You should give details and also append any relevant supporting documentation, providing references to the relevant sections if appropriate. 3.2.04 Please indicate if you have sought regulatory approval in relation to your proposal from any organisations, within or outwith Scotland, whether received or pending. This would include e.g. approvals from such bodies such as the Confidentiality Advisory Group (CAG) of the Health Research Authority (HRA). You should provide names of organisations and / or specific roles as appropriate, and append any relevant documentation associated with these approvals.

#### 3.3 Research Ethics Governance

If you declared in Q 2.4 that your project is not research and does not require a Research Sponsor, please go to Q 3.4.

For all research applications, the requirement for some form of ethical review, whether by NHS REC ethics or another ethical review body, needs to be considered. This section details the ethical opinion which you have obtained or sought for your proposal, or otherwise provides evidence as to why such approval is not appropriate. Where such approval is not in place, it is important that you demonstrate why this is the case and provide assurances if approval is pending. It is the responsibility of the applicant and the Research Sponsor to ensure that suitable ethical review has taken place. Please note that HSC-PBPP is not an ethical review body and does not give ethical opinion on any application, but wishes to ensure that this is in place, where appropriate.

If you need advice on whether NHS REC ethics approval is necessary, you should approach your local NHS ethics service in the first instance. Information about UK research ethics committees and ethical opinions can be found on the Health Research Authority website. If NHS REC ethical review is not required, you still may require ethical review by another ethical body, such as the ethics committee in your University.

#### For applications that will use the National Safe Haven, they may come under the generic ethical approval obtained. The criteria for this are:

- Data held / accessed in National Safe Haven
- Research is in field of Health or Social care
- There will be no contact with participants
- Study has undergone external scientific peer review
- Study will be carried out by UK-based research team

3.3.01 Please indicate whether you have sought NHS and / or University research and ethics approval (by selecting 'Yes or 'No') . If you answer 'No', please proceed directly to question 3.3.01b. 3.3.01a If you have answered 'Yes' to question 3. 3.01, please provide details of the relevant research ethics committee, and status of the approval (whether approved or pending) and reference number. You should append relevant documentation in relation to the applications. 3.3.01b If you have answered 'No' to question 3.3.01 , will your application be covered by the National Safe Haven generic ethical approval? If you have answered 'No' to question 3. 3.01b, please provide a full explanation of why research and ethics approval has not been sought or is not appropriate for your proposal. Where this has been indicated by relevant colleagues with research and ethics expertise, you should provide an explanation and details of the colleague or committee which has advised you. Wherever relevant supporting evidence for this decision is available, it should be appended.