Highly publicized events, such as the death of teenager Jesse Gelsinger at the University of Pennsylvania from his participation in a clinical trial, and the temporary closure of several prominent university research programs, have galvanized reforms. Conducting research that is ethical and safe requires a safety net that is woven out of the fabric of investigator knowledge and integrity, and institutional safe-guards. At the core of this fabric is the integrity of the individual investigator, whose high ethical, scientific, and medical standards and knowledge of research principles are essential. To strengthen this safety net and meet federal requirements, the School of Medicine will implement additional safe guards in the coming weeks and months. Not only must the research be ethical, it also must be scientifically valid.
Bad science is unethical.
To facilitate the scientific and ethical review undertaken by the IRB, senior investigators from the multiple disciplines represented on our diverse campus have recently agreed to join the IRB, and both the size and scope of scientific expertise of the committee have been greatly augmented. Such service is critical to the ongoing and increasing success of the School s investigators to gain research funding. To insure uniformity in research review, detailed scientific protocols will be required for all high risk research projects submitted for IRB review. The CCT has proposed a format for these protocols and CCT personnel will be available to provide guidance in protocol development. In addition to precise description of all procedures, personnel and their qualifications and a statistically justified sample size will be required.