Dissertation Ethical Approval Process

Ethical Review Process

The University Ethics Form can be accessed through the link below:

Newcastle University Ethics On-line Form [version 2.1.1 updated 08/08/2017]

If the form takes a long time to complete you can save the form by clicking the ‘Resume Later’ button. You can return to your form by clicking the 'Load unfinished survey' button. Changes cannot be made once submitted; any changes after submission will need a new form.

The University Ethics Form is a combination of the previously separate ‘Preliminary Ethical Approval Form’ and the ‘Full Ethics Review Form’. The content is the same as in the old forms however the combined form reduces duplication and administrative effort.

Although one form it works in two parts.

Part One – Preliminary Questions

 In the first stage you are asked for key details about your project (title, Principal Investigator etc.) as well as whether you already have approval in place.

The preliminary questions are designed to determine whether your project will need a full ethical review. There are six distinct sections; Animals, NHS & Social Care, Humans In a non-clinical setting, Data, Environment International and depending on your answers  you will be directed to the most appropriate ethical review committee. The four potential outcomes from the preliminary questions are:

- External ethical approval required from the NHS REC (www.nres.nhs.uk)
- Ethical approval required from Animal Welfare Ethics Review Board
- Ethical approcal required from a Faculty Ethics Committee
- No further ethical review required

(If you have already obtained ethical approval, you will be provided with the opportunity to note this and in doing so you will not be required to complete the rest of the form).

If you do require further ethical review from a Newcastle committee then you will be asked for further information in part two.  The first part of the form should take no more than ten minutes.

Part Two – Further Details

Part two is completed where part one has highlighted the need for further information. This can be due to the potential ethical risk of the project but also where your answers have highlighted some potential governance issues.

The additional questions in part two correspond to the risk areas in part one but the actual questions you will have to answer will depend on your answers in part one. For example you will only be asked further questions on the environment if your responses to part one flagged the project as potentially harmful to the environment. There are some sections which are asked for all high risk projects, these include:

  • Project Outline & Research Methods
  • Data
  • Risk Considerations & Insurance
  • Permissions
  • Supporting Documentation
  • Declaration and Submission (this is the only section that low risk projects need to complete in part two)

As you progress through the form you will be asked to upload all the relevant documents e.g. Research data Management Plans, Consent forms etc. You will then be asked to sign the declaration and submit.

The amount of time it takes to complete the second part of the form will depend on the risk areas highlighted and how much information / supporting documentation you already have developed. As a minimum you should set 30 minutes aside.  Should the form take longer than expected you are able to save the form by clicking the ‘Resume Later’ button, you can then return to your form by clicking the 'Load unfinished survey' button. Please note that amendments cannot be made once submitted, so careful attention should be paid when completing the form. Should any substantive changes be required after submission a new form will need to be completed.

An introductory training session on the ethics process is available to all staff and students - please see the booking form on this page for upcoming dates. If you require more information or a specific section then you should contact res.policy@ncl.ac.uk.

Ethics Next Stages

For low risk projects and projects with pre-existing approval

At submission, a copy of the form and any associated attachments will be saved on the system and where it is a funded project on the relevant MyProjects record. The applicant will receive an email summarising the decision (i.e. that no further ethical review is required). Please save this email as some publishers require proof of ethical approval.

For high risk (non NHS) projects

At submission the form and any associated attachments will be sent directly to the relevant committee for review. Additional copies will be kept on the system and where it is a funded project on the relevant MyProjects record. The applicant will receive an email summarising the reasons for further review and the committee which will undertake the review.

For NHS projects

At submission, a copy of the form and any associated attachments will be saved on the system and where it is a funded project on the relevant MyProjects record. The applicant will receive an email summarising the decision.

Where further review is required, no work should begin until all the relevant approval has been secured. The decision will be communicated to you directly from the relevant committee. 

 

Approval pathway diagrams

  • Category A projects
    Externally funded project involving human participants (not NHS patients) (students and staff)
  • Category B projects
    Externally/internally funded project involving human participants (NHS patients) (students and staff)
  • Category C projects
    Externally/internally funded project using human tissue as defined by the Human Tissue Act 2004
  • Category D projects
    Internally funded project involving human participants (not NHS patients)
  • review process
    The research ethics review process via the university or Faculty research ethics committees.

Completing an ethics application

You should aim to prepare ethics applications early, as the processes and procedures of scrutiny can take up tosix weeks to complete.

Human participant research

Please complete the application form for research involving human participation and ensure you read the guidance in the form. Please consider carefully any ethical issues relating to your research.

Applications should provide sufficient information for a decision to be reached by the Committee.

Human tissue research

All research using human tissue requires ethical approval. Please complete the application form for research involving human issue and ensure you read the guidance in the form. Human tissue is defined as material that has come from a human body and consists of, or includes, human cells. 

See the Policies and Procedures for the University's policy relating to research using human tissue and the operating procedures related to the ethical review, oversight and management of human tissue research.

Student research

There are specific operating procedures that relate to the ethical review process for student research projects. Please see Student project review and the Student research FAQs.

Research with ethical issues but not involving human participants

Research which does not involve human participants but which is high risk or has potential for negative impacts on the environment or society may be submitted for review by a UWE research ethics committee.  

You can apply using the application form (research not involving human participants). Please ensure you read the guidance in the form and consider carefully any ethical issues relating to your research. You can also download Guidance for Ethical Approval of Research Projects without Human Participants.

Applications for approval by /

On receipt of a valid completed application form and all supporting documentation the or officer will register the application. The application is scrutinised by members of the Committee, who decide whether or not to approve the application, and where necessary, seek further information from the applicant. In exceptional circumstances a may refer the application to the for review. The approval process may take up to six weeks or longer over the summer vacation.  

Application outcome and feedback

Applicants will be notified and generally feedback from the or will be made available. Applicants are encouraged to regard the comments and feedback from a research ethics committee as helpful and to respond constructively, especially where further work is required for the Committee to be able to reach a favourable decision.

Applications for approval by and other research ethics committees

If your project is research, and involves NHS patients, service users, organs, tissue, data or other bodily material, or is to be conducted on NHS property you may need NHS Research Ethics (REC) approval.  Please note, this will be in addition to, and in advance of, the University's research ethics approval but will not normally require two separate applications.

Details on how to apply to the  are available on the NHS Health Research authority website. If you are unsure as to whether you require approval, please refer to the approval guidance available on the Health Research Authority website.

Some projects in social care settings may be submitted to the National Social Care Research Ethics Committee.

Amendments to the research protocol

Once ethical approval has been given by /, the researcher is required to notify the Research Ethics Committee, in advance, of any proposed significant amendment to the original protocol (for example changes to the study population, revised methodology) using the official amendment form. The Committee may then wish to review its opinion.

Further advice and guidance

For further advice on how to seek research ethics approval for your project, students should consult their supervisor, and staff may contact a member of their Faculty Research Ethics Committee. See further information on guidance and support.

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