The core governance and ethics fields is the default screen behind this icon.

It can also be accessed via the  on the “Compliance – Insurance” screen, via the upper link on the icon tooltip , or via the  option on the project edit page ..

 

 Compliance - Governance

The compliance section consists of generic questions and answers in a common format of a simple value response, and optional description.

Tooltips over each field provide full details.

Note that additional options can easily be added here - so if you need more items just ask.

 

In addition, a section titled “Approved Site(s) – none defined” may appear. This enables sites covered by the governance/ethics approval to be selected. Site(s) can be setup/added if required, as initially there are none defined. An example is :-

Below 'Approved Site(s)' there may also be some custom options replacing some of the generic ones mentioned above for :-

•Participant Consent (with Applies To),

•Privacy,

•Tissue Storage,

•Headers & Footers,

•Departmental Support (with optional 'Other' text).

 

 Compliance - Ethics

The ethics section may vary depending on the selected  Ethics Review Type.

When the “Governance Only” option is selected, it indicates that a third party has provided the ethics approval (i.e. not your ethics office or ethics committee). Accordingly, the system requires data to be entered relating only to this third party ethics approval :-

 

 

Other options for the Ethics Review Type indicate that either your ethics office (internal) or committee (external) will be providing the review, then the data required differs slightly, and relates to your internal/external requirements.

 

Please note that the Reviewing HREC ('third party') ethics section is still available. This is for the scenarios where your ethics office or committee does a review, however, you still need to make note of a another HREC's ethics review.

By default, the "Reviewing HREC" area is hidden, and remains hidden if no values are filled in. It can be displayed or hidden by selecting the heading area; and will automatically display if there are any entered values.

An option is always available for Ethics Comments :-

The “There are no ethics checklist options defined.” note that may appear after this section indicating that there are no additional generic ethics questions defined for your HREC – similar to the compliance list in the upper section. This is, however, available if required.