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		<title>Preparing for review</title>
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							<p>However the review system works at your institution, getting approval for your research is essential and must be taken seriously. Applying for approval to conduct research involving human participants can be time-consuming and might, at times, seem counterproductive.</p>
							<p>Researchers sometimes complain that the approval process is slow and poses an unreasonable burden on their time. However, the flip side of this is that reviewers (either governance reviewers or those within RECs) are frequently frustrated by the sloppy and incomplete applications submitted by researchers.  </p>
							<p>As with other aspects of research, it is important to provide complete and accurate information when you apply for approval to allow reviewers to do their jobs.</p>
							
							<h3>Approval process</h3>
							
							<p>The approval process for research involving human participants generally begins with an application and research protocol submitted by the researcher or the research team proposing to undertake a study. To approve a project (or, in the case of a REC, to provide a favourable opinion), reviewers need to know the following:</p>
							
							<instructional-text class="hide-in-mobile"><p>Click on each tab to learn more about what a review committee would need to know about your project.</p></instructional-text>
							
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							<accessible-text class="show-in-mobile"><p>Continue on to learn more about what a review committee would need to know about your project.</p></accessible-text>

							<!-- ACTIVITY START -->
							<tab-set orientation="vertical" show-in-accessible-version="false" class="hide-in-mobile">
								<tab-item>
									<tab-heading><p>Overall plan and goals</p></tab-heading>
									<tab-content>
										<p>Begin with a description of the research you plan to undertake. This should be written in a way that can be understood by those who are not experts in your field. To help the reviewers understand your project, you should:</p>
										<ul>
											<li>Provide an overview of objectives, key steps and important issues</li>
											<li>Limit the use of technical terms and jargon</li>
											<li>Anticipate and answer questions that reviewers might ask</li>
											<li>Logically organise the proposal (or your responses to the questions) so that it is easy to understand.</li>
										</ul>
										<p>Reviewers must understand what you plan to do and why. Submitting a densely worded and convoluted proposal can result in long delays as reviewers request clarification.</p>
									</tab-content>
								</tab-item>
								<tab-item>
									<tab-heading><p>Your research methods</p></tab-heading>
									<tab-content>
										<p>You should provide a complete description of the methods you plan to use, which might include any of the following:</p>
										<ul>
											<li>Interviews</li>
											<li>Surveys</li>
											<li>Clinical trials</li>
											<li>Tissue analyses</li>
											<li>Database analyses.</li>
										</ul>
										<p>You should also include details, such as:</p>
										<ul>
											<li>How will you conduct interviews?</li>
											<li>What questions do you plan to ask in your survey?</li>
											<li>How will a clinical trial be conducted?</li>
											<li>What equipment will you use?</li>
											<li>How will samples be tested?</li>
										</ul>
									</tab-content>
								</tab-item>
								<tab-item>
									<tab-heading><p>How you will recruit participants</p></tab-heading>
									<tab-content>
										<p>Explain how you will identify, approach and then enrol participants in your study. You should ask yourself the following questions:</p>
										<ul>
											<li>How will you identify your participants (what is your population and how will you identify the study sample)?</li>
											<li>What recruitment materials will they see?</li>
											<li>How will you inform participants and get their consent to participate?</li>
											<li>How will you screen potential participants?</li>
											<li>What are your inclusion/exclusion criteria for participation in the study?</li>
										</ul>
										<p>Reviewers must be able to track the participation of every person, from enrolment through to the completion of the study.</p>
									</tab-content>
								</tab-item>
								<tab-item>
									<tab-heading><p>Your plan for protecting sensitive information</p></tab-heading>
									<tab-content>
										<p>Explain the ways in which you will ensure that the information you collect will only be available to those with approved access. You should make sure you know:</p>
										<ul>
											<li>Who will have access to the data</li>
											<li>Whether the data will be anonymised/link-anonymised (see the definitions in the "Additional information" pod)</li>
											<li>How information will be stored and what security measures will be put in place to ensure that only approved personnel can access the information</li>
											<li>How you plan to comply with relevant data protection legislation (e.g. GDPR/DPA 2018 in the UK)</li>
											<li>How sensitive data will be destroyed at the end of the study (if applicable).</li>
										</ul>
										<p>It is important to keep in mind that the plan you set out for data protection will be the one used to check whether you are living up to your responsibilities &ndash; both during the study and after it has been completed.</p>
									</tab-content>
								</tab-item>
								<tab-item>
									<tab-heading><p>Your plan for responding to unexpected events or findings</p></tab-heading>
									<tab-content>
										<p>Provide a description of the steps you will take if the research does not progress as planned. For example, what will you do if:</p>
										<ul>
											<li>Unexpected findings emerge that could be relevant to a participant?</li>
											<li>A participant responds to the research in ways you did not predict, posing additional risks?</li>
											<li>Safeguarding or participant wellbeing issues arise?</li>
											<li>Your data security plan is breached and protected data becomes public?</li>
										</ul>
										<p>It is difficult to plan for every eventuality, but the more problems you can anticipate and plan for, the fewer you will have to deal with after the fact.</p>
									</tab-content>
								</tab-item>
								<tab-item>
									<tab-heading><p>Your plan for disseminating your findings</p></tab-heading>
									<tab-content>
										<p>Describe how you will share your data and how it will be presented. You should state which information will:</p>
										<ul>
											<li>Be shared with participants</li>
											<li>Not be shared with participants and why</li>
											<li>Be shared with colleagues</li>
											<li>Be added to open data repositories (or if not, why not)</li>
											<li>Be published and made publicly available.</li>
										</ul>
										<p>This information is essential, not only for reviewers but also for research participants, who must be told what personal information will be made available to them and to others. Any failure to anticipate the ways in which you plan to share information could result in restrictions being placed on what you can publish once a study has been completed.</p>
									</tab-content>
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								<h4>Overall plan and goals</h4>
								<p>Begin with a description of the research you plan to undertake. This should be written in a way that can be understood by those who are not experts in your field. To help the reviewers understand your project, you should:</p>
								<ul>
									<li>Provide an overview of objectives, key steps and important issues</li>
									<li>Limit the use of technical terms and jargon</li>
									<li>Anticipate and answer questions that reviewers might ask</li>
									<li>Logically organise the proposal (or your responses to the questions) so that it is easy to understand.</li>
								</ul>
								<p>Reviewers must understand what you plan to do and why. Submitting a densely worded and convoluted proposal can result in long delays as reviewers request clarification.</p>
								<hr>
								<h4>Your research methods</h4>
								<p>You should provide a complete description of the methods you plan to use, which might include any of the following:</p>
								<ul>
									<li>Interviews</li>
									<li>Surveys</li>
									<li>Clinical trials</li>
									<li>Tissue analyses</li>
									<li>Database analyses.</li>
								</ul>
								<p>You should also include details, such as:</p>
								<ul>
									<li>How will you conduct interviews?</li>
									<li>What questions do you plan to ask in your survey?</li>
									<li>How will a clinical trial be conducted?</li>
									<li>What equipment will you use?</li>
									<li>How will samples be tested?</li>
								</ul>
								<hr>
								<h4>How you will recruit participants</h4>
								<p>Explain how you will identify, approach and then enrol participants in your study. You should ask yourself the following questions:</p>
										<ul>
											<li>How will you identify your participants (what is your population and how will you identify the study sample)?</li>
											<li>What recruitment materials will they see?</li>
											<li>How will you inform participants and get their consent to participate?</li>
											<li>How will you screen potential participants?</li>
											<li>What are your inclusion/exclusion criteria for participation in the study?</li>
										</ul>
										<p>Reviewers must be able to track the participation of every person, from enrolment through to the completion of the study.</p>
								<hr>
								<h4>Your plan for protecting sensitive information</h4>
								<p>Explain the ways in which you will ensure that the information you collect will only be available to those with approved access. You should make sure you know:</p>
								<ul>
									<li>Who will have access to the data</li>
									<li>Whether the data will be anonymised/link-anonymised (see the definitions in the "Additional information" pod)</li>
									<li>How information will be stored and what security measures will be put in place to ensure that only approved personnel can access the information</li>
									<li>How you plan to comply with relevant data protection legislation (e.g. GDPR/DPA 2018 in the UK)</li>
									<li>How sensitive data will be destroyed at the end of the study (if applicable).</li>
								</ul>
								<p>It is important to keep in mind that the plan you set out for data protection will be the one used to check whether you are living up to your responsibilities &ndash; both during the study and after it has been completed.</p>
								<hr>
								<h4>Your plan for responding to unexpected events or findings</h4>
								<p>Provide a description of the steps you will take if the research does not progress as planned. For example, what will you do if:</p>
								<ul>
									<li>Unexpected findings emerge that could be relevant to a participant?</li>
									<li>A participant responds to the research in ways you did not predict, posing additional risks?</li>
									<li>Safeguarding or participant wellbeing issues arise?</li>
									<li>Your data security plan is breached and protected data becomes public?</li>
								</ul>
								<p>It is difficult to plan for every eventuality, but the more problems you can anticipate and plan for, the fewer you will have to deal with after the fact.</p>
								<hr>
								<h4>Your plan for disseminating your findings</h4>
								<p>Describe how you will share your data and how it will be presented. You should state which information will:</p>
								<ul>
									<li>Be shared with participants</li>
									<li>Not be shared with participants and why</li>
									<li>Be shared with colleagues</li>
									<li>Be added to open data repositories (or if not, why not)</li>
									<li>Be published and made publicly available.</li>
								</ul>
								<p>This information is essential, not only for reviewers but also for research participants, who must be told what personal information will be made available to them and to others. Any failure to anticipate the ways in which you plan to share information could result in restrictions being placed on what you can publish once a study has been completed.</p>
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							<!-- ADDITIONAL INFORMATION START -->
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								<pod-heading>Additional information</pod-heading> <!-- pod title -->
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								<pod-modal-heading>Additional information</pod-modal-heading>
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									<p><strong>Anonymous:</strong> No identifying information will be collected.</p>
									<p><strong>Anonymised/de-identified:</strong> Identifying data is collected but then later removed.</p>
									<p><strong>Link-anonymised/Coded:</strong> Identifying information is collected and kept but is then coded to limit access to the identifying information.</p>
									<p><strong>Identifying information:</strong> Information that can be used either singly or in combination with other information to identify the person (e.g. name, government-issued ID, address, age, gender, DNA profile).</p>
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							<p>Different institutions have different ways of gathering and reviewing this information. For instance, research requiring review by the HRA, MHRA and various other government review bodies uses a common online Integrated Research Application System (IRAS) platform. Many universities have their own application forms (either paper or online). Often your protocol, a specific application form and various other supporting documents and agreements will need to be provided.</p>
							<p>Whatever forms you need to fill out or provide, you should take the time to provide the reviewers with a complete, accurate and understandable statement of your research plans. Be careful to read the question forms carefully, not replicate information and seek help from more experienced colleagues (e.g. researchers, mentors, supervisors, research support officers).</p>
							
							<h3>Additional information</h3>
							
							<p>The decisions reviewers make require additional information, alongside your research plan or protocol. Reviewers must be assured in advance that the research team is qualified to undertake the research, and need to be convinced that the research is important enough to justify any risks and the time commitments required of participants. You should, therefore, expect to be asked about the following additional areas.</p>
							
							<instructional-text><p>Click on each card to learn more about the additional information that reviewers might need to know about your project.</p></instructional-text>
							
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							<accessible-text><p>Continue on to learn more about the additional information that reviewers might need to know about your project.</p></accessible-text>
							
							<!-- ACTIVITY START -->
							<flashcards show-in-accessible-version="false">
								<flashcard size="medium">
									<flashcard-front variant="heading">Researcher qualifications/<br>competencies</flashcard-front>
									<flashcard-back variant="text">What are the qualifications and prior experience of the principal investigators and co-principal investigators (including training and prior publications)?</flashcard-back>
								</flashcard>
								<flashcard size="medium">
									<flashcard-front variant="heading">Participant-facing information</flashcard-front>
									<flashcard-back variant="text">Reviewers (especially RECs) will need to see all advertising materials (e.g. recruitment posters), invitation letters, participant information sheets (PIS), consent forms, questionnaires, focus group scripts, debriefing forms and any other study-related documents that participants will be given or see.</flashcard-back>
								</flashcard>
								<flashcard size="medium">
									<flashcard-front variant="heading">Research sites</flashcard-front>
									<flashcard-back variant="text">Where will the research be conducted (both at the research institution and at any off-site locations)?</flashcard-back>
								</flashcard>
								<flashcard size="medium">
									<flashcard-front variant="heading">Research funding</flashcard-front>
									<flashcard-back variant="text">Who is funding the research? Are there any restrictions or requirements that might be attached to the funding?</flashcard-back>
								</flashcard>
								<flashcard size="medium">
									<flashcard-front variant="heading">Conflicts of interest</flashcard-front>
									<flashcard-back variant="text">What are the potential and actual conflicts of interest of everyone involved in the research (particularly financial interests, but also any professional service roles or affiliations that could be seen as threatening to compromise the objectivity of the research)?</flashcard-back>
								</flashcard>
								<flashcard size="medium">
									<flashcard-front variant="heading">Peer review</flashcard-front>
									<flashcard-back variant="text">You should provide information on whether the proposed project has been peer reviewed. Getting a peer review in advance of governance or REC reviews can be helpful in convincing reviewers that your project is scientifically justified and methodologically sound.</flashcard-back>
								</flashcard>
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								<h4>Researcher qualifications/competencies</h4>
								<p>What are the qualifications and prior experience of the principal investigators and co-principal investigators (including training and prior publications)?</p>
								<hr>
								<h4>Participant-facing information</h4>
								<p>Reviewers (especially RECs) will need to see all advertising materials (e.g. recruitment posters), invitation letters, participant information sheets (PIS), consent forms, questionnaires, focus group scripts, debriefing forms and any other study-related documents that participants will be given or see.</p>
								<hr>
								<h4>Research sites</h4>
								<p>Where will the research be conducted (both at the research institution and at any off-site locations)?</p>
								<hr>
								<h4>Research funding</h4>
								<p>Who is funding the research? Are there any restrictions or requirements that might be attached to the funding?</p>
								<hr>
								<h4>Conflicts of interest</h4>
								<p>What are the potential and actual conflicts of interest of everyone involved in the research (particularly financial interests, but also any professional service roles or affiliations that could be seen as threatening to compromise the objectivity of the research)?</p>
								<hr>
								<h4>Peer review</h4>
								<p>You should provide information on whether the proposed project has been peer reviewed. Getting a peer review in advance of governance or REC reviews can be helpful in convincing reviewers that your project is scientifically justified and methodologically sound.</p>
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							<p>Reviewers must have a complete understanding of all aspects of a project to properly judge whether it is ethical (the main focus of the REC review) and adequately protects the participants enrolled. Researchers have a responsibility to work with their reviewers in a joint effort to provide proper protection for research participants.</p>
							
							<h3>Summary</h3>
							
							<p>However the review system that you need to use works, getting review and approval is essential to research involving human participants and must be taken seriously. To help your reviewers do their job, you should:</p>
							
							<ul>
								<li>Describe your project in terms the reviewers will understand</li>
								<li>Ensure you do not omit important details</li>
								<li>Introduce your research team</li>
								<li>Provide the full context for judging the project (including details of funding, locations and conflicts of interest).</li>
							</ul>
							
							<p>As you prepare your materials, keep this in mind: your reviewers could include ethicists and members of the public (on the REC), as well as researchers and research staff. Therefore, as much as possible, you should avoid using overly complex, technical language. Anyone with an interest in your work should be able to understand what you plan to do.</p>
							
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