Frequently asked questions about the form for disclosing relationships

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. If persons from outside the Institute – patients or other persons affected or external experts – are involved in the production of IQWiG reports, their potential conflicts of interest are made clear using the form for disclosing relationships.

The completed forms are reviewed by the Institute's Conflict of Interest Committee. In a first step, the Committee assesses whether conflicts of interest arise from the relationships indicated and any additionally relationships identified. If so, it is then assessed in a second step whether there are any serious doubts about independent and appropriate collaboration in an IQWiG report. The Committee’s vote will then be taken into account in the decision on whether to involve/award a contract to the person.

In the early phase of a project, the Institute regularly invites patients or other persons affected to discuss the choice of patient-relevant outcomes. Thus, these people are involved as external contributors in the production of an IQWiG report and must also submit the form for disclosing relationships. This is the only way to make potential conflicts of interest transparent.

One of IQWiG’s legal responsibilities is the production of reports that, for example, assess the benefits of drugs or diagnostic tests. External experts are regularly involved in both the production and the review of these reports and assessments. In order to make potential conflicts of interest transparent, all external experts who apply to participate in an Institute product must complete the “Form for disclosing relationships” in full and submit it to the Institute. The law also provides for this: According to §139b (3) Sentence 2 SGB V, all experts commissioned by IQWiG must disclose “all connections to associations and contract organizations, particularly in the pharmaceutical and medical devices industries, including details on the type and amount of any remuneration received.”

Yes, even if someone has already been involved in a commission as an external expert, he or she must submit a new, fully completed form when applying for a new commission. This applies even if no changes have been made in the meantime.

The form must disclose relationships with companies, institutions or interest groups in the healthcare sector, in particular pharmaceutical companies, manufacturers of medical devices or industry interest groups - but also other relationships that may give rise to conflicts of interest, such as involvement in the development of guidelines. All details provided will be treated confidentially.

The form asks for a total of the following 7 categories of relationships that may give rise to a conflict of interest. It is also necessary to indicate the amount of any grants or subsidies, if any:

  • employment / self-employed activities / voluntary activities
  • advisory functions
  • payments (e.g. for presentations, training, 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
  • other circumstances which, from the perspective of an unbiased observer, can be considered a conflict of interest, e.g. activities in health-related interest groups or self-help groups, political, academic, scientific or personal interests

The questions generally refer to the last 3 years.

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 (for larger institutions, information on the work unit, e.g. the clinical department or research group, is sufficient).

External experts must submit the form together with their application for collaboration in 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.

Involvement as an external expert:

The completed forms are viewed by the IQWiG Conflicts of Interest Committee. The Committee comprises 4 staff members of the Institute, including at least 3 researchers.

When preparing an IQWiG report, the internal project group can inspect the forms of the external experts commissioned for the project.

The relationships disclosed in the form are summarized and published in a table in the final document. IQWiG does not publish specific information on the amount of any remuneration or fees.

Involvement as an invited patient or other person affected

When preparing an IQWiG report, the internal project group can inspect the forms of the external experts commissioned for the project.

The relationships disclosed in the form are summarized and published in a table in the final document. IQWiG does not publish specific information on the amount of any remuneration or fees. In the case of patients or other persons affected, their names will only be published with their explicit consent (separate form).

When external experts are involved in the work of the Institute, the assessment of the disclosed relationships is one of the criteria, among others, for the award of a commission.

For patients or other affected persons involved in the discussion about patient-relevant outcomes, the disclosure of relationships/potential conflicts of interest in the form does not impose any restrictions. This means that people who disclose in the form that they receive, for example, funding from companies, can also participate in the discussion.

The Institute may only work with external experts if the form is fully completed and signed and is available in its original form. Incorrect or incomplete information may lead to external experts being excluded from the work process.

If a person wishes to participate in the discussion of patient-relevant outcomes as a patient or other person affected and does not complete the form in time, he or she cannot participate in the discussion.

Must a fully completed form be submitted?

  • External experts: Yes
  • Invited patients or other people affected: Yes

What happens if the form is not submitted?

  • External experts: External experts cannot be involved in the preparation of products.
  • Invited patients or other people affected: Patients and other people affected cannot participate in the discussion.

Are the submitted forms assessed by IQWiG?

  • External experts: Yes
  • Invited patients or other people affected: Yes, with regard to formal criteria. The assessment will not, however, lead to the exclusion from a discussion.

Is the submission of a completed form necessary to participate in the scientific debate?

  • External experts: Yes
  • Invited patients or other people affected: Not applicable

Is the information provided in the form published in the IQWiG report?

  • External experts: Yes, with their name, but only in summary and without giving payment sums or cooperation partners.
  • Invited patients or other people affected: Yes, without their name, but only in summary and without giving payment sums or cooperation partners.