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							<p>The global codes of conduct and ethical principles for research involving human participants are implemented differently in different countries. This is due, in part, to the fact that governments fund and regulate research through different offices and programmes. Countries also have different concerns and priorities. For instance, different social and religious customs could translate into different ways of understanding and protecting privacy, or ensuring informed consent.</p>
							<p>Given the different ways in which human research participant protection policies are written, you must be familiar with:</p>
							
							<ul>
								<li>Your institutional policies</li>
								<li>Your national policies</li>
								<li>The policies of other countries in which you conduct research.</li>
							</ul>

							<p>This screen introduces the policies adhered to in the UK. If you plan to conduct research in another country, check with your institution's research office to get advice on how to gain access to their policies.</p>

							<h3>Policies for protecting human participants in research in the UK</h3>

							<interactive-text><p>The activity below sets out the key policies and processes concerned with research involving human participants in the UK. Please, however, note that national laws and policies have been designed to focus mostly on medical and clinical research, whereas research in other fields is more likely to be subject to local or professionally derived processes or codes of practice.</p></interactive-text>
							<accessible-text><p>The following activity sets out the key policies and processes concerned with research involving human participants in the UK. Please, however, note that national laws and policies have been designed to focus mostly on medical and clinical research, whereas research in other fields is more likely to be subject to local or professionally derived processes or codes of practice.</p></accessible-text>
							

							<instructional-text><p>Click on each question to access a discussion of the situation in the UK. For links to the documents referenced in this activity, see the "Useful links" pod.</p></instructional-text>

							<accessible-text><p>Continue on for an overview of the situation in the UK. For links to the documents referenced in this activity, see the "Useful links" pod.</p></accessible-text>

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								<acc-item>
									<acc-title>Review. How is research involving human participants reviewed in the UK?</acc-title>
									<acc-contents>
										<p>Most universities have policies on how research involving human participants should be reviewed, and well-established procedures that researchers must follow to apply for approval to conduct the research and seek a favourable opinion from their institutional or other research ethics committee (REC).</p>
										<p>Research conducted within, or in collaboration with, the NHS must be reviewed by Health Research Authority ethics committees. These committees must also review any non-NHS research that falls under the UK Policy Framework for Health and Social Care Research. Other government departments (e.g. the Ministry of Defence, HM Prison & Probation Service and Public Health England) have their own review requirements, and often ethics committees, as defined by their policies.</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Review criteria. What are the criteria used to determine which research projects must be reviewed?</acc-title>
									<acc-contents>
										<p>In general, if your research will involve human participants in any way, you should discuss your proposed project with a research support/governance officer at the earliest opportunity to determine the relevant review pathway (which could be either national or through local committees). In the first instance, they will want to know:</p>
										<ul>
											<li>What your research question/aim is</li>
											<li>Who your participant group is likely to be</li>
											<li>What your intervention/test/data collection will be</li>
											<li>Who your collaborators are.</li>
										</ul>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Final authority. Who has final authority to approve or reject projects that require review?</acc-title>
									<acc-contents>
										<p>Final authority for the approval of research rests with the research sponsor (i.e. the institution or company that has legal responsibility for the researcher and the conduct of the research). The research sponsor conducts and coordinates any governance review/checks and takes into account the opinion of a REC (if required) prior to providing approval for the research to proceed.</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Ending projects. Who is responsible for ensuring research involving human participants is conducted as approved and is ended properly?</acc-title>
									<acc-contents>
										<p>Once the research commences, the research sponsor, working with the research team, has further responsibilities to ensure that the research is conducted as planned, and that any necessary amendments are submitted to the relevant authorities (or RECs) for approval. It should be noted that RECs are unable to monitor research, and instead rely on the research sponsor and their governance processes to conduct this monitoring and inform the REC if any relevant issues arise (whereupon the REC may be forced to withdraw their favourable opinion if necessary).</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Training. Do researchers who conduct research involving human participants need to have special training?</acc-title>
									<acc-contents>
										<p>The 2019 UUK Concordat to Support Research Integrity states that institutions that adopt the Concordat should provide appropriate training for their researchers. In addition, certain types of research may have additional, legally required, training obligations/competencies (e.g. clinical registration if conducting certain procedures or operating medical scanning equipment).</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>National policies. Does the UK have national rules, regulations or guidance for conducting research involving human participants?</acc-title>
									<acc-contents>
										<p>It depends on the field of research. The UK Policy Framework for Health and Social Care Research, overseen by the Health Research Authority (HRA), outlines what reviews are required by law, and what governance processes should be in place, for specific kinds of research. This mainly applies to pharmaceutical and clinical research, which are more regulated than other fields of research.</p>
										<p>Researchers in all fields should be aware of any other legislation that applies to their research with human participants (for example, complying with the requirements of the General Data Protection Regulation and the Data Protection Act 2018 is important when protecting participants' data).</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Government policy. Does the UK have a common government policy for reviewing and approving research involving human participants?</acc-title>
									<acc-contents>
										<p>Only for projects that fall under the UK Policy Framework for Health and Social Care research, which must undergo a specific review process. The REC part of this review must be conducted by a committee that is recognised by the UK Ethics Committee Authority (UKECA)  as operating in accordance with the Department of Health's Governance Arrangements for Research Ethics Committees (<span aria-label="G A f R E C">GAfREC</span>).</p>
										<p>Fields that fall outside of the scope of the UK Policy Framework, but where research is conducted in collaboration with, or funded by, other government departments (e.g. Ministry of Defence, HM Prison & Probation Service and Public Health England), have their own policies for review and approval. The majority of all other research is not subject to a common government policy for its review, and local institutional review processes apply instead.</p>
									</acc-contents>
								</acc-item>
								<acc-item>
									<acc-title>Codes and principles. Does the UK have or follow a basic code of conduct or set of principles for conducting research involving human participants?</acc-title>
									<acc-contents>
										<p>Not solely in relation to research with human participants. However, the UUK Concordat to Support Research Integrity specifies a basic code of conduct that most organisations conducting any research endorse. In addition, professional organisations (e.g. the British Psychological Society, the Royal College of Nursing and the British Educational Research Association), as well as other discipline-specific organisations, may well have further codes of conduct/practice that their members must follow when conducting research involving human participants. Indeed, this is often a condition of their maintaining membership/professional registration.</p>
										<p>Finally, research funders such as charities, UK Research and Innovation funding councils and the EU may place specific review or reporting obligations on researchers as a condition of receiving research funding.</p>
									</acc-contents>
								</acc-item>
							</accordion>
							<!-- ACCESSIBLE START -->
							<accessible-block>
								<h4>Review. How is research involving human participants reviewed in the UK?</h4>
								<p>Most universities have policies on how research involving human participants should be reviewed, and well-established procedures that researchers must follow to apply for approval to conduct the research and seek a favourable opinion from their institutional or other research ethics committee (REC).</p>
								<p>Research conducted within, or in collaboration with, the NHS must be reviewed by Health Research Authority ethics committees. These committees must also review any non-NHS research that falls under the UK Policy Framework for Health and Social Care Research. Other government departments (e.g. the Ministry of Defence, HM Prison & Probation Service and Public Health England) have their own review requirements, and often ethics committees, as defined by their policies.</p>
								<hr>
								<h4>Review criteria. What are the criteria used to determine which research projects must be reviewed?</h4>
								<p>In general, if your research will involve human participants in any way, you should discuss your proposed project with a research support/governance officer at the earliest opportunity to determine the relevant review pathway (which could be either national or through local committees). In the first instance, they will want to know:</p>
								<ul>
									<li>What your research question/aim is</li>
									<li>Who your participant group is likely to be</li>
									<li>What your intervention/test/data collection will be</li>
									<li>Who your collaborators are.</li>
								</ul>
								<hr>
								<h4>Final authority. Who has final authority to approve or reject projects that require review?</h4>
								<p>Final authority for the approval of research rests with the research sponsor (i.e. the institution or company that has legal responsibility for the researcher and the conduct of the research). The research sponsor conducts and coordinates any governance review/checks and takes into account the opinion of a REC (if required) prior to providing approval for the research to proceed.</p>
								<hr>
								<h4>Ending projects. Who is responsible for ensuring research involving human participants is conducted as approved and is ended properly?</h4>
								<p>Once the research commences, the research sponsor, working with the research team, has further responsibilities to ensure that the research is conducted as planned, and that any necessary amendments are submitted to the relevant authorities (or RECs) for approval. It should be noted that RECs are unable to monitor research, and instead rely on the research sponsor and their governance processes to conduct this monitoring and inform the REC if any relevant issues arise (whereupon the REC may be forced to withdraw their favourable opinion if necessary).</p>
								<hr>
								<h4>Training. Do researchers who conduct research involving human participants need to have special training?</h4>
								<p>The 2019 UUK Concordat to Support Research Integrity states that institutions that adopt the Concordat should provide appropriate training for their researchers. In addition, certain types of research may have additional, legally required, training obligations/competencies (e.g. clinical registration if conducting certain procedures or operating medical scanning equipment).</p>
								<hr>
								<h4>National policies. Does the UK have national rules, regulations or guidance for conducting research involving human participants?</h4>
								<p>It depends on the field of research. The UK Policy Framework for Health and Social Care Research, overseen by the Health Research Authority (HRA), outlines what reviews are required by law, and what governance processes should be in place, for specific kinds of research. This mainly applies to pharmaceutical and clinical research, which are more regulated than other fields of research.</p>
								<p>Researchers in all fields should be aware of any other legislation that applies to their research with human participants (for example, complying with the requirements of the General Data Protection Regulation and the Data Protection Act 2018 is important when protecting participants' data).</p>
								<hr>
								<h4>Government policy. Does the UK have a common government policy for reviewing and approving research involving human participants?</h4>
								<p>Only for projects that fall under the UK Policy Framework for Health and Social Care research, which must undergo a specific review process. The REC part of this review must be conducted by a committee that is recognised by the UK Ethics Committee Authority (UKECA)  as operating in accordance with the Department of Health's Governance Arrangements for Research Ethics Committees (<span aria-label="G A f R E C">GAfREC</span>).</p>
								<p>Fields that fall outside of the scope of the UK Policy Framework, but where research is conducted in collaboration with, or funded by, other government departments (e.g. Ministry of Defence, HM Prison & Probation Service and Public Health England), have their own policies for review and approval. The majority of all other research is not subject to a common government policy for its review, and local institutional review processes apply instead.</p>
								<hr>
								<h4>Codes and principles. Does the UK have or follow a basic code of conduct or set of principles for conducting research involving human participants?</h4>
								<p>Not solely in relation to research with human participants. However, the UUK Concordat to Support Research Integrity specifies a basic code of conduct that most organisations conducting any research endorse. In addition, professional organisations (e.g. the British Psychological Society, the Royal College of Nursing and the British Educational Research Association), as well as other discipline-specific organisations, may well have further codes of conduct/practice that their members must follow when conducting research involving human participants. Indeed, this is often a condition of their maintaining membership/professional registration.</p>
								<p>Finally, research funders such as charities, UK Research and Innovation funding councils and the EU may place specific review or reporting obligations on researchers as a condition of receiving research funding.</p>
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								<pod-heading>Useful links</pod-heading> <!-- pod title -->
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								<pod-modal-heading>Useful links</pod-modal-heading>
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										<p><a href="https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/" target="_blank">UK Policy Framework for Health and Social Care Research</a></p>
										<p><a href="https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/governance-arrangement-research-ethics-committees/" target="_blank">Governance Arrangements for Research Ethics Committees</a></p>
										<p><a href="https://www.hra.nhs.uk/approvals-amendments/" target="_blank">Health Research Authority &ndash; Approvals and Amendments</a></p>
										<p><a href="https://www.gov.uk/government/groups/ministry-of-defence-research-ethics-committees" target="_blank">Ministry of Defence Research Ethics Committee</a></p>
										<p><a href="https://www.gov.uk/government/organisations/her-majestys-prison-and-probation-service/about/research" target="_blank">Research at HMPPS</a></p>
										<p><a href="https://www.universitiesuk.ac.uk/policy-and-analysis/reports/Documents/2019/the-concordat-to-support-research-integrity.pdf" target="_blank">UUK Concordat to Support Research Integrity</a></p>
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							<h3>Summary</h3>

							<p>The importance of the good conduct of research involving human participants is globally recognised and defined. How you get approval to conduct your research and ensure that it meets the various standards is established by your national and local policies, as well as the policies of any other countries in which you conduct your research.</p>
							<p>You are responsible for knowing and following these policies. For most research, this means submitting an application to a REC and getting governance approval to conduct your research. For both your own protection and the protection of your research participants, you must follow the proper procedures.</p>

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								<pod-heading>Your context</pod-heading> <!-- pod title -->
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								<pod-modal-heading>Your context</pod-modal-heading>
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									<p>Make sure to check your institution's policies to familiarise yourself with its rules and guidelines concerning conflicts of interest.</p>
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