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							<interactive-text><p>RECs are tasked with ensuring that human studies are ethical. For some projects, reaching an agreement on what is or is not ethical can be complex and controversial. The basic introduction provided below summarises the main ethical considerations that need to be taken into account when conducting research with human participants, although it is not exhaustive.</p></interactive-text>

							<accessible-text><p>RECs are tasked with ensuring that human studies are ethical. For some projects, reaching an agreement on what is or is not ethical can be complex and controversial. The basic introduction provided on this screen summarises the main ethical considerations that need to be taken into account when conducting research with human participants, although it is not exhaustive.</p></accessible-text>

							<p>Generally speaking, an 'ethical study' is one that lives up to the principles set out in local, national and global policies. An ethical study ensures that:</p>

							<ul>
								<li>Participation in the research is based on voluntary, informed consent and participants are free to withdraw (autonomy principle)</li>
								<li>The risks to individuals have been minimised (beneficence principle)</li>
								<li>The benefits to be gained from the research outweigh any risks (non-maleficence principle)</li>
								<li>The research is fair to participants and society (justice principle).</li>
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							<p>How do RECs judge whether a project is ethical?</p>

							<h3>Addressing ethical challenges</h3>

							<p>While every study is different and can raise unique challenges, RECs often expand the four main ethical principles into eight areas (Trace and Kolstoe, 2017).</p>

							<instructional-text class="hide-in-mobile"><p>Click through the various tabs to learn more about the areas that RECs will consider when judging whether a project is ethical. The eight areas explored here are based on the review domains described in Trace and Kolstoe (2017).</p></instructional-text>
							<accessible-text class="show-in-mobile"><p>Continue on to learn more about the areas that RECs will consider when judging whether a project is ethical. The eight areas explored here are based on the review domains described in Trace and Kolstoe (2017).</p></accessible-text>
							
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									<tab-heading>Social or scientific value; scientific design; and conduct of the study</tab-heading>
									<tab-content>
										<p>RECs will seldom have members with all the expertise needed to assess the scientific justification and methodological soundness of the project. It is, therefore, up to you as a researcher to provide a clear, but brief, justification of why your research is important and why your methods are appropriate. Obtaining evidence that your protocol has been reviewed externally by patient and participant involvement (PPI) committees or subject experts (peer reviewers) can help to reassure the REC.</p>
									</tab-content>
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									<tab-heading>Recruitment arrangements; access to health information; and fair participant selection</tab-heading>
									<tab-content>
										<p>You need to explain, clearly and logically, how you will identify your study population, contact your study sample, provide information to your potential participants, and then ask for consent to participate in your study. You especially need to show that you are not putting undue pressure on potential participants through this process, and are also not accessing confidential information until the relevant permissions (normally consent) have been obtained.</p>
									</tab-content>
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									<tab-heading>Favourable risk&ndash;benefit ratio and anticipated benefits/risks for research participants</tab-heading>
									<tab-content>
										<p>For many types of studies, especially those that involve randomisation or the use of control groups, you will need to consider whether you are unduly disadvantaging one group over another. Here, the idea of 'equipoise' (see the "Additional information" pod) is important. You will also need to consider any potential harms or burdens that the participants may encounter, and what steps could be taken to mitigate these. It is now commonly accepted that one advantage of taking part in research is payment (see the "Additional information" pod).</p>
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								</tab-item>
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									<tab-heading>Protection of research participants and respect for their welfare and dignity</tab-heading>
									<tab-content>
										<p>Linked to the favourable risk&ndash;benefit ratio, you need to consider practical arrangements for the care and protection of participants. This might include careful arrangements for screening potential participants against exclusion criteria before they are allowed to participate, the availability of first aiders, provision of meals or rest breaks, factors surrounding modesty/privacy and a host of other context-specific considerations. With regards to payment, values should not be derisory, and should be provided in an appropriate way (e.g. online vouchers should not be provided to participants without computer access).</p>
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									<tab-heading>Informed consent process and the adequacy of participant-facing information</tab-heading>
									<tab-content>
										<p>In promoting the principle of autonomy, RECs pay careful attention to how you will be identifying, contacting, recruiting and asking for consent from participants. They will want to see a clear and well-thought-out process that caters for the needs of the specific population that you will be recruiting your sample from. They will want to see all participant-facing recruitment material in order to check that it is easy to understand and clear to participants.</p>
									</tab-content>
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									<tab-heading>Suitability of the researchers and support staff</tab-heading>
									<tab-content>
										<p>RECs will want to check that all researchers and support staff are suitably qualified to fulfil their proposed roles. In cases where students will be conducting research (perhaps for the first time), the REC will want to see evidence of suitable training and supervision.</p>
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									<tab-heading>Independent review</tab-heading>
									<tab-content>
										<p>Linked to the scientific and methodological justification of the project, the more risky or invasive the research the more RECs will need to be reassured that the proposed study is appropriate. The most effective way to do this is to provide independent (but still favourable) reviews by established experts in your field. If a REC is not satisfied upon first review, they may well ask for additional reviews as a condition of their favourable opinion.</p>
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									<tab-heading>Suitability of supporting information</tab-heading>
									<tab-content>
										<p>Alongside the study protocol, any necessary application forms, participant-facing data or CVs, the REC may need to see additional letters of permission, risk assessments, authorisations, insurance documents and evidence of governance reviews.</p>
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									<h4>Social or scientific value; scientific design; and conduct of the study</h4>
									<p>RECs will seldom have members with all the expertise needed to assess the scientific justification and methodological soundness of the project. It is, therefore, up to you as a researcher to provide a clear, but brief, justification of why your research is important and why your methods are appropriate. Obtaining evidence that your protocol has been reviewed externally by patient and participant involvement (PPI) committees or subject experts (peer reviewers) can help to reassure the REC.</p>
								</div>
								<div class="section">
									<h4>Recruitment arrangements; access to health information; and fair participant selection</h4>
									<p>You need to explain, clearly and logically, how you will identify your study population, contact your study sample, provide information to your potential participants, and then ask for consent to participate in your study. You especially need to show that you are not putting undue pressure on potential participants through this process, and are also not accessing confidential information until the relevant permissions (normally consent) have been obtained.</p>
								</div>
								<div class="section">
									<h4>Favourable risk&ndash;benefit ratio and anticipated benefits/risks for research participants</h4>
									<p>For many types of studies, especially those that involve randomisation or the use of control groups, you will need to consider whether you are unduly disadvantaging one group over another. Here, the idea of 'equipoise' (see the "Additional information" pod) is important. You will also need to consider any potential harms or burdens that the participants may encounter, and what steps could be taken to mitigate these. It is now commonly accepted that one advantage of taking part in research is payment (see the "Additional information" pod).</p>
								</div>
								<div class="section">
									<h4>Protection of research participants and respect for their welfare and dignity</h4>
									<p>Linked to the favourable risk&ndash;benefit ratio, you need to consider practical arrangements for the care and protection of participants. This might include careful arrangements for screening potential participants against exclusion criteria before they are allowed to participate, the availability of first aiders, provision of meals or rest breaks, factors surrounding modesty/privacy and a host of other context-specific considerations. With regards to payment, values should not be derisory, and should be provided in an appropriate way (e.g. nline vouchers should not be provided to participants without computer access).</p>
								</div>
								<div class="section">
									<h4>Informed consent process and the adequacy of participant-facing information</h4>
									<p>In promoting the principle of autonomy, RECs pay careful attention to how you will be identifying, contacting, recruiting and asking for consent from participants. They will want to see a clear and well-thought-out process that caters for the needs of the specific population that you will be recruiting your sample from. They will want to see all participant-facing recruitment material in order to check that it is easy to understand and clear to participants.</p>
								</div>
								<div class="section">
									<h4>Suitability of the researchers and support staff</h4>
									<p>RECs will want to check that all researchers and support staff are suitably qualified to fulfil their proposed roles. In cases where students will be conducting research (perhaps for the first time), the REC will want to see evidence of suitable training and supervision.</p>
								</div>
								<div class="section">
									<h4>Independent review</h4>
									<p>Linked to the scientific and methodological justification of the project, the more risky or invasive the research the more RECs will need to be reassured that the proposed study is appropriate. The most effective way to do this is to provide independent (but still favourable) reviews by established experts in your field. If a REC is not satisfied upon first review, they may well ask for additional reviews as a condition of their favourable opinion.</p>
								</div>
								<div class="section">
									<h4>Suitability of supporting information</h4>
									<p>Alongside the study protocol, any necessary application forms, participant-facing data or CVs, the REC may need to see additional letters of permission, risk assessments, authorisations, insurance documents and evidence of governance reviews.</p>
								</div>
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							<interactive-text class="hide-in-mobile"><h3>Summary</h3></interactive-text>

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							<!-- ADDITIONAL INFORMATION START -->
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								<pod-modal-heading>Additional information</pod-modal-heading>
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									<h4>Equipoise</h4>
									<p>The word 'equipoise' is derived from the phrase 'equally poised', as used in relation to two different treatments for the same condition. Within a research context, equipoise relates to genuine uncertainty as to which treatment/intervention is better, and thus provides an ethical justification for randomising participants to determine which is most effective. However, problems can occur if one treatment/intervention is already known to be much better, in which case researchers need to think very carefully about how they justify their research (appealing to pragmatism, convenience, cost effectiveness, etc.).</p>
									<hr>
									<h4>Payment for research</h4>
									<p>It is now commonly accepted that participants can be paid for taking part in research. A parallel is often drawn with the fire service or military, where payment is made on the basis of risk. The size of payments should be determined by taking into account the expected burden on participants. At the very least travel costs and any out-of-pocket expenses (such as meals) should be covered. Any additional payments above this should be appropriate and not coercive. RECs play an important role in helping researchers determine the appropriate level of payment for participants in their study.</p>
									<hr>
									<h4>Fully informed consent</h4>
									<p>In the past, obtaining fully informed consent has been seen as a a requirement for research involving human participants. However, ethicists have since asked the question 'How informed does a participant need to be to count as being fully informed?'. It is clearly unreasonable to expect research participants to be aware of the entire scientific, medical or methodological context of a study, and yet they must still receive a certain level of information. As there is no clear standard, ethicists and RECs now consider whether participants are suitably or appropriately informed. The phrase 'fully informed consent' is no longer used. PPI groups and RECs can help researchers determine the level of information that participants require.</p>
									<p>Information that is not clear, or information that is missing, might invalidate consent if participants did not realise what the study involved. The one exception is for studies where deception is necessary (often psychology studies), and here RECs will look carefully at why the deception is needed, and then the proposed process for asking for consent and allowing for withdrawal of information after the study has been completed.</p>
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							<accessible-text class="show-in-mobile"><h3>Summary</h3></accessible-text>

							<p>Defining ethical responsibility in research involving human participants is not an exact science and can lead to frustration on the part of researchers if they disagree with the decision made by a REC. It is important to remember, however, that the REC is there to protect participants and to support the researcher in the design and conduct of an effective, and ethical, project. The best approach is to be well prepared, present a high-quality application without any contradictions, and be prepared to discuss your project  with the REC if necessary.</p>

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