This is the text only version of the toolkit. You can also access an interactive PowerPoint version.
Before you start:
- this toolkit is designed for use by students and academic supervisors/course leaders only
- 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
- in Northern Ireland, some social care services are provided by HSC. If your research is taking place in Northern Ireland, please ensure that you consider social care when answering questions regarding the NHS
- when answering questions, refer to guidance text or HRA’s glossary. For further advice, or support please contact queries@hra.nhs.uk.
The toolkit is comprised of 5 decision tools. Work through each decision tool until the action END when final outcome is provided for that decision tool.
- Is my study research?
- Is my research being carried out in the NHS and needs NHS approval? HRA and HCRW approval in England and Wales or equivalent in Northern Ireland and Scotland.
- Do I need NHS REC review?
- What type of NHS REC review is needed?
- Can I carry out my research? (Once you know the approvals you need, complete this decision tool to find out whether you are eligible under the student research eligibility criteria. If you are not eligible then the research cannot take place in the NHS.)
Decision tool 1: Is my study research?
You first need to check if your project is defined as research under the UK Policy Framework for Health and Social Care Research. Go to the is my study research? decision tool. This link will take you to a web based tool on an external site.
Decision tool 2: Is my research being carried out in the NHS and needs NHS Approval?
The purpose of this tool is to determine whether your research is considered to be taking place in the NHS and needs NHS approval (HRA and HCRW Approval in England and Wales or equivalent in Northern Ireland and Scotland).
This is important because not all students are eligible to apply for NHS approval for their research.
If you are not eligible your research will not be able to take place in the NHS
There are a maximum of 7 questions in this tool.
Step 1: Is your study defined as research according to the 'is my study research' decision tool
Don’t know – go to decision tool ‘Is my study research?’
No – HRA and HCRW Approval (in England and Wales) or equivalent in Northern Ireland and Scotland will not be 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.
- HRA and HCRW Approval (in England and Wales) or equivalent in Northern Ireland and Scotland will not be needed.
- An NHS/Social Care research ethics review of any kind is not needed.
- The student research eligibility criteria does not apply.
You do not need to complete any other decision tools in this toolkit.
Please check with any participating NHS organisations and your academic institution as local approvals may be required for non-research projects. Non-research projects are outside of the scope of this toolkit. End of decision tool 2. Proceed to decision tool 3
Yes – go to step 2 of decision tool 2
NHS Patient/ Service User Questions
Step 2: Are you recruiting NHS patients, service users or their carers/relatives to participate in your research?
What do we mean by NHS patients or service users? These are individuals identified in the context of, or in connection with, their past or present use of NHS services and care, including services provided under contract with the private or voluntary sectors. This would include healthy individuals recruited to act as controls in the research and/or individuals recruited because of their status as relatives or carers of past or present users of these services. It is assumed that new data and/or tissue may be collected from participants specifically for the purposes of this research.
Yes – go to step 3 of decision tool 2
No – go to step 4 of decision tool 2
Step 3: How are you identifying those NHS patients, service users or their carers/relatives to participate in your research?
What do we mean by via NHS? This could include NHS database searches, referrals by NHS staff, promotional material displayed in NHS primary, secondary of tertiary care locations and approaches made to individuals receiving care or visiting those receiving care at these locations.
What do we mean by other means? For example, people with cancer may be identified from a cancer charity’s contact list or recruited via social media.
Via NHS – go to outcome 2
Other means - go to step 4 of decision tool 2
Data Questions
Step 4: Will your research use NHS patient or service user data?
What do we mean by NHS patient or service user data? This covers previously collected information on past or present NHS patient or service users that has been collected as a result of their interactions with the NHS. Data collected specifically for the purpose of this research is covered in an earlier question. Select YES even if the data is anonymised or pseudo-anonymised.
Yes – go to step 5 of decision tool 2
No – go to step 6 of decision tool 2
Step 5: What type of organisation holds this patient or service user data?
What do we mean by hold? This is the organisation that has overall responsibility for the security, integrity and access to this data, irrespective of the physical location.
NHS primary, secondary or tertiary care organisation/s – go to outcome 2
Any other organisation* - go to step 6 of decision tool 2
* This could mean non-NHS research databases or non-patient facing NHS organisations such as NHS X or NHS England.
Tissue Questions
Step 6: Will this research use human tissue
What do we mean by human tissue? Any material consisting of/or including human cells, including material sourced from those who have died within the last 100 years from existing holdings. Material sourced specifically for this research would be covered in an earlier question.
Yes – go to step 7 of decision tool 2
No – go to step 8 of decision tool 2
Step 7: What type of organisation holds this human tissue?
What do we mean by hold? This is the organisation that has overall responsibility for the security and access to this tissue, irrespective of the physical location. Examples of a non-NHS organisation that might hold tissue for research purposes include universities and charities.
NHS primary, secondary or tertiary care organisation/s – go to outcome 2
Any other organisation - go to step 8 of decision tool 2
NHS Staff Questions
Step 8: Are you recruiting NHS staff, in their capacity as NHS employees, to participate in this research?
What do we mean by in their capacity as NHS employees? If participants are recruited because of their employment status as part of the NHS workforce, then you should say YES.
Yes – go to step 9 of decision tool 2
No – go to outcome 1
Step 9: What is your strategy for identifying or recruiting NHS/ HSC Staff?
You may intend to use several strategies - if one (or more) of these strategies appears in the NHS box, select NHS. Select one option.
NHS (from NHS staff records or by contacting NHS staff via an NHS organisation) – go to outcome 2
Non-NHS (personal contacts, social media, records held by non NHS professional bodies) – go to step 10 of decision tool 2
Step 10: Does your research require the NHS staff involved to provide or access NHS confidential or otherwise privileged information?
Information already in the public domain would not be considered NHS confidential or otherwise privileged information. This would cover, for example, all information published on websites accessible to the public.
Yes – go to outcome 2
No – go to outcome 1
Outcome 1
HRA and HCRW Approval (England and Wales) or equivalent in Scotland & Northern Ireland is NOT required. Based on your responses, your study is NOT considered to be taking place in the NHS, so HRA and HCRW Approval (in England and Wales) or equivalent in Northern Ireland and Scotland is NOT needed. Other approvals may still be needed, depending on the content of your research, including NHS/Social Care research ethics review. Check using the Do I need NHS REC review? tool. End of decision tool 2. Proceed to decision tool 3
Outcome 2
Based on your responses, you will need HRA and HCRW Approval (in England and Wales) or equivalent in Northern Ireland and Scotland. Processes for NHS approval vary by UK nation. Go to step 11 of decision tool 2.
Step 11: Select the nations (one by one) where your research will be carried out. Applications for all nations can be made, via a single application, using IRAS.
England and Wales
HRA and HCRW Approval is needed. HRA and HCRW Approval (in England and Wales) will not be issued until all other approvals are in place, including an NHS/Social Care ethics Favourable Opinion, where needed. Go to Do I need NHS REC review? tool to check. In addition to HRA and HCRW Approval (in England and Wales), in most cases each site involved will need to confirm that they have the capacity and capability to support your research before it can start. End of decision tool 2. Proceed to decision tool 3
Northern Ireland
Confirmation of Capacity and Capability is needed for each Health and Social Care Trust in Northern Ireland. Confirmation of Capability and Capacity will not be issued by the site until all other approvals are in place, including NHS/social care research ethics Favourable Opinion, where needed. Go to Do I need NHS REC review to check if this is needed. End of decision tool 2. Proceed to decision tool 3
Scotland
NHS Permission is needed for each site in Scotland. Before your research can start NHS Permission is needed for each site involved in Scotland. NHS Permission will not be issued by the site until all other approvals are in place, including NHS/Social Care Research Ethics review if needed. Check using the Do I need NHS REC review? tool. End of decision tool 2. Proceed to decision tool 3
Decision tool 3: Do I need NHS REC review
You now need to check if NHS REC review is required. Click here to access web-based decision tool. Use the 'Do I need NHS REC review decision tool. This link will take you to a web based tool on an external site.
If NHS REC review is required proceed to decision tool 4: what type of NHS REC review is needed
If no NHS REC review is required proceed to decision tool 5: Can I carry out my research?
Decision tool 4. What type of NHS REC review is needed?
Before you start.
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.
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 of decision tool 4.
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. End of decision tool 4. Proceed to decision tool 5
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 of decision tool 4
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. End of decision tool 4. Proceed to decision tool 5
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’ End of decision tool 4. Proceed to decision tool 5
No – Go to step 4 of decision tool 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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 5 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 6 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
No – Go to step 7 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 8 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 9 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 10 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 11 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 12 of decision tool 4.
Step 12: What type of research do you plan to carry out?
Guidance on selecting the right option is available in IRAS
- 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’. End of decision tool 4. Proceed to decision tool 5
- Clinical investigation or other study of a medical device. Go to step 13 of decision tool 4
- 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’. End of decision tool 4. Proceed to decision tool 5
- Other clinical trial to study a novel intervention or randomised clinical trial to compare interventions in clinical practice. Go to step 18 of decision tool 4.
- Basic science study involving procedures with human participants. Go to step 23 of decision tool 4
- Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology. Go to step 26 of decision tool 4.
- Study involving qualitative methods only. Go to step 33 of decision tool 4.
- Study limited to working with human tissue samples (or other human biological samples) and data (specific project only). Go to step 36 of decision tool 4.
- Study limited to working with data (specific project only). Go to step 47 of decision tool 4.
- 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’. End of decision tool 4. Proceed to decision tool 5
- 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’. End of decision tool 4. Proceed to decision tool 5
- 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’. End of decision tool 4. Proceed to decision tool 5.
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 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
Step 14: Research Type 2: Is the medical device being used within its intended purpose and intended population?
Yes – go to step 15 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
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 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 17 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 19 of decision tool 4.
Step 19: Research Type 4: Is your research a randomised clinical trial to compare interventions in clinical practice?
Yes – go to step 20 of decision tool 4.
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 of decision tool 4 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 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 22 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5
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 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 25 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5
Step 26: Research Type 6: Are you doing research involving questionnaires or interviews/focus groups?
Yes – go to step 27 of decision tool 4.
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 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 28 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – Go to step 29 of decision tool 4
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 30 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 31 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 32 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5
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’. End of decision tool 4. Proceed to decision tool 5
No – go to step 34 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5.
No – go to step 35 of decision tool 4.
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’. End of decision tool 4. Proceed to decision tool 5
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. End of decision tool 4. Proceed to decision tool 5
Step 36: Research Type 8: Is the human tissue anonymous to the researcher?
Yes – go to step 37 of decision tool 4.
No – go to step 39 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 38 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5.
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 of decision tool 4.
No – go to step 43 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 41 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 42 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5.
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 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 45 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 46 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 48 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
No – go to step 49 of decision tool 4.
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’ End of decision tool 4. Proceed to decision tool 5.
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. End of decision tool 4. Proceed to decision tool 5
Decision tool No 5. Can I carry out my research?
Once you know the approvals you need, work through the questions below to find out whether you are eligible under the student research eligibility criteria.
Step 1: Is your study defined as research according to the 'is my study research?' decision tool (Tool number 1. The answer should be based on the output of the 'is my study research?' tool.)
Yes – go to step 2 of decision tool 5.
No – Student research eligibility criteria does not apply. 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 student research?' decision tool. You do not need to complete any other tools in the student research toolkit. Please check with any participating NHS organisations and your academic institution as local approvals may be required for non-research projects. Non-research projects are outside of the scope of this toolkit. Thank you for completing this decision tool. Stop.
Don’t know – please complete the 'is my study research?' decision tool.
Step 2: Is the primary purpose of your research to obtain a qualification?
If you are a student undertaking part in elements of an existing funded and/or nationally peer reviewed research project, answer NO
Yes – Go to step 3 of decision tool 5.
No – If a student takes part in elements of an existing funded and/or nationally peer-reviewed research project, then the project is not regarded as primarily to obtain an educational qualification. There is NO need to identify the project as an educational project or name the student/s in the IRAS application. Usual approvals will still be needed before this research can take place. The student must not take responsibility as Chief Investigator for the research. If you are uncertain, please seek guidance from queries@hra.nhs.uk.
Thank you for completing this decision tool. Stop
Step 3: Is the study a group student research project?
What do we mean by group student research project?
Group student research is where a course leader or supervisor designs a project in which a number of students, often over different year groups, play a part in different aspects of the research. The course leader or academic supervisor must take responsibility as Chief Investigator for the research.
Yes – ELIGIBLE. A research project involving a group of student can be undertaken, subject to relevant approvals. Based on your responses, you would be eligible to:
- carry out research in the NHS, subject to relevant approvals.
- NHS approval (HRA and HCRW Approval in England and Wales or equivalent in Northern Ireland and Scotland) is needed before any research takes place in the NHS.
- apply for an NHS/Social Care research ethics review, if needed.
- A Favourable Opinion from an NHS/social care research ethics committee must be in place before research can take place in the NHS, where an ethical review is needed.
- Ensure the IRAS application details the involvement of more than one student (use the text field in Filter Question 9). You do not need to record the individual names of the students on Q2-2.
- Thank you for completing this decision tool. Stop
No – go to step 4 of decision tool 5.
Step 4: What level of qualification are you studying for?
Undergraduate or equivalent (Scotland this is SCQF 10 or below, and England, Northern Ireland or Wales NQF 6 or below) - go to step 5 of decision tool 5.
Masters or equivalent (Scotland this is SCQF 11, and England, Northern Ireland or Wales NQF 7) – go to step 6 of decision tool 5.
PhD or equivalent – (Scotland this is SCQF 12, and England, Northern Ireland or Wales NQF 8) – eligible. Based on your responses, your research (which is being carried out to obtain a doctorate level qualification) would be eligible to apply for approval to take place in the NHS (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland). Approval is needed before any research can be carried out in the NHS (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland). A review by NHS/Social Care REC may also be needed. If you have not already done so, use other tools in the student toolkit to understand if your research needs NHS/social care research ethics review or is taking place in the NHS and needs NHS approval. Thank you for completing this decision tool. Stop
Step 5: Ineligible
Based on your responses, your research (which is being carried out to obtain an undergraduate qualification or below) would NOT be eligible to be carried out in the NHS. You should not apply for NHS/social care research ethics review and/or NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland). Your research will not be able to take place in the NHS. Please visit our website for ideas on alternative ways to gain an educational experience of research. Thank you for completing this decision tool. Stop
Step 6: Are you completing a health and care course?
What do we mean by health and care course?
Health and care courses would include courses providing skills for provision of healthcare or health research in the NHS. For example, pharmacy, psychology, dentistry, speech and language therapy and pathology. This is not intended to be an exhaustive list.
For Northern Ireland, this would also include social care qualifications as the remit of Health and Social Care (HSC) in Northern Ireland includes social care.
Yes – go to step 7 of decision tool 5.
No – ineligible. Based on your responses, your research (which will be carried out by a student on a non-health and care course) would NOT be eligible to apply for an NHS/social care research ethics review, or to be carried out in the NHS. Do not apply for NHS/social care research ethics review and/or HRA and HCRW Approval (in England and Wales) or equivalent in Northern Ireland and Scotland. Your research will not be able to take place in the NHS. Please visit our website for ideas on alternative ways to gain an educational experience of research. Thank you for completing this decision tool. Stop
Step 7: Is the university department running your master’s course active in health and care research?
What do we mean by active in health and care research?
The expectation is that the academic supervisor or research support function within the university department would have recent experience (within the last two years) of completing an IRAS application and an understanding of the approvals process.
Yes – go to step 8 of decision tool 5.
No – ineligible. Based on your responses, your research (which would be carried out under the supervision of a university department that is not active in health and social care research) would NOT be eligible be carried out in the NHS. Do not apply for NHS/social care research ethics review and/or NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland). Your research will not be able to take place in the NHS. Please visit our website for ideas on alternative ways to gain an educational experience of research. Thank you for completing this decision tool. Stop
Step 8: Are you a health and care professional or training to become one?
What do we mean by health and care professional or trainee?
A health care professional would include NHS-employed clinical & non-clinical staff, or those with recent NHS experience (i.e. in the last two years). For Northern Ireland, this would also include those working in social care settings within Health and Social care (HSC). Trainees are individuals who are employed in the NHS and have not yet attained the level of qualification required for their vocation. Applicants must have current NHS experience to ensure they understand how to undertake the research without creating undue burden on the NHS.
There is an expectation that the research is within the scope of the individual’s professional discipline.
Yes – eligible. Based on your responses, as a health and care professional or trainee you would be eligible to:
- carry out research in the NHS, subject to relevant approvals.
- NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland) is needed before any research can take place in the NHS.
- apply for an NHS/Social Care research ethics review, if needed.
- A Favourable Opinion from an NHS/social care research ethics committee must be in place before research can take place in the NHS, where one is needed.
Download Supplementary Declaration Form A. This should be completed by your Academic Supervisor or Course Leader and submitted with the IRAS application. Thank you for completing this decision tool. Stop
No – go to step 9 of decision tool 5.
Step 9: Does your research need an NHS/social care research ethics review? Your answer should be based on the outcome of the 'Do I need NHS REC review?' decision tool
Yes – go to step 10 of decision tool 5.
No – eligible with some limitations. Based on your responses, you would:
- Be eligible to carry out research in NHS, subject to relevant approvals
- NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland) is needed before any research takes place in the NHS.
- NOT need any type of NHS/social care research ethics review due to the type of research being carried out
Download Supplementary Declaration Form C. This should be completed by your Academic Supervisor or Course Leader and submitted with the IRAS application. Thank you for completing this decision tool. Stop
Don’t know – please complete the 'Do I need NHS REC review?' decision tool
Step 10: What type of NHS/social care research ethics review does your research need in addition to NHS approval? Your answer should be based on the outcome of the 'What type of NHS ethics review do I need?' decision tool.
Full Review – ineligible. Based on your responses, you would not to able to conduct your research as you are not eligible to apply for a FULL NHS/Social Care research ethics review. Without a Favourable Opinion from a full NHS/Social Care research ethics committee, your research would not be able to take place in the NHS. Do not apply for NHS/Social Care research ethics review and/or NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland). Your research cannot be carried out. Please visit our website for ideas on alternative ways to gain an educational experience of research. Thank you for completing this decision tool. Stop.
Proportionate review – eligible with some limitations. Based on your responses, you would be eligible to:
- carry out research in the NHS, subject to relevant approvals
- NHS approval (HRA and HCRW Approval in England and Wales, or equivalent in Northern Ireland and Scotland) is needed before any research takes place in the NHS.
- apply for a proportionate NHS/Social Care research ethics review, if all other options to obtain your necessary educational experience have been explored.
- A Favourable Opinion from an NHS/social Care research ethics committee is needed before any research takes place in NHS
- You would not be eligible to apply for a full NHS/Social Care research ethics review, if needed.
Download Supplementary Declaration Form B. This should be completed by your Academic Supervisor or Course Leader and submitted with the IRAS application. Thank you for completing this decision tool. Stop.