Ethics Policy
University Ethics Committee
Codes of Ethics for work with Human Subjects have been in existence since the World
Medical Association (Declaration of Helsinki 1985 and the World Health Organisation 1982).
The professional bodies of most academic disciplines in the United Kingdom, Europe, and
the United States, as well as many other countries have developed codes based on the
Declaration of Human Rights and in many cases on subsequent legislation.
There are specific European Directives on the movement of data and on clinical trials, which
follow the broad philosophy of human rights and make the work of the University Ethics
Committee essential. It is important that the University has a structure and a procedure that
will raise awareness of the importance of ethical principles and provide a method of scrutiny
and approval for all research in which human participants are involved.
There are some important common points in the codes of ethics that are available that should
inform the University in operating a procedure for ethical review.
1.
Investigators should not be the sole judges of whether their research does conform to
ethical requirements
Whilst the value of research to society is recognised in the codes of ethics it is
necessary to provide independent advice to participants, researchers, funders,
sponsors, employers, care organisations and professionals on the extent to which
proposals for research studies comply with recognised ethical standards.
The purpose of a Research Ethics Committee in reviewing the proposed study is to
protect the dignity, rights, safety and well-being of all actual or potential research
participants. Research Ethics Committees should provide independent, competent
and timely review of the ethics of proposed studies. Although operating within the
general framework of the University policy in their decision-making Committees need
to have independence from political, institutional, profession-related or market
influences.
The issues about the need for scrutiny of procedures and of human dignity apply not
only to experimental studies of behaviour (psychology) and of field and survey
studies of people (sociology, planning and management) but also to investigations
involving human tissue and body fluids (anatomy, physiology, organic chemistry,
biology and medical engineering).
2.
People who are subjects should be made clearly aware of their position and of the
nature of research in which they are being asked to take part
Consent needs to be obtained from the individuals being asked to participate in
research. It is not adequate to seek consent only from senior people in the
organisation.
EC/policy
2
Subjects should know that they are involved in research, although to ensure this can
sometimes be difficult.
Codes of ethics state that potential research subjects are entitled to choose whether or
not they will participate in research, obtaining valid (informed – understanding,
voluntary) consent. This is particularly important if the research involves clinical
investigation because individuals and organisations have legal liabilities. Consent is
equally important in all studies in which people are asked to take part.
There is no single preferred method of obtaining and recording consent that is
appropriate to all research, but Research Ethics Committees should decide whether
sufficient information has been provided for an adequately informed choice to be
possible.
Where it is proposed to withhold from subjects information that would be material to
a decision to participate, this should always be disclosed to an Ethics Committee.
Written consent protects subjects since it leaves no doubt that they were entering
research. It protects investigators in the event of there being any dispute. Written
consent does not reduce the rights of subjects.
3.
The objectives of research are directed to justifiable advancement in the discipline and
that the knowledge obtained is consonant with prevailing interests and priorities
This is a further expression of the rights of participants, as well as to the profession.
The intention is to avoid needless or inappropriate intervention and to promote a high
standard of interaction with the public.
4.
The responsible investigator must be appropriately qualified and experienced, and
have the appropriate facilities to ensure that all aspects of the work will be undertaken
with due discretion and precaution to protect the subjects
The issue is particularly important if the study involves a clinical intervention. It is
equally important if the study involves a survey questionnaire or a psychological test.
The principle that no harm should occur to research participants can only be upheld if
safe procedures are conducted by qualified researchers.
Special consideration needs to be given to student projects and to postgraduate
researchers. The onus is on supervisors to ensure that professional guidelines are
followed and are fully understood. Undergraduate and postgraduate students need to
be fully appraised of Codes of Ethics that apply. Many disciplines now ensure that
ethics are taught as part of the central curriculum.
5.
Adequate preliminary literature research has been undertaken to define, as far as
practical, the possible risks in participation
The advice here is to conduct a risk assessment and to inform the researcher of the
techniques. The literature review will also inform several of the requirements noted
above.
EC/policy
3
6.
Any arrangement to delegate consent has adequate justification, and appropriate
safeguards will be instituted to ensure the rights of subjects will in no way be abused
Although the principle has been articulated primarily in medical research contexts it
could also apply when studies involving children are concerned. It might also be a
consideration when supervised research is undertaken.
7.
Appropriate measures will be adopted to ensure confidentiality of data generated in
the course of research
This principle not only applies to data transmitted electronically but also to data
obtained through questionnaire and interviews conducted face-to-face or by
telephone.
8.
Every effort will be made to ensure that subjects have an opportunity to comment on
and, if they wish, to withdraw easily and without penalty from the investigation
This principle not only extends informed consent it places researcher and participant
on a more equal footing. It may be particularly important to guard this principle when
there is a power difference between subjects and participants, as could occur in
organisational studies, but also when a questionnaire (for example) might include
items that could be seen to raise emotionally difficult issues, or of those concerned
with matters that may be regarded as being private.
9.
Particular care to ensure that the rights of participants from different ethnic
backgrounds, children, women, people with learning disabilities are fully recognised
is taken
Legislation applies in many cases and has to be followed in full. Working with
children may require particular care.
It is important to be continuously aware of the need to avoid impeding good research indeed
an Ethics Committee seeks to facilitate good research. It is often the case in the behavioural
and social science that unethical procedures are poor methodologically and that improving
the procedure from an ethical position improves methodology as well as the interaction with
subjects. The same may apply to all other areas of research.
It is not likely that an ethics committee will be able to provide a full scientific evaluation.
Where a Committee is doubtful about the scientific quality and/or risk evaluation it should
tell the applicant to obtain expert advice, and the Committee may assist in the advice giving
process.
In research with human subjects there are two major classes of work:
i)
which involves observations without any direct interference with the subject (nonintrusive or non-invasive) such as research involving the use of records. There are
issues of permissions, confidentiality and feedback that require ethical scrutiny.
ii)
which involves interference with the subject (psychological intrusion, including
intrusion on privacy, or physical invasion). The interference raises ethical issues
which may be sometimes very large or very small; both should be subject to ethical
review.
EC/policy
4
The University Research Ethics Committee comprises research directors, or their substitutes,
from each School plus independent members who are not University staff. The University
Secretary, the Deputy Principal for Research and Knowledge Exchange, and a senior member
of staff from Technology and Research Services are also on the Committee.
In addition to a University Committee that includes ‘lay’ members, each School has set up its
own Ethics Committee to review proposals. Membership needs to reflect the diversity of
interests in the School, so that informed discussion may take place. School committees are
ideally small so that quick decisions can be made. They report to the University Committee,
which adjudicates on any matters that the School Committee cannot resolve, and audits the
operation of School ethical approval procedures at regular intervals. Schools should
normally handle student project scrutiny but report all these projects to the University Ethics
Committee. Schools should maintain a file on applications so that they are available to be
called on by the University Committee. It is important that the University can audit the
research scrutiny procedure in each School through PME and can respond to any enquiry
about its research activities in general as well as in specific cases.
The Committee reports to the Research and Knowledge Exchange Board on a regular basis,
at least twice per year.
The University has adopted Code of Ethical Practice for Research with Human Subjects,
based on the points made above. The Code will be developed as practice determines.
Schools follow this general policy but have some local variations to suit their research
programmes.
Suggested format for applications to Research Ethics Committees
School Ethics Committees use standard forms for applications. These are based on a
University standard approved by the Research Ethics Committee, but may include further
sections related to local requirements. The following points indicate the information that
should be included in an application.
i)
ii)
iii)
iv)
v)
vi)
vii)
viii)
ix)
x)
xi)
State the title of the proposed project.
State the question to be answered and the value of answering it.
Give an outline of the proposed project, including the procedures to be used, the
measurements to be made and how the data will be analysed.
Specify the type of subjects who will be involved, how they will be recruited, whether
they are in a dependent relationship with the investigator, eg student, or whether
especially vulnerable, eg children, people with learning disabilities etc.
State the likely duration of the project and the premises in which it will be undertaken.
State the potential hazards to subjects, if any, their estimated probability (if possible)
and the precautions to be taken to meet them.
State the procedures which may cause discomfort or distress to subjects and the
degree of discomfort or distress entailed, and their estimated probability.
State the personal experience of the applicant in the field of investigation concerned.
State the manner in which the subjects’ consent will be obtained.
State whether the subject’s general practitioner is to be informed of the recruitment of
the subject before the study begins, and whether the subject’s consent to such
information being passed on is a condition of participation.
Attach any other relevant matter: for instance, letters or information sheets to subjects
(which must be in simple, non-technical language), payments to subjects, copies of
advertisements or any other recruiting matter for healthy or patient volunteers etc.
EC/policy
5
xii)
xiii)
xiv)
If the project is designed to test a drug or appliance, state its exact regulator status.
State any ‘interest’, ie of profit, personal or departmental, financial or otherwise,
relating to the study.
Testing Medicines – Is the study sponsored by an industrial company? What
arrangements, if any, for compensation in the event of injury to subjects (where there
is neither fault, nor strict liability under the Consumer Protection Act, have been
made?
The ethical codes for a number of professional bodies, as well as the codes for clinical
governance applying to clinical trials, have been consulted in developing the University
Ethics policy. It is clear that awareness of ethical issues is an essential feature of the
practices of all researchers and that staff should be fully conversant with the requirements of
the University Research Ethics Committee. The Chair of the Research Ethics Committee is
happy to assist researchers if they require advice.
May 2011
EC/policy