I’m generally a big fan of guidelines—in fact, I’ve written a few myself, but a recent conversation with a wise Indian researcher made me ponder their darker side. We were talking about research integrity and he explained how he endeavours to embed this into every stage of the research process at his institution, from the initial ethics committee (IRB) approval right through to publication. He believes that ethical considerations, as well as reporting standards, need to be emphasised at every stage. If this doesn’t happen, then well-meaning guidelines might actually teach poor researchers how to be dishonest or help them cover their misdeeds.
For example, if researchers discover reporting guidelines such as CONSORT only when they come to write up a study, they may realise (too late) that they should have recorded not only the number of patients randomised but also the number screened (as this provides useful information on the generalizability of the findings). If this figure was not recorded, but the researchers see that a journal requires them to follow CONSORT, they may be tempted to make up a number rather than admit that they didn’t record it. This isn’t just a problem in India—I remember a painful conversation with a young Italian doctor attending one of my publication workshops who asked me to read her draft paper. The title described the study as randomised, yet when I read the methods, and saw references to cases and controls, I quickly realised that it wasn’t, but the young researcher got quite upset when I tried to explain this to her. I assumed this was an isolated incident (and I blamed the mentors more than the student), but I recently found a paper suggesting that most Chinese studies that claim to be randomised actually aren’t (Wu et al, Trials 2009;10:46 doi:10.1186/1745-6215-10-46).
Integrity, of course, means wholeness and perhaps that’s a clue. We can’t vaccinate against misconduct by a single, swift intervention or waving the relevant guidelines under a student’s nose just as they are about to write a paper. The spirit of the guidelines (i.e. to encourage honest, accurate reporting) is probably more important than their detail …. but changing attitudes is a lot harder than getting people to tick boxes.
Liz Wager PhD is a freelance medical writer, editor, and trainer. She was the chair of the Committee on Publication Ethics (COPE) (2009-2012).