Research ethics. Why handbooks and guidelines don’t help.

Posted by Heather Yoeli

If you had asked me, before I began my PhD, to define research ethics, I’d have told you that ethics is about morals and values, about how and why we conceptualise, construct or differentiate right and wrong and about what we do with our judgments or perceptions of right and wrong – and that research ethics is thereby about how we promote the personhood and dignity and human rights of our subjects, and about how we know that what we’re doing isn’t going to harm them. I was idealistic, principled, and, fresh from a Religious Studies degree, prone to expressing my every academic thought in an 85-word sentence, and prone to using too many commas. These days, I’d define research ethics more succinctly, and less naively: it’s about placating the insurance companies by assuring your host institution that you won’t do anything that’d get them sued, and it’s about following the rules.

Within health academia, the contemporary drive towards research ethics developed primarily in response to the horrific atrocities committed during the clinical and epidemiological ‘research’ undertaken by Nazi doctors in the World War II concentration camps. In 1947, the Nuremberg Code was published, and in 1964, the Helsinki Declaration, most recently updated in 2008. Both of these documents provide clear standards and principles designed for researchers to interpret and apply with regard to their own contexts and situations, but never a how-to guide to manage every conceivable scenario. In conceptual terms, this is known as teleological ethics: advocating doing what is right, however this is to be achieved. But many people criticise teleological methods for their inherent lack of common-sense safeguards. For example, it’s great that the Helsinki Declaration tells us (Section A5) that we have a particular duty to those underrepresented in research, but how far can I go and what can I do to find the underrepresented of Cowgate?

Josef Mengele: one of the leading Nazi doctors in the medical research programme at Auschwitz

Within the UK academic community, research governance has appropriated responsibility for ethics, ensuring that every university, NHS Trust and Local Authority produces a detailed handbook of rules mandating what researchers should do in absolutely any situation they may encounter. In conceptual terms, they provide a deontological ethic: stipulating that the rules are followed, because rules are rules and the organisational insurance provider has set their premium on the understanding that the rules will be followed.

The problem, however, with such a deontological minutiae of rules is that it reduces research ethics to a vast set of forms to be completed and a prescribed sequence of actions to be completed. By depriving researchers of the capacity to think for themselves about what might be right or fair or appropriate in their own particular study, such handbooks prevent researchers from using their creativity to respond innovatively to the most vulnerable of participants.

Throughout the history of research, ethics has been an evolving, changing discipline, always discussing responding to the new challenges it is posed. A few years back we were considering whether it was ethical to accept typewritten student essays (in case somebody else had written it) and a few years before that we were considering whether it was ethical to accept women into medical schools (because the academic pressure might disrupt their menstrual cycles). Today we’re considering gene therapy and social networking, and the lesson from the history of ethics is that the generation below us will see no problem whatsoever with mitochondrial gene transplants or Facebooking study participants – assuming, of course, that mitochondrial disease and social media still exist. But when all of our ‘ethics’ comes distilled in a university or NHS-approved directive of ordinances simply to follow, and when we know that we’ll never get our proposal agreed without doing exactly what we’re told, it can be hard to innovate, or even to think. For example, I know that I should anonymise all data (Northumbria University Research Ethics and Governance Handbook, p.20), but am I not permitted to make an exception for the participant who says she will consent to participation only if I agree her real name when quoting from our conversations in my PhD thesis?

Or, to put it more succinctly, we’re all spending too little time thinking about how we can do the very best for our research participants because we’re all wasting too much energy poring through the rulebooks and filling in the forms.

Am I right? And if so, what does it mean that I’m right? And if I’m wrong, what do you mean? Discuss.

Research, personal information, information governance etc.

Posted by Rose Watson

So, we all know about the Data Protection Act. 

We all know that if we want personal information about people (e.g. research participants) then we have to get ethical approval to obtain that information and that this  requires us to state how and where that information will be stored; who will have access to it; and what we will do with it. We have to promise to keep it confidential. We also have to inform our participants of the same details. This is particularly true if we require access to NHS patients or staff for our research. 

Firstly a favourable ethical opinion must be sought and there is a national system for this: the Integrated Research Application System. Secondly, each NHS Trust who will be involved in the research must validate something called a Research Passport, another national system (invented by Mr Bureaucracy, as written about by Bronia Arnott a short while ago). It basically boils down to this – if you are employed by a Higher Education Institute (HEI) you fill in some forms about yourself, you get a criminal records bureau (CRB) check to check that it is OK for you to work with children and/or vulnerable adults and you undertake an occupational health assessment. This is all signed off by the HEI human resources department and then sent off to the lead NHS Trust Research and Development Department to be validated. 

This protection of people is all good. I hope my personal details held by others are well guarded too. Nobody wants to think that the people and organisations we have trusted with our personal details will just go around giving them to anyone willy nilly. 

However, as researchers, we are expected to hand out our personal details on a regular basis, often in duplicate, without any information given to us about how it will be stored, who will have access, what it will be used for (although, it is implied that it will only be used to check you are suitable to work with children and/or vulnerable adults). This is all fine, I expect to give a certain amount of information about myself, I understand the need to safeguard people (and of course to not bring research into disrepute). 

It does worry me though. These are my personal details after all. Of course there are the issues with the system not being entirely followed and NHS Trusts obviously feel the need to cover their backs in case anything should go wrong, hence all of the duplication. Risk averse society and all that jazz. 

However, in the spirit of being risk averse, I would ask that my personal details are also treated carefully. With the same due respect I give to my research participants’ personal details. Unfortunately my details have now twice been lost in the post in this system. I would ask that people let me know why they are collecting information (especially details which are extra to the national Research Passport system); where they will store it (and please, a bit more information than ‘electronically’: what on earth does that mean?); and who will have access to it. These are simply the same questions that researchers must answer (and rightly so) when they ask people for personal details.

In short, it is perhaps time we were all a bit more conscious of the personal details that people are collecting about us as researchers. Do they really need ALL of that information? Why? What about how it is transported?

This post would have been about bureaucracy, but it got caught up in red tape

Posted by Bronia Arnott

When your research is funded it is such a great feeling. You have spent hours toiling over your budget spreadsheet, having it rejected by the Institute finance officer, reclassifying your directly incurred and indirectly incurred costs. You have carefully crafted your theoretical argument and honed your methodological choices. You have even agreed to do another systematic review. And all that hard work has paid off; your research grant has been funded. Now that the money is finally in your hands you can do what you wanted. Right? You clearly haven’t worked in a University before, have you? 

If you had, you would have met the Director of the Institute of Red Tape: Mr Bureaucracy*. Mr Bureaucracy doesn’t care what your research project is, how much money you got, or who it was funded by; all that he cares about are rules and regulations. Before his promotion to Direction of Red Tape, he was Head of Health & Safety. The most impressive thing on his CV to date is his design of the Research Passport System.

I wouldn’t mind but I’m not asking to go out and buy a designer handbag with the money, I’m not asking to inflict torture on participants, I’m not even suggesting that my colleagues and I go on a round the world cruise; I’m asking to do what I said I would do and what I was funded to do. If I carefully researched the cost of an iPhone, made sure I put it into the right costings column on my grant application, and then the funding body agreed that we needed it so that we could develop a smartphone app to investigate mHealth then please, PLEASE, don’t tell me that a Nokia is just as good AND significantly cheaper.

Thankfully, all of the staff within my research institute who deal with finance and research governance are absolute stars and are not like Mr Bureaucracy at all. But if you do come across him please let me know; I need to speak to him about an iPhone.

*This character is entirely fictional, and any resemblance to any individual dead or alive is coincidental.

Routine Secondary Data

Posted by Lynne Forrest

We all know what a nightmare it is trying to recruit participants for research studies. So if you only have to get hold of some routine data that’s just sitting there, well, that’s going to be much simpler, isn’t it? You’d think....

The plan for my PhD was to look at inequalities in cancer care by linking cancer registry and Hospital Episode Statistics data for lung cancer, and also linking to audit data. This is routine data that has already been collected and so I naively assumed it was just a case of getting ethical approval to access the data, finding someone to cobble the data together and off we go. I wrote an optimistic project timetable where I would get my hands on the data about seven months into the PhD. Eighteen months in I’ve finally got hold of some unlinked data and I’m still waiting for the rest.


I don't work for News International, so what's the problem? Photo: Christian Sinibaldi

So, what went wrong?

I think my first mistake was assuming that just because the data was there it would be easy to get hold of. There are a lot of hoops you have to jump through first.

I thought that what I wanted to do was simple but it turns out that it’s not. This is apparently the most complicated linkage that the cancer registry has undertaken and the bottom line was, nobody wanted to do it. I spend a lot of time begging people to speak to me and basically being fobbed off, in the nicest possible way. Luckily I eventually found a newly-joined analyst who was willing to give it a go. I’m not sure that she’s thanking me now...

Issues then arose of whether the data I wanted might be identifiable. Variables such as date of birth and death are classed as identifiable and individual records are ‘potentially-identifiable’, even if they don’t include identifiable information (which is an excellent catch 22 – they are identifiable even though they are not identifiable...)!

Finally it seemed like it was all coming together. I’d agreed with the registry that they would supply me with anonymised data containing ages rather than dates, I’d made it through ethics, and I’d got some data. But, on checking, not exactly the data I wanted. So, currently I am discussing with the registry how it will be possible for me to calculate survival time if they won’t allow me to have data on the number of days from diagnosis to death. Survival from lung cancer is short and rounding to the nearest year isn’t going to identify survival differences with any degree of accuracy.

The sticking point is that although they are not supplying me with date of death I could theoretically work it out from this information and that makes the data (aaagh!) ‘identifiable’. However, as I don’t have an NHS number, date of birth, or place of death, I don’t know how I would identify anyone from the 140,000 records I have. Plus I’m a researcher, not a News International journalist, and I’m not interested in anyone individually, so I’m not going to attempt to do this.

Can’t I just sign something to that effect and have the data I need please?

A case of mistaken identity?

Posted by Janet Shucksmith

Towards the end of my undergraduate days I was directed to the notoriously duff University Careers Service. With no inclination to follow traditional Cambridge careers – think Burgess, Philby and MacLean spy ring or Cleese, Cook, Fry, Frost showbiz alumni – I told the careers officer that I wanted to make a difference to the world. Lacking information on entry level schemes to Supergirldom, he gave me a leaflet on the UN. Luckily for the world’s population, I grew up shortly thereafter.

Traditional Cambridge career: Footlights, 1981

My grown up understanding is more modest: as public health researchers we should perhaps be content to make small contributions. It is also morally unacceptable to claim more power for one’s work than is sensible when recruiting participants. I remember community education workers telling me how difficult it made life when youngsters naively believed things would change as a consequence of their research contribution – that they would get a dedicated playground with skateboard ramp or a sexual health service. The workers were the ones who had to cope with the let down kids when commissioners shelved our research report in the drawer marked ‘Pie in the Sky’.

Now our participant information letters are tediously correct in pointing out to people that they will get nothing personally from contributing to our research and nothing may change as a consequence. The best we can promise is that they will suffer no harm or detriment to the service they receive. Given this rather depressingly realistic estimate of how unimportant and inglorious research is, it still takes me by surprise that the general public occasionally invests the researcher with power beyond anything I currently dream of.

Lawrence, my PhD researcher, was castigated frequently by the citizenry of Gateshead last year for having singlehandedly introduced the National Child Measurement Programme. Whilst trying to explore the impact of the policy, a number believed him to be the original perpetrator of a rather unpopular regime, and called him to account for not having thought through the impact on children and parents.

Recently, invited to present research evidence to a local health scrutiny committee, my colleague and I spoke about a specific project on the impact of Human Resources leave policies on carers of those at end of life. At the conclusion, a councillor drew herself up to her full height and demanded to know why I had decided to close their local palliative care hospital? What on earth had convinced her that I had the responsibility and power to do any such thing? Me? I’m only a researcher, madam. You mistake me for someone with power and authority.

My worst case of mistaken identity came when we undertook research prior to the implementation of HPV immunisation. Despite ethically approved invitation letters and information sheets, it became evident that many parents thought we had come not to ask their views, but actually deliver the ‘jag’: despite our lack of medical qualifications or kit. We were more alarmed when it became apparent that many parents believed the vaccination was a precautionary small dose of cancer, and delivered straight into the cervix! The very limited permission we had to explore perceptions was construed by some as being sufficient to allow us to lay their children out and perform an intimate intervention. So much for informed consent?

As a researcher, one often feels relatively distant from the intervention that is being evaluated. But Joe Public sometimes has a great deal of difficulty working out our researcher role and distinguishing us from the rest of the cohort of powerful but unnamed and unspecified authorities who ‘do things’ to them.

Data sharing

Posted by Jean Adams

As you may know, I am fairly relaxed about the idea of sharing data about me for the purposes of research.  But now I find myself in a dilemma about sharing my research data.

The vast majority of public health research funding in the UK comes directly, or indirectly, from government, or charities. As someone who has benefitted personally (they pay my salary) and professionally (they pay for my research) from this public funding, I feel some duty to remember who is paying for it all. I make efforts to share my findings with the public, and have tried to learn how to do this better. I believe strongly in the very concept of Fuse and the need to engage with those working in public health policy and practice to ensure that my research is relevant and usable, and is used.

The research data produced as a result of my public funding is not my data, it is our data. I know this. And yet now that I have been asked to share some, I keep trying to think of reasons not to.

Sharing is caring

A few years ago, Ofcom introduced new regulations on the content and scheduling of television food advertising to children. A complex definition of what constituted ‘unhealthy’ food was devised and the regulations prevented advertisements for these foods during programmes that have particularly high child viewerships. We were awarded funding from a consortium of public and charity funders to explore the impact of these regulations on what advertisements children were seeing on TV.

The research was very data intensive. We bought a large spreadsheet of information describing every single advertisement on UK television over four different weeks – before, during, and after the regulations were implemented. From among these 2.5 million adverts, we picked out the food ads and collected separate information on the nutritional content of every food advertised. Next, we worked out which foods met the definition of ‘unhealthy’ and compared the number of ads seen for unhealthy foods across our four study weeks. You can imagine that it needed a very special sort of person to have the patience and attention to detail to do all of this. It took her a year.

Our findings were published last week and there was a small amount of media coverage. I thought it wasn’t enough coverage, but it was enough to attract the attention of a snack food marketing organisation. Now they would like to know if our data could be used to track changes in snack food advertising. They are even suggesting that they could pay for a researcher to perform such an analysis.

I feel deeply unsure about getting involved in this. As someone who has real concerns about the public health impacts of the food industry in general, merely speaking to these people feels like dancing with the devil. But, presumably my publically funded data belongs to British industry as much as it does to the British public.

Right now I am employing delaying tactics – and not just writing this. Soon I will have to make a real decision about what to do.

Research governance - or is Jean a geeky weirdo?

Posted by Jean Adams

It took me a while to work out what ‘governance’ means – and a lot of “I know this might be a stupid question, but…” My conclusion is that research governance is about maintaining high standards of research conduct. This includes not breaking the law. And who would have known there were so many laws that I could break, sitting here in my university cubicle, geeking around with data and statistics?

This week’s saga involves linking disease register data to Hospital Episode Statistics (HES) data. Now stick with me here, because I hope this is going to be more interesting than you think right now.

A disease register collects information on all the people with a particular disease in a particular area. Fuse has access to quite a few different disease registers. Hospital Episode Statistics is a massive database of information recording every treatment delivered in hospitals in the UK, every outpatient appointment that takes place, and the diagnoses of every patient involved. It’s geek-heaven.

Medical records

So, we would like to link our disease register to HES to work out what other illnesses people on the register suffer from. This is possible because both the register and HES use NHS numbers to identify individual patients. We know the NHS numbers of the people of the register, and we can use these to look up the same people on HES.

The problem is that we do not have patient consent to link the registry data to the HES data. To be honest, I bet you no-one has ever asked your consent to collect the HES data. And, to tell the absolute truth, no-one asked consent of the people on the disease register to include them on it. This is because all of the information in both the disease register and HES is extracted from routine medical records. Your doctor writes in your notes that you have a particular disease and so your information is sent to the disease register. You get admitted to hospital with breathlessness and someone writes in your notes that you had a chest x-ray and were treated with antibiotics and this information is sent to HES.

This turns out to be legally challenging because us geeks are now asking to use that routine medical information for research. Your information was collected by medical professionals for their work and to maximise yoru care. That's generally accepted to be okay. We now want to use it for research and the legal position is that that's not okay unless we ask you first - or seek special permission for the law to be waived on this occasion.

There is one more thing I need to tell you here. I, and none of my colleagues, will ever be able to tell who the individuals on the disease register are. The hospital that holds the register stripped out all the names, addresses, and dates of birth before they let us have it. Similarly, if we ever get hold of the HES data there is no way we will ever be given names, addresses, dates of birth or anything else that would allow to tell who was who. The data provided to us is entirely anonymous.

Probably quite a lot of people have no idea there was a massive UK hospital data warehouse or that disease registers exist. But now that I’ve told you, you might not be that surprised? What I’m wondering is: are you bothered? Do you care that there is information on all your hospital visits? Do you care that someone could link it to something like a local disease register to do some research? Remember, it’s all totally anonymous. All it is is a spreadsheet showing that person number 73 is male, attended an cardiology outpatient appointment in September 1989, was started on blood pressure lowering medication in October 1989, was admitted with chest pain in July 1993, blah, blah, blah.

I don’t care that much. But that’s maybe because I’m a geeky weirdo.