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3.7 Research involving human participants, human material or personal data

3.7.1 Organisations and researchers should make sure that any research involving human participants, human material or personal data complies with all legal and ethical requirements and other applicable guidelines. Appropriate care should be taken when research projects involve: vulnerable groups, such as the very old, children or those with mental illness; and covert studies or other forms of research which do not involve full disclosure to participants. The dignity, rights, safety and wellbeing of participants must be the primary consideration in any research study. Research should be initiated and continued only if the anticipated benefits justify the risks involved.

3.7.2 When conducting, or collaborating in, research in other countries, organisations and researchers based in the UK should comply with the legal and ethical requirements existing in the UK and in the countries where the research is conducted. Similarly, organisations and researchers based abroad who participate in UKhosted research projects should comply with the legal and ethical requirements existing in the UK as well as those of their own country.

3.7.3 Organisations and researchers should ensure the confidentiality and security of: personal data relating to human participants in research; and human material involved in research projects.

3.7.4 Organisations and researchers working with, for, or under the auspices of, any of the UK Departments of Health and/or the National Health Service must adhere to all relevant guidelines, for example the Department of Health’s Research Governance Framework for Health and Social Care and the National Research Ethics Service’s Guidance for Applicants. Organisations and researchers involved in clinical trials on medicinal products for human use should comply with the principles of Good Clinical (Research) Practice.

3.7.5 Organisations should set up systems to ensure appropriate ethical, regulatory and peer review of research projects involving human participants, human material or personal data. The systems should include mechanisms to ensure that such research projects have been approved by all applicable bodies, ethical, regulatory or otherwise.

3.7.6 Organisations should also set up systems to ensure that appropriate procedures for obtaining informed consent are established and observed in projects involving human participants, having particular regard to the needs and capacity of the subjects involved.

3.7.7 Organisations should set up systems to ensure the confidentiality and security of: personal data relating to human participants in research; and human material involved in research projects.

3.7.8 Organisations should make sure that their researchers are aware of all of the above systems and have access to all relevant guidance and legal and ethical frameworks.

3.7.9 Researchers should submit research projects involving human participants, human material or personal data for review by all relevant ethics committees and abide by the outcome of those reviews. They should also ensure that such research projects have been approved by all applicable bodies, ethical, regulatory or otherwise.

3.7.10 Researchers on projects involving human subjects must satisfy themselves that participants are enabled, by the provision of adequate accurate information in an appropriate form through suitable procedures, to give informed consent, having particular regard to the needs and capacities of vulnerable groups, such as the very old, children and those with mental illness.

3.7.11 Researchers should inform research participants that data gathered during the course of research may be disseminated not only in a report but also in different forms for academic or other subsequent publications and meetings, albeit not in an identifiable form, unless previously agreed to, and subject to limitations imposed by legislation or any applicable bodies, ethical, regulatory or otherwise.

3.7.12 Researchers who are members of a regulated profession must ensure that research involving human participants, human material or personal data complies with any standards set by the body regulating their profession.

3.7.13 Researchers have a duty to publish the findings of all clinical research involving human participants. In addition, it is government policy to promote public access to information about any research and research findings affecting health and social care, including the principle that trials should appear on public registers. In this context “trials” means all comparative studies of health interventions, not just ones conducted in a clinical setting.

3.7.14 If researchers consider that human participants in research are subject to unreasonable risk or harm, they must report their concerns to their manager, or other appropriate person as identified by their organisation, and, where required, to the appropriate regulatory authority. Similarly, concerns relating to the improper and/or unlicensed use or storage of human material, or the improper use or storage of personal data, should be reported.

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