Ethics Guidance
PRINCIPLES OF SAFETY AND WELL-BEING
The University’s ‘Ethics Policy for Research Involving Human Participants, Data and
Tissue’, which this fact sheet complements, is at:
www.shef.ac.uk/researchoffice/gov_ethics_grp/ethics/system.html
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Protecting participants from harm
Researchers have a responsibility to protect participants from any harm arising from
research. As a general rule, people participating in research should not be exposed
to risks that are greater than or additional to those they encounter in their normal
lifestyles. If it is expected that harm, unusual discomfort or other negative
consequences might occur in the prospective participant’s future life, as a result of
participating, the Principal Investigator must, prior to the person’s participation,
obtain:
(i)
(ii)
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The disinterested approval of and informed consent of independent advisors
(e.g. from University Ethics Reviewers or, if appropriate, from an NHS
Research Ethics Committee) and
The informed consent of the prospective participant.
Informing participants about factors in the research that might create
risks to them if they participate in the research
Depending on the nature of the research, researchers have a responsibility to ask
participants about any factors in the research, such as pre-existing medical
conditions, that might create risks to them if they participate, and they must
subsequently be advised of any special action they should take to avoid risk.
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Informing participants of procedures for contacting the Principal
Investigator
Before participating, people should be informed of procedures for contacting the
Principal Investigator within a reasonable time period if, following participation, they
experience stress, harm or have related concerns.
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Discovering physical or psychological problems about participants
If during research a researcher obtains evidence of physical or psychological
problems of which a participant is apparently unaware, the researcher has a
responsibility to inform the participant if s/he believes that by not doing so the
participant’s future well being may be endangered. However, if the issue is serious
and the researcher is not qualified to offer assistance, then the appropriate source of
professional advice should be recommended to the participant. For some types of
research the giving of advice will be appropriate, intrinsic to the research, and will
have been agreed prior to the person’s participation, as part of the consent process.
The University of Sheffield, University Research Ethics Committee
Ethics Guidance
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Special considerations in respect of clinical trials
In the case of clinical trials, research should only take place where the foreseeable
potential risks and inconveniences to the prospective participants (trial subjects /
patients) are usually outweighed by the potential benefits for them and for future
patients. In certain cases a patient may explicitly support a research project and
support invasive treatment that may be very harmful if, due to the particular
circumstances (e.g. s/he is terminally ill), s/he feels that it is worth taking a significant,
potentially life-threatening risk. This example represents the point at which
participants may feel they have a right to participate as well as to withdraw, a right to
be harmed, in exceptional circumstances, as well as for harm to be prevented.
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Asking sensitive questions
In the case of non-invasive research methods such as interviews and questionnaires,
the content and line of questioning may be highly sensitive, raise confidential,
personal issues and intrude, or be perceived to intrude, upon a participant’s comfort
and privacy. The initial judgment on whether or not questions are sensitive and likely
to cause harm rests with a Principal Investigator. For advice the Principal Investigator
should initially consult the ethics administrator of his/her department if the project
does not involve the NHS and then, on the Principal Investigator’s behalf, the ethics
administrator will ask the department’s ethics reviewers for advice and feed this back.
If, however, the project involves the NHS then the Principal Investigator should seek
advice from the appropriate NHS Research Ethics Committee.
Article 8 of the Human Rights Act 1998 is entitled ‘RIGHT TO RESPECT FOR
PRIVATE AND FAMILY LIFE’. The Article states that:
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“Everyone has the right to respect for his private and family life, his home and his
correspondence;
There shall be no interference by a public authority with the exercise of this right
except such as in accordance with the law and is necessary in a democratic
society in the interests of national security, public safety or the economic wellbeing of the country, for the prevention of disorder or crime, for the protection of
health or morals, or for the protection of the rights and freedoms of others”.
Protecting researchers from harm
As well as protecting participants, researchers should also take steps to protect their
own safety and well-being and should familiarise themselves with appropriate codes
of practice and guidance produced by Safety Services: www.shef.ac.uk/safety/.
All researchers carrying out research work out of normal working hours should attend
an out-of-hours course, unless they have a current first-aid, nursing or medical
qualification. Annual fire-training is also required.
Where researchers are liaising with participants outside University premises, a prior
risk assessment may be useful. Before conducting such research, a researcher could
notify his/her line manager (in the case of a member of staff) or Supervisor (in the
case of a student) in writing stating where s/he is going, the anticipated length of time
s/he will be there, and a time at which s/he will report back to the designated place of
work. A person could be nominated to monitor the absence and to raise the alarm
should the researcher not report back or return at the notified time.
The University of Sheffield, University Research Ethics Committee
Ethics Guidance
If, due to the nature of the proposed research and in respect of qualitative research,
the researcher may be put in a situation where s/he runs the risk of being assaulted
then the researcher should:
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consider whether the interview is essential.
consider conducting the interview in a neutral place, rather than in the
interviewee’s home (if interviewees’ homes do have to be visited, this should take
place during daylight hours).
ensure that s/he is carrying a mobile telephone, that an emergency contact
number is available, that times have been pre-arranged for check-up calls, that
someone will be available to take these throughout the period of absence, and
that a procedure has been agreed in the event of something untoward occurring.
consider if personal accident insurance is necessary for fieldworkers and make
the necessary arrangements.
consider making some special provisions because of special circumstances such
as the fieldworker being accompanied by another person.
consider what should happen if the researcher is travelling by private transport,
and it breaks down.
As with all fieldwork, researchers should carry clear identification. Many particularly
vulnerable participants may be unaccustomed to dealing with visitors. If interviewing
particularly vulnerable participants in their homes, try to ensure the security of their
homes by reminding them to lock doors etc. (particularly where it may be expedient
for interviewers to see themselves out).
The University of Sheffield, University Research Ethics Committee