Methodological Rigour as Ethical Requirement
Here’s a good example of why those assessing clinical trials have an ethical obligation to care not just about protecting research subjects, but also about methodological rigour.
The FDA has just approved a process that uses magnetic pulses to treat depression. It’s the first time noninvasive brain stimulator has been used to treat depression. It’s a neat trick.
It’s expensive, and doesn’t work for most subjects, but it does have some effect. It’s a promising addition to the range of tools available to treat depression. The FDA has asked for more data, so another trial is now recruiting. I’m not qualified to judge the design of this trial, but I know the details matter. Scientific rigour is all that stands between this magnetism-based form of therapy and the charlatans selling magnetic bracelets to cure any- and everything. The public needs to know there’s a difference, and they need to know that both researchers and research ethics boards are working hard to maintain the difference.