New system for ethics approval is unacceptable
http://www.100md.com
《英国医生杂志》
EDITOR—Greenhalgh is right to highlight the idiocies of the new game to obtain "ethical approval" for a research project.1 As a comparatively new member of a committee I hate the new system, which seems to generate far too much paper. The weight that comes through the post is overwhelming.
It seems the system is based on covering the most complex projects for drug trials in many sites and many countries. Simple projects have to fit the most complex model.
In attempting to review a project, all I need is:
A statement of the problem to be studied and a description of the methods to be used—the introduction and methods section of the final paper
The information sheet for patients—what patients can carry away, hopefully written in plain English
The patients' consent form
All the rest is really to do with administration. Ethics committees do not need to review the finances of the projects or the consent and approval of departmental heads and research committees. They do not need to check on the data protection officer, the chief pharmacist, etc. Those are matters for the research worker, who is, after all, the one to carry the can.
We are confusing administration with ethics. It is time for the research workers of the world to rise: you have nothing to lose.
John Norman, emeritus professor of anaesthetics
Southampton SO17 1NU JohnNorman1@aol.com
Competing interests: JN is a member of a research ethics committee.
References
Greenhalgh T. The new ethics. BMJ 2004;328: 651. (13 March.)
It seems the system is based on covering the most complex projects for drug trials in many sites and many countries. Simple projects have to fit the most complex model.
In attempting to review a project, all I need is:
A statement of the problem to be studied and a description of the methods to be used—the introduction and methods section of the final paper
The information sheet for patients—what patients can carry away, hopefully written in plain English
The patients' consent form
All the rest is really to do with administration. Ethics committees do not need to review the finances of the projects or the consent and approval of departmental heads and research committees. They do not need to check on the data protection officer, the chief pharmacist, etc. Those are matters for the research worker, who is, after all, the one to carry the can.
We are confusing administration with ethics. It is time for the research workers of the world to rise: you have nothing to lose.
John Norman, emeritus professor of anaesthetics
Southampton SO17 1NU JohnNorman1@aol.com
Competing interests: JN is a member of a research ethics committee.
References
Greenhalgh T. The new ethics. BMJ 2004;328: 651. (13 March.)