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The research ethics review process (RECs/IRBs)

There is a wide range of ways of performing the research ethics appraisal process. Some are highly formalised, some are available via online decision trees, some entail checklists of a more advisory/aide memoire nature and even those checklists vary in their detail and depth. The range of ways of conducting research ethics review reflects the variations in the agencies using such a process and the governance arrangements that they have to apply. Some review processes need research proposals to be formally ‘approved’ before being permitted to proceed, others require an ‘opinion’ from the ethics review process and the decision to proceed will depend on the governance process in the funding, commission or managing research agency. Such divisions are sometimes found in the difference between Research Ethics Boards (REBs), Research Ethics Committees (RECs) or Institutional Review Boards (IRBs). A sample of these different procedures are presented here.

The UK Research Integrity Office (UKRIO) and the Association of Research Managers and Administrators (ARMA) published Research Ethics Support and Review in Research Organisations, to support the research community in achieving high standards of research ethics review. The guidance offers benchmark policies and processes which organisations can use to create, revise or audit institutional practices in order to support the functions of research ethics committees. It also synthesises developments in academic work on ethics and integrity, the expectations of research funders and government and existing examples of good practice, to help researchers and organisations to develop a positive culture of integrity and ethics in research. Appendix 1 offers a straightforward checklist that can be used as part of a research ethics appraisal process.

This links to the first ‘port of call’ for the ethics appraisal process within the European Commission.
Within this guideline section, there is a link for researchers to discover how best to address the ethical elements within their research proposal, which also indicates how the ethics reviewers will take account of those elements within their proposal. Successful passage through the European Commission’s ethics appraisal system requires these guidelines be followed.

Any research to be conducted within the UK’s National Health Service requires approval by a research ethics committee. Detailed information and advice on the process can be found here:

The UK Integrated Research Application System

This is an online application and decision-tree process for applications to conduct research in the National Health Service. It is quite useful to explore this system by introducing a ‘test’ proposal even if you have no current plans to seek approval for a project.

TRREE provides training and resources that are relevant to the work of all those who must ensure the protection of the interests and well-being of humans who participate in research as well as the promotion of the highest ethical standards. While some modules may focus on more specific training needs of research ethics committee members, or research teams including investigators, nurses, or study coordinators, the training is open to all and may be of interest to health authorities, funding agencies and universities, as well as to political authorities, patients and the media. Variations between systems in different countries is outlined.

The Open University’s research ethics review process can be accessed here, together with resources and guidelines:

Checklists in research methods texts

Useful ethics review checklists aimed at guiding applicants and reviewers are often found in texts on research methods. This is an example:

The checklist in this book was constructed from a wide variety of published sources and experience of working at local, national and international levels to perform research ethics review for a range of agencies. It was primarily designed for social science research ethics review, but can easily be applied or amended for any proposed scientific research. It can be used as an aide memoire, as a guide to ethical assurance for contracting parties, and as the basis for an ethical scrutiny protocol for research projects conducted by any individual researcher, research group or commissioning body. Completing this form is designed to help in ‘thinking through’ and anticipating harms and benefits at the outset of a project, but also to support ongoing monitoring of such concerns throughout the life of a project. Use tick boxes to show decisions taken and fill in comment sections briefly to record rationales for decisions. If a fuller comment is required to explain the rationale for a decision then it is suggested to append parallel sheets.