<!DOCTYPE html>

<!--
 * Project   : Research Integrity (RI_INT)
 * Version   : 2.0.0
 * Release   : Fri Apr 24 2020 11:39:36 GMT+0100 (British Summer Time)
 * Copyright : Oxford University Press / Epigeum
-->

<html data-programme="Research Integrity" data-course="Research Involving Human Participants">

	<head>
		<title>Review and approval</title>
		<meta charset="UTF-8">
		<meta http-equiv="X-UA-Compatible" content="IE=edge">
		<meta name="viewport" content="width=device-width, initial-scale=1">

		<link rel="stylesheet" type="text/css" href="../css/project.min.css">
		<link id="basic-print" rel="stylesheet" type="text/css" href="../css/print.min.css" disabled>
		<link id="summary-print" rel="stylesheet" type="text/css" href="../css/print_interactive.min.css">
		<style>table, th, td { padding: 5px; } table {margin-top: 15px;}</style>
	<script type="text/javascript" src="../scripts_scorm_12/SCORM_12_APIWrapper.js"></script>
<script type="text/javascript" src="../scripts_scorm_12/courseFunctions.js"></script>
</head>

	<body onLoad="javascript:Initialize();" onUnload="javascript:Terminate();">
	  
		<div id="app" v-cloak>
			<base-container
				screen-id="hsp_1_30"
				current-module = "Research Involving Human Participants"
				page-title = "Review and approval"
				screen-time = "4"
				screen-time-period = "mins">

				<page-container>

					<page-row>
						<page-content-main>
							
							<p>Researchers who do not properly protect their research participants often fail to recognise what they are doing as wrong. Their interest in advancing their research clouds their judgement when it comes to the impact on their participants. For this reason, research that poses a risk to participants must be reviewed by  <glossary content="Review committees for research involving human participants are called institutional review boards (IRBs) in the United States. In the UK and many other nations, independent 'research ethics committees' (RECs) are used to review the ethics aspects of projects. In these nations, governance issues tend to be reviewed by specialist research officers or other committees." placement="bottom">independent committees</glossary>.</p>

							<h3>Review processes</h3>

							<p>In the UK and most of Europe, a two-stage review process is used. This encompasses a governance review and a research ethics committee (REC) review:</p>

							<instructional-text class="hide-in-mobile"><p>Click on each of the terms for descriptions of the two different facets of the review process.</p></instructional-text>

						</page-content-main>
					</page-row>

					<page-row>
						<page-content-main>

							<accessible-text class="show-in-mobile"><p>Continue on for descriptions of the two different facets of the review process.</p></accessible-text>

							<!-- ACTIVITY START -->
							<labelled-text show-in-accessible-version="false" class="hide-in-mobile">
								<p><text-label placement="top" content="<p>This review, or series of processes, is conducted by the <strong>organisation employing the researchers and providing facilities for the research</strong> (this is often a university or company, sometimes referred to as the 'research sponsor'). Before receiving permission to conduct any project, researchers need to work with their institution to ensure that their project is justified; suitably financially costed; and meets all legal, practical and safety considerations.</p><p>The desired outcome of the governance review/process is <strong>approval to conduct the research</strong>, but this approval is almost always contingent upon gaining a favourable opinion from a REC (for further discussion of this, see the &ldquo;Additional information&rdquo; pod).">Governance reviews and processes</text-label></p>
								<p><text-label placement="top" content="<p>The REC review is primarily focused on whether the proposed research addresses ethical principles (often represented by autonomy, beneficence, non-maleficence and justice). It is conducted by an independent committee (i.e. independent of the research team, or sometimes even the sponsor) consisting of a mix of academics and lay members.</p><p>The outcome of a REC review is <strong>an 'opinion' as to whether the research, if conducted in accordance with the protocol submitted to the committee, can be considered ethical</strong> (i.e. consistent with the committee's understanding of current ethical norms).</p>" placement="bottom">Research ethics committee (REC) reviews</text-label></p>
							</labelled-text>
							<!-- ACCESSIBLE START -->
							<accessible-block class="show-in-mobile">
								<h4>Governance reviews and processes</h4>
								<p>This review, or series of processes, is conducted by the <strong>organisation employing the researchers and providing facilities for the research </strong>(this is often a university or company, sometimes referred to as the 'research sponsor'). Before receiving permission to conduct any project, researchers need to work with their institution to ensure that their project is justified; suitably financially costed and meets all legal, practical and safety considerations.</p>
								<p>The desired outcome of the governance review/process is <strong>approval to conduct the research</strong>, but this approval is almost always contingent upon gaining a favourable opinion from a REC (for further discussion of this, see the "Additional information" pod).</p>
								<hr>
								<h4>Research ethics committee (REC) reviews</h4>
								<p>The REC review is primarily focused on whether the proposed research addresses ethical principles (often represented by autonomy, beneficence, non-maleficence and justice). It is conducted by an independent committee (i.e. independent of the research team, or sometimes even the sponsor) consisting of a mix of academics and lay members.</p>
								<p>The outcome of a REC review is <strong>an 'opinion' as to whether the research, if conducted in accordance with the protocol submitted to the committee, can be considered ethical</strong> (i.e. consistent with the committee's understanding of current ethical norms).)</p>
							</accessible-block>
							<!-- ACCESSIBLE END -->
							<!-- ACTIVITY END -->
							
						</page-content-main>
						
						<page-content-sidebar>
							
							<!-- ADDITIONAL INFORMATION START -->
							<pod variant="b" has-modal="true">
								<pod-heading>Additional information</pod-heading> <!-- pod title -->
								<pod-content></pod-content>
								<!-- pop-up pod content -->
								<pod-modal-heading>Additional information</pod-modal-heading>
								<pod-modal-content>
									<hosted-link id="RI_INT_hsp_1_30">
										<h4>Responsibility for approving research</h4>
										<p>As RECs are considered to provide an independent opinion on a piece of research, they do not have the legal authority to approve a piece of research. Instead, this authority comes from the sponsoring institution or company (see Kolstoe and Carpenter, 2019). Apart from clinical trials (and a couple of other specialist research areas) where a favourable opinion from a REC is required by law, technically a sponsor can approve research without a REC opinion, but doing so puts the sponsor (and researcher) at significant reputational risk, often invalidates insurance policies, and will prevent the results of the research being accepted into academic journals. In practice, a favourable REC opinion is usually a condition of sponsorship at UK universities.</p>
										<h4>Protocols vs research plans</h4>
										<p>Research involving human participants that requires governance or REC review must have a formalised protocol. A protocol is more extensive, detailed and systematic than a research plan, and must contain details on all aspects of the research study, from participant identification through to data analysis and dissemination. The <a href="https://www.spirit-statement.org/" target="_blank">SPIRIT Statement</a> has been created specifically to help researchers designing protocols that involve human participants. Be aware that a formal protocol is often required in addition to any application form required by a REC or governance review.</p>
									</hosted-link>
								</pod-modal-content>
							</pod>
							<!-- ADDITIONAL INFORMATION END -->
							
						</page-content-sidebar>
					</page-row>

					<page-row>
						<page-content-main>

							<h3>How will your research be reviewed?</h3>

							<p>To determine the appropriate reviews needed for your project, you will need to contact your research support office and describe your project to them (you may be asked to fill out an application form or submit your protocol). They will then tell you if they are happy for you to conduct the research (in technical terms, becoming the '<glossary content="The institution or company that has legal responsibility for the researcher and the conduct of the research.">research sponsor</glossary>') and help you to determine what subsequent reviews or permissions are required.</p>
							
							<interactive-text><p>Some projects may be relatively straightforward with few risks, potentially making them exempt from a full REC committee review and meaning they only require a relatively light-touch governance review (in the form of gaining permission from heads of department, health and safety officers, etc.). (For more on potential exemptions, see the activity below.)</p></interactive-text>
							<accessible-text><p>Some projects may be relatively straightforward with few risks, potentially making them exempt from a full REC committee review and meaning they only require a relatively light-touch governance review (in the form of gaining permission from heads of department, health and safety officers, etc.). (For more on potential exemptions, see the following activity.)</p></accessible-text>
							
							<p>What questions will a research sponsor/institution ask when made aware of your project? At the very least, they will be interested in your answers to the following four questions:</p>

							<instructional-text><p>Consider each question, and then click the "Click to view more" button to read our thoughts on how each question should be approached. Use the "Next" and "Back" buttons to move between the different questions.</p></instructional-text>

						</page-content-main>
					</page-row>

					<page-row>
						<page-content-main>

							<instructional-text-accessible><p>Consider each question, and then continue on for our thoughts on how each question should be approached. Then proceed to the next question.</p></instructional-text-accessible>

							<!-- ACTIVITY START -->
							<process variant="ctvm" show-in-accessible-version="false">
								<process-page>
									<ctvm>
										<ctvm-question><p>Is the study research?</p></ctvm-question>
										<ctvm-feedback>
											<p>The goal of research is usually to produce generalisable knowledge. If you hope to learn something from a study of one group of participants that can be applied more broadly, you are conducting research. To ensure that the research has been properly conducted, it normally undergoes a governance review and an independent ethics review.</p>
											<p>Not all studies that involve human participants are research. If your goal is to learn about a system that includes humans, such as a healthcare system or an industrial workplace, you might be conducting a service evaluation/quality improvement study or audit (refer to the "Additional information" pod for definitions of these terms). Such projects may be exempt from some types of review (e.g. the REC review). If you believe you are conducting this type of study and not research, you should check with your sponsor/governance officer, who will help you to make this decision. Sometimes, the relevant REC can be approached and asked whether they need to review the project.</p>
										</ctvm-feedback>
									</ctvm>
								</process-page>
								<process-page>
									<ctvm>
										<ctvm-question><p>Are the humans in the study identifiable?</p></ctvm-question>
										<ctvm-feedback>
											<p>Studies involving human participants generally collect some identifiable information and involve a level of interaction with the participants. When identifiable information is collected, studies are usually subject to REC review since identifiable information must be protected and participants will often need to provide their consent to participate in the research.</p>
											<p>If the information you are collecting is entirely anonymous, cannot be linked to individuals, and the research is unlikely to cause harm it <strong><em>could</em></strong> be exempt from some types of review. Again, you should check with your sponsor/governance officer, who will help you make this decision. Be aware that different institutions/sponsors may have different policies on what is or isn't exempt.</p>
										</ctvm-feedback>
									</ctvm>
								</process-page>
								<process-page>
									<ctvm>
										<ctvm-question><p>Does the research pose risks?</p></ctvm-question>
										<ctvm-feedback>
											<p>If there are potential risks to research participants, or others, a REC review will almost always be required. The main reason for a REC review is to protect participants from risk, although RECs will often also review projects that have other types of risks (e.g. to researchers, institutions (often reputational), the economy, the environment). Unfortunately, the interest researchers have in conducting their research could cloud their judgement about risk. For example, a researcher might reason (incorrectly!) that:</p>
											<ul>
												<li>"My journalist colleagues ask these questions all the time without getting permission. Surely I can ask the same questions without getting permission? These are not risky questions."</li>
												<li>"I collect this information from patients as part of their routine medical check-up. Using the information in a research study doesn't add any risk. My patients might even benefit if I discover something useful."</li>
											</ul>
											<p>Because researchers have conflicts that can cloud their judgement, decisions regarding acceptability and the processes that should be put in place to mitigate risks must be made by an independent REC.</p>
											<p>In some cases, low- or no-risk research may not require a full REC review or could be eligible for a quick review. If you believe your research falls into this category, you should discuss this with your sponsor/governance officer.</p>
										</ctvm-feedback>
									</ctvm>
								</process-page>
								<process-page>
									<ctvm>
										<ctvm-question><p>Are there any laws or policies that require your research to be reviewed?</p></ctvm-question>
										<ctvm-feedback>
											<p>The UK Policy Framework for Health and Social Care Research outlines the legal requirements for governance and REC reviews of research that falls under the Clinical Trial Regulations 2020, the Human Tissue Act 2004 or the Mental Capacity Act 2005 (and a number of other more minor pieces of legislation).</p>
											<p>Although governance reviews of such work are still carried out by the sponsoring organisations (i.e. universities, hospitals or companies), there may be additional review requirements from national bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), or RECs coordinated by the Health Research Authority (HRA).</p>
											<p>If your work is outside the scope of the UK Policy Framework, you will find that your institution or sponsor has specific requirements for how research involving human participants must be reviewed. It is your responsibility to contact your research support office to determine these requirements.</p>
										</ctvm-feedback>
									</ctvm>
								</process-page>
							</process>
							<!-- ACCESSIBLE START -->
							<accessible-block>
								<h4>Question 1 of 4:</h4>
								<p>Is the study research?</p>
								<h4>Feedback:</h4>
								<p>The goal of research is usually to produce generalisable knowledge. If you hope to learn something from a study of one group of participants that can be applied more broadly, you are conducting research. To ensure that the research has been properly conducted, it normally undergoes a governance review and an independent ethics review.</p>
								<p>Not all studies that involve human participants are research. If your goal is to learn about a system that includes humans, such as a healthcare system or an industrial workplace, you might be conducting a service evaluation/quality improvement study or audit (refer to the "Additional information" pod for definitions of these terms). Such projects may be exempt from some types of review (e.g. the REC review). If you believe you are conducting this type of study and not research, you should check with your sponsor/governance officer, who will help you to make this decision. Sometimes, the relevant REC can be approached and asked whether they need to review the project.</p>
								<hr>
								<h4>Question 2 of 4:</h4>
								<p>Are the humans in the study identifiable?</p>
								<h4>Feedback:</h4>
								<p>Studies involving human participants generally collect some identifiable information and involve a level of interaction with the participants. When identifiable information is collected, studies are usually subject to REC review since identifiable information must be protected and participants will often need to provide their consent to participate in the research.</p>
								<p>If the information you are collecting is entirely anonymous, cannot be linked to individuals, and the research is unlikely to cause harm it <strong><em>could</em></strong> be exempt from some types of review. Again, you should check with your sponsor/governance officer, who will help you make this decision. Be aware that different institutions/sponsors may have different policies on what is or isn't exempt.</p>
								<hr>
								<h4>Question 3 of 4:</h4>
								<p>Does the research pose risks?</p>
								<h4>Feedback:</h4>
								<p>If there are potential risks to research participants, or others, a REC review will almost always be required. The main reason for a REC review is to protect participants from risk, although RECs will often also review projects that have other types of risks (e.g. to researchers, institutions (often reputational), the economy, the environment). Unfortunately, the interest researchers have in conducting their research could cloud their judgement about risk. For example, a researcher might reason (incorrectly!) that:</p>
								<ul>
									<li>"My journalist colleagues ask these questions all the time without getting permission. Surely I can ask the same questions without getting permission? These are not risky questions."</li>
									<li>"I collect this information from patients as part of their routine medical check-up. Using the information in a research study doesn't add any risk. My patients might even benefit if I discover something useful."</li>
								</ul>
								<p>Because researchers have conflicts that can cloud their judgement, decisions regarding acceptability and the processes that should be put in place to mitigate risks must be made by an independent REC.</p>
								<p>In some cases, low- or no-risk research may not require a full REC review or could be eligible for a quick review. If you believe your research falls into this category, you should discuss this with your sponsor/governance officer.</p>
								<hr>
								<h4>Question 4 of 4:</h4>
								<p>Are there any laws or policies that require your research to be reviewed?</p>
								<h4>Feedback:</h4>
								<p>The UK Policy Framework for Health and Social Care Research outlines the legal requirements for governance and REC reviews of research that falls under the Clinical Trial Regulations 2020, the Human Tissue Act 2004 or the Mental Capacity Act 2005 (and a number of other more minor pieces of legislation).</p>
								<p>Although governance reviews of such work are still carried out by the sponsoring organisations (i.e. universities, hospitals or companies), there may be additional review requirements from national bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA), or RECs coordinated by the Health Research Authority (HRA).</p>
								<p>If your work is outside the scope of the UK Policy Framework, you will find that your institution or sponsor has specific requirements for how research involving human participants must be reviewed. It is your responsibility to contact your research support office to determine these requirements.</p>
								<hr>
							</accessible-block>
							<!-- ACCESSIBLE END -->
							<!-- ACTIVITY END -->

						</page-content-main>
						
						<page-content-sidebar>
							
							<!-- ADDITIONAL INFORMATION START -->
							<pod variant="b" has-modal="true">
								<pod-heading>Additional information</pod-heading> <!-- pod title -->
								<pod-content></pod-content>
								<!-- pop-up pod content -->
								<pod-modal-heading>Additional information</pod-modal-heading>
								<pod-modal-content>
									<p><strong>Service evaluation/quality improvement study:</strong> An in-house study designed to determine the effectiveness of a current practice or activity. These are often designed to help an organisation operate more efficiently or effectively and are entirely observational. They are not designed to produce generalisable knowledge, although the results can often be published as a case study.</p>
									<p><strong>Audit:</strong> An audit compares an existing practice or activity with a 'gold standard'. Importantly, the practices/activities being compared must already be happening regardless of whether the proposed study occurs &ndash; therefore, an audit is entirely observational (i.e. no intervention occurs).</p>
								</pod-modal-content>
							</pod>
							<!-- ADDITIONAL INFORMATION END -->
							
						</page-content-sidebar>
					</page-row>

					<page-row>
						<page-content-main>

							<p>Determining the most appropriate review process for research involving human participants can be a complex process. Most organisations conducting research will have experienced research officers who can help you by acting as your 'research sponsor', guiding you through the process.</p>

							<h3>Summary</h3>

							<p>When you consider whether your research needs to be reviewed, you should remember that decisions about the regulation and the ethical conduct of research involving human participants rest with institutional governance officers (acting as research sponsors) and RECs, not the researcher(s) conducting the research. Your responsibility, as the researcher, is to provide detailed and balanced information, and then act on recommendations and/or requirements.</p>
							<p>If you make decisions about the need for review on your own, you are personally responsible for the consequences (for example, most institutional insurance policies do not cover research that has not been reviewed appropriately). For some types of research, you could find yourself subject to criminal investigation if you do not follow the appropriate review process. Furthermore, you may also find that journals or other academic publishers will not accept your work if you have not engaged with appropriate review processes.</p>

						</page-content-main>
					</page-row>
					
				</page-container>
			</base-container>
		</div> <!-- END content wrapper -->
		
		<!-- scripts -->
		<script src="../js/vendor.min.js"></script>
		<script src="../js/vue-components.min.js"></script>
		<script>
			new Vue({
			  el: "#app",
			  data: {},
			  mounted: function () {
				var core = document.createElement('script');
				core.src = "../js/core.min.js";
				document.getElementsByTagName('head')[0].appendChild(core);

				var project = document.createElement('script');
				project.src = "../js/project.min.js";
				document.getElementsByTagName('head')[0].appendChild(project);
			  }
			});
		</script>

	</body>
</html>