online database system that could be used to report the same information to appropriate institutions and to the public.
The consensus-development process would set out minimum standards as to the data elements that must be reported by people in specific roles (such as physician researchers and hospital administrators) to their institutions and would allow institutions to have higher standards if they so choose.
Each institution would require that any information on financial relationships or conflicts of interest that must be reported to it—or at least all information included in the consensus-defined minimum standards—also be made available to the public through the online system.
We envision the broader-disclosure model working as follows:
The first time that a person was required to report information on financial relationships or conflicts of interest to an institution, he or she would register on the secure national online database system; create a profile with name, location, and other nonconfidential information; select a permanent ID; and get a confidential password. The system would have procedures for verifying the person’s identity. The person’s profile associated with the ID would be sufficient to identify the person to public users of the database. (In the case of physicians, the profile might include a field for the National Provider Identifier number.)
The person would enter, in a standardized format dictated by the database system, at least the minimum standard information on all financial relationships or conflicts of interest that he or she was required to report to an institution. Depending on the person’s role in each institution with which he or she had a relationship, more or less information might be required.
When the person instructed the database to make any information available to any institution, the same information would automatically become available to the public. (Provisions might be made to protect some details of intellectual property, for example, of a drug formula until patent registration.)
The person-reported information in the database designed by the consensus-development process would ideally be linked to industry-reported information called for in Recommendation 3.4. One objective of the consensus-development process would be to make it convenient to find—in one place, in one format, for any person—any information reported by the person (to an institution) or by industry. Each database could be used to check the completeness of reporting in the other.