To simplify the ethics review process in COBE Lab, we have revised our procedure for studies that need approval from AU’s legal department. 

Our previous procedure was to forward the necessary documents to the legal department if any personal data other than CPR-numbers were collected for the study. We would then communicate the legal reply and the Human Subjects Committee’s (HSC) reply to the researchers simultaneously to avoid confusion. However, this created a lot of extra and unnecessary communication, which the new procedure will eliminate. 

Under our new procedure, studies and study documents will no longer automatically need legal approval if anything more than CPR-numbers are collected. It remains the full responsibility of the researcher to make sure their study lives up to legal requirements. As always, the HSC has no legal authority and assume no responsibility for the study. However, the HSC can recommend or require that a study is approved by AU’s legal department if they deem it necessary. This recommendation or requirement will be given along with the other comments from the HSC that researchers receive. It is then up to the researchers themselves to communicate with the legal department directly regarding legal approval of the study and study documents. 

As a rule of thumb, and under most circumstances, the HSC will not want to review or comment on something again once the legal department has approved it. But if changes are made to certain important parts of the consent form, then the HSC may want to confirm this does not conflict with the Lab’s ethical standards. It will be clearly stated in the official reply from the HSC if the documents must be reviewed again after having been legally approved. If for example the HSC made important notes on "Benefits and risk" in a high-risk study, then changes to this section by the legal department may require that the HSC is notified.

This new procedure aims at making the application process easier for researchers without sacrificing the ability of the HSC to ensure a high ethical standard of research. It should be noted that communications with the legal department may delay a study up to several weeks depending on the issue and how busy the legal team is. Researchers should therefore be prepared for this sort of delay.