Governance approval for multisite, non-interventional research: what can Harmonisation of Multi-Centre Ethical Review learn from the New South Wales experience?

• Published in: Internal medicine journal 2012-02, Vol.42 (2), p.127-131
• Main Authors: Vajdic, C. M., Meagher, N. S., Hicks, S. C., Faedo, M., Ward, R. L., Pearson, S.-A.
• Format: Article
• Language: English
• Subjects: Biomedical Research - methods; Biomedical Research - standards; Ethical Review - standards; ethics; governance; harmonisation; Humans; Learning; Multicenter Studies as Topic - ethics; Multicenter Studies as Topic - standards; New South Wales; Retrospective Studies; review; standardisation; Time Factors
• ISSN: 1444-0903; 1445-5994
• DOI: 10.1111/j.1445-5994.2011.02431.x

Background:  In 2007, New South Wales Health mandated the separation of ethical and scientific review from research governance at all New South Wales public health sites based on their distinction in the National Health and Medical Research Council National Statement. This separation allowed for single‐site ethical review of multicentre studies. Aims:  To investigate the time taken for governance approval of multicentre studies through the site‐specific approval (SSA) process. Methods:  A retrospective audit of the SSA process for five non‐interventional studies proposed by a university cancer research unit. Results:  The median total governance approval time for all submissions (n= 28) was 12 weeks (range 2.5–64); median time from starting the SSA to submission was 8 weeks (range 1–48) and median time for governance approval was 5 weeks (range 0.3–40). Approval times were shorter for public compared to private institutions. Reasons for delays in finalising submissions for approval were the absence of institutional governance officers, lack of clarity regarding signatories, the need to identify a principal investigator employed by the institution, and lack of recognition of ethical approval by private institutions. The need to develop legal agreements between the university and hospital was the main reason for lengthy delays in obtaining approval. Conclusions:  The advantages of a harmonised single ethical review process were undermined by the coexistence of a fragmented, complex and lengthy governance approval process. This experience has implications for the success of the national Harmonisation of Multi‐Centre Ethical Review (HoMER) model. A harmonised and fully supported national approach to research governance should be developed contemporaneously with HoMER.