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A hands-on guide on obtaining research ethics approval

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It is an uncontested truth that many medical students and practising clinicians dread having to get their research proposal through a research ethics committee. In this paper, the author, a long-standing member of a research ethics committee, offers
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  Title: A hands-on guide on obtaining research ethics approval CORRESPONDING AUTHOR: David Hunter Lecturer in ethicsCentre for Professional EthicsKeele UniversityEmail:d.hunter@peak.keele.ac.uk KEY WORDS:Research Ethics, Research Ethics Committees, .WORD COUNT: 3 605 (Without abstract and references) Abstract: It is an uncontested truth that many medical students and practising clinicians dreadhaving to get their research proposal through a Research Ethics Committee (REC).In this paper the author, a long-standing member of an REC, offers a practical guide onapplying for research ethics approval, detailing common mistakes and flaws in applicationsand giving specific guidance on getting through what can seem a daunting process. Introduction: In the UK research ethics approval is a tangled and confusing affair, difficult to navigatefor many students and indeed staff at UK Universities.[1] This is largely because thelegislation and regulation that creates obligations to seek ethical approval is rather piecemeal, focusing on particular activities and regulating each activity separately. Worsestill, each individual piece of legislation applies to different parts of the UK . The aim of thispaper is to provide some advice – primarily for medical students and junior doctors whoare seeking to do research – from someone who is on the inside of the research ethicsapproval system, having sat on research ethics committees over the last 8 years and beeninvolved in the training of research ethics committee members in the UK. Why do we have a research ethics system? Why do I have to go through this? It is undeniable that research ethics approval is time consuming and can be a hassle,holding up good medical research projects. 1 So one might reasonably ask “why shouldresearch have to go through an approval system at all?”[2][3]Research ethics as a subject area arose with the increasing formalisation of medicalresearch in order to address the ethical concerns arising from the conduct of research.Historically, the development of research ethics has been greatly influenced by scandalssuch as the Tuskegee syphilis trial in the United States andthe Alder Hey research in the UK. 2 These are clearly ethically troublesome, but these high-profile cases form only a minorityof cases of unethical research. Most countries have had public scandals regarding somebreaches of ethical norms in research, and even in those that have not, it is likely thatunethical research, at least by today’s standards, has been carried out. Not all worriesabout research ethics are spectacularly big issues, nor is it always the case, even in thewellknown scandals, that unethical research involves researchers knowingly doing what theybelieve to be wrong. Often researchers are either unaware of the ethical implications of their research or, being aware of them, believe that they are outweighed by the positivebenefits of their research. Here are two examples that I have seen while on researchethics committees. 3 Psychology of depression with eight-year-olds In this case the researcher wanted to use a questionnaire, part of which consisted of theBeck Depression Index, with 30 eight-year-old children. The Beck Depression Index  asks participants to express their agreement or disagreement on a scale of 1 to 5 withstatements like:I feel like harming myself;If I died today no one would notice;I think about killing myself;There is no point growing up;I am useless.The disturbing thing about this research was that the researcher was not actuallyinterested in the children’s responses to these questions, but included them in thequestionnaire as a ‘blind’ to conceal the true nature of the research from the participants. Sports science muscle biopsy  For a piece of research on the oxidation of muscle tissue a sports scientist wanted to takepea-sized chunks of muscle out of the legs of athletes. The main piece of information onthe participant information sheet was that this might hurt a little. No information was givenabout ongoing pain, nor about the possible implications that the removal of muscle mighthaveon athletic performance.In both of these cases the researchers declared that there were no ethical issues.Obviously in the first case there are clear risks involved in suggesting the notion of suicideto eight-year-old children. In the second case, while the research was not necessarilyproblematic, not enough information was given to participants to allow them to decide for themselves. Aside from the past scandals, perhaps the most important reason to have a researchethics system is simply that most people would like to behave ethically. Given thecomplexityof ethical issues related to research, it makes us more likely to know how to achieve thisgoalif we have the advice of a knowledgeable and experienced group of individualsreflecting on ethical issues in our research before we carry it out.[4] Where do you need to seek approval from? Broadly, there are two regulatory systems in the UK: the NHS research ethics committeessystem and the university research ethics committees system. The NHS research ethicscommittee system is regulated by a central body, the National Research Ethics Service(NRES) and certain research – including most medical research – is legally required toseek approval from these research ethics committees. I will focus on navigating thissystem in this article. 4 However, it is worth mentioning that outside of this legally requiredethical approval, universities have also developed their own frameworks and systems, andeven if you don't need to seek ethical approval from an NHS committee you may berequired to seek approval from your own institution's systems (best to ask your supervisor or consultant). When do you need to seek ethical approval from an NHS research ethicscommittee? Before we can identify the ethical issues that arise in research we need to have at least aworking account of what research is. To readers who are engaged in research thisquestion may seem too obvious to need an answer, it is simply what we do. However, sucha definition is needed in order to distinguish research from related activities such as auditor service evaluation, which fall outside the scrutiny of research ethics committees, and itis surprisingly difficult to find a definition that distinguishes satisfactorily between these  things.[5] These considerations suggest that we should adopt an inclusive workingdefinition of research, such as the following:Research aims to generate (new) information, knowledge, understanding, or someother relevant good, and does so by means of a systematic investigation.While acknowledging that this doesn’t distinguish all research from all other humanactivities, it nonetheless appears to describe most activities which are currently thought of as research. The NHS has a helpful guidance paper which aims to distinguish betweenresearch, audit and service evaluation.[6]However, not all research requires ethical approval from anNHS research ethics committee. It depends on where you are based in the UK becausedifferent laws apply to different areas and, as laws are modified or made, advice becomesoutdated fast. As such the best place to check this is the NRES website:http://www.nres.npsa.nhs.uk/applications/apply/ethical-reviewrequirements/#RequirementsGAfREC As a rule of thumb, if you are doing research which involves NHS patients, people who havereduced capacity to consent to the research, or you plan to use human tissue where either your institution doesn't have a license to use this tissue or the nature of your proposedproject means that you will not be obtaining specific consent from the participants to usethis type of tissue, you willprobably need to get approval from an NHS research ethics committee. When in doubt thebest thing to do is to contact the NRES helpline to enquire about whether you need toapply. 6 Application process This is fully documented on the NRES website and the best advice is to simply go thereand read the guidance for answers to specific process questions. Some general points cannonetheless be made. The first thing to say is the most important thing in any application isto ensure that what you want to do is expressed clearly and in language that a lay member of a committee (who could be anyone, from any background) can understand. If this islacking then the committee cannot really assess your project and so will be forced into aposition where they either have to reject it, or ask you lots of follow up questions. Giventhis, the most important part of the form to fill in is the lay summary – this is your chance toensure committee members understand what you are doing.You will be asked to attach a methodology section. I recommend not simply using your project proposal as this methodology section – this is likely to be written in a technicalfashion, and give more detail than is really necessary. Although more work, it would bebetter to rewrite the document for this purpose. Likewise, don't just cut and paste from your project proposal into the form since this will make the form hard to follow for lay members.The second most important part of the form is the section which asks you to identify theethical issues that your research raises and how these have been resolved. Under nocircumstances write “N/A” in this box - this is usually a good marker for people who haven'treally thought about what they are doing. All research with human participants raises someethical issues, if even only how confidentiality will be kept – it is just that these have(usually) been resolved at the planning stage. So identify those issues (more on this later)and explain how you have resolved them.The final important part of the form is the participant information sheet and consent formthat you will give to the research participants. It is important to spend time getting this rightas many committee members begin by reading this part, and most feedback involveschanges to the information sheet.  7] Fortunately NRES provide substantial guidance on writing these, and I would suggestthat you use their sample templates for guidance.. 7 It is a good idea to ask someone who knows nothing about your subject area to readthrough your application and then to ask them a few questions to check that they knowwhat you are doing. Likewise, checking whether they have any questions mayhelp you anticipate what will happen in the committee meeting when you are beingquestioned. In the committee meeting It is likely that you will be invited to attend the ethics committee meeting where your application will be considered. It is important to realise that this isn't an exam – instead it isan opportunity for the committee to clarify your application and to resolve any (usually)minor niggles there might be. So don't be too nervous, and do have a clear understandingof what you are planning to do, so you can explain it to the committee. Unless you knowyour application like the back of your hand, you should take your application with you, aswell as any important documents that you mention in the protocol, such as questionnairesyou may use. Be prepared to explain things in lay language. If at all possibleencourage your supervisor to attend the meeting with you - research shows that thisimproves the chances of your application being approved. It is worth trying to anticipatethe key questions that you may be asked, and issues that might be addressed so that youare ready to answer them if need be. Outcomes There are three possible outcomes - approval; approved subject to conditions; andrejection. Approximately 15% of applications receive approval immediately, most receive aconditional approval, and only 5% receive a rejection. If you receive a rejection don'tdespair, often projects are rejected not because the committee thinks that they arefundamentally unethical, but instead because changes are needed which would so changethe project that a new application is needed. Conditional approvals often require relativelyminor changes, for example, clarification of the patient information sheet, so they should beable to be taken care of pretty fast. You should receive a letter detailing the requiredchanges, and if you have any questions about these don't hesitate to contact thechair or administrator of the committee. Ethical issues in research – or what the committee is looking for  There are many potential ethical issues in research, more than I can possibly cover here,so I will only give a brief overview of key issues to think about, as well as some commonlyneglected issues later on, and other than that refer you on to the many papers and booksthat focus on specific ethical issues in research.[8][9]The first thing to say is this: most ethical issues can be identified and resolved using somesimple common sense. So think about your study from the point of view of a participant:would you be prepared to be involved?; Do you have enough information about the projectin order to make an informed decision about whether or not to participate?If not, then you need to change the proposal so that potential participants are able to giveinformed consent before participating.Commonly the ethical issues in research cluster around several core concepts. Informed consent: There are several reasons to be concerned about informed consent,  including respect for autonomy, avoidance of harms, and to allow participants to waive their rights (such as the right to bodily integrity).[10]Informed consent is made up of three aspects:1. Enough information to make the decision2. Ability to weigh up the information, come to a decision, and communicate this decision3. A lack of any undue outside interference or influence on the decisionIt is important that information is presented in language that is accessible to theparticipants (remember that the effective reading age of the average adult in the UK isnine), and this will depend on who the participants are.[11] As a general rule of thumb,technical language should be avoided as far as possible, and the information sheet shouldbe easily understood by a person with no prior knowledge in this field of research.There is one special case where full information need not be given; this is when it isnecessary for the design of the study that it be deceptive in nature. However, usually if youwant to do deceptive research you will need to make a good case for why the deception isscientifically necessary, and why the benefits of the research outweigh the costs of deceiving the participants, particularly if the participants will suffer some harm or be at risk.Ideally the participants should not be in a position of vulnerability or perceived vulnerabilityin regards to the researcher. This is the case because if the participants are in a vulnerableposition they may feel they have to participate. So, for example, if the participants are thestudents of the researcher then they may feel if they don’t participate then they will bemarked down in the next assignment; likewise if the researcher is a medic who isresearching on their own patients the patients may feel that they will not get the samequality of care if they don’t participate.It is also usually best to approach the participant indirectly, either by contacting themthrough an intermediary or by recruiting in such a way that the participant approaches yourather than vice versa as this ensures that their participation is voluntary.In general, given appropriate information, normal adults are considered to be competent toconsent. Certain groups of people may not have capacity to consent on their own behalf.These groups include children, as well assome people with certain learning difficulties or mental disabilities. However, it is importantto assess capacity and competency to consent on an individual basis as, for example, somechildren will be able to understand the information and come to a decision aboutparticipation at an earlier age than others, and some people may demonstrate capacity toconsent to some procedures or trials but not others. Likewise people who would ordinarilybeable to consent may not be able due to the situation, so for example if they are insignificant pain, or on heavy levels of pain killers their capacity to consent might becompromised. In all of these cases these people can still be recruited onto a study if someone in the appropriate legal standing to them (usually their next of kin or care givers)will consent on their behalf. However, simply because someone is not competent to consent does not mean that theyare not competent to dissent. Researchers should make all reasonable efforts tocommunicate their research in a way that potential participants can understand – this may
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