Israel tightens up hospital research proceduresBMJ 2005; 330 doi: https://doi.org/10.1136/bmj.330.7493.690-c (Published 24 March 2005) Cite this as: BMJ 2005;330:690
Israel's health ministry is to issue new directives for closer scrutiny of studies on patients. The move comes after newspaper publicity about several alleged irregularities in clinical research.
Every hospital will have to appoint a “follow-up body,” comprising three members and headed by the institution's internal financial controller or legal adviser. This independent supervisory body will periodically report on its activities to hospital management and to the hospital's Helsinki committee, which is responsible for approving clinical research projects at present.
About 2500 new clinical studies are approved each year by Helsinki committees in Israeli general, geriatric, rehabilitation, and psychiatric hospitals.
Director general of the health ministry, Professor Avi Israeli, said that although research was important to the country's health system, inadequate supervision and fierce pressure on doctors to “publish studies or perish” as a prerequisite for professional advancement may also lead to abuses and shortcuts in procedures.
Researchers will have to present reports on their work at least twice a year to the hospital's Helsinki committee (compared to once a year or less frequently, under the old system) and if the potential risk to patients in the study is significant they will have to report more often.
Researchers need permission not only from the hospital's Helsinki committee but also from the ministry's supreme Helsinki committee, which must be persuaded that they have met the requirements of the international Helsinki Treaty on Human Medical Experimentation, which defines the safety, dignity, benefit, and rights of participants in such research.
Two months before each study is due to be completed, the new follow-up body will remind the researchers to present a report on their progress or a summary of their study. If the follow-up body discovers shortcomings or irregularities, including any diversion by the actual study from approved protocols or patient consent forms, it must report immediately to hospital management and consider sanctions.