It is unclear whether the extraordinary amount of detail sought by the new application form is intended primarily to alert investigators to potential ethical difficulties or to ensure that committees have all the information they might need to consider the submission. Whatever the explanation, the result is a lengthy and cumbersome document that is ill suited to several common types of investigation such as descriptive epidemiological analyses of routinely collected data or qualitative studies using in-depth interviews. In addition, the new form risks either slowing the process of ethical review or, through making relevant information more difficult to find, reducing the scrutiny given to each application.
From the committee's point of view, the ideal applicant is one who submits a succinct protocol that makes the rationale and methods of the proposed study clear, together with an insightful and focused document that identifies the likely points of ethical sensitivity, explains why the study is required and must be conducted as designed, and describes the steps that will be taken to minimises the risk of harm.
To submit such an application, researchers require thorough training in both the methods and the ethical issues relating to research in human subjects or their tissues or data. Almost half of the applications that come to the ethics committee of which I am a member fail to obtain approval at the first submission. This suggests that appropriate training is either not widely available or not taken up. Elsewhere I have argued for training and certification of research investigators and for simplifying the process of approval of new projects.7
This would allow ethics committees to spend more of their time checking that approved research is conducted properly. The new national ethics form, however, seems likely to take up more rather than less of committees' time.
The new application form for ethical approval is too long and cumbersome
Research ethics committees need enough information to ensure that potential hazards are minimised and balanced by the benefits
Researchers need training in the methods and ethical issues of research
Such training would improve applications, making the committee's task easier and reduce the number of rejections