Anticipating and Preparing for Risks

in Research

Mrs Lindsay UnwinResearch & Innovation Services

UREC Minute Secretary

University Research Ethics Committee

What risks are we talking about?

Risks to:

• Participants

• Researchers

• The University• Anyone affected by the research

(funders, collaborators, the public etc.)

• Research data

& ultimately...the success of the the success of the researchresearch

Key risks to PEOPLE involved/ affected by the research

• Physical harm: injury, discomfort, fatigue

• Psychological harm: stress, distress, boredom

• Inconvenience

• Loss of privacy or dignity

• Risks to social standing, personal values, position in community/occupational settings

• Risk of revealing illegal or deviant behaviour

• Damage to categories of people or communities

• Reputational damage

Key Risks to the Research itself

• Loss of research data

• Lack of research data/being unable to use key data

• Poor data quality

...and as a result being unable to:

• reach conclusions or publish findings

• submit thesis/complete degree

• meet funder requirements/departmental targets

Key risks to the University

• Reputational damage/negative press

......& knock on effects for student/staff recruitment, research funding, collaborations etc.

• Complaints from staff/students/ participants/members of public

• Legal proceedings

• Financial costs

What affects risk?• Research methods (e.g. covert)

• Focus of study (e.g. sensitive topics)

• Tasks/activities involved (e.g. Interventions)

• Location/situation (e.g. overseas, participant’s homes)

• People involved (e.g. children)

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Some examples.....

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A project involves adults with learning disabilities but the researcher forgets to make it clear to them that they can withdraw from the study if they wish

Some participants struggle with the task they are asked to do but feel under pressure to complete it, resulting in distress and leading to complaints from their carers

A researcher’s project involves participants undertaking a brief medical test which results in mild discomfort; the information sheet includes many technical terms...

Several participants did not fully understand what they were being asked to do and refuse to continue resulting in a lack of research data

18/04/23 © The University of Sheffield / Department of Marketing and Communications

A research project involves interviewing alcoholics about the effects on their family life; one participant becomes very distressed and asks for help with a serious family situation...

The researcher is out of her depth and unable to help - the participant is so upset she complains to the local press about the lack of support

18/04/23 © The University of Sheffield / Department of Marketing and Communications

A researcher is interviewing members of the public on the street...

One individual approached is not happy about the questions being asked and becomes aggressive towards the researcher.

18/04/23 © The University of Sheffield / Department of Marketing and Communications

A researcher is conducting ethnographic research in a community; a participant he has become friendly with mentions a crime he committed in the past which the researcher refers to later in a published paper...

The participant contacts the researcher upset that he has betrayed the participants’ trust and demanding that the paper is retracted.

A researcher publishes a paper about life in the 1800s which mentions the name of an high-profile individual in relation to involvement in prostitution.

The relatives of the named individual sue the University for resulting damage to the family’s reputation/social standing.

18/04/23 © The University of Sheffield / Department of Marketing and Communications

A researcher enlists the help of a colleague to analyse their data; the data identifies the individual participants, one of whom the colleague knows and who mentions this to the participant in question...

The participant was not aware that their data would be seen by anyone other than the researcher and makes a complaint.

18/04/23 © The University of Sheffield / Department of Marketing and Communications

A researcher recruits participants who will be making records of their diet habits over a period of 6 months; by the end of this period, the researcher has been off sick for a few weeks.

A participant complains to the University that she has heard nothing from the researcher and she feels her work over the 6 month period has been pointless

18/04/23 © The University of Sheffield / Department of Marketing and Communications

So what can we do to manage these risks?

A summary....

18/04/23 © The University of Sheffield / Department of Marketing and Communications

During the design process

• REFLECTION/EVALUATION - What are the potential risks? Is the design appropriate? (e.g. likely to offend/upset?)

• PREPARATION – What can be done about the risks? Think ahead (e.g. what will you want to publish?)

• DOCUMENTATION – Keep records of your thought process and decisions

• JUSTIFICATION – Clear explanations for ethics committees/funders (& in case of complaints)

18/04/23 © The University of Sheffield / Department of Marketing and Communications

Put yourself in the participants’ shoes!

18/04/23 © The University of Sheffield / Department of Marketing and Communications

During the informed consent process

KEY = Fully informing participants

• Information sheet in lay person’s language

• Talk through information sheet with the participant – check understanding

• Make it clear they are not obliged to participate

• Make it clear what will happen to the data collected & plans for publication/further research – BE CAREFUL WHAT YOU PROMISE!

Ethics website: Guidance document on compiling an information sheet!18/04/23

Know your audience!

18/04/23 © The University of Sheffield / Department of Marketing and Communications

During the informed consent process

• Purpose and research methods;• Explanation of technical terms;• Who is undertaking and who is sponsoring?• Potential risks and inconveniences;• Potential benefits;• What participation will involve;• How confidentiality will be safeguarded; • What will happen to the data?• How will data be stored?• How to raise concerns, or to complain (at least 2

contact names);

• The consequences of non-participation (e.g. alternative treatments)

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During the research itself

• Consent: ongoing process?

• Are the participants comfortable/happy?

• If long timeframe, maintain regular contact

• Think about your own safety/well-being (Be aware of changing situations)

• Be prepared to deal with questions/issues that may arise (e.g. have leaflets/contact details for advisory services ready)

18/04/23 © The University of Sheffield / Department of Marketing and Communications

Use of data/publication/ dissemination

• Ensure secure storage & take care (don’t leave your notes on the train!)

• Anonymise ASAP (limit key to 1 person!)

• Don’t identify anyone in publications without consent!

• Take care with anonymising data (can be difficult to make individuals truly anonymous)

• Abide by agreements made during consent (e.g. for sharing/future use of data)

• Data Protection Act 18/04/23 © The University of Sheffield / Department of Marketing and Communications

Final thought...

You can’t predict all the possible risks in your research

BUT

You can take time to reflect & prepare for foreseeable risks

18/04/23 © The University of Sheffield / Department of Marketing and Communications

For further guidance…

http://www.shef.ac.uk/ris/other/gov-ethics/researchethics/index.html

• Detailed guidance documents

• Template information sheet

• Template consent form

….and much more!

18/04/23 © The University of Sheffield / Department of Marketing and Communications

Thank you!

Lindsay Unwin, Minute Secretary to the University Research Ethics Committee

l.v.unwin@sheffield.ac.uk

x 21443

18/04/23 © The University of Sheffield / Department of Marketing and Communications