Utilization of political and policy processes to assure ethical post disaster research

Survivors of disasters are excellent sources of first person information about the event. However, this group is likely to be more vulnerable and at risk for re-victimization as a consequence of participation in post disaster research. Recognizing this we utilized political and policy processes to develop, implement and evaluate a human subjects protection plan for the World Trade Center Evacuation Study (WTCES).

On a political level, to develop this protection plan the Columbia University investigator team met with investigators from other universities, and various New York City and federal agencies. Agreements were made regarding interagency coordination so that multiple studies being conducted were: coordinated; asking worthwhile, but different questions; utilizing appropriate recruitment strategies; and not over sampling the survivors.

On a process level, within the WTCES, the investigators worked closely with the university legal counsel and institutional review board to assure ethical recruitment and study procedures. Strategies included use of a data safety monitoring board; delimitations to exclude the psychologically fragile; mental health clinicians on the study team; rigorous study team training; pre-establishment of mental health support for participants; participant pre/post study post traumatic stress screening (PTSS); researcher debriefing; and a study community advisory board.

To test success for participant protection, pre/post study PTSS screening scores (range 1-5) were compared. The mean pre PTSS score was 2.05 (SD = 0.84); 1.97 (SD = 0.82) directly following participation, and 1.80 (SD = 0.79) two weeks later. A paired samples t-test indicates significantly lower PTSS scores after participation (t(46)=-2.82, p<.01).