Confidentiality, anonymity and ownership in research

I’ve been to two very good workshops recently at the University of Leeds, both on research ethics. These workshops are always informative, and they end with a session where you discuss a few thorny case studies with people sat at your table.

At the most recent one, my group got immersed in a debate about whether and how a researcher should disclose knowledge gained about someone who knows they are HIV positive and who is having unprotected sex with someone they name who is not aware of their HIV status. Very difficult. Its best to think about these things in advance, before the research gets started! (See for instance this KSPope website, scrolling down to the heading ‘Is there a legal duty to protect or warn third parties’)

Dr Alice Temple at the University of Leeds research ethics workshop.

Dr Alice Temple at the University of Leeds research ethics workshop.

Here are some of the main points that were made by the University of Leeds Research Ethics Training and Development Officer Alice Temple at the July workshop on ‘Ownership, Confidentiality and Secrecy‘:

Anonymity: means ensuring the people who take part in research cannot be identified.

Confidentiality: relates to who has right of access to data provided by participants, and is guided by data protection legislation.

Confidentiality is enshrined in many codes, such as the Hippocratic Oath and ESRC Framework for Research Ethics (we have used this framework extensively at Bradford College in developing our policy and procedures).

Be clear about the boundaries: At the outset, you should explain to potential research participants when and why you might disclose, and that you will discuss this with them. In exceptional circumstances you may need to breach without prior discussion.

You need to be clear about this in advance (the HIV example I gave at the outset is an instance where this was not thought through) and know what your procedures will be if a breach seems necessary.

Where boundaries are set out: in the consent form. And possibly in the research contract. Informal promises must be honoured. Sometimes there is an implied requirement to be confidential – newspapers are often in a very grey area here, arguing that information a celebrity sees as private should be in the public domain. In court, you need a very strong case to claim that publication is in the public interest.

When you breach confidentiality: this is necessary where there is significant risk of harm. In rare cases there may also be a ‘public interest’ justification.

Sometimes researchers become aware of inadequate performance or malpractice at public or other organisations – the decision then is whether to go public or not. A middle road may be advising the organisation of the findings and giving them six months in which to go public. If they do not publish the information in that time, the research body releases the findings.

Get guidance and support on confidentiality disclosures: it may be necessary to have legal advice if you think you have to breach confidentiality. Sometimes it may be that sensitivie information disclosed to you in research is already in the public domain – check this is the case before you disclose the information yourself, as there are different understandings of where ‘public domain’ begins and ends.

‘Off the record’ information: if something is given to you off the record you cannot include it in the research.

Checking for approval: You may send transcripts and research text back to interviewees for checking – there is no obligation on this, but it can be good practice.

The requirements of sponsors: this is an area where tensions can arise. A sponsor may reserve the right to edit, annotate or withhold publication. The role of Univresity is to put things in the public domain. There is also a distinction between ‘research’ and ‘consultancy’ that can become blurred, and may compromise the independent, objective and public requirements of research. It is necessary to consider secrecy clauses carefully, and get all involved (including the researchers) to declare any conflicts of interest.

Ownership: any research conducted as part of an employee’s work for a university, or by staff or students using university facilities and resources, belongs to the university. With regard to inventions and commercialisation of research products, there may be agreements whereby a percentage of the profit goes to the individual(s) involved.

Where a sponsor commissions or pays a university to carry out research, the issue of ownership may require definition in the initial contract. It is here that secrecy clauses may be proposed, and these must be handled with caution.

The Data Protection Act:
This underpins most research practice relating to confidentiality. In summary, the Act has the following implications for research:

  1. Personal data will be processed fairly and lawfully: for research this means a really good consent form is usually key, with researcher name and contact details, purpose, and who has access to raw data.
  2. Personal data can only be used for one or more specified and lawful purposes. Research data is apparently exempt from this, but where possible participants should be informed if their data is going to be used in a different research project.
  3. The personal data gathered should be adequate, relevant and not excessive to the purpose of the research
  4. The data must be accurate and kept up to date. Keeping data up to date can be challenging: one option is to ask all participants to contact you if details change.
  5. Data should not be kept longer than necessary (5-7 years is seen as reasonable).
  6. Data should be processed in accordance with the rights of data subjects.
  7. Researchers must implement measures to protect data from loss, damage, destruction, hacking etc. Encryption is important. Many mobile devices are not secure, but it is hard to avoid using them, at least short term. Data should be encrypted and stored securely.
  8. The final point relates to sharing data outside the European Economic Area

Text and photos by Ruth Wilson.

Contact Ruth for a copy of the College’s model consent form and other research ethics guidance: r.wilson2 at Bradford College.

Research ethics and internet research

At Bradford College, staff and students are using the internet in various ways to develop dissertations and research projects. There are lots of possibilities: online interviews and focus groups; questionnaires; observing or participating in forums; using information from blogs, Twitter, Facebook, and more.

Involving humans in research on or through the internet raises complex ethical issues, so I went to a workshop at the University of Leeds to find out more.

The workshop: Is one of a series on research ethics, held by the University of Leeds. (You can read about an earlier workshop I attended, about involving humans in research, here on the blog).

Dr Alice Temple, University of Leeds

Dr Alice Temple, University of Leeds

The workshop was led by Dr Alice Temple, who works with the University Research Ethics Committee, other University Ethics Working Groups, the Inter-disciplinary Ethics Applied Centre for Excellence in Teaching and Learning and the UK Universities Research Ethics Committees Group, concerned with national issues of the ethical review process in Universities.

Recent situations: During the talk, Alice mentioned real instances to show how ethics can play out with regard to the internet. Here’s an example:

  • participants in a sexual abuse survivors online forum found their words had been used for research. Their response was that this was a form of violation, and their online support community no long felt like a safe place.

Sitting on park bench? Alice explained that one academic asks people to visualise that they are sitting on a park bench (a public space) chatting to friends. If you then found you were being recorded for research purposes, how would you feel? (Waskul, 1996)

The workshop explored these and other issues raised by internet research. A summary is set out below. For the best set of guidelines, Alice recommended a report from the Association of Internet Researchers (AoIR) titled ‘Ethical Decision-Making and Internet Research’.

Privacy and confidentiality
The internet presents greater risks to individual privacy than many other forms of communication. Many people aren’t aware that IPS addresses can be traced back to them. You may think you are participating anonymously in a discussion, but in all likelihood you can be identified. And people don’t realise how public or permanent information is, or how easily it can be picked up by search engines.

This means that a researcher must be clear about anonymity, including the instances when anonymity might not be respected (for instance if a participant discloses something illegal).

The internet offers researchers the possibility of eavesdropping – of observing behaviours and attitudes, of taking part in conversations without disclosing that you are doing research. Nearly all these approaches are likely to be unethical.

What is public and what is private?
This is no easy matter, but it is vital that researchers assess how ‘public’ an online environment is before they make it part of their research. Most blogs, and some forums, are in the public domain, easily accessible. Other groups you have to register to join and it is clear that a greater degree of privacy is expected. However, people who comment in more open online environments can be unaware of how easy it is to find what they are saying, and that it is a permanent record, so they may have shared information openly that was meant to be private.

Other factors to take into consideration when defining the degree of confidentiality that might apply include the sensitivity of the information that is shared or discussed. There is a considerable difference between a group that meets to talk about sports fixtures and a group that is reflecting on sexual abuse.

The vulnerability of participants is also a concern, and the profile of the people involved – people who are high profile have an expectation that their words will attract attention and that their privacy will not be respected. The potential harm that the research process or publication could cause is another consideration.

Participants as subjects and participants as authors
This has been put forward as a useful way of determining the degree to which privacy should be respected. Where participants are subjects, they are taking part in discussions without seeing their communication as something they intend for wider publication. Where people author material, for instance on a website or blog, they are deliberately placing information in the public domain for others to read.

Informed consent
The guidance on best practice from AoIR deems that consent is essential if using private or semiprivate sources, such as email groups and closed chat rooms. With regard to open access forums (newsgroups, bulletin boards) consent is not always a necessity – the more open the place, the less onus for consent.

How to get informed consent: If you are using material on a blog, you can contact the author and ask their permission. But on a chat forum it can be much harder because people come and go.

One option is to post comments on the forum several times, explaining your research and their role in it. You can do this before and during the research. Seeking retrospective consent is more problematic, because the people may be harder to contact.

Even on a public site, such as a newspaper with comment forums, you should try to gain consent if you intend to quote participants. If you use aggregated data from an open forum, without quoting participants, this lessens the need to get consent.

Options include contacting the owner of a forum and requesting their consent, and/or arranging for people to tick a box to indicate they consent to taking part. With online surveys and questionnaires, if a clear introduction is given to the participant, their consent is implied once they choose to take part.

The credibility of the researcher is important to securing consent. You should have a link to somewhere online that explains who you are, the research you are doing, and how to contact you. You also need to consider whether you are confident that people taking part in the research are who they say they are, including whether children might be taking part in appropriately.

Acknowledgement
It is standard research practice to acknowledge sources. Copyright law can apply, requiring acknowledgement. This is to be balanced with providing confidentiality and anonymity where appropriate – this requires the stripping out of demographic data and names. Sometimes it is impossible to ensure confidentiality, and in these cases the ethics issues should be considered very carefully before research goes ahead.

Digital divides
The ethical issue here is whether your sample is representative or inclusive if you use only online sources: many people do not or cannot access the internet. In addition, it becomes harder to be ethically sensitive online, where so many different cultures can be present. Language is another factor – in international or transnational research, it is possible that many or the majority of participants will not have English as a first language.

Data security
There are a number of risks: emails can go to unintended recipients, messages in a chat room can be copied, and in general security can be breached in a number of ways.

Feedback procedures
Good practice in ethics requires the researcher to feedback to those involved in the research. This is also important to building a long-term positive research environment – poorly conducted research can alienate participants and make them reluctant to be part of future studies.

The law
Key areas of law are libel, harassment and intellectual property. These vary from one country to another. EU legislation has been increased recently: it is necessary to have tobtain explicit, freely given, specific and informed consent from individuals in order to be able to lawfully process their personal data under EU data protection laws.

What is legal falls short of what is ethical here,” Alice explained, “because there isn’t sufficient legislation to deal with all situations.”

Using the internet in research: University of Leeds workshop, May 2013

Using the internet in research: University of Leeds workshop, May 2013

At Bradford College, all research is submitted to ethics review. Student research up to masters level is reviewed by staff within the relevant Department. Individual research proposals that cause concern are then referred to the College Research Ethics Committee. All research conducted by staff and outside researchers is reviewed by the Committee. Contact me (Ruth Wilson) for further information.

 

The ultimate in recycling: the ethical re-use of human tissue

Next door to Bradford College, on the top floor of a secure building on the University of Bradford campus, is a unique service: Ethical Tissue.

Ethical Tissue: a secure space on the top floor of the Institute for Cancer Therapies, University of Bradford

Ethical Tissue: a secure space on the top floor of the Institute for Cancer Therapies, University of Bradford

It responds to requests from researchers for human tissue, and it stores tissue for biomedical research. Ethical Tissue is unique in providing a primary source of tissue solely for research purposes.

There are important ethical issues in human tissue donation and use, so I went to talk to Dr Susan Boyce about the work of her team. Although they deal with many requests for tissue in a year and have thousands of samples serving multiple uses, the space is surprisingly compact: a small office, and a laboratory where the samples are stored and prepared, and just three members of staff delivering the service: Susan (Head of Ethical Tissue), Senior Scientist Wayne Burrill, and Khadeja Suleman, Research Nurse.

First, Susan provided a definition of tissue: “Tissue is anything that contains human cells – that might be substantial body parts, small slithers of flesh, or blood, urine and so on.”

Susan then explained what makes Ethical Tissue special: “Being a primary source of tissue means we are involved in finding potential donors, meeting them, explaining what is needed, and getting their consent.”

Dr Susan Boyce in the Ethic Tissue laboratory.

Dr Susan Boyce in the Ethic Tissue laboratory.

photo

Senior Scientist Wayne Burrill.

“Nearly everyone has something to give,” Susan says. “Sometimes we need donors with particular conditions, or from particular ethnic groups. Sometimes we need normal tissue. We usually get a very good response. Nearly everyone we ask says yes they want to help researchers. We are always very grateful when people do decide to donate.”

The legal requirements are covered by the Human Tissue Act and regulated by the Human Tissue Authority :

Relevance:  The tissue has to be collected for relevant research. In most cases, the research is providing new insight into medical conditions, or helping with the development of treatment.

Donor consent: Samples must be provided with the informed consent of the donor. “You own your body tissue,” Susan says, “and you have the right to say what happens to your tissue during life and after death.”

Securing consent means accepting without pressure someone’s decision not to donate. Most people are very keen to help: we are hardly ever turned down. None of the major faiths have an objection to tissue donation. Sometimes people are facing complex and serious operations and they do not want to consider donation. This is of course acceptable, we always respect the wishes of the individual.“

Informed consent: Another important ethical aspect of consent is that the donor understands the purpose of the donation, and can ask for further information if they want. Not everyone is capable of informed consent: “We do not take consent from vulnerable adults ” Susan says. “We take samples from children if the parents consent, and if the child actively assents.  The next of kin can consent following the death of a patient – this does not delay the funeral arrangements.”

Generalised consent: “When people donate tissue to a tissue bank, they cannot specify what they want the samples used for,” Susan says. “They cannot request or rule out a particular kind of research. But sometimes we are able to tell them if there is a specific research project involved, and they can read the findings if they want when those are made public.”

Not for profit: “We make it very clear that there is no financial element for the donor. This is an altruistic gift,” Susan says. In addition, the service only seeks to recover costs from the researchers that it helps. “This applies whether our client is a public sector or charity researcher or a large pharmaceutical company developing a drug. We are heavily funded by the University, and this enables us to provide the service at a cost which enable research to go ahead.”

Anonymity, confidentiality and security: Every tissue donation is unique and is assigned a number, so the database is anonymous. The donor names are never stored on a computer. The samples and all records are in a highly secure, restricted access building and office, with any sensitive information kept in locked filing cabinets.

Timeliness and optimisation: If somebody gives tissue it will often be with the researcher very soon after, or it may be optimised – this means that the tissue can be used in several ways, to minimise waste and increase utility.

Deciding which research requests to respond to: “We don’t decide who gets what tissue,” Susan says. “We have independent scientific advisers (ISACs), all reputable and appropriate experts, and they decide which research requests we should respond to. We never meet the ISACs. This means we don’t send tissue to projects run by our friends, and we can’t favour investigations into health issues we are particularly concerned about.”

Validity of the research requests: “The research must be relevant and reasonable, the standing of the researcher must be acceptable, and they must have sufficient funding to complete,” Susan explains. It is the role of the ISACs to determine whether this is the case.

Dr Susan Boyce, Head of Ethical Tissue

Dr Susan Boyce,

Susan Boyce is a clinical scientist with a PhD in neuroscience. She began her career working in a burns unit in the NHS. She then moved on to set up a skin bank for therapeutic transplantation at the University of Sheffield, before coming to lead Ethical Tissue at Bradford.

“This is the ultimate in re-cycling,” Susan says. “It is very ethical. It gives you relevant results that are for the benefit of all.”

Involving human participants in research – the key ethical concerns

Last week I went to the University of Leeds to attend a morning workshop run by Dr Janet Holt on ‘Involving the Public in Research’, organised by the University’s Research Support Team.

I went to this training to learn more as we continue to develop our research ethics procedures at Bradford College. We don’t do medical experiments or large-scale scientific or environmental tests. Our most common research ethics issues are around the involvement of human beings in research, as researcher or participant. So this was the workshop for me.

Dr Janet Holt

Dr Janet Holt of the University of Leeds.

Dr Holt was an excellent – and impressively qualified – guide. She is a Senior Lecturer in the School of Healthcare at the University of Leeds, and a registered nurse and midwife with a BA (Hons) in Philosophy from the University of Leeds, an MPhil in Applied Philosophy from the University of Manchester and a PhD in Psychology from the University of Leeds. At the University, she is Chair of the Faculty of Medicine and Health Research Ethics Committee. She is an expert member and Vice Chair of Leeds Central NHS Research Ethics Committee. She is also an external member of the Research Ethics Committee in the Faculty of Business and Law at Leeds Metropolitan University and one of ten people appointed to the Ethics Committee of the Royal College of Nursing.

These are some of the main points from the workshop:

Trust: there is a reliance on researchers being honest and the best thing is to be morally responsible from the outset. I was interested in this, because no research ethics committee can fully know whether its ethical guidance or requirements are applied, though many universities run spot checks and there can be hefty penalties for those who get it wrong. A good ethical culture and training has to underpin the research ethics policy.

Informed consent: this is key. Dr Holt dwelt on the importance of the concept of autonomy in the UK. People expect and have the right to make informed choices about whether they participate in many things, including research. They need to do this freely, without concern for power relations or possible consequences. The information sheet given to potential research participants is an essential component and needs to considered early in the development of the research project. There was a short but stimulating discussion about the possibilities of using video, audio and other online tools to inform potential participants in appropriate ways, of great interest to me with my communications hat on, and as I complete a course in E-learning and Digital Cultures. The bottom line is that securing evidence of valid informed consent is a prerequisite to doing research, and this is not always easy. Persuading people to take part in your research is a fine art, and sometimes very sensitive.

Protection from harm: harm may be physical or psychological, or perhaps take other forms such as time and cost. The researcher may be at risk as well as the participant. Sometimes research requires that the participant be kept in the dark in some way, or even deceived. This can be acceptable, but needs to follow strict ethical guidelines and needs scrutiny and clearance by the research ethics committee.

Confidentiality: this is distinct from anonymity. Anonymity refers to concealing the identities of participants in all outputs resulting from the research; confidentiality is concerned with who has the right of access to the data provided by the participants. The data protection act provides a legal framework for this. Researchers have a duty to ensure confidentiality, which can only be breached with prior consent (and must be breached in particular circumstances such as potential harm or disclosure of criminal activity).

Dr Janet Holt teaching research ethics

Dr Janet Holt teaching research ethics, University of Leeds.

It’s really important at the College that we have a system that is robust but at the same time not overly bureaucratic or disproportionate to the scale of risk, and Janet was very alert to this. We could have spent a week or longer on the topic overall. It is always helpful to meet up with others who have to address research ethics principles. Real life issues do not always fit neatly with the guidelines! So a very useful morning.

By: Ruth Wilson, Development Consultant, Bradford College (see ‘About’)