The Rome Foundation Members Relations with the Pharmaceutical Industry Guidelines
The Rome Foundation takes ethics and conflict of interest issues very seriously, and therefore, developed specific guidelines to which its members are held. Completed disclosure forms for Rome Foundation are kept on file by Rome Foundation administration.
Members of the Rome Foundation are involved with the development of creative educational products including book chapters, journal articles, monographs, CD slide sets and other materials. Other activities include research to validate the diagnostic criteria and questionnaire development. The results of these processes are widely based and publicly recorded, and has gained the confidence of professional groups, researchers, the pharmaceutical industry and regulatory agencies around the world. Since much of the funding of the Rome process is derived from the pharmaceutical industry, it is important that the committee’s work be independent of sponsor influence and that any perception of its direction by industry or conflict of interest of its members be avoided. Therefore, the members of the Rome Foundation hereby agree to the following principles:
- No Rome Foundation Member shall be a regular employee (>50% time) of any pharmaceutical company or any group with a commercial interest in the Rome process.
- The Rome Board shall not undertake projects on behalf of individual companies or commercial concerns, nor will it enter into any confidential agreements with them.
- Rome Foundation Members shall declare and have on record any relationship with the pharmaceutical industry or other commercial entity that may be supporting the Rome process. These relationships must be updated biennially. In principle, members should not confine their advisory board, consulting or speaking arrangements to only one company.
- No Rome Foundation Members shall represent the Rome Foundation to a regulatory agency that is adjudicating acceptance of a drug or device for functional gastrointestinal disorders by a regulatory agency.
- No Rome Foundation Member shall advocate a drug for the treatment of a functional gastrointestinal disorder, nor support its application to a regulatory agency or drug funding authority in the name of the committee. Members may do so as individuals.
- When consulting or lecturing, members shall ensure that it be known they are acting as individuals, not on behalf of the Rome Foundation. This applies to members’ relationships to pharmaceutical companies, regulatory agencies or any other group with a vested interest in the Rome process. This does not apply when the Rome Committee is sponsoring a meeting or is invited to present at a meeting.
- No pharmaceutical company or other interested commercial concern shall directly reimburse Board Members or Subcommittee Members for Rome activities.
- Communications of an academic nature involving the Rome Foundation with the pharmaceutical industry shall be conducted through the Rome Advisory Council (RAC). The RAC consists of representatives of all Rome Foundation sponsors, Rome Board members and representatives of interested scientific and regulatory agencies. Representations and proposals by industry regarding the Rome process submitted to the Board shall be discussed and debated at RAC meetings. Board members may interact with industry as individuals but not on Rome matters or as Board representatives.
- Industry representatives may not sit on the Rome subcommittees, nor should they be seen to have undue influence on the deliberations of any subcommittee. Representations from Industry regarding subcommittee activities should be addressed to the Board through the RAC.