Whistleblowers: Research projects lacked ethical approval

The University of Staffordshire has been conducting research without proper ethical approval.

In a document seen by The THES , the university's academic ethics committee warns that "projects that require ethical approval are either going out of the university without it, or being undertaken without appropriate scrutiny". The committee calls for tighter approval procedures because "existing arrangements do not seem to be working consistently".

The university said in a statement this week that ethics procedures have been in place at school level for some time, and that it was the signing-off procedure at university level where problems had emerged. But it admitted that it had received a complaint regarding ethics from an individual who had taken part in a research project, which it is investigating.

The document, from the ethics sub-committee of the quality development committee, was written by sub-committee chair Anne Parry in December 2001. It warns that there has been "little interaction" and communication between schools and the central university ethics committee. "This has become an issue of concern because evidence has emerged that research projects that require ethical approval are either going out of the university without it, or being undertaken without appropriate ethical scrutiny."

The document, the committee's report for 2000-01, says: "This could represent a serious issue for Staffordshire University were anything untoward to happen, or should there be any media interest around student or staff activities because, in such circumstances, the processes that the university has in place would not appear rigorous and thoroughgoing, particularly at their point of origin in fields and schools."

It says field trips have also escaped proper scrutiny. "In undergraduate awards there is a growing emphasis upon undertaking field work or placements and these should properly receive ethical scrutiny in order that students are best advised, participants protected and the university assured that things being done in its name are proper."

Research ethics have become an increasing concern in universities, especially where people are used in research that could cause them mental or physical harm. Proper approval can be crucial to prevent damage to health, for example, and to ensure subjects have given proper consent.

The committee recommends tightening procedures, formalising the system of approval at the level of the university "to assure the university that appropriate scrutiny is being given to such proposals. We are aware that this formalises procedures that may be in place, but it is our view that all these suggestions are necessary, particularly as existing arrangements do not seem to be working consistently."

The university said in a statement that it "has had formal procedures at school and field level covering research ethics for student research at all levels for a considerable period of time".

It said that the document was referring only to ethical approval of projects at university level. "It did not mean that there was no process at all but that the existing school-level procedures may not be sufficient for external bodies in all cases.

"The evidence referred to in the paper came to us at the stage of approval by an external body that required university-level formal signature of approval in addition to school-level approval. It needs to be stressed that, at this stage, the research in question had not been started, nor was started, without such approval."

The university said the tightening of procedures "was not a reactive response, since no complaints had ever been received at the time".

But it admitted it had received a complaint from a research subject. "The university has only ever received one complaint that relates to a research ethics matter. This is very recent and we will, of course, take it very seriously, but we are not in a position to comment on it because it is at the earliest stages of investigation.

"The current position is that no research is conducted involving human subjects without consent being obtained in writing on a pro forma. Until the pro forma is approved by the appropriate group in the university in the initial approval process, the research cannot begin. Other key issues such as participants' interests and rights, consent, deception, confidentiality etc are also addressed at this first stage."