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Research Design Service London
 
 
RDS London Newsletter - Spring 2017
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Ethical approval - getting it right the first time

by Jennifer Bostock, Ethics Lead 

It may surprise you to learn that a recent Health Research Authority review found that only 15% of ethics applications pass at first review (HRA 2017). As an NHS Research Ethics Committee (REC) Vice Chair, I see many research proposals that have achieved funding, gone through R&D, employed staff, and then either stall or fail at the REC.   

Some are given unfavourable opinions (4%) or conditional approvals (18%), but the majority are given provisional opinions (61%). This means that applicants must respond to the REC in writing or in person for the committee to consider changes. This costs the REC time and money, other applicants have their reviews pushed back, and most crucially it results in delays for the researchers. These delays are frustrating and can have knock-on effects, such as delayed contractual agreements, extensions being sought from funders and delayed recruitment.

In my experience on RECs and funding panels, the types of studies that most commonly have ethical issues include: mental health studies; studies where participants lack capacity; studies involving vulnerable populations (e.g. prison, forensic, learning disability and care home environments); methodologies such as ethnography; interviews and questionnaires; placebo studies; and studies in general practice. Studies also often have difficulties with qualifying for the Proportionate Review Service (accelerated review of research studies which raise no material ethical issues).
 
Tips:
  • Think about the overarching aim of the study - what will be the ultimate benefit to patients or the public? Prepare a clear, coherent and honest answer for the REC interview.
  • Think about whether you would be happy to participate or if you would want your mother or child to do so. If not, why not?
  • Qualitative questionnaire/interview/ethnographic studies should be careful not to include unnecessarily intrusive methods or questions, which could be seen as fishing exercises.
  • Patient information sheets, consent forms and recruitment strategies are frequent ‘offenders’ when it comes to provisional opinions. Always get a lay person, who is outside of academia or healthcare, to read study documents.  If possible, have a relevant PPI group review the documents and ask for honest critical feedback.
  • If study participants are likely to lack capacity at any stage, you must adhere to the Mental Capacity Act. 
  • Remember that the primary job of the REC is to protect participants, not to approve research. 
     
As part of RDS London’s free support, I can provide expert ethical input into your funding applications to highlight and mitigate against ethical issues that may result in delays in achieving ethical approval.  Speak to your RDS advisor if you feel your application could benefit from ethics input.
 


Patient and Public Involvement (PPI) update

by Jonathan Paylor, PPI Advisor
 
RDS London have been working with our Public Advisory Group to develop ways to better embed PPI in our activities. This has led to members of the group offering their advice to researchers who present at our Proposal Feedback Forums.
 
We have also been working with INVOLVE and RDS East of England on a research project that that explores how the concept of co-production can be used to inform and advance PPI in health research. The project consists of a roundtable event, a literature review, interviews and a workshop and will ultimately inform INVOLVE’s guidance on co-production.
 
Finally, we are excited to announce that Charlotte K├╝hlbrandt will be joining us in June as the PPI lead for RDS London.  Charlotte brings a wealth of expertise in ethnography and patient and community involvement in healthcare settings.