1024ºË¹¤³§

Submission of Proposals to External Ethics Committees

For some research proposals, an application to an external ethics committee (or research/governance committee) may be required. Any application to an external ethics committee must receive sponsor sign-off from the University.

To arrange this you must notify your Faculty Ethics Committee of your intention so that any necessary advice and support can be provided. This will normally involve assurance from your head of department that the work will be conducted in accordance with the .

The most obvious example of work requiring external review is any research involving NHS patients, relatives and carers, or NHS data. Ethics review forms part of the wider Researchers must apply for HRA approval using the .

There are also some other types of research that do not require the HRA Approvals process, but must still be reviewed by an NHS REC as a matter of law. This includes research involving human tissue, adults lacking capacity, Clinical Trials of Investigative Medicinal Products (CTIMPs), trials of medical devices, and human participant research involving ionising radiation. We advise using this . Please note, applications must again be made through IRAS.

Most work funded by the MOD or including military participants (but not veterans) must be reviewed by . The requirement for MODREC review can be determined by .

Research requiring access to prisoners or prison staff must also be authorised by . The HMPPS research committee is no longer an ethics committee, so now require a favourable opinon from a Faculty Ethics Committee prior to submitting an application to the HMPPS research committee.

Please note, it is University policy that only one formal ethics review should take place. If the review must be conducted by an NHS REC or MODREC then their opinion will suffice for University purposes.

If the external body states that a review by them is not required, an application must be made to your Faculty Ethics Committee instead. For example: it is possible to get HRA approval without the ethics component of the approval, in which case a faculty ethics review is required.

For further guidance please contact your faculty ethics chair or the University Ethics Advisor.

NHS Research Passports

If you're either a member of staff or research student at the University, and are proposing to carry out research in the NHS – and have no ongoing contractual relationship with the NHS – you will need a Research Passport. For further guidance, please contact the University's HR department (peopleenquiries@port.ac.uk).

Human Tissue Research

If your research involves working with human tissue, you need to ensure you comply fully with the law.  is available to assist in this process.

Any queries regarding human tissue research should be directed to Dr Simon Kolstoe, University Ethics Advisor (simon.kolstoe@port.ac.uk)

Find all the important forms, templates and documents you need in the following list:

• Creative and Cultural Industries | Ethics-cci@port.ac.uk |
• Humanities and Social Sciences | Ethics-fhss@port.ac.uk |
• Faculty of Business and Law | Ethics-bal@port.ac.uk |
• Science & Health | Ethics-sci@port.ac.uk |
• Technology | Ethics-tech@port.ac.uk |

Please note, committees may be closed during University holidays or over the summer.

1024ºË¹¤³§ Research and Innovation Project Governance Responsibilities

Appropriate governance of research and innovation activities is mandated by all research and higher education funders. It is also required by professional and learned societies. Responsibility for governance (including when research or innovation activities are conducted for educational purposes) lies initially with the member of staff responsible for the project/student followed by their department/school head, followed by dean of faculty, and ultimately PVC research.

The following list is not exhaustive as there may be additional requirements for specific types of research (such as clinical trials), but at the minimum those responsible should ensure:

General:

1. The project is justified and the primary and secondary outcomes are appropriately designed.
2. Everyone who will be involved in the project is appropriately qualified by education, training and/or experience to discharge their roles and responsibilities in the project.
3. The project has been appropriately peer reviewed.
4. Plans are in place for a suitable ethics review of the project and this will be completed prior to any work being undertaken.
5. Appropriate dissemination and engagement activities have been considered and (if required) an impact plan is in place.
6. All health and safety risk assessments and considerations have been made and/or taken into account.
7. All amendments, annual and final reports, will be submitted to the appropriate authorities if required.
8. All relevant laws and professional guidance are being followed.

1024ºË¹¤³§ specific:

1. The aims of the project, and the organisation(s) we want to work with, are consistent with the University's mission and values.
2. Any relevant project initiation forms have been completed.
3. All external support and collaborations comply with the University’s financial policies and procedures. This includes due diligence checks where necessary.
4. Data will be managed in accordance with the University Data Management Policy, and where appropriate a data management plan will be put in place.
5. The scope of the proposed project falls within the University’s insurance and indemnity policies.
6. All required declarations of interest have been made and will comply with the University’s research integrity and misconduct policies.
7. The University’s intellectual property policies has been consulted and appropriate discussions/ arrangements have been made as required.

Permissions:

1. All required contracts and/or agreements will be in place prior to starting the project.
2. Arrangements are in place for the project team to access resources and support to deliver the work as proposed.
3. Approval to conduct the project has been gained from the relevant department head(s)/deans(s).

Read the important policies and procedures from external bodies.

•  [PDF]
• [PDF]

Read research ethics and governance guidance from a selection of external bodies.