Finance and insurance
Details should be given of who is funding the study and the reference numbers for any grants.
If the study is taking place within a healthcare institution or other company, there may be local or national insurance and indemnity that will apply in the case of any participants making a claim against the design, conduct, or management of the research study. Of course, the risks of this are much less than for drugs studies where the drugs may have serious consequences for participants. Nevertheless, there are many occasions where accidents could occur or data could still be mishandled. If organizational or institutional insurance and indemnity is not available, other options may include insurance being available through the funder or sponsor, if they are willing to take on this responsibility, or private insurance being taken out directly for the study. Accompanying proof of this insurance is often required with protocols, especially for ethics applications.