<!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>Continuing responsibilities</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">
	<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_70"
				current-module = "Research Involving Human Participants"
				page-title = "Continuing responsibilities"
				screen-time = "3"
				screen-time-period = "mins">

				<page-container>

					<page-row>
						<page-content-main>
							
							<p>Once a REC's favourable opinion has been gained, and governance/institutional approval obtained, researchers and sponsoring organisations have a number of continuing responsibilities to meet.</p>
							
							<h3>Continuing responsibilities</h3>
							
							<p>For the most part, the continuing responsibilities researchers have should be obvious and agreed to during the approval process. However, some continuing responsibilities are less straightforward.</p>
							
							<instructional-text activity-element="pyramid"><p>Click through the steps one by one to find out more information about what researchers should do after getting approval.</p></instructional-text>
							<instructional-text-mobile activity-element="pyramid"><p>Work through the steps one by one to find out more information about what researchers should do after getting approval.</p></instructional-text-mobile>
							<accessible-text><p>Continue on to find out more information about what researchers should do after getting approval.</p></accessible-text>

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

					<page-row>
						<page-content-wide>

							<!-- ACTIVITY START -->
							<ladder start-from="top" class="hide-in-mobile">
								<ladder-step>
									<ladder-label>Complete the approval process</ladder-label>
									<ladder-number>1</ladder-number>
									<ladder-feedback>
										<p>With complex projects, more than one approval could be needed (e.g. from collaborating institutions, an industrial sponsor or a foreign country or REC). You should ensure you complete the approval process before beginning your research. Researchers are sometimes tempted to start recruiting participants prior to obtaining final approvals (this is an example of research misconduct).</p>
									</ladder-feedback>
								</ladder-step>
								<ladder-step>
									<ladder-label>Carry out research as approved</ladder-label>
									<ladder-number>2</ladder-number>
									<ladder-feedback>
										<p>Some researchers, for a variety of reasons, wrongly believe that they can change protocols and consent forms after review without securing approval. You must conduct your study as approved &ndash; this should include honouring all the commitments you made to participants.</p>
									</ladder-feedback>
								</ladder-step>
								<ladder-step>
									<ladder-label>Get approval for any amendments or deviations</ladder-label>
									<ladder-number>3</ladder-number>
									<ladder-feedback>
										<p>If you feel it is necessary to make changes for practical, methodological or other reasons, you should get the changes approved. If you are not sure whether the changes that are needed require approval, you should ask. Approval is usually needed for any changes to the:</p>
										<ul>
											<li>Protocol</li>
											<li>Primary or secondary research questions</li>
											<li>Informed consent process/information</li>
											<li>Number of participants</li>
											<li>Anticipated outcomes</li>
											<li>Method of analysis</li>
											<li>End date of the project.</li>
										</ul>
									</ladder-feedback>
								</ladder-step>
								<ladder-step>
									<ladder-label>Keep and retain proper records</ladder-label>
									<ladder-number>4</ladder-number>
									<ladder-feedback>
										<p>When you conduct research involving human participants, both during and after the study, you could be asked to provide evidence that participants:</p>
										<ul>
											<li>Were properly informed about the study</li>
											<li>Consented to participate</li>
											<li>Were monitored and treated as outlined in the protocol, at the proper time and as approved</li>
											<li>Continued with the study until it ended, or until they asked to end their participation.</li>
										</ul>
										<p>If you cannot provide proper evidence, publications based on the research could be retracted and you could be accused of irresponsible behaviour, or even misconduct. Keep in mind that:</p>
										<ul>
											<li>It is prudent to keep all records as long as the research is current and used by others, even if you are not required to do so</li>
											<li>Confidentiality and privacy agreements must be honoured as long as the data exist and could be accessed by others.</li>
										</ul>
									</ladder-feedback>
								</ladder-step>
								<ladder-step>
									<ladder-label>Report adverse events to the REC and any other relevant authority/review committee</ladder-label>
									<ladder-number>5</ladder-number>
									<ladder-feedback>
										<p>In research involving human participants, adverse events are generally divided into three categories:</p>
										<ul>
											<li><strong>Anticipated</strong> &ndash; reactions and responses you expect participants to have (e.g. the emotional impact of an interview or survey). Anticipated events should be identified in the research plan/protocol, along with any steps that need to be taken to deal with them. Since they were anticipated and accepted as part of the project, they generally do not have to be reported</li>
											<li><strong>Unanticipated</strong> &ndash; reactions and responses that occur during the research that were not expected but could have, in one way or another, been caused by the research. Such events should, generally speaking, be reported. For clinical trials there are specific definitions of reportable adverse effects/events</li>
											<li><strong>Unrelated</strong> &ndash; events that happen while the project is underway but have no reasonable connection to the research (e.g. aches and pains resulting from a fall). Such events do not, generally speaking, need to be reported. For clinical trials there are, again, specific definitions that need to be understood.</li>
										</ul>
										<p>Your research protocol should describe and explain how all anticipated adverse events will be handled. As part of their general training, researchers should be familiar with the different types of adverse events and their responsibilities when it comes to reporting unanticipated adverse events.</p>
									</ladder-feedback>
								</ladder-step>
								<ladder-step>
									<ladder-label>Submit required reports until the project is properly closed</ladder-label>
									<ladder-number>6</ladder-number>
									<ladder-feedback>
										<p>Researchers are generally required to submit reports on a periodic basis until a study reaches the end of its approval period. When the study comes to an end, it must be either officially extended or brought to a definitive end. If a study is being brought to a close:</p>
										<ul>
											<li>No further participants may be recruited</li>
											<li>No additional information may be collected</li>
											<li>Consent forms and other essential information, such as treatment records or survey forms, must be archived for future reference</li>
											<li>Participants should be informed in accordance with the terms set out in the consent form.</li>
										</ul>
										<p>Formal start and end dates are essential for tracking compliance with the approved protocol. Reporting processes are often clearly laid out in initial approval letters.</p>
									</ladder-feedback>
								</ladder-step>
							</ladder>
							<!-- MOBILE ALTERNATIVE -->
							<div class="show-in-mobile">
								<ol class="ladder-steps-accessible-ordered-list"><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Complete the approval process</h4><p>With complex projects, more than one approval could be needed (e.g. from collaborating institutions, an industrial sponsor or a foreign country or REC). You should ensure you complete the approval process before beginning your research. Researchers are sometimes tempted to start recruiting participants prior to obtaining final approvals (this is an example of research misconduct).</p></li><hr><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Carry out research as approved</h4><p>Some researchers, for a variety of reasons, wrongly believe that they can change protocols and consent forms after review without securing approval. You must conduct your study as approved &ndash; this should include honouring all the commitments you made to participants.</p></li><hr><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Get approval for any amendments or deviations</h4><p>If you feel it is necessary to make changes for practical, methodological or other reasons, you should get the changes approved. If you are not sure whether the changes that are needed require approval, you should ask. Approval is usually needed for any changes to the:</p> <ul><li>Protocol</li> <li>Primary or secondary research questions</li> <li>Informed consent process/information</li> <li>Number of participants</li> <li>Anticipated outcomes</li> <li>Method of analysis</li> <li>End date of the project.</li></ul></li><hr><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Keep and retain proper records</h4><p>When you conduct research involving human participants, both during and after the study, you could be asked to provide evidence that participants:</p> <ul><li>Were properly informed about the study</li> <li>Consented to participate</li> <li>Were monitored and treated as outlined in the protocol, at the proper time and as approved</li> <li>Continued with the study until it ended, or until they asked to end their participation.</li></ul> <p>If you cannot provide proper evidence, publications based on the research could be retracted and you could be accused of irresponsible behaviour, or even misconduct. Keep in mind that:</p> <ul><li>It is prudent to keep all records as long as the research is current and used by others, even if you are not required to do so</li> <li>Confidentiality and privacy agreements must be honoured as long as the data exist and could be accessed by others.</li></ul></li><hr><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Report adverse events to the REC and any other relevant authority/review committee</h4><p>In research involving human participants, adverse events are generally divided into three categories:</p> <ul><li><strong>Anticipated</strong> &ndash; reactions and responses you expect participants to have (e.g. the emotional impact of an interview or survey). Anticipated events should be identified in the research plan/protocol, along with any steps that need to be taken to deal with them. Since they were anticipated and accepted as part of the project, they generally do not have to be reported</li> <li><strong>Unanticipated</strong> &ndash; reactions and responses that occur during the research that were not expected but could have, in one way or another, been caused by the research. Such events should, generally speaking, be reported. For clinical trials there are specific definitions of reportable adverse effects/events</li> <li><strong>Unrelated</strong> &ndash; events that happen while the project is underway but have no reasonable connection to the research (e.g. aches and pains resulting from a fall). Such events do not, generally speaking, need to be reported. For clinical trials there are, again, specific definitions that need to be understood.</li></ul> <p>Your research protocol should describe and explain how all anticipated adverse events will be handled. As part of their general training, researchers should be familiar with the different types of adverse events and their responsibilities when it comes to reporting unanticipated adverse events.</p></li><hr><li class="ladder-steps-accessible-ordered-list-item"><h4 class="">Submit required reports until the project is properly closed</h4><p>Researchers are generally required to submit reports on a periodic basis until a study reaches the end of its approval period. When the study comes to an end, it must be either officially extended or brought to a definitive end. If a study is being brought to a close:</p> <ul><li>No further participants may be recruited</li> <li>No additional information may be collected</li> <li>Consent forms and other essential information, such as treatment records or survey forms, must be archived for future reference</li> <li>Participants should be informed in accordance with the terms set out in the consent form.</li></ul> <p>Formal start and end dates are essential for tracking compliance with the approved protocol. Reporting processes are often clearly laid out in initial approval letters.</p></li></ol>
							</div>
							<!-- MOBILE ALTERNATIVE -->
							<!-- ACTIVITY END -->

						</page-content-wide>
					</page-row>

					<page-row>
						<page-content-main>
							
							<p>As you consider these continuing responsibilities, keep in mind that your research sponsor maintains overall responsibility for the study and shares legal responsibility for protecting your participants. This means that they may want to audit your project at any time to ensure that everyone involved is carrying out the research as planned and agreed.</p>
							
							<h3>Summary</h3>
							
							<p>The review and approval system is designed to protect participants and ensure high-quality research. However, protection does not end with the review process. After you have gained a favourable REC opinion and governance approval, you should:</p>
							
							<ul>
								<li>Follow your protocol</li>
								<li>Get approval for any amendments/deviations</li>
								<li>Protect your records</li>
								<li>Properly bring your project to an end.</li>
							</ul>
							
							<p>Even when you formally end a project, your responsibilities continue. Confidential information must remain protected. If you agreed to share results with participants, you should respond to requests for information, keeping in mind that your participants may not have access to your scholarly publications.</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>