HONEST BROKER:

In the world of politics, an honest broker is a 'neutral mediator.' In the human research setting, the honest broker plays a similar role, serving as a disinterested intermediary between the researcher and the individual whose data are being studied. The importance of the honest broker is particularly relevant for studies that seek a exemption under §46.101(b)(4). The criteria for the exemption are clear - although not always very satisfying for a researcher: "Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available, or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects." The use of the honest broker ensures that the investigator is not interacting with those individuals nor recording any identifiable information about them.

Identifiable information about the subject (data, specimens, etc.) may be gathered from several sources (if necessary) and collated by the honest broker, who then replaces identifiers with a code. The code, along with the individual's now de-identified data, is then forwarded to the investigator. Only the honest broker can have access to the list that links the code number to the subject's identity. Honest brokers need not retain the linkage code information, although if they do so, they can provide additional information about the subject, on request from the investigator, without identifying the research subject to the current research investigators.

Individuals serving as an honest broker must meet two requirements. First, they must have legitimate access to the data desired by the research investigator (e.g., by a member of the medical records staff, a pathologist, a clinician, a university or hospital employee with a right to access). Second, they must be completely independent of the research team. For example, they cannot serve as a co-investigator or the faculty mentor.

Each individual who serves as an honest broker must be named in the IRB protocol, and must sign the honest broker certification form, attesting that:

1. I have reviewed this project with the Principal Investigator and agree to de-identify and, if applicable, to maintain linkage code information for data (including specimens) that will subsequently be accessed by the research team.
2. I will, under no circumstance, provide the PI or any member of the research team with information that would permit the identification of research subjects.
3. I will not intervene or interact with identified human subjects during the conduct of this research project.
4. I will maintain complete confidentiality of research subjects' private information.