Code of Human Research Ethics (2014)
Code of Human Research Ethics (2014)
Code of Human Research Ethics (2014)
Assessment of risk
A prior assessment of potential risks should inform the preparation
of the information to be given to potential participants and the
procedures for seeking consent. This assessment should be used to
determine the appropriate form of consent and the nature of any
risk management required. When in exceptional circumstances
harm, unusual discomfort, or other negative consequences for the
individuals future life might occur, the investigator must inform the
participants clearly of these additional risks prior to consent. For all
research where risks are present, secure liability insurance should be
in place to adequately cover the levels of possible harm identified in
the risk analysis.
Informing participants
Giving potential participants sufficient information about the
research in an understandable form requires careful drafting of the
information sheet. It is recommended that at least one pilot test of
the processes for informing and debriefing participants be carried
out with a nave person having a literacy level at the lower end of the
range expected in the planned research sample.
In certain circumstances the aims of the research may be
compromised by giving full information prior to data collection.
In such cases, it should be made clear that this is the case in the
information sheet and the means by which the withheld information
will be given at the conclusion of data collection should be specified.
The amount of information withheld and the delay in disclosing the
withheld information should be kept to the absolute minimum
necessary.
The information sheet given to potential participants for them to
keep should normally offer a clear statement of all those aspects of
the research that are relevant for their decision about whether or not
to agree to participation. The following list offers a series of headings
for consideration. Not all of these will be relevant in specific cases.
n The aim(s) of the project.
n The type(s) of data to be collected.
n The method(s) of collecting data.
n Confidentiality and anonymity conditions associated with the data
including any exceptions to confidentiality, for example, with
respect to potential disclosures.
n Compliance with the Data Protection Act and Freedom of
Information Act.
Competence
The ethics review process should be conducted by a competent body.
Value statement: This second principle addresses the need for
research protocols to be properly evaluated by reviewers with
Facilitation
The review process should facilitate the understanding and
implementation of ethical practices.
Value statement: In addition to the core duty of responding to
applications for ethics review with constructive responses, this
principle invokes a responsibility to educate, inform and support
researchers in the development of their research protocols. RECs
should be responsive and avoid delaying valuable research.
9.5 Monitoring
All research organisations should establish appropriate procedures to
monitor the conduct of research which has received ethics approval
until it is completed, and to ensure continuing review where the
research design anticipates possible changes over time that might
need to be addressed. Monitoring should be proportionate to the
nature and degree of risk associated with the research. It should
include consideration of best-practice procedures for the secure
holding and preservation (or destruction where appropriate)
of the data.
Where a REC considers that a monitoring report raises significant
concerns about the ethical conduct of the study, it should request a
full and detailed account of the research for full ethics review.
Where it is judged that a study is being conducted in a way that is
unethical, it should consider the withdrawal of its approval and
require that the research should be suspended or discontinued.
10.1.1 Children
If the vulnerable person is unable to give informed consent, consent
should be sought from those persons who are legally responsible or
appointed to give consent on behalf of persons not competent to
Scientific integrity
Where a research proposal is submitted for work intended to
contribute to the scientific literature, one aspect of ethics approval
concerns the quality of the study (see earlier Section 2.2 on Scientific
integrity) and whether participation, which occupies participants
time, is warranted by its import and value. To avoid unnecessary
replication, some ethics review procedures require a proposer to
confirm that they have conducted an exhaustive literature search to
ensure that the proposed project has not been conducted previously
elsewhere and that the development of new methods is not being
proposed where properly validated methods already exist to
adequately address the research question. Although ethics review is
primarily aimed at avoiding harm to participants, assessing the
quality of a research exercise is also important. For example, an
ethics assessor might detect a major design flaw, or believe that the
exercise is so trivial as to be worthless. There may be occasions where
allowing minor design flaws or other deviations from best scientific
practice to be experienced can fulfil a valuable educational function.
In such cases students should be made aware that this is the case.
Clearly, where students test each other in class, such issues are of
little consequence, since much can be learned by the student
trainee, and participants, from the conduct of a flawed experiment.
The flaw should be pointed out to the student in the course of
conventional feedback from tutors rather than via an ethics refusal.
Where, for a more substantial piece of scientific work, an ethics