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:
http://www.shef.ac.uk/ris/other/gov-ethics/researchethics/furtherguidance/educationresources/riskworkshop.html
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
Anticipating and Managing Risks
An ethics workshop for researchers
Question & Answer Session
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:
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session
[Scenarios have been adapted from the ‘Online Ethics Centre for Engineering and Research’ website
and the ‘Adapted from Ethics in Mental Health Research’ website]
1. Ethical Issues in Longitudinal Research with At-Risk Children and
Adolescents
Dr. Judy Brewster, long interested in the effects of exposure to maladaptive
environments on development, plans to design a study to examine resilience. Why
are some individuals able to fend off the deleterious consequences associated
with stressful environments and adverse circumstances, while others are not? What
characteristics are associated with adaptation to such environments? To learn
more about the characteristics associated with resilience to environmental insult,
Judy will study school-age teenagers who have been exposed to violence within
their communities.
Youths will be assessed at six-month intervals for a period of four years.
Assessments will be conducted in school through group-administered written
surveys and individual interviews of approximately one to two hours in length. The
amount and frequency of exposure to community violence will be measured, as
well as short- and long-term psychological (anxiety, depression, perception of
social support), behavioural (academic achievement, risk engagement) and
adaptational (psychological and behavioural coping) responses. Aside from
assessment interviews, participants will have no contact with the researcher.
Ms. Rosen, the principal of a comprehensive school, has agreed to allow her
school to participate in the study. She is eager to assist her students and suggests
that Judy begin at once. When Judy asks for advice on how to approach parents
for their permission, the principal says that it is not necessary, as the school
supports the study. Judy is unsure of how to respond.
Discussion Questions

What are Judy's responsibilities to the students, parents and Ms. Rosen, if
any?

Which of these responsibilities - if any - is the more important?

What are the potential consequences of not obtaining consent for the
students, parents, Ms. Rosen, and Judy, if any?

Given the risks, should Judy obtain parental consent?
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 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 revisited 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;
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session

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.
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session
2. The Alzheimer's Caregiver Study
You are the principal investigator for a study of the most effective respite or shortterm day care services for caregivers of persons with Alzheimer's Disease. The
study involves the use of three groups - two treatment, and one control.
One treatment group will consist of 4 hours of "day care" for the person with
Alzheimer’s Disease, five days per week. The second treatment group consists of
three 8-hour "day care" sessions per week for the person with Alzheimer’s
Disease, plus a support group for the caregiver. The control group will not have
access to either respite service, but will simply be interviewed every month for the
3 month period to measure stress and coping. Part of the data collection also
involves some baseline assessment of the person with Alzheimer’s Disease, using
mental status tests and obtaining information from medical records.
Discussion Questions

The people with Alzheimer’s Disease themselves are part of the research
group, since they are receiving an intervention and data is being collected
from them. What concern is there, if any, about using people with
Alzheimer’s Disease as subjects when they may receive no benefit and
may even be harmed (although minimally) by the "treatment"?

What are the potential risks of allowing the caregiver of the person with
Alzheimer’s Disease to give permission for the involvement of the person
with Alzheimer’s Disease, since the caregiver may be motivated by the
hope of gaining personal benefit (relief from burdens of care giving for the
duration of the study)? What could you do to eliminate those problems?

Given the special vulnerabilities of the people with Alzheimer’s Disease,
are there any additional concerns about offering incentives to participate?

What additional protections, if any, should be put in place for studies like
this that involve subjects unable to protect themselves?
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 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).
Anticipating and Managing Risks
An ethics workshop for researchers
3. Who owns a community’s oral history?Group Discussion Session
Dr. Jones wants to study the willingness of residents in an economically
disadvantaged, ethnically diverse community to use community mental health
services for any of their children who are engaging in extreme hostility and
violence at school. In focus groups and discussions with community members, Dr.
Jones learns that there is a high level of ethnic prejudice and that parents tend to
assume that their aggressive children are responding appropriately to the insults
and aggression of others.
Dr. Jones realizes that it would be unwise to study attitudes towards community
mental health programs for aggressive children without first understanding more
about how these attitudes developed. She decides to begin the project by getting
an oral history of the neighbourhood – how its demography developed, how it has
struggled with ethnic prejudice, how its youngsters have become involved in this
process, and what parents think should be done about the level of juvenile
violence. She calls on community leaders who are eager to participate in better
understanding and resolving these problems. Dr. Jones wants to operate
according to best principles of community-based research which include letting
the community define the problem, and seeking maximum inclusiveness within the
community in the research.
Once the first round of oral histories have been conducted with all of the people
who volunteer to participate, Dr. Jones plans to give the edited version back to the
entire community to critique. Although this may be tricky, it will enhance the
validity of the conclusions about the origin and nature of the problems and will
maximize the buy-in to the study by community members. In turn, the results of
the study would be used to shape an appropriate intervention program for the
community’s aggressive youths.
Discussion Questions

What are the issues of risk that are involved here?

A member of the ethics review committee objects that letting the whole
community read its history would violate individuals’ confidentiality and
cannot be permitted. Do you agree?

Are there particular recommendations you would make to ensure that this
procedure does not involve a breach of confidentiality?

Who should decide: the people whose life histories are at issue here, other
community members, or the ethics committee?
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 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
4. Waivers of Parental Permission for Research with Gay and Lesbian
Adolescents
Investigators propose a study to examine psychosocial stressors and the
prevalence of anxiety disorders and depression in adolescent gay and lesbian
adolescents. In order to obtain a large enough sample size, they plan to recruit
participants through a gay and lesbian community centre.
Centre staff members are enthusiastic about the project. However, they inform the
investigators that most of the students who come into the centre have not told
their parents about their sexual orientation. The researchers believe that getting
parental consent to participate in the study is not in the best interest of these
adolescents because notifying the parents of the purpose of the study might place
the child at risk for psychological or physical harm. Centre staff agree.
Discussion Questions

Would you grant a waiver of parental permission for this study?

How would you go about discovering whether or not the centre staff are
correct in their perception of the situation?

What other safeguards, if any, would you recommend?

Whose interests are most important here: the young people, the parents,
the centre’s, or the researchers?
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;
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session

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.
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session
5. Studying Vulnerable Individuals
Mark is a social worker who has worked for several years in a large group home
for people with learning disabilities who function comparatively well in society. He
is very good at his job and it shows through the hugs and high-fives he receives
while at work.
Mark has decided to pursue his doctorate degree in social work and has chosen a
PhD program that specializes in learning disabilities research. As an unofficial
condition of his admission into the prestigious program, Mark proposes an
ambitious dissertation to the director. Basing his study on previous research on
persons with schizophrenia, he seeks to study the tendency of violent/aggressive
behaviour in high functioning developmentally disabled individuals as a function
of their spatial brain activity and abuse history.
His participants will need to agree to a closed MRI scan and a record review of
past physical, mental, and/or sexual abuse. Mark realizes that it is a lot to ask of
any research participant, more so with a learning disabled individual. Recruitment
could be difficult but he is confident that he can achieve sufficient power in his
study, by drawing upon his client contacts at the group home. The clients are
eager to please Mark, and most wouldn’t dream of saying “no” to him. In cases
where a legally authorized representative is necessary, Mark has agreed to meet
with both the client and the surrogate decision maker to explain the details of the
study. Most of the surrogate decision makers are parents of the clients or the
group home administrators, who also like Mark as equally as the clients.
Mark and the university argue that although the participation is intensive, the
benefits of the study are great, as psychopharmacological and counselling
therapies could better treat violent behaviour in people with learning disabilities.
Mark submits his proposal for ethics review, including a comprehensive informed
consent form.
Attendees
made the following points about this case study (points are not listed
in order of importance – all points have equal merit):
Questions
 Discussion
It was agreed
that the project should not be approved in its current form;

As a member of the ethics committee reviewing this project, you learn of
Mark's affiliation with the group home. Do you approve the study?

Why or why not?

Are any other ethical concerns raised by this study?
Anticipating and Managing Risks
An ethics workshop for researchers
Group Discussion Session

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.