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Sprinting to the start line: concerns with expedited ethics review

 


Allow me to start with a short story.

A recent conversation I had with an established academic evolved as follows. The academic had funding to explore how involvement with classical music impacted a child’s development. He planned to interview parents of children, aged 2-13, who played musical instruments. The interviews were exploring how music was involved in the children’s daily schedule. The questions were likely to centre around everyday activities and conversations the parents had with their family and friends, so he considered the research low risk. Expedited ethics review was gained, and the research was approved almost immediately. Upon ethics approval, the researcher then explained how he used the amendment process to include children in the research; something he had planned to do all along. The amendment involved a small submission explaining how the research was differing and what some of the new potential ethical issues might be. The interviews with the children would be about their experiences playing musical instrument. They were likely to mimic conversations the children had daily. This manipulative even blasé approach to ethics review concerned me. The researcher here took advantage of the low risk expedited review, using it as a short cut to dodge full ethics review which would have involved lengthy paperwork. When I asked him about his approach he claimed it was fairly common practice in his department. It saved time and avoided unnecessary ethical bureaucratic practices.

As a budding researcher and novice ethicist, I want to make it clear from the beginning that I am not against expedited ethics review process for low risk projects, nor do I think all projects involving children are high risk. After completing and submitting a handful of ethics applications for various projects in my postgraduate studies and research assistant work, I understand the benefits of expediting low risk projects. I do, however, have some concerns with what may be lost in the rush to expedited review, particularly if expedited review is being used as a loophole.

Typically ethics committees tend to be protective of groups deemed ‘vulnerable’, children included. So my curiosity grew when I heard the ethics committee not require the academic to resubmit a full ethics application. Many ethics committees would see red flags because of the children and require a completely new application. Ethics committees’ idiosyncrasies are discussed often enough in ethics literature, and perhaps magnified through their approaches to expedited review. Yet, little explanation around the decisions to accept or reject amendments is offered. Would other ethics committees have reacted differently to the amendment submitted?

I am apprehensive that expedited ethical review may render the primary purpose of ethics review secondary. Ethics review was originally created to protect participants from harm. Expedited ethical review has definite benefits for the researcher and ethics committee, decreasing the time review takes, and reducing the workload for committee members. But does it come at a cost to participant protection?

I have two main concerns: the level of ethical scrutiny applied during expedited review; and the temptation for expedited review to be used as a ‘shortcut’. One of the main benefits of full ethics review is that research proposals are scrutinised by multiple sets of eyes, and critiqued and examined by members with different skill sets, concerns, and expertise. I am unsure how during expedited review, one or two ethics committee members can ensure the same level of review is applied. In the past, expedited review of applications I have submitted certainly missed some key mistakes which I found after receiving ethics approval. Furthermore, I am unsure if just one member of the ethics committee can identify all the potential risks of low risk projects.

The second main concern I have with expedited review is that it may be used as a ‘shortcut’. Expedited review may be seen as a way to obtain ethics review quickly. “The identification of ‘doing ethics’ with ‘getting through ethics review’ creates a risk that ethics questions focus on data gathering, with the result that (re)use of data is either seen as ethically unproblematic or ignored” (Morrow et al 2004 p. 4). Israel (2015) argues qualitative researchers are frustrated with ethics procedures that do not understand qualitative methods. The researcher’s approach to ethics review above may be a result of this frustration. However, finding loopholes and using or abusing the expedited review process should not be the answer.

My short reflection of this expedited review process is not intended to criticise ethics committee members’ work. I simply cannot fathom the volume of work they undertake each month. Introducing systems such as expedited review may be a productive way to reduce the monthly workload ethics committees face. Rather, I have questioned how thoroughly expedited review can explore a complex project. Perhaps we should be asking not if projects reviewed through an expedited review process offer the same level of ethical scrutiny as a full review process, but rather how this shortened review process can ensure projects are still reviewed sufficiently?

References

Israel, M. (2015). Research ethics and integrity for social scientists: Beyond regulatory compliance (2nd ed.). London: Sage.

Morrow, V.; Boddy, J.; Lamb, R. The ethics of secondary data analysis: Learning from the experience of sharing qualitative data from young people and their families in an international study of childhood poverty. Institute of Education, University of London, UK (2014) 24 pp.

Amber Chambers
Otago University MA graduate
Research assistant at Griffith University
Centre for Governance and Public Policy, Nathan

This blog may be cited as:
Chambers, A (2015, 23 August) Sprinting to the start line: concerns with expedited ethics review. AHRECS Blog. Retrieved from https://ahrecs.com/human-research-ethics/sprinting-to-the-start-line-concerns-with-expedited-ethics-review

 

Sean says:

Interesting post and I agree with the sentiment. Low risk review should not be used as a way to ‘game the system’. However, it seems to presuppose that once categorised as a low risk research project the designation is irrevocable. I can only speak to the way my organisation manages this matter but that is certainly not the case here.

I take the attitude that ethical review is a process requiring applied critical thought. Consideration must be given to the nature of any additions to a project and any implications those changes may have for the participants, institution or investigators. I review low risk applications on behalf of the HREC of my institution as well as the associated amendments. When doing this, one of the primary issues I look for are matters that I consider require the greater degree of rigor associated with a review by the full committee. In the past when additions have been made to a study that take it beyond the scope of what was initially approved I will ask the full HREC to consider the project to ensure that the necessary robust review is conducted.

While ethics committees in Australia are guided by the National Statement, the Code of Conduct, state specific legislation/policies etc. these are by necessity broad and ethics by its very nature can be a very varied and subjective field at times. Those of us that represent ethics committee’s need to critically appraise research applications, not only with these policies in mind but our own understanding of the needs of the participants and the institutions. This sort of consideration should not only be exercised upon initial submission and review but should be applied to the whole of the project to ensure that any subsequent amendments are in keeping with the context under which the project was approved.

Gary Allen says:

First of all I want to stress that these comments are my own and I am not speaking on behalf of Griffith University, AHRECS or our clients, or the few NHMRC working groups/committees that I am involved in.

This post touches on a serious (and topical) matter for institutions and potentially also for researchers (if trust in the use of proportional review becomes irrevocably broken).

You will notice in my comments I use the term ‘proportional review’ rather than expedited review. I do so because the focus should be upon correlating the review process, the paperwork and timeframe to the ethical sensitivity/complexity and risks of a proposed project, rather than merely speeding up/abridging the review (to manage workload and speed up the review).

I am ‘by trade’ and predilection a policy officer. I prefer *systems* that test whether a proposed project qualifies for proportional review and then a process where an experienced policy officer confirms that automated assessment. Both the automated and manual assessment are then recorded in the research administration database. I do not favour processes that ask applicants if her work is ‘low risk’ or facilitates ‘gaming the system’ to qualify for proportional review. If executed well such systems can provide a nuanced, transparent and policy-based process that can deliver faster processing times and managed workload (e.g. Griffith University processes around 1200 research ethics review applications each year) but the primary objective is providing a framework that is proportional and responsive to the specifics of every project. Another important element of a good proportionate process is that it offer some degree of predictability for researchers

I think the case Amber has referred to highlights the importance of including in the process to consider proposed variations to projects the question “Does the proposed change include ethical considerations that are new/compounded beyond those previously reviewed?” Clearly the addition of young people is significant and does warrant substantive review.

The title of this post is very apt. We all need to be careful that in our race to the start we maintain the confidence of regulators, funding bodies and the wider community. The peril of failing to do so is that the whole use of review ‘outside of a HREC’ might be brought to disrepute.



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