Research 'lacked ethical scrutiny'

University says it has had only one complaint

By Gary Eason BBC News Online education staff

Researchers at a UK university are said to have carried out medical research without appropriate approval at a senior level for their work.

Research projects that require ethical approval are either going out of the university without it, or being undertaken without appropriate ethical scrutiny

Internal university report, December 2001

A complaint has been made by one research participant.

The university - Staffordshire - says it is investigating the complaint and cannot comment further on that until the inquiry is complete.

It said its procedures on getting ethical approval for research were always rigorous but were now also being done at a new, corporate level.

The statement followed a report from the university's academic ethics sub-committee, which said: "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."

Rigour

The report added: "As a result 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...".

The current position is that no research is conducted by the university's students involving human subjects without consent being obtained in writing

Staffordshire University

The two-page report, leaked to BBC News Online, said that in such circumstances "the processes that the university has in place would not appear rigorous".

In a statement, Staffordshire said the report was referring to a lack of scrutiny at university level.

It said there had always been approval at a lower level, within schools or departments.

"The evidence referred to in the paper came to us at the stage of approval by an external body which required university-level formal signature of approval in addition to school-level approval," a spokesman said.

Formalised

"It needs to be stressed that, at this stage, the research in question had not been started, nor was started without such approval.

"It was, however, from this evidence that the university research ethics sub-committee determined to formalise the university's procedure further by ensuring that all projects had university-level approval."

The university's statement said it "has only ever received one complaint that relates to a research ethics matter".

"This is very recent and the university 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 nature of the research activity in that case has not been disclosed.

But the statement said the tightening up of the procedures had not been reactive, "since no complaints had ever been received at the time".

'Proper' approach

Another reason for concern given in the ethics report was the growing emphasis on fieldwork in undergraduate courses.

The report said these needed proper scrutiny so that students were best advised, "participants protected" and the university assured that things done in its name were proper.

The spokesman said: "The current position is that no research is conducted by the university's students 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."

Confidentiality

The university's deputy vice-chancellor Paul Richards said the issue involved the work done with third parties - such as health authorities - by students on degree or masters courses.

He stressed that doctoral work and work done under contract had always had university-level approval.

This had now been extended to more junior research projects.

"To make sure they weren't bounced back we needed to put another stage into our review procedure," he said.

"We are talking about questionnaire surveys and that sort of thing - so it's about guarantees of confidentiality and so on. We don't do pure science research."

Mr Richards said Staffordshire felt that it was ahead of some other universities in this regard.