Very important changes to clinical trials being proposed by HHS. U.S. members should read. - Mothering Forums

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#1 of 5 Old 08-08-2011, 07:01 AM - Thread Starter
 
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(Cross-posted at restoringforeskin.org and foreskin-restoration.net)

 

The Office for Human Research Protections is currently accepting public comments on 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).

The deadline for submissions is 26 September 2011.

You can download the document here (click the PDF icon, 260kb):
http://www.regulations.gov/#!documentDetail;D=HHS-OPHS-2011-0005-0001

A summary of the proposed changes can be viewed here:
http://www.hhs.gov/ohrp/humansubjects/anprmchangetable.html


Many of the proposed changes, particularly relating to informed consent to participants, use of biospecimens (eg neonatal foreskins) and research design, seem amenable to anti-circumcision arguments, and an extension of themes that have developed on this and other forums (eg the "adaptive research design" of those three African trials).

Researching and preparing a reply to this document that we can each download from a file-sharing site and submit individually under our own names (to show the HHS the strength of our sentiment), would present an ideal opportunity for someone studious who has been looking for practical opportunities to reduce the availability, incentive and incidence of circumcision, but does not want to do so publicly as an "intactivist".

I feel strongly that it should be a member(s) from the United States who takes the lead in developing this response document, since this is a U.S. Government agency, and the vast majority of the membership of these forums are also from the U.S.

 

 

EDIT:  The deadline has been extended by the HHS to 26 October 2011.

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#2 of 5 Old 08-28-2011, 01:28 AM - Thread Starter
 
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To help members prepare a response document to these proposed changes, here a some links that may prove helpful:

Flaws in the methodology of those three African trials - http://www.futuremedicine.com/doi/full/10.2217/17469600.2.3.193

NIAID (NIH) retroactively trying to make the flawed methodology of those three African trials the gold standard of "adaptive research design" - 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

Information about the functions of the prepuce that was not made available to participants in those African trials - http://www.cirp.org/library/anatomy/taylor/

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#3 of 5 Old 08-30-2011, 08:06 PM - Thread Starter
 
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#4 of 5 Old 09-03-2011, 04:29 PM
 
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Moving to intactivism

 
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#5 of 5 Old 10-02-2011, 09:56 PM - Thread Starter
 
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I have commenced a post for developing an anti-circumcision response to HHS-OPHS-2011-0005, here:

 

http://www.foreskin-restoration.net/forum/showthread.php?t=9173

 

I'd like to keep the developing document in one place (over at FR.net), but constructive feedback and suggestions are welcome and can be left on this thread here at MDC.

 

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