Improper trial/study conduct

Before a randomised controlled trial or other study gets the go ahead, an ethics committee needs to approve it. Ethics committees may be private, part of a university, a national agency, or a local public committee.

In the case of private ethics committees, they may be run as a business. There is a risk that because they rely on a direct financial transaction, they may not want to turn down a study and put off other organisations coming to them in the future for ethical approval.

Similarly, university ethics committees may have a conflict of interest if the university relies on funding from a study or trial or the members of the committee are colleagues of the applicants. The risk of personal connections constituting conflicts of interest also applies to other types of ethics committees.

Research misconduct by academics and investigators may also occur. This may come in the form of fabricating data, falsifying or manipulating results and processes, and plagiarising ideas, words and results. For example, in terms of manipulating results researchers can substitute surrogate end points for true clinical endpoints, or may selectively analyse results so negative findings are hidden. If the true findings of a trial/study are obscured healthcare providers will be unaware of the risks of dispensing or using the product and patients will be put at unnecessary risk.