Draft policy on the register of members and reviewers — submissions
The 13 submissions received, published in full with declared interests and secretariat responses.
§2Submissions and responses
13 submissions were received. Each is published in full below with its declared interest, the secretariat response and the disposition. The Institute publishes submissions it did not accept in the same form as those it did.
The Institute publishes no telephone number and no messaging channel
The respondent states that a body inviting submissions ordinarily provides a channel for questions about the process, and that the written address alone is a high barrier for a first-time respondent.
The respondent asks that a route for procedural questions be provided.
The secretariat notes this submission. The written route is the only route and that is a deliberate constitutional position rather than an omission.
No amendment arises. The Institute holds no telephone number and uses no messaging channel, because a submission made in writing is a document that can be published with its response and an oral exchange is not. Guidance on making a submission has been expanded so that the written route requires no prior enquiry to use.
What the site collects about a reader is not stated in terms a reader can check
The respondent states that a body assessing evidence should be checkable in its own conduct, and that a general privacy statement does not permit a reader to verify what is collected.
The respondent proposes that the statement enumerate what is collected and that it be verifiable from the page itself.
The secretariat accepts this submission. An unverifiable statement about data is exactly the kind of claim the Institute declines to accept from others.
The statement now enumerates what is collected and what is not, and is written so that a reader can verify it from the page source, which is the only form of the statement that can be checked without trusting the Institute.
An industry submission should be identifiable without reading the declared interest
The respondent states that a declared interest printed below a submission is read after the submission, and that a reader who has already absorbed the argument reads the declaration as an afterthought.
The respondent proposes that a submission made on behalf of a company be labelled at the head of the submission as well as in the declaration.
The secretariat accepts this submission. The order in which a reader encounters the two facts changes how the second is weighed.
A submission made on behalf of a company is now identified as an industry submission on its face, at the head of the submission and in the disposition table, in addition to the declared interest published in full beneath it.
Absence of evidence is presented in a form a reader will take as negative evidence
Where the Institute has identified no study, the draft states that no evidence was found. In several places that sentence sits immediately after a paragraph describing an adverse outcome, and the juxtaposition invites the reading that the compound was studied and found wanting.
The respondent proposes a standing formulation, used identically wherever the situation arises, distinguishing an outcome that was studied and not demonstrated from an outcome that has not been studied at all.
The secretariat accepts this submission. The two states are different, they support different decisions, and the draft rendered them in language a reader could not reliably separate.
A standing formulation has been adopted and is applied wherever an evidence gap is recorded, distinguishing an outcome assessed and not demonstrated from an outcome not assessed. The formulation is identical at every occurrence so that it can be recognised at a glance.
The document is unreadable without specialist training
The respondent, a trustee of a patient organisation, states that the draft is written for a reader who already understands certainty grading, and that the people most affected by the subject matter will not reach the assessment at all.
The respondent proposes a plain-language summary at the head of every document, written to the same standard of accuracy as the document itself and not as a promotional abstract.
The secretariat accepts this submission in part. A plain-language summary is added. The proposal that it replace the technical abstract is declined, because the abstract is the part of the document other assessors read and cite.
Every document now opens with a plain-language summary of not more than 150 words, placed above the technical abstract and carrying the same certainty language, so that the two cannot diverge.
A sortable table implies a comparison the underlying data do not support
The draft presents a sortable table whose columns are drawn from sources of differing quality. The respondent states that sorting on such a column produces an ordering that looks like a ranking and is not one.
The respondent proposes that sorting be disabled on any column whose values are not commensurable.
The secretariat notes this submission and records that the point is correct in principle.
No amendment arises here because every sortable table in the document set already carries a standing statement above it that the ordering is not a ranking and that the values in each column are commensurable only where the column header says so. The proposal to disable sorting was considered and not adopted, because a reader who cannot sort a table generally sorts it elsewhere and without the statement.
The policy does not say what happens to a document the Institute is asked to remove
The respondent states that assessments of named parties will attract removal requests, and that a policy silent on them will be applied inconsistently under pressure.
The respondent proposes that the grounds on which a document may be withdrawn be stated in advance and be exhaustive.
The secretariat accepts this submission. A policy written after the first request will be written under the conditions least suited to writing it.
The grounds for withdrawal are now stated exhaustively, being a factual error that cannot be corrected in place and a legal obligation, a withdrawn document is replaced by a notice recording the fact and the ground rather than removed, and every withdrawal is recorded in the corrections log.
The same concept is given three different names in one document
The draft refers to the same quantity as a response rate, a responder proportion and a categorical outcome in different sections. The respondent, who works in health-technology assessment, states that a reader cannot tell whether the three refer to one thing or to three.
The respondent proposes that the glossary term be used at every occurrence and that the glossary entry be linked at first use in each section rather than only at first use in the document.
The secretariat accepts this submission. The variation was stylistic and its cost to the reader exceeds any benefit.
A single term is now used throughout for each defined concept, and the glossary entry is linked at first use within each section rather than once per document.
The document set should be published in translation
The respondent notes that the assessments concern compounds supplied internationally and that publishing only in English restricts access to the assessment to readers who work in it.
The respondent proposes machine translation of the document set as an interim measure, with human review of the certainty language.
The secretariat does not accept this submission, and records that the underlying point is sound and that the proposed remedy is the difficulty.
A translation whose certainty language has drifted is a different assessment carrying the Institute's name, and the Institute cannot review translations it does not have the capacity to review. The documents remain in English. The submission is published in full because the access problem it identifies is real and unresolved.
Recusal should follow automatically from any declared financial interest
The respondent states that case-by-case recusal decisions require the body making them to judge its own members, and that an automatic rule removes the judgement and with it the appearance of partiality.
The respondent proposes automatic recusal on any declared financial interest in a named company.
The secretariat does not accept this submission. An automatic rule of that breadth would recuse most of the people competent to assess the evidence, and the Institute would be left with assessors chosen for their distance from the field.
Recusal remains determined against the specific document, with the decision, its reasons and the person recused published in the document front matter. The submission is published in full because it identifies a genuine tension the Institute has resolved in one direction rather than removed.
A superseded version should remain reachable from the version that replaced it
The respondent states that the draft supersedes an earlier document and that a reader who cited the earlier version has no way to reach it from the new one, which makes it impossible to see what changed.
The respondent asks that every version carry a link both to what it supersedes and to what supersedes it.
The secretariat notes this submission. The corrections and versioning policy already requires bidirectional version links and every superseded document is retained at its own address.
No amendment arises. The requirement is stated in the corrections and versioning policy and the amendment log of this document links to the version it replaced. The respondent is correct that the link was absent from the draft page furnished for consultation, which was a defect of the consultation copy and not of the policy.
The position of a contributor who withdraws consent is not stated
The respondent states that consent to be named is obtained at submission and that the policy is silent on what happens if it is later withdrawn, which leaves both the Institute and the contributor without a rule.
The respondent proposes that the position be stated in advance and be the same for everyone.
The secretariat accepts this submission. A rule made at the point of the first withdrawal is a rule made about a particular person.
The policy now states that a contributor may withdraw from the register at any time and that the register entry is removed, while a signed submission already published remains published, because the consultation record is a record of what was said and by whom. The position is stated at the point consent is given.
The disclosure requirements exceed those of comparable bodies
The submission is made on behalf of a manufacturer. It states that the per-page disclosure requirement is more extensive than that applied by comparable assessment bodies and that the repetition may be read as implying a relationship of greater significance than exists.
The submission does not object to disclosure and objects to its placement and frequency.
The secretariat notes this submission and records that the point about repetition is a fair one.
No amendment arises. Per-page disclosure was consulted on separately and retained, on the ground that a reader arriving at a single page from a search engine does not see a disclosure held elsewhere. The wording has been standardised so that the repeated statement is identical at every occurrence and is not read as a series of different claims. The submission is identified as an industry submission.
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- International Organization for Standardization. ISO/IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories. ISO/IEC Standard 2017;3rd edition. identifier not held by the Institute
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.