De Marco and colleagues claim that the standard account of invasiveness as commonly encountered ‘...does not capture all uses of the term in relation to medical interventions 1 ’. This is open to challenge. Their first example is ‘non-invasive prenatal testing’. Because it involves puncturing the skin to obtain blood, De Marco _et al_ take this as an example of how an incision or insertion is not sufficient to make an intervention invasive; here is a procedure that involves an incision, (...) but it is regarded as non-invasive. However, this ignores the context, and the term should really be understood in reference to the fetus. It is hard to believe healthcare professionals regard taking blood to measure, for example, ferritin levels as invasive but taking blood to look for fragments of fetal DNA as not. If anyone uses the term thinking it is not invasive to the mother, the... (shrink)

Research consent processes must provide potential participants with the necessary information to help them decide if they wish to join a study. On the Oxford ‘A’ Research Ethics Committee we’ve found that current research proposals mostly provide adequate detail (even if not in an easily comprehensible format), but often fail to support decision making, a view supported by published evidence. In a previous paper, we described how consent might be structured, and here we develop the concept of an Information and (...) Decision Aid (IDA) that can support decision making and be used to guide the dialogue between researcher and potential participant. Our proposal requires limited changes to current processes or paperwork and would provide an easily accessible document for others that the potential participant might approach for advice. It could later be integrated with the Informed Consent Form to ensure all matters of concern to the individual participant have been addressed before consent is formally signed off. (shrink)

In their paper “Research approvals iceberg: how a ‘low-key’ study in England needed 89 professionals to approve it and how we can do better” Petrova and Barclay highlight concerns with the health research regulatory environment in the UK. As long-standing chairs of NHS research ethics committees, researchers, and also academics in research ethics, we are also often frustrated with the regulatory process in the UK. However, we think that Petrova and Barclay’s analysis is misleading because it conflates research ethics with (...) governance and funding processes, thus failing to adequately distinguish between the national coordinating function of the Health Research Authority, local research governance processes, and interactions with research sponsors and/or the Clinical Research Network. (shrink)