Research Ethics Approval Form

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GUIDANCE NOTES


If you are undertaking a research project, you are required to complete this form. Doing so will help you identify any potential ethical implications in your research.

You can download the form to discuss the questions with your supervisor before completing it online.

The Guidance along with the Glossary of terms used in the form, will help you understand how the questions on the form relate to your project. For more information on academic research involving personal data, and to help you to determine if you are collecting personal data, you can also refer to the University’s webpages on Research Integrity.

If your research project involves collection of primary data (for example, interview, live observation, experiment) you will be asked to upload a copy of your Participant Information Sheet and Consent Form. Please note that you won’t be able to save your online form halfway through, so we recommend you have the Participant Information Sheet completed and available before you start the online form.

Once you submit the form it will be reviewed by PACE Research Ethics Committee.

Confidentiality
This form and any supporting evidence will be treated confidentially within PACE. The form will only be viewed by those necessary to consider your request and support you in the process. The information you supply on this form will be used solely for these specific purposes.

Further details about our general uses of your personal information, and your rights under data protection legislation, are available at the University webpages on Data Protection.


Most research under the Research Governance Framework for Health and Social Care will require National Research Ethics Service (NRES) ethical review. Please submit your Research Ethics Request Form to PACE Research Ethics Committee (REC) for initial advice. You may also need to contact the Clinical School Governance Team for further advice by completing the Health Research Authority (HRA) Research Toolkit.

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Most research under the Research Governance Framework for Health and Social Care will require National Research Ethics Service (NRES) ethical review. Please submit your Research Ethics Request Form to PACE Research Ethics Committee (REC) for initial advice. You may also need to contact the Clinical School Governance Team for further advice by completing the Health Research Authority (HRA) Research Toolkit.

Please continue by clicking Next Page below.
Please continue by clicking Next Page below.

Human tissues from NHS patients require NRES ethics approval. In all other cases research using human tissues is subject to the Human Tissues Act 2004. Some exceptions exist (e.g. anonymised donated samples from the National Blood Service). If you are storing tissue in a facility that is not covered by the University’s Human Tissue licence, you must either seek NRES approval or register the new facilities under the Act.

Please submit your research ethics request form to PACE Research Ethics Committee (REC) for initial advice.
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The Animals Scientific Procedures Act 1986 (As Amended 2012) regulates any experimental, or other scientific procedure applied to any vertebrate other than man.
You may contact the Named Animal Care Welfare Officer in the animal unit in which you wish to work. In the case of Clinical Veterinary Research, the Veterinary Clinical Research Ethics Committee of the University of Cambridge will consider these applications and will advise the University Establishment Licence Holder.

Please submit your research ethics request form to PACE Research Ethics Committee (REC) for initial advice.
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Please submit your research ethics request form to PACE Research Ethics Committee (REC).

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Your project is probably at low risk. for confirmation or advice, please submit your research ethics request form to PACE Research Ethics Committee (REC).

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  • Use of data which has not been anonymised (including any record showing date of birth)
  • Use of anonymised data which could be combined with other data (e.g. tracking of an identifiable location or behaviour), causing subjects to be identifiable
  • Research of data whose outcome has implications for an identifiable class of people e.g.
    - genealogy of war criminals
    - estimating genetic potential for disease in an identifiable class of living people
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Your project is probably at low risk. For confirmation or advice, please submit your research ethics request form to PACE Research Ethics Committee (REC).

Please continue by clicking Next Page below.

1. Participants at risk
  • Vulnerable people (e.g. children, older people
  • “Dependent” subjects / people less able to refuse consent (e.g. researcher’s students)
  • Adult refugees
  • Adult prisoners
  • Subjects involved in illegal acts
  • “Gate-keeper” communities (where authority is required to conduct the study – e.g. school, residential care, prison)
  • Study of individuals without their prior knowledge and consent
2. Data collection methods
  • Scans (e.g. MRI), recordings (audio or visual), or other non-invasive tests (e.g. physiological assessment, pain induction including traumatic memory)
  • Potential to cause pain, discomfort, harm to subject
  • Deception of subject
  • May expose subject to a risk of legal or disciplinary action
  • Financial inducements
  • Use of drugs, placebos, foods
  • Sensitive topics (e.g. sex, drugs, abuse, sexuality)
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Please submit your research ethics request form to PACE Research Ethics Committee (REC).

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Please submit your research ethics request form to PACE Research Ethics Committee (REC).

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Checklist Risk Level Result
Thanks for completing the initial checklist questions, your risk level result is shown below.

Part A: Your Details





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Part B





Include information about: Procedures that for some people could be physically stressful or might impinge on their safety; Procedures that for some people could be psychologically stressful; Are there any other types of personal data that are planned or likely to be collected?

Make sure you describe in detail all the strategies you will use to mitigate those discomforts, disadvantages or risks. Include external support organisations to which you might refer the participant.






Consent Guidance
There are subject specific rules for informed consent e.g. for education studies the research guidelines to follow would be from BERA (http://www.bera.ac.uk/researchers-resources/publications/ethical-guidelines-for-educational-research-2018). If you are unsure which subject specific guidance to follow please discuss with your Supervisor.
Participant Information Sheet and Consent Form
Please upload a completed copy of the Participant Information Sheet and Consent Form. 




PACE REC requires research data to be retained for a minimum of 1 year after the project has been submitted to allow external examiners access to the original data if required. The University of Cambridge recommends retaining research data for up to 10 years -  Statement of Records Management Practice and Master Records Retention Schedule.Please make sure the retention period you specify here is the same as the period you enter in the Participant Information Sheet.

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Submission

What happens next:

Your form will be sent to the Research Ethics Committee for approval. The Committee will make a decision as soon as possible and you will be informed of their decision. If any concerns are raised you will be asked to respond to these by emailing to the Quality Assurance Team at qa@pace.cam.ac.uk, or with an amended application form and supporting documents, if necessary.

Once approval has been granted, an email from Quality Governance <qa@pace.cam.ac.uk> will be sent to you and your Supervisor. No research may commence without the ethical approval of the PACE REC.

Once submitted, if you require any changes to your application you will need to resubmit a new application.