Ensuring the Success of Your Research with Human Participants by

Anticipating and Managing Risks

An ethics workshop for researchers

Report

Synopsis:

The workshop’s purpose was to help researchers build a greater awareness of the potential risks and challenges of undertaking research involving human participants, in order to successfully anticipate and manage the risks in their own research. The key aims were to:

  1. Help researchers to develop their awareness of the potential risks at each stage of a research project;
  2. Explore the tips and techniques that researchers can use to manage risks ethically and to protect themselves, their research, and all those affected by it;
  3. Provide a forum in which to discuss risks in research with other researchers across the disciplines;
  4. Introduce the University Research Ethics Committee’s (UREC’s) perspective on risk.

The Presentations:

The workshop opened with two presentations:

  1. ‘Risk: The UREC’s perspective’ (Professor Richard Jenkins, Chair of the UREC)
  2. ‘Anticipating and preparing for risks in research’ (Mrs Lindsay Unwin, Minute Secretary to the UREC)

The presentations can be viewed and downloaded from:

The Q&A Session:

Following the introductory presentations, an open question and answer session provided an opportunity for attendees to ask questions about risks relevant to their own research, for consideration by members of the UREC.

A summary of the questions asked and answers given is provided on the following pages.

The Group Discussion session:

Following the presentations, the audience split into small groups for a discussion session.

Each group was asked to consider a research scenario, to think about the potential ethical risks it presented, and to discuss what could be done to manage these risks. Each scenario included a few discussion questions to help get the discussion started. The aim of this session was to help develop awareness of the kinds of risk that can present themselves in research, and to provide an opportunity to consider the techniques for managing them, with others from across the disciplines.

The discussion material, along with the key points raised, are included on the following pages.

Brief summary of the conclusions drawn by Professor Richard Jenkins, Chair of the University Research Ethics Committee, at the end of the workshop:

  • Clarifying what we mean by the term ‘risk’ is an important starting point when considering risks in research. Risk can be summarised in general terms as ‘the potential undesirable consequences of doing something’.
  • Researchers should aim to carry out informed assessments of what the risks of their research might be, including assessment of both the potential frequency of risks and the potential seriousness of risks.
  • True anonymisation of participants can be very difficult to achieve, especially when the research is looking in detail at aspects of their lives. However, participants may actually want to be identified, or may not be unduly concerned about being identified. The key is to discuss the issue with participants at the outset, and make it clear that you can do your best to disguise their identities if they wish, but that it may not be possible to make them totally unidentifiable. Fictionalising aspects of participant’s lives can be a useful tool in disguising their identities.
  • Consent can be a tricky issue and may need to be an ongoing process.
  • There is rarely a right and wrong answer with respect to ethics – only better or worse answers. There are also no template answers, and each project will require a bespoke solution to the particular issues it raises, so researchers need to think carefully about their research and always document their thinking.
  • It is important to recognise that it will never be possible to consider and address all the potential risks of a project in advance; there will always be unexpected issues and challenges, and you can’t control everything. Risks tend to be connected to each other in complicated networks, and there is no such thing as risk-free research that involves human participants. The important thing is doing your best to think about the foreseeable risks and manage them appropriately – and to document this! And remember that you do have control over what you write and where/how you publish your findings.

/ / / Anticipating and Managing Risks
An ethics workshop for researchers
Question & Answer Session

A summary of the questions asked and answers given during the Q&A session is provided below:

Question 1: A PGR student was planning to undertake an ethnographic study in Tibet, studying folklore in a small-scale community. Whilst the researcher was proposing to anonymise the participants, some locals expressed a desire to be identified in the thesis.

The UREC’s response:It can be difficult to truly anonymise participants anyway, and it can also be difficult to anonymise some and to identify others in the same project (e.g. people can then make guesses about who hasn't been identified but who did participate). One option could therefore be to refuse to identify anyone. Another option could be to choose not to use data from some individuals (i.e. to self-vet leave people out of an account in certain cases). The key was to ask the participants about their concerns, if any, about being identified; some people may feel they own folklore traditions. There is therefore a need to recognise the problem and devise a means of talking about the problem with those involved.Richard Jenkins mentioned an ethnographic project of his (suspected witchcraft in South West England) that he had to abandon - i.e. because whilst some people were happy to participate they went on to make comments about other people. It was also pointed out that sometimes it is impossible to anonymise people - i.e. public figures who would expect to be identified.

Question 2: A researcher was planning to conduct research on church-state interactions in China, and wished to know whether the use of pseudonyms to protect the identity of a place or community would be acceptable.

The UREC’s response: It would be very difficult to truly anonymise participants in this research in today's age - and of course the individual researchers leave an audit trail of their actions. It was pointed out that there was a need to be careful to not cause harm to the participants, but also not to damage the integrity of the data collected (i.e. care would need to be taken to ensure that data is not distorted in order to maintain anonymity). One option would be to change the back-story of individual participants (i.e. fictionalise their biographies) without distorting the data but the aspects of the individual participant's back-story that can be changed will depend on the research project. It is worth remembering that participants should be allowed to take their own risks - but they need to know what the risks are before participating (they may not have thought through the potential risky consequences of taking part).
Question 3: A researcher wished to know whether it is appropriate to feed back research findings to the participants.

The UREC’s response: This can be a useful process that can create more research data (Richard Jenkins mentioned a study he did to investigate racism in the workforce - the feedback process produced conflict...but more great data).

Question 4: A researcher was planning to conduct research into 1930s Chinese archives and wished to know what ethical issues this raised.

The UREC’s response: Providing the archives are public then the researcher does not need to seek permission from the next of kin of people or from organisations which are mentioned in the archives. But it is good practice to inform the next of kin or the organisation that they are doing the research and ask them if they would they like to comment (i.e. give advance notice, give opportunity to participate, but not seek permission).

/ / / Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session

The research scenarios that were discussed and a summary of the key points raised:

[Scenarios have been adapted from the ‘Online Ethics Centre for Engineering and Research’ website and the ‘Adapted from Ethics in Mental Health Research’ website]

Attendees made the following points about this case study (points are not listed in order of importance – all points have equal merit):

  • It was noted that Judy’s responsibilities include keeping the students safe (she would need a CRB check), maintaining their dignity, rights and confidentiality as well as maintaining the trust of the students and their parents;
  • The Principal has a responsibility/priority to maintain the school’s standards and reputation, and she may put this before the welfare of individual students;
  • The Principal also has a responsibility to really understand what the research entails and how it may affect the students (i.e. not to rush in but to give the project full consideration) – the students may have to talk about traumatic experiences and may need considerable support (e.g. having someone available to talk things through with after participation);
  • There was a concern that parents could be the perpetrators of violence towards the children and so requiring consent from them could result in students who have experienced such violence being excluded from the research, and could put the students at risk of further harm;
  • Consent (or at least assent) should be obtained from the students themselves, especially since the project involves discussion of potentially sensitive topics; the students need to be fully informed and agree to be involved without coercion;
  • Since the study would be conducted over a 4 year period, consent should be re-visited regularly (at least verbally), particularly as it involves teenagers who are likely to change considerably over this time period;
  • The researcher should think about the effect of the students’ peers and how students will be perceived if they are/are not involved;
  • The researcher should think carefully about situations where she may not be able to maintain the participant’s confidentiality (e.g. the need to inform the relevant authorities in the case of child abuse), and be prepared to discuss this at the outset with participants;
  • The researcher should ensure she has an understanding of the types of violence and issues that are likely to arise in this community, and be prepared to deal with these appropriately;
  • One key question raised was ‘is it really necessary to conduct the study with children?’ Conducting the research with older teenagers (over 18s) for example may reduce the risks.

Attendees made the following points about this case study (points are not listed in order of importance – all points have equal merit):

  • It would be important to manage the expectations of all those involved in the study, and to make sure all are fully informed to avoid confusion;
  • It was noted that it can be difficult to assess harm, and that the effects of harm should be evaluated post-research;
  • There was a concern over the motivation of caregivers since they could benefit through being involved in the study; it would therefore be important to randomise the treatment groups;
  • There was a concern over who could be legally defined as the caregiver, since different kinds of caregivers could have different motivations;
  • An appropriate Alzheimer’s Disease charity could be contacted to give advice to the researcher;
  • It was noted that the researcher should not expect too much caregivers from since they may be vulnerable themselves (e.g. close relatives struggling to cope);
  • A realistic coping strategy would need to be put in place to enable those who had been receiving support throughout the research to manage after the withdrawal of that support (this would need to be discussed as part of the informed consent process); for example, could support be obtained through a charity instead?
  • Those in the control group could also be given the contact details of a care support group following completion of the study;
  • Whilst one treatment group would be getting the best deal, other incentives could be offered such as refunding the cost of travel, and possibly some other financial compensation (especially if the participant would not be receiving any support benefits);
  • The researcher would need to consider the potential for the disclosure of illegal behaviours during the research process (and how this would be dealt with).

Attendees made the following points about this case study (points are not listed in order of importance – all points have equal merit):

  • It was noted that there are risks to the community itself, since the information provided by individuals could trigger an emotional response and result in violence/confrontations;
  • There are potential risks to the researcher, if the oral histories anger members of the community;
  • There are also potential risks to the data, depending on the outcomes of the critique by the community;
  • It was agreed that the community should have access to the oral histories in some form, but that care would need to be taken in the presentation and language used (e.g. non-inflammatory language); however this could also lead to a risk of the histories not being fully comprehensive;
  • The above risks would depend on the level of detail provided in the presentation of the data; it would be preferable for data to be generalised if possible rather than including individual responses;
  • It was noted that ‘who owns the oral history of the community’ was a difficult issue, as people are always going to see things from different perspectives.

/ / / Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session

Attendees made the following points about this case study (points are not listed in order of importance – all points have equal merit):

  • It was agreed that a waiver of parental permission should be granted in order to protect the participants;
  • Individual participants would need to be asked at the outset whether they had told their parents about their sexuality, in order to identify whether the centre’s perception of this is correct;
  • Data collected from the study would need to be anonymised – including participants’ names and the name of the centre, in order to protect participants;
  • Interviews should be tape recorded and participants should be interviewed individually;
  • Counselling/support for participants and researchers should be available;
  • The researcher should ensure that CRB checks are obtained and that the centre’s policies are complied with when carrying out the research.

Attendees made the following points about this case study (points are not listed in order of importance – all points have equal merit):

  • It was agreed that the project should not be approved in its current form;
  • This was because of: the personal relationship between the researcher and the participants; the unclear, potentially traumatic methodology; the difficulty of obtaining informed consent; the (undue?) burden that would be placed on participants; and the potential stigmatisation of participants; in general, the risks appear to outweigh the benefits;
  • The project should be re-designed, to involve other homes, and other carers, with which the researcher does not have a personal relationship;
  • The researcher should provide more information to justify and explain the methodology (e.g. can potentially intrusive methods be replaced with alternatives – such as the MRI scan);
  • It was noted that the method for informed consent would need to be considered carefully to ensure it was appropriate;
  • All the above may mean having to revisit the aims of the research.