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							<p>Governments issue laws and regulations that cover some types of research when it is felt that self-regulation (in the form of the types of policies and guidelines covered on the "Professional responsibilities" screen) is not sufficient to protect researchers, research participants or the public's investment in research. Laws and regulations can apply to individuals and/or to institutions, and researchers must understand and comply with those that apply to their research.</p>  
							
							<h3>The scope of government laws and regulations</h3>
							
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							<p>Government laws and regulations usually address a specific problem or issue. Depending on where and how you conduct your research, you could be subject to laws and regulations concerning any of the following areas:</p>
							
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								<li>The involvement of human participants</li>
								<li>The use of animals </li>
								<li>The use of human tissue </li>
								<li>Research involving embryos</li>
								<li>Health and safety requirements </li>
								<li>Data sharing and protection policies </li>
								<li>Foreign research and import/export controls</li>
								<li>The copyright and ownership of government-funded research.</li>
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							<p>As a researcher, you must know which laws and regulations apply to your research and ensure they are followed; as part of this, you should ensure you are aware of any specific reporting or inspection requirements. Not knowing about a particular law or regulation could lead to a mistake that would end your time as a researcher. If the misstep is significant enough, it could even result in a fine or time in prison. For links to some of the key UK legislation relevant to research, see the "Useful links" pod.</p>
							
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										<p>A list of the main UK legislation that applies to research can be found in the appendix of the <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>However, this list is not complete and largely focuses on health-related disciplines. There may be other legislation applying to your field of research, which you will need to take account of.</p>
										<p>General legislation such as the <a href="http://www.legislation.gov.uk/ukpga/2018/12/contents/enacted" target="_blank">Data Protection Act 2018</a>, as well as common law duties (the laws that apply to almost all activities), also applies to research.</p>
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							<h3>How government laws and regulations function</h3>
							
							<p>Governments address issues relating to research in the same way they address any other issue. Typically, the process proceeds roughly as follows:</p>
							
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								<h4>Step 1 of 4: Public concern</h4>
								<p>A public interest group, a government official, the press, a business or someone else calls attention to an issue. If the government is interested in the issue, it may produce a consultation document called a 'green paper'.</p>
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								<h4>Step 2 of 4: Government action</h4>
								<p>Legislation is introduced into Parliament, often accompanied by public hearings and a 'white paper' setting out the proposed policy.</p>
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								<h4>Step 3 of 4: Government implementation</h4>
								<p>Once legislation is passed or other government action is approved, steps are taken to implement the law/policy.</p>
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								<h4>Step 4 of 4: Institutional compliance</h4>
								<p>Unless central government (commonly through a regulatory authority) assumes complete authority for a particular rule or regulation, some responsibility is usually passed down to the institutional level (and eventually the level of the individual researcher).</p>
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							<p>Through this process, public concerns are addressed and, when needed, resolved (for an example of how this process has been put into action in the UK, see the "Additional information" pod). Although this is a complex area and you can be held responsible if you break the law, almost all the relevant laws and regulations are interpreted and implemented through research institutions. This means that the best place to get advice on your public (i.e. regulatory) responsibilities is your local institutional research office or legal department.</p>
							
							<h3>Summary</h3>
							
							<p>The laws and regulations that apply to research can be complex, but help is available to understand them. Your institution and research supervisor are responsible for providing you with training, but you are still expected to know which laws and regulations apply to your research and when they will become relevant. Therefore, it is always best to be proactive and seek out any knowledge or support you require.</p>
							
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										<p>A case demonstrating the need for government legislation concerned with research is the <a href="https://www.theguardian.com/society/2001/jan/30/health.alderhey1" target="_blank">Alder Hey organ scandal</a>, which found that many thousands of tissue samples and organs had been removed from dead babies at Alder Hey Children's Hospital in Liverpool without their parents' informed consent.</p>
										<p>In response to the scandal, the UK Parliament passed the <a href="http://www.legislation.gov.uk/ukpga/2004/30/contents" target="_blank">Human Tissue Act in 2004</a>, in order to regulate the use of human bodies, organs and tissue in research.</p>
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