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Research and knowledge exchange

Ethical Review Audits

Ethical review audits are a means for C-RECs to assure themselves, University and the wider academic community that researchers are undertaking their ethically throughout the whole life cycle of their endeavours.

EXAMPLE AUDITING FORM

Requirement for monitoring of previously approved ethical review applications

The University is a signatory to the and required to operate policies that meet expectations from funders and regulatory bodies that there is an institutional oversight of internal ethical review processes that goes extends to the full lifecycle of research and does not ‘cease’ when the reviewing body has granted approval prior to researchers commencing engagement with human participants.

Monitoring of Approved studies

The University may undertake periodic monitoring of approved studies. Researchers will be requested to report on the outcomes of research activity in relation to approvals that were granted (full applications and amendments).’

The University Research Governance Committee (URGC) agreed in May 2017 that the principle motivation of auditing will be to to encourage a culture of ethical reflection by researchers at all stages of research and to inform future good practice.

Process

A list of ethical review application (ER) numbers will be selected and entered into the Ethical Review Audit   tool. In the event that any application numbers fail validation (researcher or student no longer being active in the university database), further applications will be selected.

The owners of applications selected for audit will have up to three weeks to complete their audit.

The Research Governance Office (RGO) will contact the School offices of researchers who fail to submit a response within the indicated timescales to understand if there are legitimate reasons for non- completion. Where these exist, the audits will be withdrawn from the audit.

Applicants who do not have a legitimate reason for completion will be given another week to submit after which the relevant Director of Research and Knowledge Exchange will be informed.

Numbers of researchers per School of Study who fail to respond to requests to complete and return audits will be reported to URGC and Research and Knowledge Exchange Committee.

Completed questionnaires will be reviewed by the RGO who will ensure that (as far as can be discerned) all relevant sections have been addressed and any documents likely to be required by the auditor have been attached.  The RGO will transfer the application to the designated auditor for appraisal.

This audit review can be either undertaken by email (with the completed questionnaire sent as a PDF attachment) or else through the online ethical auditing tool in ßÏßÏÊÓƵ Direct.

Standards for auditing

 The following will serve as the standards against which the audit responses will be reviewed:

  • The  University’s Code of Practice for Research
  • Any conditions of approval as evidenced through the comments and feedback from the C-REC or SREO through ßÏßÏÊÓƵ Direct. The online audit form provides a link to the original ethical review application form allow this document to be accessed.

Findings

The auditor will, in response to the completed audit questionnaire select one of three responses:

 AUDIT APPROVED

The auditor is satisfied that there has been sufficient consideration of ethical matters during the research and that there are no significant unanswered questions arising from the responses.

 RETURNED TO RESEARCH GOVERNANCE

 The auditor considers that the researchers has not sufficiently engaged with the audit process or the responses made have raised questions or queries that require further information. The Research Governance Officer will be asked to contact the researcher explaining the additional information needed to satisfy this request.

AUDIT NOT APPROVED

This response will be used in exceptional circumstances to indicate that in spite of efforts to elucidate clearer or more detailed responses, the researcher’s responses are unsatisfactory. In instances that may suggest that research misconduct may have occurred, the matter will be escalated via the appropriate University processes.

The C-REC Chair will review all findings and may, in the event that significant findings are observed, in consultation with the Research Governance Officer suggest that matters are referred to the Procedure for Investigation of Allegations of Misconduct in Research or any other appropriate University procedure.