What are the most common reasons for return of ethics submissions? An audit of an Australian health service ethics committee

Abstract

One of the key criticisms of the ethical review process is the time taken to decision, and associated resource use. A key source of delay is that most submissions are required to respond to at least one request for further information or clarification from the Human Research Ethics Committee (HREC). This study audited the request letters of a single Australian public health HREC using content analysis. Twenty-four submissions were analysed, including 355 individual request elements. Most submissions received a single request letter. There was a mean number of 14.2 (SD = 5.5) elements per letter for the first request and a mean of 2.1 (SD = 1.2) for subsequent requests. Administrative errors were the most common source of request for further information, occurring in all submissions. The second most common theme was the content of the Participant Information and Consent Form, occurring in 79% of submissions. Other common themes, present in over 50% of submissions, concerned: data collection and study procedures; general ethical considerations; recruitment and consent; site, setting or patient pool; research design and methodology; and data management and security. In terms of the general purpose of the HREC comments, 44% were direct corrections or specific requests for changes, 42% were asking for more information or clarification of existing information, and 14% were the HREC expressing concerns about an element of the study, without directly suggesting a change. Overall, the study provides some evidence to show that the quality of the submission (ensuring correct attachments, up to date documents, clear information etc.) could account for a significant proportion of the burden and delay associated with ethical review.

Research made simple: ethics committee approval

“…7 It is important that nurse researchers factor in the time taken to secure REC approval when planning research projects; even the most experienced researchers often need to revise their REC applications before being approved, and the process can take longer than expected. 6 This could have implications for funding or -in the case of student projects -for meeting academic deadlines. Taking simple steps before submitting the REC application can help minimise the chances of having to resubmit the REC application and can help expedite the research process.…”

“…Though some different terminology may be used in different countries, REC decisions usually fall into one of the following: approved, approved with conditions, or revise and resubmit (table 2). 6…”

“…Approval times vary between RECs, but some RECs can take several months to provide a decision on an application 7. It is important that nurse researchers factor in the time taken to secure REC approval when planning research projects; even the most experienced researchers often need to revise their REC applications before being approved, and the process can take longer than expected 6. This could have implications for funding or—in the case of student projects—for meeting academic deadlines.…”

Better Mechanisms Are Needed to Oversee HREC Reviews

“…While existing data is limited, there is some evidence that Australian HRECs are highly engaged in their review functions. Brandenburg et al (2021) report in their study of one Australian HREC that 83% of applications in the study period triggered requests for further information, and 17% had more than one request. While the majority of requests related to minor administrative changes, 79% related to amendments to consent forms, and over 50% were concerned with data collection; study procedures; general ethical considerations; recruitment and consent; site, setting or patient pool; research design and methodology and data management and security.…”

“No Country Bureaucratised its way to Excellence”: A Content Analysis of Comments on a Petition to Streamline Australian Research Ethics and Governance Processes

“…Nearly all proposed health and medical research involving human participants is reviewed prior to its commencement, to ensure that the research proposals are compliant with the relevant laws and regulations, and to protect the safety and well-being of the participants (Abbott & Grady, 2011). This involves an assessment to ensure that participants are protected from excessive burdens or risks from participating in research, and that the benefits of the research outweigh the harms (either real or potential) (Brandenburg et al, 2021; Scott et al, 2021).…”