July 19, 2001
MEDIA CONTACT: Joann Rodgers
In what Johns Hopkins believes to be an unwarranted, unnecessary, paralyzing and precipitous action, the Office of Human Research Protection (OHRP) has today suspended all federally supported medical research projects involving human subjects at almost all of our institutions. We strongly believe that this action was taken in utter disregard of patients’ health and potentially of life. Even a temporary interruption in therapeutic clinical trials, such as those involving cancer patients, could be devastating. In addition, the OHRP letter forbids us from enrolling new, sick patients in these trials.
Hopkins believes the OHRP’s draconian action is outrageous because we addressed the criticisms of our procedures noted in today’s OHRP letter in a letter we sent to the agency on December 28, 2000. Despite the passage of seven months, we never received any indication –not a word – that our responses did not in all respects satisfactorily address the agency’s concerns.
Equally outrageous from our standpoint is that in its letter today, OHRP suggests that careful review of our research protocols does not take place at Hopkins. Nothing could be further from the truth. As we have pointed out to OHRP, every Institutional Review Board (IRB) member reviews each protocol thoroughly, comments on that protocol and has the opportunity for all questions to be answered by the investigator prior to final approval by the full IRB. We would have worked with the agency to address any remaining concerns if it had indicated its dissatisfaction in any way. This suspension was entirely unnecessary to accomplish what both the agency and Hopkins want: to protect human subjects. We remain committed to working with the OHRP in constructive ways.
We want to reassure patients enrolled in our clinical trials, or considering enrolling in them, that we are committed to putting their health and interests first and to continuing our care of them. Their safety and their health is of paramount importance to us.
To the best of our knowledge, in our entire history, we have had only one death of a healthy research volunteer out of tens of thousands who have participated in such research. We agree that this is one too many, and that is why we announced earlier this week the steps we are taking to strengthen our processes. In light of this, the OHRP’s action seems to us to be an extreme example of regulatory excess.
Since our last statement, OHRP has agreed to work with Johns Hopkins University and Johns Hopkins Health System in an expedited review of the corrective action we are submitting to them. We also want to emphasize again that we will do what is right for our patients.December 28, 2000 LETTER