Reviewing code consistency is important, but research ethics committees must also make a judgement on scientific justification, methodological approach and competency of the research team

Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

“…They found that, "[b]roadly speaking, NHS RECs have been getting more consistent over time in terms of their decision-making, but the reasons for the final decisions as described in the committee minutes continue to vary widely." 50 They suggest that qualitative research needs to be done "to understand why different committees can have such different discussions in relation to exactly the same research project and yet come to essentially the same conclusion." 51 I would attribute this similarity in outcome (i.e.…”

“…For example, Samantha Trace and Simon Kolstoe conducted an analysis of the outcomes of several “Shared Ethical Debate” (ShED) exercises undertaken by some NHS RECs in England, with the resulting minutes from each REC compared along with the final decisions made by each REC on the project under consideration. They found that, “[b]roadly speaking, NHS RECs have been getting more consistent over time in terms of their decision-making, but the reasons for the final decisions as described in the committee minutes continue to vary widely.” 50 They suggest that qualitative research needs to be done “to understand why different committees can have such different discussions in relation to exactly the same research project and yet come to essentially the same conclusion.” 51…”

A Framework for Reviewing Dual Use Research

“…This has brought about challenges especially in fields where methodologies, culture and sometimes philosophy differ from the 'medical model' of research. However, although still viewed as a problem by some in the humanities (Lincoln & Tierney, 2004), the issues highlighted by the expansion of RECs have been broadly positive as it has helped to move the philosophy of research ethics beyond just considering the physical protection of research participants, to also encompass the support of researchers and good research practice (Trace & Kolstoe, 2018).…”

A clinical trial is a success, not a failure, if it does not demonstrate efficacy or does identify safety concerns

“…As a group involved with the ethics review of clinical trials we enjoyed the article by David Fogel describing the reasons why clinical trials “fail” [ 1 ]. We firmly believe that along with protecting participants, an important role of Research Ethics Committees (RECs) is to support researchers in carrying out high quality and successful research [ 2 ].…”