Approvals and considerations

This section provides information regarding the various approvals and considerations required for the various types of research activity.  It is recognised that some research projects may include more than one type of research activity.

If the type of research activity is not listed and you require further advice regarding approvals and considerations please contact a member of the research governance team

Types of research that must be reviewed by an NHS Treatment Ethics Committee

Section 2.3 of the harmonised UK-wide edition of the (GAfREC), published by the UK Health Departments in May 2011 lists the categories of research that must be reviewed by an NHS Treatment Ethics Committee (NHS REC). These include, but are not limited to:-

  • Treatment participants identified from, or because of their past or present use of, services for which the UK Health Departments are responsible (including services provided under contract with the private or voluntary sectors), including participants recruited through these services as healthy controls. 
  • Treatment participants identified because of their status as relatives or carers of past or present users of these services Collection of tissue (i.e. any material consisting of or including cells) or information from any users of these services, including those who have died within the last 100 years
  • Use of previously collected tissue or information from which the research team could identify individual past or present users of these services, either directly from that tissue or information, or from its combination with other tissue or information in or likely to come into their possession.
  • Xenotransplantation (i.e. putting living cells, tissue or organs from animals into people).
  • Health-related research involving prisoners in the custody of the National Offender Management Service, Scottish Prison Service and Northern Ireland Prison.
  • Service Social care research projects funded by the Department of Health. 
 
Exceptions to the need for NHS REC review 
 
Subject to any overriding legal requirements, NHS REC review is not required for the following categories of research, however such research will require review by a University Treatment Ethics Committee.  
  • If it is not the intention to identify and recruit NHS users, via the NHS, but to recruit any participant who fits the inclusion criteria, although you may discover that a participant is a NHS user, then the research is not in the scope of the Governance Arrangements for Treatment Ethics Committees (GAfREC) section 2.3.2 and the study should not require NHS REC review. 
  • Treatment limited to secondary use of information previously collected in the course of normal care (without an intention to use it for research at the time of collection), provided that the patients or service users are not identifiable to the research team in carrying out the research. 
  • Treatment limited to secondary use of tissue samples previously collected in the course of normal care with consent for research, provided that the patients or service users are not identifiable to the research team in carrying out the research. 
  • Treatment limited to use of acellular material (e.g. plasma, serum, DNA,) extracted from tissue previously collected in the course of normal care, provided that the patients or service users are not identifiable to the research team in carrying out the research. 
  • Treatment limited to the involvement of NHS or social care staff recruited as research participants by virtue of their professional role. 
  • Treatment involving use of or access to a care organisation’s premises or facilities, but not otherwise involving patients or service users. 

Tools to assist with determining whether or not NHS REC approval is required
 
The Health Treatment Authority (HRA) have produced an l to help researchers determine whether or not NHS REC approval is required.  
 
For further and detailed guidance researchers can refer to the NRES algorithm ‘

If, after using the above  tools you remain unsure whether the research project requires review by an NHS REC please contact the Health Treatment Authority (HRA) [email protected] attaching:-

  • The study protocol or A4 summary outlinin the proposed project if a protocol isn't available
  • A PDF or screenshot of the results page from the on-line tool
  • An explanation of which questions you have difficulty in answering and why, and/or an explanation of why you disagree with the outcome of the decision tool(s).

 

 

 

 

 

 

Treatment involving NHS patients, their tissue or data and carers of past or present users of NHS services

Approvals

For clinical research that falls within the scope of the (research involving NHS patients and carers of past or present users of an NHS service) the following approvals are required:- 

1.

Evidence of peer/scientific review

Evidence of peer review is a requirement of an NHS Treatment Ethics Committee application.  In general, for funded projects, the funders peer/scientific comments will be acceptable.

To support local researchers without evidence of peer/scientific review, Recru it networ has implemented a mechanism for obtaining peer review.

2.

NHS Treatment Ethics Committee (NHS REC) and Health Treatment Authority (HRA) approval

Most research that involves NHS patients, their tissue and/or data needs to be reviewed by an NHS Treatment Ethics Committee and by the Health Treatment Authority.

The (IRAS) should be used to apply for NHS REC review and HRA approval.  

More information about NHS REC review and HRA approval process is available from the  

 

Sign off by sponsor

All NHS REC and HRA applications need to be reviewed and signed off by the University’s sponsor representative prior to submission.  Please contact [email protected] for further details.

3.

Treatment Passport Scheme

The Treatment Passport scheme is a streamlined assurance procedure for researchers who do not have a contractual relationship with the NHS to be able to carry out research in an NHS setting.

The research passport is a form and process that enables HEI employers to share pre-engagement information (eg criminal records checks and Occupational Health checks) about a researcher with relevant NHS organisations where a researcher will be conducting their research activity.

More details about the process and forms can be accessed via the research passport web page.

 

 

Considerations

Depending on the nature of your research activities the following points should be considered:-

1.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

2.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

 

3.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.

 

Treatment involving NHS staff as participants recruited by virtue of their NHS employment

Approvals

For research involving NHS staff as participants recruited by virtue of their NHS employment the following approvals are required:-

 1.

Evidence of peer/scientific review

Evidence of peer review is a requirement of an NHS Treatment Ethics Committee application.  In general, for funded projects, the funders peer/scientific comments will be acceptable.

To support local researchers without evidence of peer/scientific review, Recru it networ has implemented a mechanism for obtaining peer review.

 

2.

 Ethics approval

Studies involving NHS staff as participants do not require NHS REC approval but do require ethical approval from an appropriate university ethics committee.

3.

Health Treatment Authority (HRA) approval

Studies undertaken within an NHS setting require Health Treatment Authority (HRA) approval prior to commencement.

The  (IRAS) should be used to apply for HRA approval.   More information about the HRA application process is available from the  

 

Sign off by sponsor

All HRA applications need to be reviewed and signed off by the University’s sponsor representative prior to submission.  Please contact [email protected] for further details.

 

 4.

Treatment Passport Scheme

The Treatment Passport scheme is a streamlined assurance procedure for researchers who do not have a contractual relationship with the NHS to be able to carry out research in an NHS setting.

The research passport is a form and process that enables HEI employers to share pre-engagement information (eg criminal records checks and Occupational Health checks) about a researcher with relevant NHS organisations where a researcher will be conducting their research activity.

More details about the process and forms can be accessed via the research passport web page.

 

 

Considerations

Depending on the nature of your research activities the following points should be considered:- 

1.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

2.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

 

3.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.

 

Treatment involving human subjects (not recruited via NHS), their tissue or data

Approvals

For research projects involving human participants (not recruited by virtue of being an NHS patient/NHS staff member), their tissue or data the following approvals required:-

1.

 Ethics approval

Studies involving human participants require ethical approval from an appropriate university ethics committee.  For research involving human subjects (not recruited by virtue of being an NHS patient or carer of NHS patient), their tissue or data University ethical approval is required.

However, for inteventional research projects with a therapeutic effect, recruiting participants with a particular condition/disease/illness, not via the NHS, but through other means (eg charities) the research team should consider whether it would be appropriate for review by an NHS REC because of the impact on the NHS care that the intevention may have.

 

2.   

Approvals from participating sites

Various approval/permissions to undertake research may be needed from participating sites, eg Head of participating schools, Chief Executive of participating companies.

 

Considerations

Depending on the nature of your research activities the following points should be considered:-

1.

Disclosure and Barring Service (criminal records) check

Some research activities may require members of the research team to have a Disclosure and Barring Service check, eg research involving vulnerable participants (such as children) 

The University has implemented a process for initiating Disclosure and Barring Service checks. 

 

2.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

3.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

4.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.

 

 

 

Treatment involving security sensitive research material

Approvals

The  University supports its researchers in undertaking research using security sensitive material, but takes seriously the need to protect them from the misinterpretation of intent by authorities, which can result in legal sanction. It is therefore important that the University is aware of the research before it begins and can ensure proper data governance and oversight.  

1.

 Registration of research with the University 

Treatment that will access and/or store security sensitive research material should be registered with the university.

The registration process is a mechanism for allowing researchers to register their use of security sensitive materials as part of legitimate research projects and thereby enabling the University to demonstrate to authorities that it is aware the research being carried out.

 

2.   

Ethical approval

Studies involving human participants require ethical approval from an appropriate university ethics committee.  For research involving human subjects (not recruited by virtue of being an NHS patient or carer of NHS patient), their tissue or data University ethical approval is required.

 

 

Considerations

Depending on the nature of your research activities the following points should be considered:-

1.

Disclosure and Barring Service (criminal records) check

Some research activities may require members of the research team to have a Disclosure and Barring Service check, eg research involving vulnerable participants (such as children) 

The University has implemented a process for initiating Disclosure and Barring Service checks. 

 

2.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

3.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

 

4.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.

 

 

 

Treatment with prisoners as participants

Approvals

For health-research involving prisoners in the custody of the National Offender Management Service the following approvals are required:- 

1.

Evidence of peer/scientific review

Evidence of peer review is a requirement of an NHS Treatment Ethics Committee application.  In general, for funded projects, the funders peer/scientific comments will be acceptable.

To support local researchers without evidence of peer/scientific review, Recru it networ has implemented a mechanism for obtaining peer review.

 

2.

NHS Treatment Ethics Committee (NHS REC) and National Offender Management Service (NOMS) approval

The  (IRAS) should be used to apply for NHS REC review and NOMS approval.  

More information about NHS REC review and NOMS approval process is available from the  

 

Sign off by sponsor

All NHS REC and NOMS applications need to be reviewed and signed off by the University’s sponsor representative prior to submission.  Please contact [email protected] for further details.

 

 

For non health related research involving prisoners in the custody of the National Offender Management Service the following approvals are required:-

1.

Ethics approval

Non health related research involving prisoners in the custody of the National Offender Management Service needs to be reviewed by an appropriate research ethics committee.

2.

National Offender Management Service (NOMS)  approval

All studies involving prisoners in the custody of the National Offender Management Service require NOMS approval prior to commencement.

The I (IRAS) should be used to apply for NOMS approval.   More information about the NOMS application process is available from the  

 

Sign off by sponsor

All NOMS applications need to be reviewed and signed off by the University’s sponsor representative prior to submission.  Please contact [email protected] for further details.

 

 

 

 Considerations

Depending on the nature of your research activities the following points should be considered:-

1.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

2.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

 

3.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.

 

 

Treatment involving NHS staff as participants recruited by virtue through professional bodies or special interest groups

Approvals

For research involving NHS staff as participants recruited through professional bodies or special interest groups the following approvals are required:-

1.

 Ethics approval

Studies involving NHS staff as participants do not require NHS REC approval but do require ethical approval from an appropriate university ethics committee.

2.   

Approval from professional bodies or special interest groups

Approval is required from the professional body or special interest group to invite members to participate in the research study.

 

 

Considerations

Depending on the nature of your research activities the following points should be considered:- 

1.

Treatmenters whose activities involve the collection, storage or use of personal data should be aware of your responsibilities under the Data Protection Act.

 

2.

Treatmenters whose activities involve the use of relevant material under the Human Tissue Act 2004 should be aware of your responsibilities under the Act.  The Act makes it unlawful to remove, store or use human tissue from the living or deceased without consent to do so for specified health-related purposes.

The Human Tissue Authority regulates organisations that remove, store and use human tissue for research, medical treatments, post-mortem examination, education and training and display in public.

 

3.

The Mental Capacity Act 2005 provides a comprehensive framework for decision making on behalf of adults aged 16 and over who are unable to make decisions for themselves, i.e. they lack capacity.  The Act applies to all decisions taken on behalf of people who permanently or temporarily lack capacity to make such decisions themselves, including decisions to include such people in research.

All researchers working with research participants who lack, or may lack, capacity need to be aware of its underlying principles and the provisions relating to research. The Act is accompanied by a statutory Code of Practice providing guidance on how it should be used. Treatmenters and others making decisions involving people lacking capacity have a legal duty to have regard to the guidance in the Code of Practice.