POSTED ON BEHALF OF LUCETTE FLANDROY (MODERATOR)

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Dear Members of the Open Ended Online Forum,

I am honored to have been invited to moderate this round of discussion in continuing our task to develop of a package that aligns the “Guidance on Risk Assessment of LMOs” (e.g. the Roadmap) with the training manual “Risk Assessment of LMOs”.

As indicated in our calendar of activities, this discussion will focus on the alignment of Modules 1 and 2 of the Training Manual with the relevant sections of the Guidance. The secretariat has kindly prepared a draft alignment between the corresponding sections of the two documents for our ease of reference. I encourage you to review the two documents and provide comments on the appropriateness of the links made between the two documents and whether or not you feel additional links and improvements to the text can be made.

Moreover, you are also invited to propose a way forward to further align the sections of the two documents.

I would like to reiterate our mandate that any suggestions for improvements to the Guidance will be forwarded for the consideration of the COP-MOP along with recommendations as to who would be responsible to carry out such improvements (e.g. the Secretariat, an AHTEG, a consultant, etc.).

Apart from the recommendations to improve the Guidance, I also encourage you to consider ways, in line with our mandate, by which we can fully accomplish the alignment between the Manual and the Guidance within this intersessional period. For example, could this be achieved by means (e.g. cross-references, links, notes, etc.) that would enable users to navigate easily between the corresponding sections of the Training Manual and the Guidance if they require further explanation of a concept?

I am looking forward to your comments and suggestions and am counting on an insightful set of comments and recommendations from you.

Best regards,
Lucette

Dear members of the Open Ended Online Forum,

I am conscious that the exercise asked to you in this round of discussions may be time consuming as it may imply reading again the 2 documents concerned, which are the "Guidance on Risk Assessment" ( e.g. the Roadmap ) and the training manual " Risk Assessment of LMOs". This may explain why we still do not have many postings with comments and suggestions till now.

As a reminder: the texts of the Guidance and the Training Manual can be found at http://bch.cbd.int/forum/ahteg/oeof_ahteg_2012-2014/guidance_and_manual_with_line_numbers/ra_guidance_rev19jul2012.doc and http://bch.cbd.int/forum/ahteg/oeof_ahteg_2012-2014/guidance_and_manual_with_line_numbers/ra_training_manual_revjul2012.doc respectively. Lines are numbered in these texts to facilitate exchanges of views.

I thus take the opportunity of this quiet time to reiterate the kind of comments/suggestions that are waited from you in this session, and that can be grouped under main questions and sub-questions. ( I hope this grouping can facilitate your reflection and answers ):


1)      a) Do you agree with the draft alignment between modules 1 and 2 of the Training Manual and the corresponding sections of the Guidance that was proposed through the link http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml in the mail of the Secretariat sent on 26/06 ?
         b) Do you feel that additional alignment can be drawn between these sections of the 2 documents ?


2)      a) In the draft alignment, do you consider that modules 1 and 2 of the Manual and the corresponding sections of the Guidance are complementary?
       b) Do you think improvements to the text can be made in order to reach a better complementary package? For example, do you think more details should be brought in a section of one of the document if it has to be an explanation of a concept mentioned in the other document ? If yes, where exactly?



3)      Where there are differences between the Guidance and the Manual, are these differences only in the structure or do you feel that they are conceptual differences? If the latter, in which of the documents is a given concept more appropriately described?


4)      How - by which way - do you propose the alignment(s) between the 2 documents to be made to ensure an easy navigation between the 2 documents for the development of a coherent and complementary package? By cross-references, links, notes, etc..... ?





To better contextualize these questions I also invite you to have another look at decision BS-VI/12, including the Annex, available at http://bch.cbd.int/database/attachment/?id=13599.



I wish you a fruitful reflection and am looking forwards to your comments and suggestions.

Best regards

Lucette Flandroy


Disclaimer : http://www.health.belgium.be/eportal/disclaimer/

Dear Participants to the Open-ended Online Forum,

Let me start by thanking Lucette for moderating this discussion and for her very helpful message of 4 July. I would also like to thank the Secretariat for preparing the draft comparative alignment between modules 1 and 2 of the Manual and the corresponding sections of the Guidance, including the useful schematic alignment.

At this point, I believe it is crucial that we establish a common vision and realistic expectations of what we can achieve before COP-MOP7 and how we can best use our time and efforts to get there.

In her message, Lucette provided several questions to guide the discussion which, in my point of view, are vital for the successful achievement of our task. In the same lines, I would like to elaborate a bit further and share some ideas for a possible way forward through which we could achieve one of the outcomes that is expected from us as per the COP-MOP, specifically:

“A package that aligns the Guidance on Risk Assessment of Living Modified Organisms (e.g. the Roadmap) with the training manual ‘Risk Assessment of Living Modified Organisms’ in a coherent and complementary manner”.

I would also like to recall that, in the same decision, the COP-MOP requested that the Guidance be tested and that recommendations for its improvement be forwarded for its consideration at its next meeting.

In my view it is also important to take into account that the Guidance and the training manual result from different processes. The Guidance has been developed by the open-ended online forum and the AHTEG through a multi-stakeholder process as mandated by the COPMOP. At this stage we can make suggestions for changes but only the COPMOP can decide on actual changes. Also as mandated by the COPMOP , the Manual has been developed by the Secretariat and experts. Here we can already make changes of the text at this stage. I will come back to this difference later when I will suggest what that may mean in practical terms concerning a possible way forward.

While both the Guidance and Manual are written in the context of the requirements of the Cartagena Protocol, their target audiences are different. On the one hand, the Manual is meant to provide an introduction to risk assessment, including the relevant provisions of the Protocol, and its target audience is novice risk assessors or persons aspiring to become risk assessors. The Guidance, on the other hand, is more detailed providing an in-depth and practical overview of the risk assessment process and it is intended as a reference for risk assessors while conducting an actual case of risk assessment. Consequently, the documents are not identical, but rather complementary.

In the first round of discussion on the alignment of the Guidance and Manual that took place in December 2012, some of the views posted recommended that the Manual and the Guidance should retain their separate identities in the aligned package. After some consideration of a possible way forward, my suggestion is that we proceed in a stepwise manner to develop the aligned package by:

i) Mapping all corresponding sections between the Manual and the Guidance.

ii) Identifying if there are sections or concepts contained in the Guidance that are missing in the Manual, and vice-versa, for which users would benefit from more introductory explanation (i.e. in the Manual) or more in-depth analysis (i.e. in the Guidance), taking into account the different scopes of the documents

iii) Adding new text to the Manual if and where necessary to better explain some sections and concepts contained in the Guidance in a coherent manner.

iv) Making recommendations to the COP-MOP on ways to improve the Guidance, taking into account the results of the testing.

v) Presenting the aligned package of the two documents in an electronic format that allows for easy navigation between corresponding sections of the two documents. This can be achieved, for example, through links and explanatory notes offering additional information and guiding the users between the two documents.

In the interest of maximizing the use of our time, I suggest that we could proceed by working simultaneously on steps i) and ii) as we go through the entire documents in accordance to our calendar of activities. With the help of the Secretariat, this would be followed by tackling steps iii) to v), possibly during additional rounds of online discussions, if needed.

As such, I reiterate Lucette’s questions and invite colleagues to share their views in the remaining time of this discussion on modules 1 and 2 of the Manual by (i) focusing on the schematic alignment provided by the Secretariat and identifying if additional concepts can be further aligned, as well as (ii) identifying any concepts that should be included either in the Manual’s modules 1 and 2 or in the corresponding sections of the Guidance.

In spite of the challenging nature of the task at hand, I am confident that through our collaborative efforts we will be able to develop a package that will assist many countries in training their risk assessors and in carrying out their risk assessments.

I look forward to your contributions.

Best regards,
Helmut Gaugitsch

Dear All
First of all I like to join Helmut in congratulating and thanking Lucette for moderating this online discussion forum and the secreteriat for preparing the draft comparative alignment.
What we have to do is really not an easy task. Helmut  made very good suggestions. I would like to add a small additional proposal. We should try to have the same concepts, explanations and informations under the same or similar headings and preferably in one and the same chapter of each of the documents. That would also be very helpful in context of step v) of Helmuts suggestions proposing an electronic format for easy navigating between corresponding sections. In the draft alignment it can be seen that sometimes parts of topics addressed in the manual are at different places in the guidance and vice versa. 
For example: the manual addresses protection goals and how to translate protection goals into assessment endpoint etc. under the heading of Broad national context whereas the guidance sees this as a preparatory part and first step of the RA as such (planning phase of the RA).
I enclose the training manual where I highlighted some sections indicating where this topic is addressed in the guidance.
I am not sure: is it an option to reshuffle the training manual a little bit for a better alignment of the same topics in the chapters?

best regards
Beatrix

POSTED ON BEHALF OF MAHAMANE GADO

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Dear colleagues

I want to join my first colleagues in this online discussion forum to thank Lucette for contribution in moderating this online discussion particularly by asking several guide questions and the Secretariat for preparing the draft comparative alignment.

The Manual is an introduction to risk assessment and is very helpfull for assessors from developping countries where appropriate tools of risk assessment are not available and there is a complementarity with the guidance which provides  case of risk assessment that can be tested.
I agree with Helmut suggestion to map all corresponding sections between the Manual and the Guidance.

As suggested by Beatrix, the same concepts, explanations and informations under the same or similar headings will improve these documents.

Best regards
Gado

Dear members of the Open Ended Online Forum,

I first want to warmly thank the members of the forum who participated till now with encouraging and constructive messages in this rather complex session of the forum.
Some interesting reflections and suggestions were so already made.

Anyway, as announced by the Secretariat on 26 June, the discussion on this session is closing on next Sunday 14 July 2013 at 1 a.m. GMT.

This forum is yours, and we would really appreciate to hear more from you before the closing of this session in order to make a step forwards in the alignment of the Guidance and the Manual, to respect the mandate of this forum. Remember that you are helped by the draft alignment proposed by the Secretariat and by further guiding questions suggested to be answered.

Summer time has come, but the forum should not be abandoned .............

Best regards, waiting for your hoped participation.


Lucette Flandroy


Disclaimer : http://www.health.belgium.be/eportal/disclaimer/

Dear colleagues,
I would like to thank the Secretariat for providing Draft alignment between Modules 1 and 2 of the Training Manual and Guidance and I agree with it. Many thanks to our Moderator  Ms. Lucette Flandroy for helpful questions.
Answering the questions I would also like to express that I feel need the additional alignment between Modules of the Training Manual and the corresponding sections of the Guidance. On the other hand I am aware different purposes of the two documents, accepting Manual as an introduction into risk assessment teaching new risk assessors and Guidance as a practical overview for risk assessors. So they have different purposes I feel there is no necessity of making them quite uniform in introduction questions describing in Modules 1 and 2 of the Training Manual. But in my opinion it is important to make them consistent in subsequent chapters dealing with directly issues of risk assessment. I would like to propose  not to overload the text of the Guidance with the additional information from the Modules 1 and 2, but simply provide a link in the electronic version of the corresponding sections of Part I of the Guidance to detailed description of the corresponding information in Modules I and II of the Training Manual (in the case of the printed version it could be links to the corresponding pages).
To the Chapters of this two Documents rifer the risk assessment process directly I accept more details adding to them to rich a better complementary package (looking ahead). But it is the question of the next round of discussions.
I also would like to say that from my point of view better alignment between the Documents is cross-reference for electronic documents and links for printed. As for me I wouldn’t like to see a lot of notes in the text. I think such form of alignment is distracting from the text prescription. If the reader would like to learn broad description of the material he couldn’t find in the Guidance he always should go to the link which will lead him to the Training Manual.
My best wishes.
Galina Mozgova.

Dear collegues:

I would like to thank Lucette and the Secretariat for their very helpful and hard work in trying to bring forward very good elements to be able to draw a relevant path forward in relation to starting the process of aligning the guidance with the training manual.

I personally found the comparative alignment of modules 1&2 very useful. This type of approach is an easy way for anybody to understand how these two documents are related to each other.

What I feel is missing, and I do not know if this was already taken into consideration in previous discussions is a need for a common introductory section explicitly explaining/contextualizing the nature of each document (scope, context, audience, etc), the reasons behind developing both of them and how these are connected.

Once the way in which the alignment should and would occur is settled, then this also should be made explicit.

These explicit texts will contribute to clarity for users (either it being the training manual or the guidance) and to transparency of the whole process.

I agree completely with the approach proposed by Helmut Gaugitsch (points i to v) including his suggestion that we focus on i and ii simultaneously as the main priority leaving iii, iv and v for later rounds of discussion with the help of the Secretariat.

Trying to answer Lucette´s Q:


1)      a) Do you agree with the draft alignment between modules 1 and 2 of the Training Manual and the corresponding sections of the Guidance that was proposed through the link http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml in the mail of the Secretariat sent on 26/06 ?
         b) Do you feel that additional alignment can be drawn between these sections of the 2 documents ?

I agree with the alignment proposed by the Secretariat.

2)      a) In the draft alignment, do you consider that modules 1 and 2 of the Manual and the corresponding sections of the Guidance are complementary?
       b) Do you think improvements to the text can be made in order to reach a better complementary package? For example, do you think more details should be brought in a section of one of the document if it has to be an explanation of a concept mentioned in the other document ? If yes, where exactly?

I think the two documents in relation to modules 1&2 are complimentary in nature eventhough they have been developed for different purposes. I do not think it necessary that they be reedited so as to include what is absent in one or the other document, or to organizing them in such a way that the sections/subsections/ideas follow a similar order. What is most relevant is to make sure they are not inconsistent or are contradictory between them in any way that would lead to misunderstandings. 


3)      Where there are differences between the Guidance and the Manual, are these differences only in the structure or do you feel that they are conceptual differences? If the latter, in which of the documents is a given concept more appropriately described?

The main difference seen up to now have to do with the nature/purpose of the two documents. As others have stated already, this should not be a concern as long as it is clearly stated from the very beginning that the purpose of each document is different.


4)      How - by which way - do you propose the alignment(s) between the 2 documents to be made to ensure an easy navigation between the 2 documents for the development of a coherent and complementary package? By cross-references, links, notes, etc..... ?

Cross-references, links, notes…..all of these are useful tools to make a clear connection between the documents (as long as the “conceptual connection” between them has already been stated). These could be constructed along the way and on the basis of our discussions by the Secretariat as further input to our discussions.


I hope my contribution up to now was clear and somehow useful.

Un abrazo desde Mexico!!!!!
Francisca

Dear AHTEG colleagues:

I thank Lucette for chairing this session and the Secretariat for their very hard work in making this online discussion easier to discuss on aligning the guidance document with the training manual.

I personally feel that these 2 documents are handy, and not that complicated to understand. Below is my feedback:

1)      a) Do you agree with the draft alignment between modules 1 and 2 of the Training Manual and the corresponding sections of the Guidance that was proposed through the linkhttp://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml in the mail of the Secretariat sent on 26/06 ?
         b) Do you feel that additional alignment can be drawn between these sections of the 2 documents ?

Overall, I agree with the arrangement and I think it is also a logical way to present in this way. And hence additional alignment may not be necessary. In this case, Helmut’s points from i to iii are agreeable.
But if I may, I would suggest that the for the References in Module 1 in the Manual (as in line 528 of the Manual document; line 948 in Module 2) be referred to in the text by appropriate citation so that the reader can easily find the appropriate suggested references at the corresponding section in the text (unless the suggested references are for general/further reading.

2)      a) In the draft alignment, do you consider that modules 1 and 2 of the Manual and the corresponding sections of the Guidance are complementary?

Considering the 2 modules are a simpler document and the detail information can be derived from the Guidance document, as long as these 2 main documents are not contradicting (which they are not), therefore I think these sections are complementary.

       b) Do you think improvements to the text can be made in order to reach a better complementary package? For example, do you think more details should be brought in a section of one of the document if it has to be an explanation of a concept mentioned in the other document ? If yes, where exactly?

At this stage, I don’t think a major editing of the texts are necessary, but I am of the opinion that the specific terms used should not be contradicting in these 2 documents. 

3)      Where there are differences between the Guidance and the Manual, are these differences only in the structure or do you feel that they are conceptual differences? If the latter, in which of the documents is a given concept more appropriately described?

It doesn’t appear to me that the differences are conceptually different, and because these 2 documents were prepared by separate processes and served different purposed, it may not be necessary to have major improvement.


4)      How - by which way - do you propose the alignment(s) between the 2 documents to be made to ensure an easy navigation between the 2 documents for the development of a coherent and complementary package? By cross-references, links, notes, etc..... ?
As suggested by my colleagues in the AHTEG and I agree, cross-reference and hyperlink are useful tools for easy navigation.

Thank you and regards,
Kok Gan Chan
University of Malaya, Malaysia

Dear Lucette, dear colleagues,

In the first place I would like to thank all who have contributed to the organization of this discussion and to the discussion itself.
I have to apologize for not being able to participate very effectively. This is due to quite a number of other duties (not even holidays ;-), or rather ;-( )

Just some considerations to the questions:

1) a) Do you agree with the draft alignment between modules 1 and 2 of the Training Manual and the corresponding sections of the Guidance that was proposed through the link http://bch.cbd.int/onlineconferences/forum_ra/discussion.shtml in the mail of the Secretariat sent on 26/06 ?
b) Do you feel that additional alignment can be drawn between these sections of the 2 documents ?

I think that the alignments are OK in principle.
But, looking at this I think that the Manual takes much better care of the needs of novice risk assessors, and is much closer to the heart of the Protocol.
I am not sure that all the arguments that we have gone into in the Guidance are of immediate interest to the beginning risk assessor. Maybe that should be made clear.

2) a) In the draft alignment, do you consider that modules 1 and 2 of the Manual and the corresponding sections of the Guidance are complementary?

Yes, I think they are very complementary, but probably mainly in one direction.
Readers of the Guidance will find the need to go back to the source, i.e., the Protocol, and they will find that explained in the Manual.

b) Do you think improvements to the text can be made in order to reach a better complementary package? For example, do you think more details should be brought in a section of one of the document if it has to be an explanation of a concept mentioned in the other document ? If yes, where exactly?

Therefore, I am not very happy with all arrows between Manual and Guidance being bidirectional.
That is, if this means that the links between them go exactly to the same place. In the Manual the links should be at the end of various sections, explaining that the principles in the Manual are further worked out in the Guidance. Links from the Guidance could probably go much more focused from various parts in the Guidance to the start where the fundamentals of a particular issue are treated in the Manual.
But, see my answer to question 3, things will not be so easy.

3) Where there are differences between the Guidance and the Manual, are these differences only in the structure or do you feel that they are conceptual differences? If the latter, in which of the documents is a given concept more appropriately described?

The two solid arrows are the heart of the matter: alignment of the planning phase and the context and scope.
Here we see that the Manual and the Guidance are on completely different tracks. My ideas about arrows in the answer to question 2 apply, but I am afraid that in practice it will not even be readily possible to make direct links.
Nothing more than general links, from the introductory material in the Manual to the only distantly related material in the Guidance will be possible. I think Beatrix is right in her analysis, but this goes for more issues than what she has highlighted.
Again I have to apologize that I have not yet been able to go into this into the required detail.

4) How - by which way - do you propose the alignment(s) between the 2 documents to be made to ensure an easy navigation between the 2 documents for the development of a coherent and complementary package? By cross-references, links, notes, etc..... ?

As I implied above, by cross references. Hyperlinks would be optimal, but then, that should be hyperlinks to explanatory text, as I proposed earlier: some explanatory text like ‘this issue is further elaborated in the Guidance where it is dealing with … (link to a location in the Guidance)’ or, ‘this issue is placed in the context of the Protocol more clearly in the Manual where it deals with … (link to the location in the Manual)’.

Again, as usual, I wish the Secretariat all the wisdom and success in their very difficult task!

Best regards,

Hans

Thank you, Lucette, for guiding us in this endeavor. I must apologize for not having the time in these weeks to ponder these questions in depth. Briefly and generally in response to Lucette’s four questions:

1. I agree with the draft alignment, and that the alignment can be drawn between these sections of the two documents.
2. Modules 1 and 2 appear quite complementary to the corresponding sections of the guidance.
3. I cannot identify any conceptual differences between the guidance and the manual.
4. For me, hypertext links, specific cross-references between particular sections, and explanatory notes would be most useful.

Further, I thank Helmut very much for his useful orientation to our work and explanation of the relationship between the guidance and the manual. The five steps outlined by Helmut seem a reasonable course of action for us to pursue to complete our tasks. I also agree with Beatrix’s small modifications to his proposal.

Regards,

Doreen