Frequently asked questions about the “Form for disclosure of potential conflicts of interest”
List of frequently asked questions
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 or responding to requests on the Institute’s products.
Essentially, three types of participation can be distinguished. Participation as:
- an “external expert”
- a patient or other person affected who is involved in discussions about patient-relevant outcomes
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.
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.
Must the form be submitted again if a person is repeatedly involved?
Yes, even if someone has already worked on a commission as an external expert, he or she must submit a new, fully completed form when applying for a new commission, even if there have been no changes in the meantime.
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.
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.
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 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).
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 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.
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 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.
Overview of the differences between external experts and invited patients or other people affected
External experts Invited patients or other people affected Must a fully completed form be submitted? Yes Yes What happens if the form is not submitted? External experts cannot be involved in the preparation of products. Patients and other people affected cannot participate in discussion. Are the submitted forms assessed by IQWiG? Yes 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? Yes Not 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, without their name, but only in summary and without giving payment sums or cooperation partners.