The General Section provides an opportunity for the researcher to describe the Objectives, Hypothesis and Rationale for their study, in keeping with the emerging best practice being expounded by the NIH in the USA, EMA in Europe, NHMRC in Australia, and so on. As the preclinical research sector moves towards standards of compliance for animal based research, such as the ARRIVE Guidelines, this section will have increasing importance as part of the review and approval process for new studies.
Importantly, this section enables the researcher to set out and document the justification for the study which is often a prerequisite for protocol / ethics / licence approval.
In defining the study’s Objectives, Hypothesis and Rationale in advance of the study starting, the expectation is that post-study rationalisation of outcomes is avoided.
This section is intended to offer an opportunity to describe the expected results of the study: what problem or opportunity is the study expected to address.
This section should set out a testable hypothesis, and how it will be tested.
This section should be used to explain why the research is necessary and appropriate, in particular, why the use of animal models is justified and what non-animal alternatives have been considered. It should address key questions, such as:
- Whether this is original research or is seeking to test or validate previously run studies
- How the use of the particular animal models and species is justified and what alternatives were considered (such as alternative lower level species or in-silico options)
This section enables key contacts for the study to be recorded so that any staff working on the research know who to contact in the event of any key questions or concerns.
Grant approval details
If applicable, the source of study funding and the budget can be captured here.