Table 5 Main and subthemes derived from the qualitative, open-text question

Comment on the survey

39

“Well presented and structured survey”

Extra question or options needed

8

“I'm a retired clinician - nowhere to say this in the survey”

Questions not specific enough

10

“Unable to make any nuanced response with categorical choices”

Thanks, appreciation, offer of help

9

“Glad you are examining these matters”

Comment on specific study designs

7

“The survey should study research where non consenting bystanders may be unwittingly involved and privacy compromised and research that involves facial recognition”

Broader methodology concerns

5

“I consider poor study design likely to cause biased findings to be a significant risk”

Conduct of researchers

7

“I think it depends on the intent and conduct of the researchers”

Clinical trials

2

“I have greater experience of clinical studies and trials and I am aware this affects my perception of risks when NHS treatment is involved”

Observational study

2

“If you are running a covert observational study in public that has different risks associated in comparison to a clinical controlled environment”

Surveys

1

“Our committee is seeing increasing numbers of studies where psychological screening tools, for eg anxiety and depression, are being used in anonymous online questionnaires. If they were being used in a face to face setting by a qualified practitioner, there are scores that would indicate that the person concerned should be urged to see further help, even though they do not provide a clinical diagnosis…”

Comments on risk and benefit

25

“Risk is not directly linked to potential benefits”

Consent

3

“Consent becomes highly apposite in the context of full and understandable explanations of potential risk; we are all entitled to choose our risk level provided we are properly informed”

Context

25

“All of the above answers depend on the context, the participants, researchers experience and the potential benefit of the research”

Data & privacy

7

“There is a relationship in many people eyes between privacy and risk which I have factored into my answers”

Anonymity

4

“I think ensuring participant anonymity wherever possible is a very important element of good ethical practice”

Confidentiality

1

“In my view, weaknesses in study design and in particular uncertainty about the risk that a study may not have enough power to reach a valid conclusion in the public interest, are quite often hard to weigh against the risk of disclosing personal information that could be objectionable to some individuals”

PPI (patient & public involvement)

2

“I was hoping that participatory designs might have been included in the study as this affected how I answered the earlier question about risk in all kinds of design. When studies can include participants in their design then this empowerment/opportunity for voice can reduce the risk”

Reference to national guidance

1

“Determination of risk in part is guided by the Australian National Health and Medical Research standards. However, risk must be determined on more than methodology. Inappropriate data management plans and publication can make low risk methodological studies into ethical nightmares. Applications must be reviewed on a case by case basis”