eMJA: Multicentre research: negotiating the ethics approval obstacle course

Lynne M Roberts,* Lucy Bowyer,† Caroline S Homer,‡ Mark A Brown§

* Research Midwife [corresponding author], † Senior Lecturer in Obstetrics (University of New South Wales), ‡ Midwifery Consultant, Department of Women’s and Children’s Health, St George Hospital, Research Building, St George Hospital, Kensington Street, Kogarah, Sydney, NSW 2217; § Professor of Medicine (University of New South Wales), Department of Renal Medicine, St George Hospital. RobertslyATsesahs.nsw.gov.au

To the Editor: The obstacles presented by Human Research Ethics Committees (HRECs) have caused a significant delay in commencing a valuable research project.

We are currently conducting a multicentre study investigating the outcomes of hypertensive pregnancies in a cohort of 1620 women. It is a retrospective review of medical records and does not entail any participation of the women. Ethics approval was sought and gained from the New South Wales Health Department and one other NSW area health service (AHS) involved in the study. The bulk of the medical records (85%) are held by this AHS and a smaller proportion by eight other AHSs in NSW. Despite these prior approvals, the process of gaining ethics approval from the eight AHSs was fraught with obstacles at every stage. After 8 months’ work, we have received approval from the HREC of each of the AHSs.

Our experience has revealed many inconsistencies in the requirements of the HRECs in the different AHSs, as summarised in the Box 1. These inconsistencies highlight discordances with the guidelines to support researchers and HRECs drawn up by the National Health and Medical Research Council (NHMRC).

The NHMRC’s National Statement on Ethical Conduct in Research Involving Humans1 clearly outlines that, once approval has been gained from one HREC, other sites should accept that approval. Unfortunately, it seems that the HRECs involved in giving approval for our study did not follow the guidelines relating to multicentre projects. Other researchers have reported similar problems. 2-4 Breen and Hacker2 suggest that HRECs are slow to adopt a simplified review process because this interferes with traditional practices of each committee making its own assessment.

It is indisputable that ethics considerations are a vital component when undertaking human research. It is also crucial to have a reliable and trustworthy process that evaluates research proposals in order to protect participants from physical and psychological harm. However, it has taken the research midwife (who is on a 1-year non-renewable grant) 8 months to secure ethical approval at all sites. This process is cumbersome and counterintuitive to the principles and guidelines for multicentre research in this country.

1: Summary, by area health service (AHS, coded S to Z), of different requirements for gaining ethics approval for a multicentre study

Area health service	S	T	U	V	W	X	Y	Z

No. of pages of application form	19	20	19	20	12	23	2	11
No. of copies of form required	1	1	17	15	20	16	1	14
No. of hospitals in AHS covered by approval	2	2	4	1	3	5	3	5
Approval covered private hospitals in AHS also	na	na	Yes	No	No	na	No	na
No. of contacts made (phone/letter/email) to gain approval	20	15	20	15	20	30	10	20
Time taken to gain approval	3 months	5 months	4.5 months	8 weeks	6 weeks	6 weeks	1 week	3 weeks
Special requests during approval process	A	F	A, B, C, E	A	A, D	A		G, H
Approved after first submission	Yes	No	No	Yes	Yes	Yes	Yes	Yes

na = not applicable. A = Asked for local researcher to be a contact person for the study. B = Charged a $33 fee to submit application. C = Requested scientific protocol with references. D = Requested budget form. E = Reviewed by scientific advisory committee before human research ethics committee (HREC). F = Requested consent and subject information forms. G = University HREC’s approval as well as approval of area health service HREC required. H = Final approval required from chief executive officer of major hospital in that AHS.