulation-Science/Babies-foreskin-dubbed-as-new-anti-aging-treatment Retrieved 25 September 2011
SkinMedica (2011) Key Ingredients Link archived at http://liveweb.archive.org/http://www.skinmedica.com/skin-care-products/skin-rejuvenation/tns-recovery-complex#tab2 Retrieved 25 September 2011
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 archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed?term=20700861 Retrieved 25 September 2011
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 Abstract archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed?term=8800902 Retrieved 09 October 2011
Wada N, Bartold PM, Gronthos S (2011) Human foreskin fibroblasts exert immunomodulatory properties by a different mechanism to bone marrow stromal/stem cells in Stem Cells Dev. 2011 Apr;20(4):647-59. Epub 2010 Oct 12 Abstract archived at http://liveweb.archive.org/http://www.ncbi.nlm.nih.gov/pubmed?term=20712449 Retrieved 25 September 2011
It would be greatly appreciated if those with Facebook, Twitter, Myspace or accounts with any other social networking sites, could circulate the link to this page amongst their contacts, accompanied by whatever text you feel will get the highest uptake:
This is also a good way of promoting MDC
I've noticed that there have only been 6 downloads from my 4shared account.
Is there a reason people are reluctant to lodge this submission? Is there something I could do to increase the uptake?
As Harvard University noted (in their request for an extension), these are "the most sweeping reforms proposed to human research protections in two decades", so once this opportunity is gone, it could be gone for a long time.
You may also want to post this on Facebook in the anti-circumcision groups there. Those intactivist groups seem to be more active there on FB and I'm sure you'll get more responses there.
Honestly, every time I check on MDC, I read "The Case Against Circumcision" I completely forget about the Intactivist sub-forum. I don't think it gets a lot of traffic.
Mom & RN
Pardon the typos - CWOK (cat walking on keyboard)