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Comments on the draft questionnaire
thank you very much for the many active contributions over the last hours to the draft concept note. At this stage I take note of your comments and drafting suggestions and do not want to add any observation from my side. We will have to solve a few issues of contents as well as a few more editorial points but I am confident that this will be possible on the basis of the discussion. As mentioned in my opening statement I will prepare a short summary after the next round and share it with you Tuesday next week.
With this I now invite you to focus on the Draft questionnaire. I would just like to repeat my suggestion made in my first statement that in the questionnaire I suggest that we focus on the follwoing issues:
- The appropriateness of the type of answers (e.g. by numbers, descriptors or both);
- Further clarity to the existing questions;
- Need of additional questions. If so, which additional questions could be posed?
The discussion is open now and for the next days, up to Tuesday, 21 May at 6:00 a.m. GMT. On Tuesday, I will attempt to provide an interim summary of the main views and emerging concepts before continuing with the second half of our discussions in the next week on the structure and focus of the process of testing the Guidance.
I am looking forward to your comments and suggestions. The floor is open.
Thank you and best wishes
posted on 2013-05-16 11:20 UTC by Mr. Helmut Gaugitsch, Austria
Dear Dr. Helmut, dear Secretariat, dear AHTEG colleagues,
First of all I wish to express my gratitude for the invitation to participate in the AHTEG forums and that I am honored to be involved in such important discussion. Secondly I want to apologize for my message delay. During the time specified I have a hard work on the conference devoted the legal aspects of pharmaceutical and food technologies. Henceforth I will try to stick to the set time.
To the discussion. I would like to add that as Dr. Wei Wei I was also faced with the difficulty in interpreting of the words «practicality», «usefulness» and excluded «utility». When the terms interpreting into the Russian language, they have the same sense. And when I read the clarification of the terms in the Questionnaire I don’t feel the satisfaction from their explanation and the way of their definition (for example “Usefulness” relates to having a beneficial use; serviceable; helpful). May be not so many words for terms description – just one crucial definition, that help to distinguish the key terms in the Survey. So I propose to think about this terms and way of their definition in the Questionnaire in the case if only this terms would be accepted for the questionnaire. As for me I liked proposition of one of the On-line forum participant to include the question about Clarity of the Sections.
posted on 2013-05-17 15:58 UTC by Dr. Galina Mozgova, Belarus
I agree that the terms “practicality”, “usefulness” and “utility” need to be better explained in a more simplistic way.
I think there might be an added value in including a set of questions on the background materials under relevant sections. Do they cover the subject sufficiently and if there are any additional background materials that need to be added to enrich the guidance document and if so what are these?
I would also like to ask the chair to extend the time to get comments on any issue to not less than a week if possible.
posted on 2013-05-18 09:38 UTC by Mr. Ossama Abdelkawy, Syrian Arab Republic
Dear Helmut, Dear All,
My general comment regarding the Concept note I would keep the structure and wording proposed by the Secretariat.
I see the only dis-accordance between (b) and (k):
(b) The Guidance will be tested nationally and regionally...
(k) Each Party, other Government or relevant organization may test the Guidance with as many actual cases of risk assessment available but may only complete and submit one questionnaire reporting their results.
Could we also provide a questionnaire reporting rules for the regional testing workshops?
I would propose to start the section-by-section evaluation with the question of relevancy to the Protocol.
I would like to see the reflection of parties and evaluators regarding the scientific consistency and completeness of each tested document (section).
I am not sure of the relevancy of the question 7." How satisfied are you with regards to the practicality of this section of the Guidance?" The testing resources or capacities might differ from country to country. At the same time we could not exclude the section of the guidance just for the reason that at present no capacities or scientific information to fulfill the assessment.
Best to all
posted on 2013-05-18 13:17 UTC by Angela Lozan
First of all I like to apologize for this late participation. I am not in my office and have difficulties with internet access. As an old and new member of the AHTEG I like to thank for the trust to be reelected and am looking forward to our ambitious work.
I take the freedom to make few comments on the concept note even at this late stage.
I am quite confident with the note as it is and would not change much. I can understand Francescas problems, may be there is an option to submit more then one questionnaire via the National focal points though only one per organisation.
And I support the proposal to indicate if the submission is by an individual or by a group.
I am not supportive of the changes proposed by Tom and I would like to caution against the use of systematic reviews. There are some discussions starting if and how systematic reviews can be used in risk assessment. But that is not really worked out yet.
Regarding the questionnaire I am "very satisfied" as it is now.
Sorry for being quite short and may be a bit blunt. But that is because of the difficult situation.
best regards to all
posted on 2013-05-18 17:08 UTC by Beatrix Tappeser, Federal Agency for Nature Conservation
I'm generally happy with the questionnaire. It if fairly brief and to-the-point, which is generally a good idea. I'm also happy that the questionnaire has a 5-point scale with a central, neutral position and two positive and two negative options on side of it. So there is no bias in the reply options.
My only suggestion is for an extra question in the questionnaire if the suggested changes to part (e) of the Concept Note, as discussed a few days ago, are accepted, in order to have coherence between the Concept Note and the Questionnaire. The changes to the Concept Note that were suggested are: “(e) The technical and scientific data of actual cases of risk assessment used in the testing may originate from various sources, including application dossiers, summaries of notifications, as well as previous and ongoing risk assessment processes”.
There is therefore a considerable range in the type and nature of documents that may be tested and therefore the type and amount of technical information in them. For example, a full application dossier would likely contain much more information and technical detail than a summary of notification. It is therefore quite possible that the testing of one type of document may result in an a different level of satisfaction being expressed in the questionnaire than if another type of document is tested. Consequently, although the aim of the testing is to test the Guidance, the responses in the questionnaire may not reflect the nature of the Guidance as much as it reflects the nature of the documents being tested. It would therefore be an excellent idea to record what types of documents are being used to test the Guidance in order to determine their influence on the outcome. I would therefore suggest an extra question be asked in the questionnaire, thus:
Which type of documents are being tested?:
Summary of notification
Previous assessment process
Ongoing risk assessment process
Other (please specify): <text entry>
Kind regards to you all
posted on 2013-05-20 15:16 UTC by Dr Judy Carman, Institute of Health and Environmental Research
POSTED ON BEHALF OF PATRICIA GADALETA
Dear colleagues, good afternoon.
I have made some comments and suggestions in track change mode in the uploaded file.
Some comment I think that needs for more clarifications, may be they could be in the instructions document. I apologize if I misunderstood something because of my language difficulties in English.
My main concern is about the use of the word ¨satisfied¨ and if a survey of satisfaction will give outcomes about the fact of testing different aspects such as practicality, usefulness of the different section of the Guidance, and their consistence with the Protocol of Cartagena on Biosafety, or will give the feelings about the text of Guidance and/or each sections. I understand that the objective of the questionnaire is gathering the outcomes of test of the Guidance with scientific dossiers (or other recourses) and isn’t to test the level of satisfaction with the Guidance, and this should be very clear.
posted on 2013-05-20 20:21 UTC by Dina Abdelhakim, SCBD
As has been pointed out in the online and more recently, the questionnaire has a fundamental problem since it asks primarily for testers level of satisfaction rather than their view of practicality and usefulness. This seems to be a deviation from the mandate, possibly to achieve some simplification of a fundamentally complex challenge.
However, I strongly object to the suggestions in #5282, which wants to turn the activity into testing the documents used to test the guidance. The current draft questionnaire requires BCH records that will give us the information we need to know what "actual cases of risk assessment" were used in the testing. I (again) caution against deviating from the task into an exercise of critiquing risk assessment that have been published using the guidance as a benchmark. This is completely the reverse of what should be done.
Finally, while some colleagues rejected every editorial suggestion I made to the Concept Note without providing a justification, I must again point out that "(e)" of the Concept Note should explain "actual cases of risk assessment", not "technical and scientific data" which is the subject of the sentence originally proposed. I feel it is our job as the AHTEG to provide as much clarity to the tester of the guidance as possible. One confusing term coming out of MOP6 (Decision BS VI-12) is this idea of "actual cases of risk assessment".
posted on 2013-05-20 21:44 UTC by Mr. Thomas Nickson, Consultant
Dear Thomas [#5286]
It is clear from the Concept Note and the Questionnaire that it is the Guidance that is being tested, not the documents. And my suggested extra question does NOT turn the whole activity into testing the documents used to test the Guidance, instead of the Guidance itself. I am surprised that you think that it does.
posted on 2013-05-21 01:08 UTC by Dr Judy Carman, Institute of Health and Environmental Research
Just four brief points for your consideration.
1) In support of Geoff and Beatrix, a little more time for commenting would be much appreciated and allow greater and more considered participation.
2) Questions 8, 10, 12 and 14 can be simplified by deleting the YES/ NO boxes and the ‘If YES …….’, but retain the option <Text entry>.
3) In support of Patricia and Tom, the subject matter of questions should be practicality, usefulness, consistency and experience; not satisfaction. Satisfaction is too subjective and was not stipulated in decision BS-VI/12. It is not in the requirements of the concept note and no clear criteria have been provided on what constitutes satisfaction and how it would be evaluated.
4) Support for testing actual risk assessments endorsed by competent regulatory authorities. All other risk assessments are hypothetical as they do not impose legal obligations.
posted on 2013-05-21 02:32 UTC by Paul Keese, Australia
Greetings to my colleagues
Perhaps I am misunderstanding, but it seems that Paul is suggesting (4): "testing actual risk assessments".
My understanding is that we are testing the Guidance, not the risk assessments. However, the information for the task may come from various sources as described adequately well by the Concept Note. I also think that the Concept Note is clear on what kind of information is to be used in actual cases of risk assessment - information that is scientific and technical - because the guidance is written to support scientific risk assessments.
I reaffirm my support for the source documents as described in the Concept Note, that might serve to support a testing of the Guidance.
posted on 2013-05-21 09:55 UTC by Mr. Jack Heinemann, University of Canterbury
My understanding is the same as Jack 's opinion. We should testing the guidance on the scientific risk assessment. I agree we should consider the results of testing as it is described in the Concept note, i.e provided by regulators, scientists, parties, organizations, regional workshops, individuals. The scientific content of the guidance on risk assessment is the scope of testing.
My best to all,
posted on 2013-05-21 16:24 UTC by Angela Lozan
I certainly agree that more time is required to adequately comment! I also agree that testing of the guidance should be based on risk assessments conducted by national competent authorities where the outcomes need to hold up to international scrutiny and legal challenges.
posted on 2013-05-21 17:18 UTC by Mr. Phil Macdonald, Canada
Risk assessments done by competent authorities *may* potentially be subject to legal challenge, but that does not mean that everyone of them is written to withstand it or if challenged would. Nor is it automatically true that all other risk assessments or actual cases of risk assessment not done by competent authorities have no legal standing or no potential to be challenged in court.
My understanding of the MOP decision is that they wanted to test the Guidance in actual cases of risk assessment because actual cases, regardless of where they come from, are what people are using. The Guidance is being tested for being practical and useful under actual circumstances.
posted on 2013-05-21 20:29 UTC by Mr. Jack Heinemann, University of Canterbury