validation for Helsinki committee

[Aryeh Weiss]

A Helsinki committee has asked whether FIji/ImageJ have "validation".
This issue was raised a some years ago in this thread:
https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4

I see that ImageJ is used in many publications which contain statements
of compliance with  Helsinki committee guidelines.
My question is,   has anyone on the list received such a request , and
if so, how did you respond?

Thanks in advance
--aryeh

--
Aryeh Weiss
Faculty of Engineering
Bar Ilan University
Ramat Gan 52900 Israel

Ph:  972-3-5317638
FAX: [phone]


--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[ctrueden]

Hi Aryeh,

> A Helsinki committee has asked whether FIji/ImageJ have "validation".

My understanding is that ImageJ would not "have validation" itself. Rather,
the organization using it for some purpose (e.g., designing or
manufacturing a medical device) must somehow ensure the software is
appropriate for that purpose.

In the U.S., from the FDA's web site's validation guide [1]:

"Where the software is developed by someone other than the device
manufacturer (e.g., off-the-shelf software) the software developer may not
be directly responsible for compliance with FDA regulations. In that case,
the party with regulatory responsibility (i.e., the device manufacturer)
needs to assess the adequacy of the off-the-shelf software developer's
activities and determine what additional efforts are needed to establish
that the software is validated for the device manufacturer's intended use."

Do you have a link to the Helsinki committee guidelines for comparison?

Regards,
Curtis

[1]
http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm#_Toc517237930

On Thu, Dec 24, 2015 at 2:46 AM, Aryeh Weiss <[hidden email]> wrote:

> A Helsinki committee has asked whether FIji/ImageJ have "validation".
> This issue was raised a some years ago in this thread:
>
> https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>
> I see that ImageJ is used in many publications which contain statements of
> compliance with  Helsinki committee guidelines.
> My question is,   has anyone on the list received such a request , and if
> so, how did you respond?
>
> Thanks in advance
> --aryeh
>
> --
> Aryeh Weiss
> Faculty of Engineering
> Bar Ilan University
> Ramat Gan 52900 Israel
>
> Ph:  972-3-5317638
> FAX: [phone]
>
>
> --
> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>

--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Kenneth Sloan-2]

Are you talking about the local Israeli IRB (“Helsinki Committee”), or the “Declaration of Helsinki”?

I think they are connected, but they are not the same.

--
Kenneth Sloan
[hidden email]
Vision is the art of seeing what is invisible to others.

> On Dec 24, 2015, at 02:46 , Aryeh Weiss <[hidden email]> wrote:
>
> A Helsinki committee has asked whether FIji/ImageJ have "validation".
> This issue was raised a some years ago in this thread:
> https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>
> I see that ImageJ is used in many publications which contain statements of compliance with  Helsinki committee guidelines.
> My question is,   has anyone on the list received such a request , and if so, how did you respond?
>
> Thanks in advance
> --aryeh
>
> --
> Aryeh Weiss
> Faculty of Engineering
> Bar Ilan University
> Ramat Gan 52900 Israel
>
> Ph:  972-3-5317638
> FAX: [phone]
>
>
> --
> ImageJ mailing list: http://imagej.nih.gov/ij/list.html

--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Aryeh Weiss]

On 24/12/2015 3:20 PM, Kenneth Sloan wrote:
> Are you talking about the local Israeli IRB (“Helsinki Committee”), or the “Declaration of Helsinki”?
I believe that it is the IRB of the Shiba Medical Center.

--aryeh

> I think they are connected, but they are not the same.
>
> --
> Kenneth Sloan
> [hidden email]
> Vision is the art of seeing what is invisible to others.
>
>
>
>
>> On Dec 24, 2015, at 02:46 , Aryeh Weiss <[hidden email]> wrote:
>>
>> A Helsinki committee has asked whether FIji/ImageJ have "validation".
>> This issue was raised a some years ago in this thread:
>> https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>>
>> I see that ImageJ is used in many publications which contain statements of compliance with  Helsinki committee guidelines.
>> My question is,   has anyone on the list received such a request , and if so, how did you respond?
>>
>> Thanks in advance
>> --aryeh
>>
>> --
>> Aryeh Weiss
>> Faculty of Engineering
>> Bar Ilan University
>> Ramat Gan 52900 Israel
>>
>> Ph:  972-3-5317638
>> FAX: [phone]
>>
>>
>> --
>> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
> --
> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>

--
Aryeh Weiss
Faculty of Engineering
Bar Ilan University
Ramat Gan 52900 Israel

Ph:  972-3-5317638
FAX: [phone]

--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Aryeh Weiss]

Hi Curtis

On 24/12/2015 3:01 PM, Curtis Rueden wrote:
> Hi Aryeh,
>
> > A Helsinki committee has asked whether FIji/ImageJ have "validation".
>
> My understanding is that ImageJ would not "have validation" itself.
> Rather, the organization using it for some purpose (e.g., designing or
> manufacturing a medical device) must somehow ensure the software is
> appropriate for that purpose.
>

I think that this is not like FDA approval. Rather, all studies that
involve animals or humans need to pass a local review board. I dont have
the guidelines -- this is what I found.
http://www.tasmc.org.il/sites/en/Research/Clinical-Trials/Pages/Helsinki.aspx

My son is doing his MD thesis using Fiji (guess where he got that
idea...) and this just came up.
I think it has to do with demonstrating fitness for purpose in the
proposed study.

--aryeh

> In the U.S., from the FDA's web site's validation guide [1]:
>
> "Where the software is developed by someone other than the device
> manufacturer (e.g., off-the-shelf software) the software developer may
> not be directly responsible for compliance with FDA regulations. In
> that case, the party with regulatory responsibility (i.e., the device
> manufacturer) needs to assess the adequacy of the off-the-shelf
> software developer's activities and determine what additional efforts
> are needed to establish that the software is validated for the device
> manufacturer's intended use."
>
> Do you have a link to the Helsinki committee guidelines for comparison?
>
> Regards,
> Curtis
>
> [1]
> http://www.fda.gov/RegulatoryInformation/Guidances/ucm085281.htm#_Toc517237930
>
> On Thu, Dec 24, 2015 at 2:46 AM, Aryeh Weiss <[hidden email]
> <mailto:[hidden email]>> wrote:
>
>     A Helsinki committee has asked whether FIji/ImageJ have "validation".
>     This issue was raised a some years ago in this thread:
>     https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>
>     I see that ImageJ is used in many publications which contain
>     statements of compliance with  Helsinki committee guidelines.
>     My question is,   has anyone on the list received such a request ,
>     and if so, how did you respond?
>
>     Thanks in advance
>     --aryeh
>
>     --
>     Aryeh Weiss
>     Faculty of Engineering
>     Bar Ilan University
>     Ramat Gan 52900 Israel
>
>     Ph:  972-3-5317638
>     FAX: [phone]
>
>
>     --
>     ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>
>

--
Aryeh Weiss
Faculty of Engineering
Bar Ilan University
Ramat Gan 52900 Israel

Ph:  972-3-5317638
FAX: [phone]


--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Kenneth Sloan-2]

Ah - so…this is local Institutional Review Board.  The papers in the literature are probably asserting that the research conformed to the Declaration of Helsinki - that’s different.

IRB’s ask all sorts of questions, some justified and some not.  If the calculations done by FIJI affect patient (or human subject) care, they it’s a legitimate question.  If not, not (in my opinion).  One might as well ask if the Java compiler is validated.

Usually these sorts of questions creep in because some commercial package *has* been “validated” and there is pressure applied to insist that everyone in the institution use the same package.  Usually, it’s not legitimate - but that doesn’t mean that it can be ignored.
Usually, you have to write a few sentences in response, and good judgement prevails.

Usually…


--
Kenneth Sloan
[hidden email]
Vision is the art of seeing what is invisible to others.

> On Dec 24, 2015, at 09:01 , Aryeh Weiss <[hidden email]> wrote:
>
> On 24/12/2015 3:20 PM, Kenneth Sloan wrote:
>> Are you talking about the local Israeli IRB (“Helsinki Committee”), or the “Declaration of Helsinki”?
> I believe that it is the IRB of the Shiba Medical Center.
>
> --aryeh
>
>> I think they are connected, but they are not the same.
>>
>> --
>> Kenneth Sloan
>> [hidden email]
>> Vision is the art of seeing what is invisible to others.
>>
>>
>>
>>
>>> On Dec 24, 2015, at 02:46 , Aryeh Weiss <[hidden email]> wrote:
>>>
>>> A Helsinki committee has asked whether FIji/ImageJ have "validation".
>>> This issue was raised a some years ago in this thread:
>>> https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>>>
>>> I see that ImageJ is used in many publications which contain statements of compliance with  Helsinki committee guidelines.
>>> My question is,   has anyone on the list received such a request , and if so, how did you respond?
>>>
>>> Thanks in advance
>>> --aryeh
>>>
>>> --
>>> Aryeh Weiss
>>> Faculty of Engineering
>>> Bar Ilan University
>>> Ramat Gan 52900 Israel
>>>
>>> Ph:  972-3-5317638
>>> FAX: [phone]
>>>
>>>
>>> --
>>> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>> --
>> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>>
>
>
> --
> Aryeh Weiss
> Faculty of Engineering
> Bar Ilan University
> Ramat Gan 52900 Israel
>
> Ph:  972-3-5317638
> FAX: [phone]
>
> --
> ImageJ mailing list: http://imagej.nih.gov/ij/list.html

--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Albert Cardona-2]

Aryeh,

I'd argue that Fiji, being under version control, and java also being under
version control, enables the researcher to fix the application at a
specific version and, with tests designed for that version, forever produce
the same results. And, by virtue of being open source, assert this
reproducibility in the strongest terms possible by being able to analyze
the source code implementing the relevant computations, even checksum it to
guarantee identity and lack of tinkering over time.

The push to reproducible builts by ImageJ2 developers goes into
facilitating this even further. It's all part of the general movement of
reproducible science.

Best,

Albert

2015-12-24 10:41 GMT-05:00 Kenneth Sloan <[hidden email]>:

> Ah - so…this is local Institutional Review Board.  The papers in the
> literature are probably asserting that the research conformed to the
> Declaration of Helsinki - that’s different.
>
> IRB’s ask all sorts of questions, some justified and some not.  If the
> calculations done by FIJI affect patient (or human subject) care, they it’s
> a legitimate question.  If not, not (in my opinion).  One might as well ask
> if the Java compiler is validated.
>
> Usually these sorts of questions creep in because some commercial package
> *has* been “validated” and there is pressure applied to insist that
> everyone in the institution use the same package.  Usually, it’s not
> legitimate - but that doesn’t mean that it can be ignored.
> Usually, you have to write a few sentences in response, and good judgement
> prevails.
>
> Usually…
>
>
> --
> Kenneth Sloan
> [hidden email]
> Vision is the art of seeing what is invisible to others.
>
>
>
>
> > On Dec 24, 2015, at 09:01 , Aryeh Weiss <[hidden email]> wrote:
> >
> > On 24/12/2015 3:20 PM, Kenneth Sloan wrote:
> >> Are you talking about the local Israeli IRB (“Helsinki Committee”), or
> the “Declaration of Helsinki”?
> > I believe that it is the IRB of the Shiba Medical Center.
> >
> > --aryeh
> >
> >> I think they are connected, but they are not the same.
> >>
> >> --
> >> Kenneth Sloan
> >> [hidden email]
> >> Vision is the art of seeing what is invisible to others.
> >>
> >>
> >>
> >>
> >>> On Dec 24, 2015, at 02:46 , Aryeh Weiss <[hidden email]> wrote:
> >>>
> >>> A Helsinki committee has asked whether FIji/ImageJ have "validation".
> >>> This issue was raised a some years ago in this thread:
> >>>
> https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
> >>>
> >>> I see that ImageJ is used in many publications which contain
> statements of compliance with  Helsinki committee guidelines.
> >>> My question is,   has anyone on the list received such a request , and
> if so, how did you respond?
> >>>
> >>> Thanks in advance
> >>> --aryeh
> >>>
> >>> --
> >>> Aryeh Weiss
> >>> Faculty of Engineering
> >>> Bar Ilan University
> >>> Ramat Gan 52900 Israel
> >>>
> >>> Ph:  972-3-5317638
> >>> FAX: [phone]
> >>>
> >>>
> >>> --
> >>> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
> >> --
> >> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
> >>
> >
> >
> > --
> > Aryeh Weiss
> > Faculty of Engineering
> > Bar Ilan University
> > Ramat Gan 52900 Israel
> >
> > Ph:  972-3-5317638
> > FAX: [phone]
> >
> > --
> > ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>
> --
> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>

--
http://albert.rierol.net
http://www.janelia.org/lab/cardona-lab
http://www.ini.uzh.ch/~acardona/

--
ImageJ mailing list: http://imagej.nih.gov/ij/list.html

[Aryeh Weiss]

Hi Albert and Kenneth,

Thanks for your replies.

On 24/12/2015 6:27 PM, Albert Cardona wrote:

> Aryeh,
>
> I'd argue that Fiji, being under version control, and java also being
> under version control, enables the researcher to fix the application
> at a specific version and, with tests designed for that version,
> forever produce the same results. And, by virtue of being open source,
> assert this reproducibility in the strongest terms possible by being
> able to analyze the source code implementing the relevant
> computations, even checksum it to guarantee identity and lack of
> tinkering over time.
>

I will pass this on, although the people asking about this probably dont
know anything  about version control.

> The push to reproducible builts by ImageJ2 developers goes into
> facilitating this even further. It's all part of the general movement
> of reproducible science.
>
> Best,
>
> Albert
>
> 2015-12-24 10:41 GMT-05:00 Kenneth Sloan <[hidden email]
> <mailto:[hidden email]>>:
>
>     Ah - so…this is local Institutional Review Board.  The papers in
>     the literature are probably asserting that the research conformed
>     to the Declaration of Helsinki - that’s different.
>
>     IRB’s ask all sorts of questions, some justified and some not.  If
>     the calculations done by FIJI affect patient (or human subject)
>     care, they it’s a legitimate question.  If not, not (in my
>     opinion).  One might as well ask if the Java compiler is validated.
>
>     Usually these sorts of questions creep in because some commercial
>     package *has* been “validated” and there is pressure applied to
>     insist that everyone in the institution use the same package.
>     Usually, it’s not legitimate - but that doesn’t mean that it can
>     be ignored.
>     Usually, you have to write a few sentences in response, and good
>     judgement prevails.
>
>     Usually…
>

I am reasonably sure that this is not directly connected to patient
care. It is basic research.
One of the papers that used ImageJ was written by a group who are at the
same med school as my son, so I hope that will do the job.

The main question is whether they will insist on something formal.

--aryeh

>
>     --
>     Kenneth Sloan
>     [hidden email] <mailto:[hidden email]>
>     Vision is the art of seeing what is invisible to others.
>
>
>
>
>     > On Dec 24, 2015, at 09:01 , Aryeh Weiss <[hidden email]
>     <mailto:[hidden email]>> wrote:
>     >
>     > On 24/12/2015 3:20 PM, Kenneth Sloan wrote:
>     >> Are you talking about the local Israeli IRB (“Helsinki
>     Committee”), or the “Declaration of Helsinki”?
>     > I believe that it is the IRB of the Shiba Medical Center.
>     >
>     > --aryeh
>     >
>     >> I think they are connected, but they are not the same.
>     >>
>     >> --
>     >> Kenneth Sloan
>     >> [hidden email] <mailto:[hidden email]>
>     >> Vision is the art of seeing what is invisible to others.
>     >>
>     >>
>     >>
>     >>
>     >>> On Dec 24, 2015, at 02:46 , Aryeh Weiss <[hidden email]
>     <mailto:[hidden email]>> wrote:
>     >>>
>     >>> A Helsinki committee has asked whether FIji/ImageJ have
>     "validation".
>     >>> This issue was raised a some years ago in this thread:
>     >>>
>     https://list.nih.gov/cgi-bin/wa.exe?A2=ind0802&L=IMAGEJ&P=R10971&1=IMAGEJ&9=A&I=-3&J=on&d=No+Match%3BMatch%3BMatches&z=4
>     >>>
>     >>> I see that ImageJ is used in many publications which contain
>     statements of compliance with  Helsinki committee guidelines.
>     >>> My question is,   has anyone on the list received such a
>     request , and if so, how did you respond?
>     >>>
>     >>> Thanks in advance
>     >>> --aryeh
>     >>>
>     >>> --
>     >>> Aryeh Weiss
>     >>> Faculty of Engineering
>     >>> Bar Ilan University
>     >>> Ramat Gan 52900 Israel
>     >>>
>     >>> Ph:  972-3-5317638
>     >>> FAX: [phone]
>     >>>
>     >>>
>     >>> --
>     >>> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>     >> --
>     >> ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>     >>
>     >
>     >
>     > --
>     > Aryeh Weiss
>     > Faculty of Engineering
>     > Bar Ilan University
>     > Ramat Gan 52900 Israel
>     >
>     > Ph:  972-3-5317638
>     > FAX: [phone]
>     >
>     > --
>     > ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>
>     --
>     ImageJ mailing list: http://imagej.nih.gov/ij/list.html
>
>
>
>
> --
> http://albert.rierol.net
> http://www.janelia.org/lab/cardona-lab
> http://www.ini.uzh.ch/~acardona/ <http://www.ini.uzh.ch/%7Eacardona/>

--
Aryeh Weiss
Faculty of Engineering
Bar Ilan University
Ramat Gan 52900 Israel

Ph:  972-3-5317638
FAX: [phone]


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