Following ‘Proper Procedures’ (Case date 2006)
I am a research manager for a national charity. Before I took up my post a researcher employed by a Primary Care NHS Trust (PCT) had been appointed for a commissioned qualitative research project to find out the experiences of a group of disabled people who were users of health and social care services. I now suspect that she has carried out her research without the necessary ethical approval. I am clear that she didn't need an honorary contract with the PCT but I still think that she should have sought clearance for the research for interviewing both users of their services and staff. In fact the area covers four PCTs - but I understand one approval is enough and other PCTs can 'sign up ' to it? She did approach local authorities for ethical approval (I presume there is no need to have an honorary contract there) but only got it from one - could the other three have signed up to that or should she have got separate agreements? What process should she have gone through?
Also what is the latest on interviewing users of 'joined up' services i.e. health and social care - how many different ethical approval processes do researchers have to go through. Our researcher is arguing that she didn't recruit ‘patients’ as such but rather social services clients and asked them about NHS services in the same interview.
I would be most grateful for any advice as this appears to be a grey area!
This is indeed a grey area - and one that is changing all the time. So much so that local variations can even apply and, not knowing your PCT, we can't say what their precise view is likely to be.
It is clear that NHS is trying to rationalise the system and make it easier for multi-site approval to be gained from one source. But whether that happens depends upon local agreements.
The ‘hard’ response is that you are right - ethical approval should have been gained in order both to interview NHS users about services and to interview staff. (Indeed so should research governance approval have been given - which is a check on potential risk to each Trust as a consequence of the research being conducted.) Given the research covered four PCTs the correct approach would have been to go to the regional MREC.
Your researcher's response that the client respondents were recruited as social service users is fair - if there is an agreement between health and social care that one ethical scrutiny procedure applies to all. If no such agreement exists then application should have been made to the PCT ethics committee too (usually the LREC for the area). Not all PCT's have research governance scrutiny yet - but they will do soon - so that may not be a problem in this case. Either way permission to interview staff should have been sought from the LREC.
As an employee of one PCT she does not need an honorary contract for that PCT - but the others would insist upon honorary contracts if she were interviewing their patients - once again unless they have some form of quid pro quo agreement.
This is one of the biggest complaints of health researchers - the number of separate committees they have to go to. Attempts being made to rationalise this and health and social care is to be reviewed by the same committees - with appropriate panel members being selected according to the match between proposal and their expertise/interest.
You are right to be concerned about this and, for future reference, you will need to ensure correct procedure. Actually, there is no legal concern to be considered here since the NHS/DH has no sanctions against "unapproved" studies. But there can be a loss of goodwill, and reluctance to assist anyone not following procedure in the future - quite apart from any moral concerns associated with the findings of the particular study.
Perhaps you could cultivate relations with a friendly secretary to one of the ethics committees. There is usually a key administrator in the Trust who holds such responsibility - or even seek a meeting "for advice" with a committee chair.
So given the work has been started you have to play this diplomatically. Ethical approval was, in fact, received from the local authority; these respondents were recruited as social services clients (with permission); a series of questions associated with their overall "care" were addressed - and leave it at that in your concluding report. Remember however that permission to interview staff was not formally given. A lot depends upon how public the report becomes and whether anyone from the PCTs reads it and, whether they notice (or care!) that approval was not received from them.
So, yes, it is a bit complex - although I believe that the will to sort it out within health and social care departments is there.
The research and the accompanying grant had to be terminated but something was salvaged from the project. The research was used as an internal document without the report being published. It was quoted from and the findings used for other things – in the end it was treated as a consultation exercise rather than research.
The Primary Care Trust's R&D manager was horrified that NHS staff had been interviewed without permission. If the manager had known about the research then support could have been given to the researcher – who had to struggle along on her own. There was no reciprocal agreement over ethics between local authorities.
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International ethical dilemmas (Case date 2008)
I am an independent researcher and I’ve been given an assignment, teaching a short course on qualitative research methods to public health professionals in Damascus. I'm wondering about the ethics of teaching research in one of the world's most repressive countries, where Internet access is limited by the unelected government, academics and students are regularly detained, it's fine for a man to rape a woman as long as he marries her afterwards, and I can't give my students any homework because they are government employees and therefore spend all their evenings and weekends working in private practice to make ends meet. Is it even ethical for me to undertake the assignment in the first place? On balance I think it is. But, then, qualitative research could be seen as subversive in a country where speech is not free, so am I offering people techniques that may endanger them? How do I deal with teaching research ethics in these circumstances? There are bound to be other aspects of this that I have not yet thought of. Also, I am aware that my views and conclusions may change while I am in Damascus and after my return.
Is there anyone in the SRA who has thought through these or similar issues? I will be discussing this with colleagues who are also involved in teaching on the same courses; I don't yet know to what extent they have considered this. The information about international research ethics on the Internet all seems to be based upon medical research. Do you know of anything that's been written about this from a social research perspective?
We recommend two sources for "international" ethics advice:
The RESPECT project: http://www.respectproject.org/main/index.php
...which although European in focus did try to approach the generic issues of transferability of ethical codes between different countries with different political structures and, consequently, variations in legislation - even in Europe.
And the Market Research Society: http://www.mrs.org.uk/standards/guidelines.htm ...given the breadth of their activities you might find something of interest there. In both cases (as well as from the SRA website ethics section) you should find links to other sources.
More generally, it seems you have already taken the first ethical decision - to agree to teach in a country whose politics you consider dubious. However, if it helps, many of your SRA colleagues will be teaching students at postgraduate levels from a range of similar countries - e.g. Brunei, Nigeria, Zimbabwe, China and so on - and they do not baulk at teaching qualitative research methods and raising awareness of appropriate ethical standards "for researchers". And this is the key point - you will be teaching about the need for professional integrity in the interests of "the profession" of social research and there is a sense in which you are participating in setting global standards which are in all our interests. It may be relatively less problematic to do that with international students in the UK!
The next problem, however, requires some ethical decision-taking in situ - such as experienced by the teacher who reportedly chose an inappropriate forename for a class teddy bear in a Muslim country! That is (and the RESPECT code advises this) that you should obey the laws of the country. That may not mean that you cannot question them in terms of ethical research practices (but we would advise you to find out what is deemed appropriate critical questioning first of all) - but you would be doing that "in the context of" ethical research standards. Thus it does not mean that you consider the laws to be ethical. There is no necessary parallel between the law and morality - even in the UK.
Many anthropologists in particular have dealt with research ethics in ways that confront the laws of the country in which they are studying - usually a proscribed group of some kind. But they are risking their own safety and freedom and so are not divorcing themselves from political activity while ostensibly engaged in scholarly research. We would also suggest checking the advice of the various anthropological associations (at least in the UK and the USA).
This is not just a problem of qualitative research. Any research can be considered subversive in any country with little respect for human rights, gender equality and political freedoms.
It goes without saying that you should exercise caution. Draw upon the basic principles that you consider to be globally appropriate in professional research terms and then explore the students’ views about what could be achieved in their own country.
After a lot of thought and preparation, the teaching went smoothly and the experience was positive for both students and teacher. Afterwards, the researcher was approached about undertaking more teaching assignments in the Middle East, and expressed an interest. The SRA asked the researcher to write up these experiences, and what had been learned, for SRA News (as it then was). In accordance with good ethical practice, the researcher informed the commissioning university of this plan. However, the commissioning university did not want the researcher’s experiences and learning to be disseminated in this way, and refused to support or even discuss the matter. No further teaching assignments were given to the researcher. We cannot conclude that this is a direct result of the piece published by SRA News in 2008 – but it seems likely.
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Gaining Access to Respondents (Case Date 2008)
I am an academic from a non-business background conducting a research project that entails investigating the practice of change management in Higher Education Business Schools. Many departments seem reluctant to allow me access – usually to do with information disclosure and confidentiality. It turns out that academia is all for research but shies away from being researched! I would very much appreciate any guidance you could provide, particularly in connection with the type of soft skills necessary to reassure academics on exposure dangers.
We sympathise with your predicament. There is no easy answer. If research subjects do not want make themselves ‘accessible’ then - in accordance with basic principles of research ethics – voluntary participation – there is little a researcher can do about it. It then becomes a question of how best to deal with ‘gatekeepers’ and/or secure respondent's commitments to your ‘cherished’ project which might not be so equally cherished by them.
A first step is always to think of a very good reason for them to get involved. Demonstrate the specific gains to their organisation from involvement. Gains could range from payment, through recommendations for good practice, to good public relations (being seen to be a helpful/concerned organisation).
Often people and institutions will comply because they feel they ‘have to’ or that they ‘ought. Thus the use of a ‘name’ – respected individual or professional association – attached to the project can help. So see if you can encourage anyone to have you exploit their prestige! Often gatekeeping is through neglect and not wilful obstruction. The secret then is to ensure you targeted your approach to the right department and the right person in the department. A preliminary phone call is vital to ensure wasting too much time. If you phone first, you might get passed around but you should eventually end up talking to some nice person who will then be waiting for your formal invitation to participate to arrive and they might then feel obliged to promote your request within the department.
As a last resort you could write an indignant piece for a professional and/or academic journal (such as the Times Higher Education Supplement) about how researchers are reluctant subjects and why they have a moral obligation to their professional colleagues to be more helpful about their research!
These are just a few suggestions. Do not be discouraged - it is increasingly a problem to secure response commitments throughout the research community. Be persistent and imaginative.
Access was eventually granted – reluctantly – after some friendly persuasion was applied. But the respondents’ reluctance to comply produced limited data which undermined the full value the research could have delivered.
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Interviewing NHS Staff (Case date 2008)
I'd be most grateful if you could offer some advice on a project we hope to undertake. Working with the DH we want to conduct an online survey of a specified group of NHS staff to ask about the training and supervision they have received. The staff are based in various locations in England. While this is a light touch snapshot survey, the question has been raised about whether or not we are required to seek research ethics committee approval to do this as it is contacting NHS staff.
I'd be most grateful if you were able to offer any advice on this. Firstly, whether we do need approval for a study of this nature and secondly, if so, which committee we should contact about this. Alternatively, if you aren't able to advise us yourself, I'd be really grateful if you could suggest who I could contact to get this advice from.
This is not as simple as it sounds unfortunately! As at 2001 any research with NHS staff - recruited as research participants by virtue of their professional role requires REC review.[see GAfREC [Governance Arrangements for NHS Research Ethics Committees] paragraph 3.1 - full file on DH Website.]
But the Warner Review (2005) concluded that "...much research, such as surveys, service evaluation and research on NHS staff, does not require ethical review."
However if you look at the NRES (National Research Ethics Service) site you will see that the FAQ's still quote GAfREC.
I would suggest, therefore, that you may have to seek ethics and governance approval for this. Governance can only be given by individual NHS Trusts - this means approaching each of the Trusts from which you wish to sample staff. If you do need ethical approval you will need to go via the MREC system that covers multiple sites. But having the backing of the DH might help you cut through all of this - you would need a "sponsorhip" agreement from them which would expedite the whole process, they might even suggest a "research passport" approach. Whatever MREC you go to should be able to operate a "Chair's action" on a study like this - especially given the Warner recommendations.
It would have been much easier if DH had simply implemented the Warner recommendations! But I suggest you don't take my word for it - contact NRES direct with an e-mail query. Explaining that their FAQ's don't answer your questions.
National Patient Safety Agency
4-8 Maple Street
Tel: 020 7927 9898
Fax: 020 7927 9899
They will not deal with phone queries so: Email: email@example.com
Also the MRS has some useful guidelines on conducting research with employees. They can be found at: http://www.mrs.org.uk/standards/employee.htm
NRES were contacted directly and they affirmed that ethics approval was not needed. Their view was that this would count as a service evaluation and, given the nature of the study, approval was not required.
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Ethics in Observation Studies (Case date 2005)
I am currently undertaking some research on drinking and would like to carry out some observation within bars/pubs. Could you tell me if it possible for me to do this without telling individuals? Would it be possible to put up a notice within venues to say that we were there and carry the research out this way?
Observational research remains a particularly contentious ethical area and with some widely diverging views. If your research proposal is subject to ethical scrutiny of some sort (a research ethics committee - REC) you may find some members regard covert observation work as inherently unethical. If that were true much of early social science would have been ruled out. If no REC scrutiny is required it is up to you, as a responsible professional researcher, to find the best way to protect your subjects and yourself. The section of the SRA’s ethical guidelines that deals with this is: 4.3 (a) (and ff. p31-4)
Not fully disclosing your presence highlights the balance between your methodological requirements and the ethical concern of protecting the subject from undue interference. If there are really strong methodological requirements for (covert) observation, and the study would be worthless without it, you can justify doing it - as long as there are no undue consequences for those under observation. Typically this is done both by concealing their identities and the site of the study. You protect the subject by ensuring that it would be impossible for anyone to find out who you are studying and where you did the study. If you can guarantee this and the "worth" of the study (to society and, possibly, even to the individuals/group under study) outweighs any conceivable harm - your ethical hand is strengthened.
If you do put up a notice your design is inevitably compromised. That is the subjects might behave differently as a consequence of knowing you are there. But, more problematically, this might not even secure informed consent. You would have no evidence, other than the notice, that the consent was truly "informed". (That is usually guaranteed by a signed consent form.) People could say they had not seen the notice and, if they hear about it subsequently, could get upset about being observed. You would then have to design a grievance procedure for redress of any "harm". Nonetheless putting up such a notice has become a standard consent procedure for observational studies.
In all cases it is vital you secure the consent of the owners of the premises. (There may be indemnity issues involved there.) In the USA there is little concern about observations in public places for a range of reasons - people are "observing" each other anyway. Whether they make notes about it, write about it and publish it is a secondary concern - and if people are unhappy about how they are described, and their identities revealed, they can take it to law! Remember journalists and novelists are less bothered about this than us professional researchers.
The important thing is to make a full rationale for however you proceed, including all measures to protect the interests of your subjects.
Also have a look at the MRS ethical guidelines - they also have a clear statement on this.
This request was made in order to inform the writing of a research tender – which was unsuccessful. Although this research was never conducted the advice still holds.
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Supporting a colleague’s research for their dissertation (Case date 2006)
I work as a manager for a health-led programme and supported a colleague to complete a Masters Dissertation. When the researcher was planning the project I suggested that the research be conducted within our programme as opposed to the researcher’s plans to conduct the research in another, more distant site. I offered support for the researcher but this was not taken up and the research project went ahead involving about half of the programme team. The proposed and agreed focus of the research was on partnership working and involved seeking staff perceptions of progress toward meeting government health targets.
I was not asked for my views after data collection. I asked for and received a copy of the submitted of the dissertation but was alarmed at the negativity that pervaded the work and in particular that the data presented did not appear to fairly support the rather harsh findings. I am personally concerned that the researcher asserts on a number of occasions that the programme is effectively managed and administered but ineffectively led.
I have the following concerns:
1. The work appears biased
The research question was supposed to be about partnership working but the findings focus heavily on the leadership of the programme. The findings appear to me to have been distorted. I carried out some informal 'member checking' to clarify if I am indeed biased and, of six participants asked, none corroborated the findings that are highly critical of the leadership and the purported negative hierarchical processes within the programme.
2. There seems to have been little attempt to consider the social and psychological well being of participants whose roles can be identified and therefore the person fulfilling a leadership role and, of course, in particular myself.
3. There was no verification of data at analysis stage only feedback on findings when asked.
4. I am concerned that in the future, in the wrong hands the findings could be misused in relation to my abilities as a leader within an organisation when the data do not appear to reflect this and indeed the research I consented to was not supposed to be focused on my leadership capability.
5. Consent I consented to be involved in research that looked at the programme’s partnership working not a study on the management and leadership capacity/capability of the leaders - whoever they may be deemed to be.
I think that the best route for me to take my concerns forward would be for me to contact the relevant faculty division at ‘Z’ University and share my concerns. Incidentally, the researcher did not receive approval through an appropriate Health Research Ethics Review Committee as it was considered that this was not necessary for the participants involved.
NOTE: After a telephone conversation the enquirer wrote to the course programme leader at the faculty in question. In addition to the points listed above they complained:
1. The participants and indeed the programme are identifiable from a number of descriptions about the setting [DETAILS]. This does not safeguard the interests of those involved in the research or affected by the research.
2. Issues relating to anonymity and confidentially are questioned due to the numerous direct references to the ‘Head of the Organisation’ - a term that is not clarified.
3. Due regard does not appear to have been considered to the consequences of the work or its misuse for those studied due to the identifiable descriptions and lack of anonymity applied.
Your letter does, in a clear and balanced way, reflect legitimate concerns about the way this project was conducted. The main problems arise out of the lack of independent ethical review – which would have advised confidentiality, anonymity and other ways of minimising the risk of harm to the subjects. (It is astonishing that individuals can be identified.) Many of the problems you raise would have been unlikely to occur if formal review had taken place. But the lack of formal review does not excuse unethical procedure. The only problem lies in how one gains redress without either such a review procedure having been conducted or an appropriate channel for complaints being provided (something that is normally required by ethical review committees).
Your suggestion to study your own programme was a reasonable and helpful suggestion. However this is not necessarily advisable since the problems that have occurred associated with confidentiality, disclosure and independence could easily have been anticipated. It would have been better to have conducted the research on another organisation, but with the benefit of the researcher already having some “insights” from their experience in your programme. In any case, you were technically acting as a “research sponsor” as well as a member of the organisation under study – never really advisable.
Given your role as “sponsor” it was best that your offer of help/support was not taken up. Your independence would have been compromised and your contribution potentially biasing the study – given your dual, contradictory, role. One assumes that the researcher had a supervisor within the University whose responsibility is to ensure adequate rigour in approach and design. As one of the subjects of such research and/or sponsor it would have been perfectly legitimate for you to seek more detail about the aims and objectives, as well as the implications of this project. The project title alone is not enough to know what the planned research engagement would actually entail. As ‘manager’ and ‘subject’ this should have been reviewed carefully before the project was allowed to start.
It is a little too late to object to research findings if you have had no previous knowledge of the substance and style of the research questions. It may be that the negativity within the final work is a consequence of the form the research questions took – in which case, the bias was inbuilt. If the research interventions could be independently seen to be “neutral” then the negativity might have to be seen as a genuine outcome/research finding which has to be acknowledged.
You observed that “…the researcher asserts on a number of occasions that
the programme is effectively managed and administered but ineffectively
led. I contest this and have recently completed an independent assessment of my leadership capabilities.
We can all recognise a distinction between leadership and management, but whether these can be judged separately in any research site depends very much on the quality of the research itself. Once again this outcome could be seen as inevitable if built into the original research questions – only independent supervision and guidance could help prevent this. The most concerning aspect of this project is the ability to identify any participants personally. This is unethical unless they gave prior consent.
Whether or not the work is biased is dependent on the points raised above. Whatever supervisory arrangements exist in the University should have ensured that this should not be the case. Without seeing the original proposal and the advice given it is hard to judge this. However, your own “member checking” cannot be seen to be genuinely objective, given your position in the organisation, and your evident grievance. It would be necessary for this to be done by an entirely independent observer/researcher. And this could still be done at this stage – by someone agreeable to you and the University.
If individuals can be identified without their consent and little concern for their social and psychological well being has been demonstrated, then this certainly represents a fundamental ethical flaw in the research as reported by you. And it is something independent ethical review could have anticipated. At the very least, that would have required the researcher to indicate what action they would take if “negative” or damaging findings did emerge.
Whether or not some verification of data by participants at the analysis stage could be allowed is a matter of judgement over research design and informed consent – which can conflict with one another. If it was not sought in the first place, the researcher is under no obligation to provide it unless alerted to the need to consider potential harm to any participant during the progress of the research. (Nonetheless it is bad practice not to address this at the outset and clearly express a rationale for both not seeking informed consent and not seeking ‘participants’ views at data analysis stage.)
The potential ‘misuse’ of the findings and the judgment about your leadership are the main grounds for your grievance. As a participant in the project (i.e. a “subject” of the research) – given the mitigation implicit in all the points made above – this is legitimate grounds for complaint. This could be seen as a personal attack and damaging to your reputation and your future career. The problem here is that you may have no formal channel through which to complain.
The formal consenting process required again depends on the original project design and any required ethical procedures. You can have additional grounds for complaint if there were procedural errors that might normally be required by any independent ethical review committee. For example, if you were given an information sheet explaining what the research was about and the research turned out to be something other than originally promised, or if you were asked to sign a consent form which allowed you to withdraw if the research process was of concern to you – in fact, you should be entitled to withdraw without giving any reason. But the project is certainly ethically flawed if no opportunity to withdraw and/or complain was offered. Contacting the University directly may be the only route open to you.
You comment that “…the researcher did not go through a Health Research Ethics Committee as ‘x’ considered that this was not necessary for the participants involved.” However, whether this was “necessary” largely depends on the individual subjects involved. Independent review by an NHS Research Ethics committee is essential if NHS patients are being interviewed as patients. In such a case submitting to the NHS Research Governance process would also be required. The former is supposed only to be concerned with ethics (such as minimising harm and seeking informed consent) while the latter assesses research design and the “scientific merit” of the project as well as any institutional risk. In fact, such committees will, if time is available, offer independent assessment on any project if requested – seeing value in their general advisory role.
In any case, such projects should be independently assessed within the University’s own system. Admittedly not all universities presently have an independent ethical or governance review system, although there are UK-wide developments in this regard. This might have been done in ‘Z’ University. If so, you should have been informed, and your seeking of redress should, in the first instance, be to them. If not they should be advised of the need to do this in the future and you should expect some form of redress from – in turn – the student’s supervisor, the course director, the head of department and the vice chancellor.
As to whether or not you should seek redress, given the caveats implied in my comments above I think you do have grounds for complaint. At the very least you could ask for the research findings to be embargoed indefinitely and, subject to legal advice, you might have a case for libel.
The state of ethical and governance review of student projects not subject to NHS RECs is still rather ad hoc and a matter of local variation – hence why it was suggested earlier that caution needs to be adopted during the planning stages of any project such as this.
Thank you for your very measured reply it has helped to set the dilemmas in context and for your honest approach I thank you. I guess in essence I lay the programme and myself wide open and this I will use as a learning point. The University were not at all interested in the queries raised and I decided that as it was only a dissertation that it was best left without causing too much of a stir. What I learnt was that it is important when, as a manager, you support a dissertation or research project that clear reporting is agreed through all stages of the research process.
SRA Forum members find it unfortunate the University did not see it necessary to respond to the enquirer’s concerns.
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Inclusion and Exclusion from a Trial Intervention Programme (Case date 2003)
We are conducting a social experiment in a trial intervention for a novel social services programme. At the moment we are saying that participation on the programme/intervention is conditional on participating in the research, in other words that if a person withdraws from the research they no longer receive the programme. We spell out that this is the case i.e. that they are free to withdraw at any time but that this has the consequence of them no longer receiving the intervention.
The thinking behind this is threefold:
(a) the assumption of the evaluation is that we do not know if the programme works or not, i.e. to withdraw from it may or may not have adverse consequences for the person;
(b) a lot of the information collected for the research is also useful for the service provider, indeed we plan to move to a situation where the information they routinely collect (to help tailor the intervention) and what we need (for the evaluation) is the same - in other words, there is a case for saying that if a person chooses not to contribute the requested information the programme cannot be delivered properly;
(c) as a comparison we understand that it is normal in medicine for receipt of a new
drug to be conditional on participating in a trial.
Can all these elements be considered to be ethical practice?
The assumption behind (a) is a reasonable one to make since this is a novel intervention, whether or not it has an “effect” (positive or negative) is presently unknown – this means that, until the completion of the trial, whether one is receiving beneficial or damaging service cannot be assessed so one may not be “depriving” anyone who withdraws of anything that could benefit them. (One may even be allowing them to remove themselves from further “harm”!) This resembles normal drug trials procedure – the subject resumes “normal treatment” or “standard treatment” (i.e. what they were receiving before the trial) and in the social experiment they would be receiving the original service.
Point (b) mixes a service audit issue with that of data protection. Routine data collection (within the terms of the Data Protection Act) is an “expected” cost of participation in any government service provision. The “penalty” to the client/research subject for withholding such information can be seen to be “reasonable”. That is, non-compliance with the accountability/service requirements of the social services agency entitles the agency to withdraw the provision.
Ethical social research requires that the research intervention is kept separate from the normal audit requirements of the social services. If audited data are to be used for secondary research in a non-anonymised manner, the permission of the service user/research subject is required. If the research intervention is seen as an addition to normal service delivery, then the service user can be treated as a voluntary participant. But, as above, the consequence of withdrawal from the study must be made clear to them – this means they must be “just as entitled” to “normal service provision” as they were prior to agreeing to participation in the trial.
The last point (c) is not strictly true. If the new drug has already been fully trialled then the decision to use it is a “negotiated” one – between physician and client. During a trial the patient should not be able to know if they are actually receiving the drug or a placebo – neither, of course, is the physician supposed to know when the trial is properly “double-blinded”. If a patient withdraws from such a trial they will neither be receiving the new drug nor the placebo (or “standard treatment”) all of which depends upon the trial design – they should then be entitled to receive normal treatment which is what they would have received prior to entry into the trial. A great deal then depends on the nature of the formal health service obligations of the country in which the trial occurs.
Overall the social experiment as proposed can be considered ethically sound as long as the participant is fully informed of all their options prior to agreeing to participate.
The study was completed successfully. Participants were invited to apply for the programme and told that places were limited. They completed paperwork accordingly. This included the research measures but was also used by the team delivering the programme to help tailor the programme to the young people (it was decided to do this to minimise the amount of paperwork young people had to complete). Candidates for the programme were told that after completing the initial questionnaire their participation in the programme was conditional on them taking part in the research study but that they had the right to refuse or withdraw participation whenever or for whatever reason they wished. However, reviewing the consent forms we could (and should) have been clearer that services as usual would continue to be provided whether or not participants withdrew from the programme under scrutiny or the research. My recollection is that this would have been made clear verbally and certainly referring agencies would have known this but we don’t state it explicitly. In the event, no young person expressed a wish to withdraw from the study but remain on the programme. All instances of withdrawal were programme drop-outs who withdrew from the research subsequently.
The study reference is: Berry, V., Little, M., Axford, N. & Cusick, G. R. (2009) 'An evaluation of Youth at Risk's Coaching for Communities programme', The Howard Journal of Criminal Justice 48 (1), 60-75.
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Interviewing Young People – Disclosure of Abuse (Case date 2003)
Under what circumstances should a researcher pass on to a service agency information that a young person - or for that matter a parent - discloses (e.g. instances of abuse or domestic violence)? What is the best way of passing on such information (e.g. what is said to the respondent)?
There is no advice on “best practice” in the SRA guidelines for such a situation since
this is really one of those “most testing” dilemmas that raises many conflicting concerns which would depend on the details of the individual case.
It is clear that since the problem is disclosed to the researcher “in the field” then they must take the decisions directly since they hold ultimate ethical responsibility themselves – whatever the project design, their manager or supervisor advises or promises. This means that although most ethical guidelines recommend compliance with the law (national and international), the researcher must make the ethical decision about responsibility to the respondent/participant if illegal activity is disclosed. It is against the law in the UK not to report incidents of criminal activity that are disclosed to anyone (including researchers) since they become “accessories” and/or “obstructing the course of justice” if they fail to report.
Putting aside legal requirements, the judgement should be made first by estimating the “balance of harm” – something that clinicians will also do – even though in both cases that will not offer them legal protection if the law requires reporting the illegality. Since this is unlikely to come to light by other means this failure to obey the law appears never to have been tested in the courts in the UK.
The most pragmatic way of dealing with this is to ensure that respondents are aware
of the necessity of reporting such a disclosure either in a consent form and/or in any explanatory documentation about the research given to participants beforehand. That should cover any “unintended” disclosures coming out. But it also protects the researcher if a respondent willingly discloses some illegal activity.
A bigger problem occurs if such illegal activity is the “topic” of the
research. Once again neither the criminal law, nor the Human Rights Act
offers any help here. It can only be tested in court and that would depend on someone seeking to prosecute the researcher.
Even if the respondent was made aware of the researcher's legal responsibility to report such activity prior to the commencement of the research, and if such a disclosure did occur, the researcher should then inform the respondent of their requirement to report the offence either to the police or to social services or, even, to a voluntary agency who might offer advice and guidance prior to legal action being taken.
Taking an ethical, if illegal, line the researcher might decide that reporting was not in the best interests of the respondent. The problem remains that if the activity was later reported to someone else, who did take the legal action further, the researcher who had earlier heard of the incident and did not report it could leave themselves liable to prosecution. If the activity reported fell short of the illegal but might be suggestive of a “problem”, then a sensitive “debriefing” policy is necessary – one which helped the researcher “counsel” the respondent towards the most appropriate service
agency for support. In all cases this shows how important it is that researchers receive full training in the law, their responsibilities under it, what alternative agencies can offer help and guidance in making ethical decisions.
There were two strategies chosen in our approach to disclosure. First, we agreed, before the survey began, a set of trigger thresholds with the health authority on our measures (self-completed by parents and children) which taken together would suggest the child’s situation met a case of probable harm. Second, we were clear that all data provided by the respondent and/or child was to be kept confidential. Where families met the threshold, the respondent would be sent a letter indicating that there was concern about the family’s situation and given the name and contact details of the relevant professional to contact for help within a week. No details about the nature of the concern would be given in the letter, to avoid escalating the danger in domestic violence cases. The child protection professional would be told only that the family had met the pre-set trigger thresholds; no specific details or data would be passed on. If the family failed to contact the professional, the health authority would follow standard protocol for following up a child protection referral.
In the event, no cases in this survey met the trigger thresholds for disclosure.
The thresholds and process in this survey were published in Berry, V. (2009) ‘Ethical considerations in conducting family violence research with children and families’, Research Ethics Review, 5(3), 91-98.
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‘Independents’ Seeking Ethical Review (Case Dates – various over ten years)
We have frequently received requests from independent researchers and/or research organizations with no ‘internal’ means of formal ethical review, or even an evident requirement for ‘external’ formal review. Admittedly this has decreased over the years but some small research organisations still find themselves wanting to have their proposals/plans reviewed and not knowing how to do it. Additionally there have been enquiries about whether formal ethical review is always necessary. For example, small research organisations might be awarded a grant to carry out a study after a competitive tendering process. Many small social/market research organisations don’t have easy access to any system of ethics review, and while ethics review is not normally sought or required within the market research community, some potential respondents might ask if it has been conducted. A successful review might therefore remove a potential hurdle – though an unsuccessful one could create major problems. Over the years we have made the suggestions below.
1) Try approaching an HRA NHS Research Ethics Committee - via the administrator to see if they are willing to review a project even though it is not immediately NHS-relevant. The Social Care Research Ethics Committee (which is part of the HRA) reviews a range of projects that are not specifically NHS focused, and has a good level of knowledge about qualitative research and survey research. However, the review process is quite cumbersome, with all documents needing to be reviewed, and the process can take quite a long time.
2) Try approaching a university that has a research ethics review committee – at ‘faculty/departmental’ level. Experts inform us that they have had success with such an approach while similar considerations made in Point1 apply. It is preferable to seek a review from a relevant (i.e. in terms of discipline or profession) faculty or departmental committee rather than a central university one (for the same reasons as above).
3) The SRA has helped out some organisations on an ad hoc basis and for a (small) fee by setting up a review of a proposal via our ethics forum. Thus we reviewed for a large funding organization by asking three reviewers to assess a project proposal and fed back suggestions that the commissioner asked the proposer to meet. This may even meet funding requirements for UK Research Councils.
In all cases these cannot be seen as formal ‘approvals’ in the sense of being essential to the award of a grant. Instead they should be seen as forms of external/independent advice.
4) Some (larger) research groups have set up their own internal review committees. However some agencies that once offered to review proposals no longer do so on the grounds that some researchers could be attempting to circumvent either the rigour or the time delays of formal reviews. It is certainly worth organisations setting up their own scrutiny arrangements if successive applications were anticipated and the resources were available for doing so. (In the current climate the expectation that formal review is conducted is increasing so this may be worth doing.)
5) Guidance may be found for the criteria normally applied for approval within the literature on research ethics.
For example, researchers could usefully test their proposals against the checklist in: Iphofen, R. (2011) Ethical Decision Making in Social Research: a Practical Guide, (paperback, Palgrave Macmillan ISBN 978-0-230-29634-3
(The checklist is freely available on the publisher's website for the book.)
6) Formal ethics review is neither a legal nor professional necessity in many areas of research work. Trust in the professional integrity of those conducting the research should be possible on the basis of their prior track record and membership of an appropriate professional body. Respondents are unlikely to challenge researchers in such a situation. Sound practice suggests the researchers should make it clear (to respondents and commissioners) how they will conduct their “consenting procedure" – there is no one way of doing it. The same applies to "information-giving" statements for respondents to clarify how confidentiality, anonymity and reporting/dissemination are to be handled.
7) While not providing a formal ethics review system, the Market Research Society do have a code of conduct and a Professional Standards Committee, which monitors good ethical practice for its members. See https://www.mrs.org.uk/standards/code_of_conduct/
Of course this is not strictly a ‘research ethics review’ but is a way of attempting to ensure that certain professional research standards are being met and some research funders may accept such a review – particularly if the research is more clearly ‘market’ research.
8) It is in response to the needs expressed above that the New Zealand Ethics Committee (NZEC ) was established. Researchers can access this facility too: http://www.nzethics.com/
NZEC is not an ‘approved’ nor an ‘approval’ committee but it is recognised by the National Ethics Advisory Board as part of the ethics fabric in NZ and endorsed by the Royal Society of New Zealand. The two articles below are drawn from a survey of applicants to the NZEC — these applicants from central and local government, NGOs and community research had no ethics review committee to go to as they were neither in the health or university sector which has mandatory ethics review. NZEC markets itself as a powerless ethics committee focusing less on governance and more on relationship building:
Marlowe, Jay and Tolich, Martin (2015) "Shifting from research governance to research ethics: A novel paradigm for ethical review in community-based research." Research Ethics 11, no. 4: 178-191.
Tolich, Martin, and Marlowe, Jay (2016) "Evolving power dynamics in an unconventional, powerless ethics committee." Research Ethics 1747016116657015.
This approach has to be seen as supplemental to or complementary with formal ethics review and might not be seen as a substitute for it by commissioners/funders. All researchers could benefit from having a sympathetic and supportive group to help with ethical (and sometimes methodological) queries – just the sort of role that the SRA Ethics Forum has provided for some years now.
9) It must be borne in mind that, in some research spheres, gaining ethical approval is necessary in order to be permitted to conduct the work. Even independent researchers should ensure they are ‘covered’ by seeking approval from the appropriate ethics review committee. As an example, if you are conducting research into children’s services and want to involve four or more children’s services departments in your project you should submit your proposal to the Research Group of the Association of Directors of Children’s Services Ltd. (ADCS) for a critical appraisal.
Researchers have occasionally been successful in securing NHS committee reviews, but most have established their own or asked one or two advisers to review their proposals. Most researchers find it useful to follow and declare their adherence to the ethical codes and/guidelines promoted by their own professional associations. SRA Ethics Forum members continue to offer informal review when asked, as does the New Zealand Ethics Committee. There has been increasing use of formally appointed ethics advisers as a consequence of policies devised by the European Commission (EC) – the appointment of such creditable advisers is a way of ensuring some form of oversight without formal review. The following EC agency keeps a list of all such experts. They are not allowed to formally recommend specific people but maintain a list of those who have acted and can act in such a capacity and their specific areas of expertise. Contact:
Head of the Ethics and Research Integrity Sector
DG Research & Innovation
Scientific Advice Mechanism
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Internet survey with children by children (Case Date – originally 2010 but occurring occasionally since then)
The National Children’s Bureau (NCB) have been approached by a third party and asked to advise them on the use of an online survey aimed at young people between the age of 14 and 18 years, seeking their views on crime and their ideas on what can be done to reduce the fear of crime among young people.
The survey questions have been developed by a group of young people, who are keen to get the views of as many of their peers as possible. They would like to put the survey out on their website, for any young person to complete if they so wish.
Our initial response to the party concerned was that they would need to seek parental consent to survey young people under the age of 16 years. Or have a screener page at the front of the survey, so only those aged 16 and over could go on to complete the survey (or indeed those under 16 years could provide details of their parent/carer, for someone to contact them to gain parental consent before the young person continues the survey - an approach detailed in the Market Research Society's (MRS) Code of Conduct).
We are currently in the process of considering our response to this issue and were wondering what the SRA's Ethics Forum members’ views were on online surveys and parental consent for young people under 16 years? Is it advisable to always seek parental consent for online surveys? Are there instances when it would be okay to put a survey up online for any young person to complete, even if they are under 16 years?
We currently work to the SRA ethical guidelines and would welcome any thoughts/views members of the forum have on this matter before we make any decisions on our policy in this area.
Our view is that your initial response is probably the best short-term solution to this. And we are sure you, at the NCB, have more experience and (with your own ‘basic principles’ in mind) the most advisable policies with regard to research with children in general.
We think the issue here is with the growing area of online research which means that, with the best will in the world, there is no way you can easily guarantee to ‘police’ the consenting process. So while there is in principle no problem with those over 16, and even those under 16 with ‘sufficient understanding’, giving their full consent to participate you may not be able to prove their age and their keenness to respond might lead them not to be entirely honest about their age.
All web researchers need to have transparent practices that in essence ‘cover’ them for normal ethical regulations. Hence it might be suggested that your enquirers need two surveys for their overall age group – one for those under 16 and another for those over 16. The under-age group could/should be asked to ask their parents for permission to respond. How you then check this has been done other than seeking parents’ consent directly is problematic.
Our experts see this as in some ways the standard methodological limitation on web surveys. While normally the ‘informed’ bit of the consenting process depends on the length and complexity of the survey and also how participants are notified; a 16+ limit for non-invasive, non high risk research would not need parental consent as they could be considered to ’have capacity’. Though this could depend on the group targeted and, once again, if they are self-selected via a website there is no way of knowing this. We do understand the resonance of using the Web for this purpose – both by and for younger people for whom it is a central source of communication.
In fact, our Forum are not sure whether the MRS rules (or any other rules for that matter) can strictly apply to young people seeking either to send a survey out to their peers, or to put it on their website. No research ethics code covers this sort of survey, or could it since they are ‘voluntary agents’ with no adherence to a professional association.
Indeed we think you should advise the people concerned that either placing a questionnaire on a website or sending out an email to all and sundry does not constitute a ‘survey’ in the normal sense of the word. What is missing of course is an attempt to get a representative sample, which is extremely difficult in web surveys anyway. Otherwise it is much more like a magazine pull-out 'survey' or seeking of a ‘vox pop’ which would not qualify strictly as research. In which case the most appropriate code could be a journalistic/media one.
Strictly the SRA can advise only on the ethics of surveys, not on the ethics of mass mailings or web networks that might be better suited to social media – such as Facebook. As with a great deal of current ‘e-research’ there is considerable overlap between the methodological and the ethical. Some e-researchers claim that the tempting potential of huge sample sizes deals adequately with response errors and the ‘public domain’ nature of the Internet, in itself, covers their consenting limitations. We are not inclined to agree with that approach.
There is considerable and growing expertise in this field. Indeed we recently had a query about some of the ethics of the “Survey Monkey” system which on enquiry we found to be quite sound. They were very responsive and speedy when we put some questions to them, so perhaps your enquirers should seek their advice too. We also suggest looking at the Oxford Internet Institute. They had an ESRC project under the National Centre for E Social Science [NCeSS] on the ethical issues raised by research on the Internet. (Dr Bernie Hogan was the contact name for that.)
One of our most informed contacts in this field is Charles Ess (who published a book on Digital Media Ethics and was President of the Association of Internet Researchers until 2009). The ESRC ethics framework (FRE) has a short paragraph that is relevant:
Why should internet research receive full ethics review?
In a fast developing area RECs may need to involve an independent expert is assessing research proposals that break new grounds. Internet research and other research using new technologies can take place in a range of settings, for example, email, chatrooms, webpages, various forms of ‘instant messaging’. These can pose new ethics dilemmas. For example, what constitutes ‘privacy’ in an online environment? How easy is it to get informed consent from the participants in the community being researched? What does informed consent entail in that context? How certain can the researcher be that they can establish the ‘real’ identity of the participants? When is deception or covert observation justifiable? Researchers, research participants and reviewers of research ethics will often encounter new or unfamiliar ethics questions and dilemmas. There is a growing literature on ethics in online research. A good starting point is the Association of Internet Researchers Guidelines and the BPS ‘Conducting Research on the Internet: Guidelines for ethics practice in psychological research online (updated 2015)’.
Unfortunately like much of the FRE it does not answer these questions - they are problematised but not resolved! In truth there is still little one can do about anyone putting out a series of questions on a web page – other then the service providers’ normal regulations and the appropriate national legislation that may apply.
What also concerns us are the claims that could be made for the ‘findings’ from such a process. From the information we have this could only be a ‘survey’ in the very broadest sense of the term – certainly not rigorous research. That too is an ethical issue!
The NCB replied that they advised the enquirer as above and have since (2016) confirmed that they would say something similar currently. What is described in the case study accords with what NCB advise now regarding online surveys and consent for under 16s – sometimes they advise those running the survey to devise an information letter/sheet for parents which can allow them to opt out their child and, in quite a few recent instances, it has been schools administering the online survey so NCB have helped them to devise processes for getting parental consent or to opt out ahead of the survey actually being run. The Ethics Forum is always pleased to have their views confirmed by other experts in the field and a consistency in approach clearly helps researchers feel a little more secure in the approaches they adopt.