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Frequently asked questions about the “Form for disclosure of potential conflicts of interest”

List of frequently asked questions

  1. 1)

    What is the purpose of the “Form for disclosure of potential conflicts of interest”?

    The Institute for Quality and Efficiency in Health Care (IQWiG) is a scientifically independent institute. The principles of its work are transparency and comprehensibility of all working steps. The “Form for disclosure of potential conflicts of interest” contributes to these principles. The purpose of this form is to disclose potential conflicts of interest in persons who are involved in the production of the Institute’s reports by working on commissions, responding to requests, or submitting comments on the Institute’s products.

    Essentially, three types of participation can be distinguished. Participation as:

    • an “external expert”
    • a “person submitting comments”
    • a patient or other person affected who is involved in discussions about patient-relevant outcomes
  2. 2)

    What is the function of a “patient or other person affected”?

    In the early phase of a project, the Institute regularly invites patients or other people affected to discuss the choice of patient-relevant outcomes with them. Patients and other people affected who are invited by the Institute and would like to participate in a discussion to determine patient-relevant outcomes must submit the “Form for disclosure of potential conflicts of interest” by the deadline noted in the invitation.

    It is also possible for patients and other people affected to apply as external experts or participate in the development of the Institute’s products as persons submitting comments (see below).

  3. 3)

    What is the function of an “external expert”?

    One of IQWiG’s legal responsibilities is the production of reports which, for example, assess the benefits and harms of drug interventions or diagnostic tests. Its responsibilities also include the assessment of manufacturer dossiers within the framework of the early assessment of drugs, the assessment of non-drug interventions including the applications within the framework of assessments of potential, assessments of new treatment and examination methods with high-risk class medical devices, and the production of HTA reports according to §139b (5) Social Code Book V. IQWiG involves external experts in the production and review of these reports and assessments. The Institute is also legally obliged to award scientific commissions to external experts.

    According to § 139b (3), line 2, Social Code Book V, the external experts involved must disclose all “connections to interest groups, contract institutes, particularly in the pharmaceutical industry and the medical devices industry, including the nature and amount of payments”. The disclosure of such connections is the basis for the evaluation of conflicts of interest. All external experts applying for participation in the preparation of an IQWiG product must therefore fully complete the “Form for disclosure of potential conflicts of interest” and submit this form to the Institute.

  4. 4)

    What is the function of a “person submitting comments”?

    During the preparation of an IQWiG product, private persons, societies, institutions or commercial enterprises may submit comments on the “preliminary report plan” (protocol) and the “preliminary report”. Various formal requirements exist for the submission of comments. These requirements are explained in separate guidelines. The comments must be submitted in writing, and the person(s) submitting comments must state his or her/their name and position. All persons signing comments should also submit the “Form for disclosure of potential conflicts of interest” to disclose any potential conflicts of interest to the Institute and the readers of the report. However, the submission of this form is not mandatory for written comments.

    If questions arise from the written comments, these can be clarified within the framework of an oral scientific debate. In order to participate in this debate, it is mandatory to submit the fully completed “Form for disclosure of potential conflicts of interest”. If this form is not received by the Institute in time for the debate, the relevant person will not be allowed to participate. Further details can be found in the “Guideline on the submission of comments on the Institute’s preliminary report plans/preliminary reports”.

  5. 5)

    Must the form be submitted again if a person is repeatedly involved?

    Yes, even if a person is involved in the production of a report at different times (e.g., submission of comments on the preliminary report plan and also on the preliminary report, or if patients or other people affected are involved as external experts and submit comments on the same report), in each step of the procedure a new, fully completed form must be submitted, even if no changes have occurred in the meantime.

  6. 6)

    Which types of connections and payments should be disclosed in the form?

    Financial connections to companies, institutions or interest groups in the health care system, particularly to pharmaceutical companies, manufacturers of medical devices or industrial interest groups, must be disclosed in the form. All detailed information will be treated confidentially.

    The form covers a total of 7 categories of connections that could create a potential conflict of interest. The nature as well as the amount of any payments (with the exception of persons submitting comments) and support must be disclosed for 6 categories:

    • Employment / self-employed activities / voluntary activities
    • Advisory functions
    • Payments (e.g. for presentations, expert opinions, or articles)
    • Third-party funds, i.e. financial support (e.g. for research activities, the conduct of clinical studies, other scientific services, or patent applications)
    • Other types of support, e.g. for equipment, staff, or the organization of meetings; reimbursement of travel costs or registration fees for trainings/conferences
    • Stocks, shares, patents, utility models

    The questions generally refer to the last 3 years.

    However, for external experts who would like to be involved in an early benefit assessment of drugs, it is necessary to provide information beyond these 3 years.

    The seventh question of the form deals with participation in a guideline or study with a topic similar to the respective project and other circumstances that, from the point of view of an impartial observer, may be assessed as a conflict of interest. This question also requires information beyond the 3 years mentioned above.

    For private persons, the information provided in the form refers to the persons themselves; for representatives of institutions or organizations, the information refers to both the representatives themselves and to payments or support for the corresponding institution or organization.

  7. 7)

    When must the form be submitted?

    External experts must submit the form together with their application for collaboration on an IQWiG product, or submit the form if requested by IQWiG. If no form is submitted, no collaboration or award of commission is possible.

    Patients and other people affected invited to a discussion on patient-relevant outcomes must submit the form within the period stated in the invitation letter. If no form is submitted, participation in the discussion is not possible.

    In the case of written comments, the completely filled-in form should be submitted to the Institute together with the comments. However, submission is not mandatory.

    Persons who are invited to a scientific debate on the preliminary report plan or preliminary report must submit the form to IQWiG before the debate within the period stated. If no form is submitted, participation in the debate will not be possible

  8. 8)

    Who has access to the completed form?

    Involvement as an external expert:

    The completed forms are viewed by the IQWiG Conflicts of Interest Committee. The Committee may verify and evaluate the information provided by means of its own investigations. The Committee comprises 4 staff members of the Institute, including at least 3 researchers. In a first step, the Committee evaluates whether a potential conflict of interest results from the reported connections and the connections which may have been investigated by the Institute. If this is the case, then it is assessed in a second step whether serious concerns exist with regard to a professionally independent and appropriate collaboration on an IQWiG product. For this purpose, the Committee votes on the issue, and informs the Institute’s Tendering Office or the Evaluation Panel (for the assessment of the suitability, as well as for the negotiation and evaluation of the submitted offers), which consider the result of the vote in the decision on the award of the commission.

    During the production of the product for which connections have been disclosed, the project group has the possibility to access the forms of the external experts who have been awarded the commission for collaboration in the product.

    As described in the form, the disclosed potential conflicts of interest are summarized and published in a table.

    Involvement as a person submitting comments:

    The completed forms are viewed by those members of the Institute’s staff involved in report production. The information provided is not evaluated.

    As described in the form, the disclosed potential conflicts of interest are summarized and published in a table.

    Involvement as an invited patient or other person affected:

    The completed forms are viewed by those members of the Institute’s staff involved in report production. The information provided is not evaluated.

    As described in the form, the disclosed potential conflicts of interest are summarized and published in a table. The names of patients or other people affected are only published after their explicit consent (separate form).

    Participation in an oral scientific debate within the framework of the submission of comments:

    The information provided is summarized: For the categories named in the questions, it is only summarized whether this type of connection exists or not. Specific cooperation partners or the amount of payments will not be disclosed. This information can be viewed by other participants of the scientific debate.

    As described in the form, the disclosed potential conflicts of interest are summarized and published in a table. If a person submitting comments did not submit a form, this information will be published.

  9. 9)

    Which consequences can the disclosure of potential conflicts of interest have?

    In the involvement of external experts in IQWiG’s work, the evaluation of the disclosed connections is, among other things, a criterion for the award of a commission.

    For persons submitting comments, the disclosure of connections / potential conflicts of interest in the corresponding form does not result in any restrictions. In principle, no type of professional dependence can lead to exclusion from the process of submitting comments. This means that persons or representatives of organizations may also submit comments even if, for example, they have disclosed in the form that they receive material support from companies.

    For patients or other people affected who are involved in discussions about patient-relevant outcomes, the disclosure of connections/potential conflicts of interest in the corresponding form does not result in any restrictions. This means that persons may also participate in discussions even if, for example, they have disclosed in the form that they receive material support from companies.

  10. 10)

    What happens if the form is not completed?

    The Institute is only allowed to cooperate with external experts who have fully completed and signed the form, and if the original form is available. The provision of incorrect or incomplete information may lead to the exclusion of the external expert from the project.

    If a person is invited to a scientific debate within the framework of the submission of comments and does not submit the completed form within the period stated before the debate, this person will not be allowed to participate in the debate.

    If a person would like to participate in the discussion on patient-relevant outcomes as a patient or other person affected and the completed form is not submitted by the deadline, he or she will not be able to participate in the discussion.

  11. 11)

    Overview of the differences between external experts and persons submitting comments

     External expertsPersons submitting commentsInvited patients or other people affected
    Must a fully completed form be submitted?YesNot mandatory. However, the fully completed form should be submitted together with the comments.Yes
    What happens if the form is not submitted?External experts cannot be involved in the preparation of products.In the published final report, it is stated that the form was not submitted.Patients and other people affected cannot participate in discussion.
    Are the submitted forms assessed by IQWiG?YesYes, with regard to formal criteria. The assessment will not, however, lead to the exclusion from the procedure of submission of comments.Yes, with regard to formal criteria. The assessment will not, however, lead to the exclusion from a discussion.
    Are the submitted forms assessed by IQWiG?YesYesNot applicable
    Is the information provided in the form published in the IQWiG product?Yes, with their name, but only in summary and without giving payment sums or cooperation partners.Yes, with their name, but only in summary and without giving payment sums or cooperation partners.Yes, without their name, but only in summary and without giving payment sums or cooperation partners.

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