+44 (0) 20 3828 1325 No 1 Croydon, CR0 0XTPromoting good practice and preventing misconduct

3.4 Research design

3.4.1 When designing research projects, organisations and researchers should ensure that:

a) the proposed research addresses pertinent question(s) and is designed either to add to existing knowledge about the subject in question or to develop methods for research into it;

b) the design of the study is appropriate for the question(s) being asked and addresses the most important potential sources of bias;

c) the design and conduct of the study, including how data will be gathered, analysed and managed, are set out in detail in a prespecified research plan or protocol;

d) all necessary skills and experience will be available to carry out the proposed research, in the proposed research team or through collaboration with specialists in relevant fields;

e) sufficient resources will be available to carry out the proposed research and that these resources meet all relevant standards; and

f) any issues relating to the above are resolved as far as possible prior to the start of the research.

3.4.2 Organisations (where appropriate) and researchers should conduct a risk assessment of the planned study to determine:

a) whether there are any ethical issues and whether ethics review is required;

b) the potential for risks to the organisation, the research, or the health, safety and wellbeing of researchers and research participants; and

c) what legal requirements govern the research.

3.4.3 Where the design of a study has been approved by ethics, regulatory or peer review, organisations and researchers should ensure that any subsequent alterations to the design are subject to appropriate review to determine that they will not compromise the integrity of the research or any terms of consent previously given.

3.4.4 Organisations should set up systems to ensure that when there are risks that proposed research or its results may be misused for purposes that are illegal or harmful, those risks are identified and addressed. They should make these systems known to researchers and provide guidance and support to researchers on projects where such risks are identified.

3.4.5 Researchers should try to anticipate any risks that the proposed research might produce results that could be misused for purposes that are illegal or harmful. Researchers should report any risks to, and seek guidance from, the appropriate person(s) in their organisation and take action to minimise those risks.

3.4.6 Researchers should be prepared to make research designs available to peer reviewers and journal editors when submitting research reports for publication.

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