Better Protection for Students and for Faculty Engaged in Educational Scholarship
There has been a significant change in how we are handling obtaining consent from students for educational research for projects where the data are derived from our professional education programs. In 2001, we implemented a process for obtaining student consent to participate in educational scholarship. Matriculating students were asked to complete a consent form during orientation and then provided with a reminder each year thereafter as well as contact information should they want to change their consent status. This process was developed in collaboration with the MSU human research protection program (MSU-HRPP).
In 2011, at the request of MSU-HRPP we were asked to consider an alternative strategy that both enhances the protections for students and reduces administrative time. As a result, we have implemented an "honest broker" system. In terms of human research, the honest broker serves as an intermediary between the investigator and the research subjects, in this case the medical students and the data that they routinely generate in completing their educational programs such as test scores or progress through their educational program. The honest broker creates a de-identified dataset that protects the identity of the students and assures that the investigator is not interacting with the students nor recording any identifiable information about them. Identifiable student information (test scores, faculty ratings, etc.) from one or more sources are linked by the honest broker, who then replaces identifiers with a code. The code, along with the students' de-identified data, is provided to the investigator. Only the honest broker has access to the list that links the code number to the student's identity, allowing the broker the ability to add additional information about students on request from the investigator, without identifying research subjects to the investigators.
In this respect, the use of an honest broker has distinct advantages over traditionally exempt studies where the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. In this latter exempt case, the dataset is limited to what was originally collected by the investigator and IRB application for study must be submitted for the exempt determination to be made. The use of an honest broker allows for additional data to be added to the dataset as appropriate for the study. Further, an IRB application might not be necessary in many cases; this can be determined by sending an e-mail to the IRB outlining the project and the use of the honest broker to create a de-identified dataset.
Individuals serving as an honest broker must meet two requirements. First, they must have legitimate access to the data desired by the research investigator, such as a university or hospital employee with a right to access. Second, they must be completely independent of the research team; they cannot serve as a co-investigator or the faculty mentor.
A project that involves data collection for a specific research question and is not part of the regular curriculum required of all students does not qualify for this process and might require submission of an IRB application for review. The MSU Human Research Protection Program provides guidance about whether a study qualifies as a human subjects research. Guidance is available here.
OMERAD will provide honest broker services to investigators using one or more educational datasets to provide maximum protection for students. To consult about a potential project, please contact Brian Mavis or Ann Taft.