This is the text only version of the toolkit. You can also access an interactive PowerPoint version.
Before you start (one)
The purpose of this tool is to indicate whether a Full or Proportionate NHS/Social Care REC review would be needed. This based on the type of research you are carrying out.
The Proportionate Review Service (PRS) provides an accelerated, proportionate review of research that raises no material ethical issues.
Before you start (two)
This toolkit is designed for use by applicants.
NHS should be read as Health and Social Care (HSC) for those in Northern Ireland or planning to conduct research in Northern Ireland, unless otherwise specified.
When answering questions, refer to guidance text or HRA’s glossary. For further advice, or support please contact queries@hra.nhs.uk
You can also provide feedback by completing this survey.
We recommend completing this tool to help establish whether your study will need a Full REC review or Proportionate Review prior to submitting your application. It will take no more than five minutes to complete.
Step 1: Is your study defined as research according to the Is my study research decision tool?
Your answer should be based on the output of the Is my study research? decision tool.
Yes:go to step 2.
No: no NHS/Social Care Ethics needed. You have said that your study is not research under the UK Policy Framework for Health and Social Care Research, based on the output of the Is my study research? decision tool. An NHS/social care research ethics review of any kind will not be needed. Thank you for completing this decision tool.
Don’t know: please complete the Is my study research? decision tool.
Step 2: Does your research need an NHS/social care research ethics review?
Your answer should be based on the output of the Do I need NHS REC review? decision tool
Yes: go to step 3.
No: no NHS/social care research ethics review needed.
You have said that your research does not need an NHS/social care research ethics review, based on the output of the Do I need NHS REC review? decision tool. You do not need to complete this tool. Go back to the main menu of the student research toolkit to access the Can I carry out my research? decision tool to check what you type of approvals you are eligible to apply for under the student research eligibility criteria (if applicable). Thank you for completing this decision tool.
Don’t know: please complete the Do I need NHS REC review? decision tool.
Step 3: Will your research involve adults lacking capacity to consent?
Answer yes, if your research will involve procedures (including use of identifiable tissue samples or personal information) involving adults who lack capacity to consent, including participants retained in study following the loss of capacity.
Answer yes, if your research involves adults whose capacity is likely to fluctuate during the study.
More information is available on relevant legislation.
Yes: full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 4.
Step 4: Will your research be funded by the US Department for Health and Human Services?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 5.
Step 5: Will your research involve prisoners or people on probation?
If your research plans to involve residents of Northern Ireland Prison Service (NIPS), please contact research.development@setrust.hscni.net for advice.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 6.
Step 6: Will your research involve residents/information about residents in Residential Care homes in Northern Ireland?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 7.
Step 7: Will your research involve patients/information about patients in Nursing Homes or Independent Health Care Clinics in Northern Ireland?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 8.
Step 8: Will your research take place in a social care setting in England?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 9.
Step 9: If your research is taking place in England and/or Wales, will your research require section 251 support from the Confidentiality Advisory Group (CAG)?
Why would you need section 251 support from the Confidentiality Advisory Group?
This is required if you are using identifiable data without consent. More information is available.
If the only disclosure is incidental, through observation at ward rounds or attendance at multi-disciplinary teams select no.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 10.
Step 10: Does your research involve exposure to ionising radiation that is additional to that received in routine clinical care for any participant?
What do we mean by ionising radiation?
Ionising radiation is radiation that carries enough energy to free electrons from atoms or molecules, thereby ionising them. Examples of ionising radiation include X-rays, CT scanning, DXA scans, Radiotherapy and Radionuclide imaging.
More information on ionising radiation and the regulatory requirements when using it in research is available.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 11.
Step 11: Does your research involve a change or a delay to patients’ standard treatment or care?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 12.
Step 12: What type of research do you plan to carry out?
Guidance on selecting the right option is available in the IRAS filter questions once you create the study.
(1) Clinical trial of an investigational medicinal product (CTIMP).
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
(2) Clinical investigation or other study of a medical device.
(3) Combined trial of an investigational medicinal product and an investigational medical device.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
(4) Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice
(5) Basic science study involving procedures with human participants
(6) Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology
(7) Study involving qualitative methods only
(8) Study limited to working with human tissue samples (or other human biological samples) and data (specific project only)
(9) Study limited to working with data (specific project only)
(10) Research Tissue Bank (RTB) – this refers to establishment of a RTB, not its use
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
(11) Research Database (RD) – this refers to establishment of a RD, not its use
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
(12) Other types of research
Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 13: Research Type 2: Is it a UKCA/CE or UKNI/CE marked medical device?
More information is available on medical devices.
Yes:go to step 14.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 14: Research Type 2: Is the medical device being used within its intended purpose and intended population?
Yes: go to step 15.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 15: Research type 2: Are the procedures involved non-invasive or minimally invasive?
What do we mean by “minimally invasive”?
A minimally invasive medical procedure is defined as one that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible to these structures. Examples of procedures considered minimally invasive in research include prick test, swabs and taking a small amount of blood. Some procedures considered to be minimally invasive in a medical setting would not be for research purposes. If the procedure is more invasive than the above example or if it involves a sensitive area of the body, for example smear or rectal examination, the procedures would be considered invasive.
Yes: go to step 16.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 16: Research Type 2: Does your research include any material ethical issues that we haven’t covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 17.
Step 17: Research Type 2: Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 18: Research Type 4: Is your research a clinical trial to study a novel intervention?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 19.
Step 19: Research Type 4: Is your research a randomised clinical trial to compare interventions in clinical practice?
Yes: go to step 20.
No: Reconsider research type selected. You have selected “Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice”, but have indicated in the last two questions that you will not be completing either type of research. Please reconsider the research type selected.
Go back to step 12 to select another option.
Step 20: Research Type 4: Are the interventions that you are comparing all routine gold standard care options in clinical practice?
Yes: go to step 21.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 21: Research type 4: Does your research include any material ethical issues that we haven’t covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 22.
Step 22: Research Type 4 Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 23: Research Type 5: Are the procedures involved non-invasive or minimally invasive?
What do we mean by “minimally invasive”?
A minimally invasive medical procedure is defined as one that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible to these structures. Examples of procedures considered minimally invasive in research include prick test, swabs and taking a small amount of blood. Some procedures considered to be minimally invasive in a medical setting would not be for research purposes. If the procedure is more invasive than the above example or if it involves a sensitive area of the body for example smear or rectal examination, the procedures would be considered invasive.
Yes: go to step 24.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 24: Research type 5: Does your research include any material ethical issues that we haven’t covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 25.
Step 25: Research Type 5 Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 26: Research Type 6: Are you doing research involving questionnaires or interviews/focus groups?
Yes: go to step 27.
No: Reconsider your research type selection.
You selected Research Type 6: Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology, but you have said that you aren’t carrying out any questionnaires/interviews or focus groups. Go back to research type selection in step 12.
Step 27: Research Type 6: Does your questionnaire/ interview/focus group cover highly sensitive topics?
What do we mean by highly sensitive topics?
This refers to questions which may cause anxiety because of the nature of the question or of the population being asked. Assessment of a question’s sensitive nature might be influenced by whether the answers are to be anonymised. Examples of topics often considered highly sensitive include HIV status, sexual activity, recreational drug use and mental health.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 28.
Step 28: Research Type 6: Would accidental disclosure of information provided in questionnaires or interviews/focus groups have serious consequences?
What do we mean by serious consequences?
Serious consequences cover any circumstances where safeguarding issues may arise, including the risk that the participant may be harmed or they may harm others. For example, children taking part in interviews where their parent mood disorders are part of the discussion.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 29.
Step 29: Research Type 6: Are the potential participants in your research vulnerable at the time of approach?
What do we mean by vulnerable at time of approach?
Examples include: parents approached for assent when child has just been admitted to ICU; a patient approached on day of diagnosis of a serious condition; a participant who has moderate to severe mental health issues (for example depression) being asked to complete a validated questionnaires about their quality of life and their treatment at home without a support mechanism in place; potential participants approached to consent shortly after an operation using general anaesthetic with no process in place to check capacity.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 30.
Step 30: Research Type 6: Will identifiable patient data be accessed by someone other than the care team without prior consent?
This would include activity undertaken to identify potential participants.
If the only disclosure is incidental, through observation at ward rounds or attendance at multi-disciplinary teams select no.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 31.
Step 31: Research Type 6: Does your research include any material ethical issues we haven’t covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 32.
Step 32: Research Type 6 Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 33: Research Type 7: Will identifiable patient data be accessed by someone other than the care team without prior consent?
This would include activity undertaken to identify potential participants.
If the only disclosure is incidental, through observation at ward rounds or attendance at multi-disciplinary teams select no.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 34.
Step 34: Research Type 7: Does your research include any material ethical issues we haven't covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer YES to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 35.
Step 35: Research Type 7 Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 36: Research Type 8: Is the human tissue anonymous to the researcher?
Yes: go to step 37.
No: go to step 39.
Step 37: Research type 8 (human tissue anonymous to researcher) Does your research include any material ethical issues we haven't covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 38.
Step 38: Research Type 8 (human tissue anonymous to researcher) Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 39: Research type 8 (tissue not anonymous to researcher) Does your research involve the use of human tissue samples that have already been taken, where there is consent for use in research?
Yes: go to step 40.
No: go to step 43.
Step 40: Will identifiable patient data be accessed by someone other than the care team without prior consent?
This would include activity undertaken to identify potential participants.
If the only disclosure is incidental, through observation at ward rounds or attendance at multi-disciplinary teams select no.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 41.
Step 41: Research type 8 (human tissue not anonymous to researcher) Does your research include any material ethical issues we haven't covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 42.
Step 42: Research Type 8 (human tissue not anonymous to researcher) Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 43: Does your research involve human tissue taken during a clinically directed procedure; which is extra or surplus and taken with consent?
Yes: go to step 44.
No: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Step 44: Will identifiable patient data be accessed by someone other than the care team without prior consent?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 45.
Step 45: Research type 8 (human tissue which is extra or surplus and taken with consent) Does your research include any material ethical issues we haven't covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 46.
Step 46: Research Type 8 (human tissue which is extra or surplus and taken with consent) Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.
Step 47: Research Type 9: Will identifiable patient data be accessed by someone other than the care team without prior consent?
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 48.
Step 48: Research type 9 Does your research include any material ethical issues we haven't covered?
This might include things such as:
- The likelihood of the research procedures throwing up incidental findings of clinical importance.
- The research procedures, when considered together, are overly arduous and/or burdensome for participants
- The inclusion of genetic testing which could have wider implications for the participant.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: go to step 49.
Step 49: Research Type 9 Has anyone told you that your research is unsuitable for proportionate review?
Answer yes, if you have been advised by the sponsor, chief investigator or the HRA that the study would not be suitable for proportionate review.
Yes: Full NHS/Social Research Ethics Review is needed for your research. Based on your responses, your research will need a Full NHS/Social Care Research Ethics Review. Please note, you should answer yes to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
No: Proportionate NHS/Social Care Ethics Review is needed for your research. Based on your responses, it is expected that your research will need a Proportionate Review. Please note, you should answer no to question number 35 on the online booking system, ‘Has your application previously been deemed as not suitable for proportionate review’.
Important: After submission, your application will be validated by Research Ethics Staff to confirm suitability for Proportionate Review. If your research is considered not suitable for Proportionate Review a full ethics review will be needed.