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A Case
THE LANCET
A Case Looking down on your swollen legs, do you
your life’s companion, as you simply express
see the trunks you’ve trimmed and utilized
the quiet frustration of their failure to
in these western woods or the parallels
get you about the house and to support
in the recent death you attended of
the now thin-blooded body and precarious
breaths which uncomplainingly nourish the activities that plainly, minimally are your however short-lived necessities? AND FURTHER QUERY
Waldweg Claudia Böse
Is there a reason we do not append poetry to medical charts?
Frederick Adler Arcata, California, USA
Project management through windows IRB Navigator: FDA/HHS Compliance Software West Beach Software.Windows (3.1 or 95); PC 486/33 processor; Macintosh System 6.0.5 or later; 8.0 MB free disk space; 256-colour monitor. RB Navigator: FDA/HHS Compliance is a database program designed to assist administrators in the extensive paper work required for compliance with the agencies that regulate the use of human beings in research. In the USA, the institutional review board (IRB) at a large academic medical centre may review thousands of research protocols each year. A userfriendly software program can be an efficient aid. IRBs were initiated after World War II when the Nuremberg Code came into effect. The code states that human beings can participate in research only if they are fully informed of all procedures and voluntarily consent to take part. In 1974 the US congress passed the National Research Act, which mandates that an IRB be established within each university or institution that conducts biomedical or behavioural research involving human beings and receives federal funding. New advances in technology, such as genetic testing and gene therapy, are continually raising new concerns in the ethical conduct of research. The purpose of an IRB is to review all research projects involving human
I
Vol 350 • November 29, 1997
beings before they are implemented to determine if they adequately adhere to basic ethical principles. The Office for Protection from Research Risks (OPRR), a unit within the Department of Health and Human Services, oversees the administration of all IRBs. IRB Navigator can be useful in generating the voluminous paperwork of an IRB. The software keeps a record of each research project including the study number, title, and version. It allows the administrator to enter information about the sponsor, investigators, adverse event reports, type and date of review, and any conflict of interest among IRB members, as well as Investigational New Drug and Investigational Device Exemption numbers obtained from the US Food and Drug Administration. Information can be quickly located by virtue of the program’s ability to conduct searches by investigator, meeting dates, drugs, devices, sponsors, or adverse events. It can also display lists of investigators and IRB members with relevant contact information as well as lists of all active studies and study activity history. Meeting agendas and minutes can be
prepared with the software and then exported to a word processing program for editing. All expedited or administrative activity that occurred between committee meetings can be printed in a report to be distributed as part of the agenda. The program generates letters informing investigators that their research protocols have been approved, approved contingent specific revisions— tabled or denied. Notices of expiring approvals or missed deadlines can be generated and the software further assists by printing mailing labels and envelopes. As the IRB administrator of a large research institution, I review nearly 2000 projects each year. Each monthly agenda consists of approximately 150 projects including new proposals, continuations, expedited projects, minor modifications, and final reports. The big dilemma for me, in attempting to evaluate this program, was how to find the time to enter data of just a few projects in order to assess the program. The chore of a total conversion to this software is a more daunting task than I could handle without a major commitment of time, probably entailing temporary help.
Shari Melman Mount Sinai School of Medicine, One Gustave Levy Place, New York, NY 10029, USA
1639
A Case Looking down on your swollen legs, do you
your life’s companion, as you simply express
see the trunks you’ve trimmed and utilized
the quiet frustration of their failure to
in these western woods or the parallels
get you about the house and to support
in the recent death you attended of
the now thin-blooded body and precarious
breaths which uncomplainingly nourish the activities that plainly, minimally are your however short-lived necessities? AND FURTHER QUERY
Waldweg Claudia Böse
Is there a reason we do not append poetry to medical charts?
Frederick Adler Arcata, California, USA
Project management through windows IRB Navigator: FDA/HHS Compliance Software West Beach Software.Windows (3.1 or 95); PC 486/33 processor; Macintosh System 6.0.5 or later; 8.0 MB free disk space; 256-colour monitor. RB Navigator: FDA/HHS Compliance is a database program designed to assist administrators in the extensive paper work required for compliance with the agencies that regulate the use of human beings in research. In the USA, the institutional review board (IRB) at a large academic medical centre may review thousands of research protocols each year. A userfriendly software program can be an efficient aid. IRBs were initiated after World War II when the Nuremberg Code came into effect. The code states that human beings can participate in research only if they are fully informed of all procedures and voluntarily consent to take part. In 1974 the US congress passed the National Research Act, which mandates that an IRB be established within each university or institution that conducts biomedical or behavioural research involving human beings and receives federal funding. New advances in technology, such as genetic testing and gene therapy, are continually raising new concerns in the ethical conduct of research. The purpose of an IRB is to review all research projects involving human
I
Vol 350 • November 29, 1997
beings before they are implemented to determine if they adequately adhere to basic ethical principles. The Office for Protection from Research Risks (OPRR), a unit within the Department of Health and Human Services, oversees the administration of all IRBs. IRB Navigator can be useful in generating the voluminous paperwork of an IRB. The software keeps a record of each research project including the study number, title, and version. It allows the administrator to enter information about the sponsor, investigators, adverse event reports, type and date of review, and any conflict of interest among IRB members, as well as Investigational New Drug and Investigational Device Exemption numbers obtained from the US Food and Drug Administration. Information can be quickly located by virtue of the program’s ability to conduct searches by investigator, meeting dates, drugs, devices, sponsors, or adverse events. It can also display lists of investigators and IRB members with relevant contact information as well as lists of all active studies and study activity history. Meeting agendas and minutes can be
prepared with the software and then exported to a word processing program for editing. All expedited or administrative activity that occurred between committee meetings can be printed in a report to be distributed as part of the agenda. The program generates letters informing investigators that their research protocols have been approved, approved contingent specific revisions— tabled or denied. Notices of expiring approvals or missed deadlines can be generated and the software further assists by printing mailing labels and envelopes. As the IRB administrator of a large research institution, I review nearly 2000 projects each year. Each monthly agenda consists of approximately 150 projects including new proposals, continuations, expedited projects, minor modifications, and final reports. The big dilemma for me, in attempting to evaluate this program, was how to find the time to enter data of just a few projects in order to assess the program. The chore of a total conversion to this software is a more daunting task than I could handle without a major commitment of time, probably entailing temporary help.
Shari Melman Mount Sinai School of Medicine, One Gustave Levy Place, New York, NY 10029, USA
1639