Institutional requirements for ethical approval
Most research and educational institutions have their own specific requirements for ethical conduct of research activity in the social sciences and humanities. Research staff should generally confer with the head of department and the research office at the institution, and students should confer with their supervisors and/or tutors for the programme of study. Institutional requirements for ethical approval may vary, but often there are requirements for:
- internal peer review before the research proposal is submitted,
- approval of project costing,
- formal risk assessment,
- employment procedures, if you are paying anyone to work on your project (even if very part-time, such as doing a bit of data entry); and
- approval by the organisation’s press office of any press releases reporting on findings from your study (cf. the Research Ethics Guidebook).
King’s College London:
All research conducted by staff and student at King’s College must have an ethical approval. King’s College’s Research Ethics guidelines can be accessed here:
The Economic and Social Research Council’s (ESRC) Framework for Research Ethics 2010 (revised 2012) can be found here:
Ethical approval for health research
The Department of Health’s Research Governance Framework for Health and Social Care requires that any research involving humans, their tissue and/or data in the National Health Service (NHS) must be ethically reviewed (Imperial College London 2014).
Research carried out in the NHS must comply with any legislation (such as the Data
Protection Act, the Human Tissue Act, the Mental Capacity, etc.) relevant to the activities being undertaken as part of that study and must obtain any necessary regulatory approvals (Health Research Authority 2013: 1).
The following are examples of the kind of research that require regulatory approvals:
· Clinical trials of investigational medicinal products (CTIMPs) require a clinical trial authorisation from the Medicines and Healthcare products Regulatory Agency (MHRA),
· Medical device studies may require a Notice of No Objection from the Medicines and Healthcare products Regulatory Agency (MHRA).
· Occasionally researchers need to be able to access to identifiable patient data without consent. To do so permission is required from the Health Research Authority, decisions are made by the Health Research Authority on the advice of the Confidentiality Advisory Group (CAG),
· Studies that involve working with prisoners must be reviewed by the National Offender Management Service (NOMS) and it is advised that they are reviewed by a Research Ethics Committee which is flagged to review this type of research,
· Most studies require a favourable opinion from a NHS Research Ethics Committee although there are exceptions, details of which can be found on the Health Research Authority website (Op.cit.: 2).
The Health Research Authority (HRA)
The National Research Ethics Service (NRES) is a core part of the Health Research Authority (HRA) supporting ethical research in the NHS. The HRA appoints RECs in England. There are equivalent appointing authorities in Scotland, Wales and Northern Ireland, with whom NRES work collaboratively. The HRA was established in December 2011 to protect and promote the interests of patients and the public in health research, and to streamline the regulation of research (Health Research Authority 2013: 2).
The Integrated Research Application System (IRAS)
HRA are also responsible for a wide range of projects to streamline research, and to provide The Integrated Research Application System (IRAS). IRAS is an online (web-based) system for preparing regulatory and governance applications for health and social care research, which allows researchers to coordinate their research applications to regulators and to sites where they intend to carry out the research (ibid.). IRAS is a UK-wide system available online:
The HRA are also in charge of Research Ethics Committees (RECs), the Gene Therapy Advisory Committee and the Confidentiality Advisory Group (CAG).
Research Ethics Committees (RECs)
Research Ethics Committees (RECs) can play a role in advising researchers how their data can be processed while maintaining data protection and research ethics’ principles. RECs have the power to approve or reject applications within their remit, but sometimes additional regulatory approvals may also be needed for certain categories of research to proceed (Baker et. al: 2005: 277).
According to the 2011 Governance Arrangements for Health Research Ethics Committees (GAfREC), research projects are required to have ethical review by Research Ethics Committees (REC) (cf. Section 2.3). These include:
- Requirements for ethical review of research under legislation applying to the UK as a whole or particular countries of the UK
- Requirements for ethical review under the policy of the UK Health Departments, where research relates to the services for which they are responsible (Health Research Authority b)).
REC review is required for specific research projects involving:
- Research 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
- Research 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 (cf. (GAfREC Section 2.3.2).
REC review is also required for the following:
- 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 (Health Research Authority b)).
Exemptions from obtaining a REC review
The following types of research are exempted from obtaining REC review:
- Research 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
- Research 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
- Research 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
- Research limited to the involvement of NHS or social care staff recruited as research participants by virtue of their professional role
- Research involving use of or access to a care organisation’s premises or facilities, but not otherwise involving patients or service users.
- Activities that are not research do not require REC review (Health Research Authority b).
The UK Data Archive’s Guidance for RECs:
The National Research Ethics Service (NRES):
Government Arrangements for Research Ethics Committees (GAfREC):
NHS Research Ethics Committees (RECs):
The Gene Therapy Advisory Committee:
The Confidentiality Advisory Group (CAG):
Association for Research Ethics (AfRE):
Baker, S., Beyleveld, D., Wallace, S., and Wright, J. 2005. “Research Committees and the Law in the UK”, in Research Ethics Committees, Data Protection and Medical Research in European Countries, D. Beyleveld, D. Townend and J. Wright (eds.). Aldershot: Ashgate. pp. 271-289.
Health Research Authority 2013. Summary of the role, structure and functionality of Research Ethics Committees within the Health Research Authority in England [Internet]. Health Research Authority. Available at: http://www.hra.nhs.uk/documents/2013/10/national-research-ethics-service-summary-ver-1.pdf, [Accessed June 19 2014].
Health Research Authority a). Section 251 and the Confidentiality Advisory Group (CAG) [Internet]. Health Research Authority. Available at: http://www.hra.nhs.uk/about-the-hra/our-committees/section-251/, [Accessed June 19 2014].
Health Research Authority b). Governance Arrangements for Research Ethics Committees (GAfREC) [Internet]. Health Research Authority. Available at: http://www.hra.nhs.uk/resources/research-legislation-and-governance/governance-arrangements-for-research-ethics-committees/, [Accessed June 19 2014].
Imperial College London, 2014. Ethics approval for health-related research [Internet]. Imperial College London, available at: http://www3.imperial.ac.uk/clinicalresearchgovernanceoffice/projectplanning/ethicsapproval/ethicsapprovalforhealthrelatedresearch, [Accessed June 19 2014].
Research Ethics Guidebook. Student Research [Internet]. The Research Ethics Guidebook: a resource or social scientists. Available at: http://www.ethicsguidebook.ac.uk/Student-research-210, [Accessed June 19 2014].