As noted before, if you conduct research using human participants, you must have approval from a research ethics committee before you can proceed. This section describes how the review process works and how you can navigate it as efficiently as possible.
Glossary term - Research
A systematic investigation intended to contribute to generalisable knowledge.
Glossary term - research ethics committee
A committee assembled to review research protocols that involve human participants. The composition and the review procedures used are established by national and local regulations.
The regulations governing the use of human participants in research vary according to where you are working: this section provides a general overview of the rules relating to approval for research with human particpants in your country. If you work internationally, you need to be aware of the policies that operate in all the countries involved in your research. Given local variations in the implementation of human participants regulations, we strongly advise those who work with human participants to seek additional training from their own institution.
The composition, duties and authority of research ethics committees
To help ensure uniformity and rigour in review, national policies provide specific guidance on the composition, duties and authority of research ethics committees (RECs). In the next section you will find out more about RECs.
Research ethics committees (RECs) review research protocols that involve human participants in order to make sure that risks to these participants are minimised and that they are treated fairly and with respect.
Procedure
Research ethics committees meet regularly. Some RECs invite researchers to present their protocols at their meetings; others deliberately use only the information submitted in writing. Larger institutions may have several RECs to keep up with the workload. Some RECs have a fast-track approval system for straightforward cases.
Membership
REC membership requirements vary. Normally, RECs have a membership with 'backgrounds that will ensure complete and adequate review of research activities commonly conducted by the institution. In addition, it is common for a number of lay persons to be members of such committees in order to provide a different perspective and voice societal concerns.
Regulations
Regulations differ from country to country. In the EU, there is a common Directive and national legislation at the member states' level. Other countries have their own national legislation and regulations. In addition, you need to be aware of and follow the rules set out by agencies – in the UK, for example, those of the National Health Service and funding agencies. It is important to follow the policies/procedures for ethical review that apply to a particular project.
What are they looking for?
In brief, the REC will be looking at the key questions we have identified in relation to human participants:
- Are risks to participants minimised and reasonable in relation to anticipated benefits? (See the 'Key terms' box at the end of this section.)
- Is the selection of participants equitable?
- Will informed consent be obtained?
- Are there adequate provisions to protect the privacy of participants?
- Are there provisions to allow participants to withdraw from the study?
Types of review
The level of review required for a project depends on what it proposes to do and the risks it poses for the human participants involved. Generally, once projects have been reviewed, they are assigned to one of three pathways:
- Exempt from review if allowed under local rules (e.g. in the UK there is no universal 'exemption' policy)
- Expedited review: carried out by the research ethics committee chair only, or by one or more experienced reviewers designated by the chair
- Full board review: carried out by the full research ethics committee.
In the following section, the criteria for assigning projects to the three paths are briefly described. (For more detail on the exact specifications for each category, refer to the link in the box at the end of this section.)
Your research may be eligible for exemption if it:
- Involves normal educational practices
- Uses educational tests, surveys, interviews and public observation (except when participants will be identified or placed at risk)
- Uses publicly available or existing datasets (if anonymised)
- Is a consumer acceptance study (e.g. food taste evaluation).
Expedited
Your research may qualify for expedited review if it:
- Presents 'no more than minimal risk' to human participants
- Involves only minor changes to something otherwise fully approved within the last year (and various other stipulations are also fulfilled)
- Is not classified, and would not put the participants at risk even if they were identified.
Full board review
If none of the descriptions in 'exempt' or 'expedited' review apply to your research, then it will require review by the full board of the research ethics committee.
It is crucial to remember that the decision on whether your research is eligible for exemption (if exemption is allowed – see note on UK above) or expedited review must come from the research ethics committee. You cannot make this determination yourself!
If you unilaterally decide that your research does not require approval, you may be subject to severe penalties later on if you are found to have made the wrong decision.
Speeding up the review process
Assuming that your project does require approval, the best advice for having it approved quickly is to get it underway as soon as you can and to provide all information required by your institution. A well-designed research protocol will facilitate ethics review. Remember:
- Provide all required documents and information
- Take time to explain what you are doing in clear, understandable terms – most members of the committee will not be experts in your field of research
- Respond quickly and meet deadlines.
The more questions the research ethics committee has to ask you, the longer your review will take.
Most major research institutions have a website explaining how project review is initiated and undertaken, as well as links to the forms you must fill out. At many research institutions this can be done electronically, but sometimes paper copies are required. Consider the 'Your context' box at the end of this section to help you find links to your institution's research ethics committee.
It may also be a good idea to talk with colleagues about their experiences, but be careful to keep comments in perspective. Researchers often complain about having their research slowed or blocked by research ethics committees. These complaints are sometimes used to justify not following the rules (Keith-Spiegel and Koocher, 2006).
Reference - Keith-Spiegel and Koocher, 2006
Keith-Spiegel, P. and Koocher, G. P. (2006) 'What scientists want from their research ethics committee', in Journal of Empirical Research on Human Research Ethics 1(1): pp.67–82.]
The following video transcript provides a sample of experiences and advice about research with human particpants and the ethics review process.
How does your research relate to human participants?
Mary Travers, 4th year PhD student in Complex Disease Genetics, Nuffield Department of Clinical Medicine, University of Oxford: So I'm primarily genetics-based, so I'm interested in DNA. So I use DNA extracted from various different body tissues, primarily blood, but also I have DNA extracted from muscle tissue, liver tissue, and also from fat tissue. So obviously, all those tissues, before the DNA is extracted, they're subject to the Human Tissue Act. So we have to be aware of all the issues surrounding that, but once the DNA is extracted, then that DNA is then exempt from the Human Tissue Act, so there are more things that we can do with it.
Dr. Ray De Vries, Professor, Center for Bioethics & Social Sciences in Medicine, University of Michigan: It's important that we think about the volunteers who work in our research projects, because there are examples, in recent history, of research participants being injured as a result of agreeing to be in research. There's a classic case, in the late 1990s, where a young boy who agreed to be in a genetics study actually died as a result of the intervention that was given him. There's another case that happened in the United States where a healthy volunteer agreed to be in research to test a new drug, and as a result of that research, she actually died from inhaling something as a part of that research. There are cases in the UK where people have volunteered to be in research and been severely injured.
I think we tend to think of physical injury as the most severe kind of injury, but there are other injuries that can happen to research participants that aren't physical. They can be mental stress. They can be violations of one's privacy and confidentiality if information is leaked about certain aspects of a person's life. As researchers, we are responsible for protecting the physical, emotional and confidentiality of our research participants.
What is the attitude in your field to ethics review?
Dr. Karen Melham, Researcher in Ethics, Centre for Health Law and Emerging Technologies, University of Oxford: Research ethics. People talk about 'getting through research', which sounds like climbing Everest or getting over a hurdle. I think that's changing, in part, as people go through the process and discover maybe it's not quite as painful as they thought, but there's a lot of administration. A concern for me is that that administration is confused with the moral concerns embedded in the kind of information the ethics committee is trying to get. So I do spend a lot of time trying to explain, there's the machinery of it and then there are the research integrity concerns that are embedded within that. The concerns remain those of the researcher, even as they go through ethics. So it's not that when you emerge from the other side, you're done with ethics. Research is a practice, and it needs to be practised.
Dr. Dónal O'Mathúna, Senior Lecturer in Ethics, Decision-Making & Evidence, School of Nursing & Human Sciences, Dublin City University: Our committee does get different reactions from different researchers about our procedures. We've recently done a survey of the research community to ask how our processes have been experienced. We had some who are very happy with the approach. They have said that we often raised questions that they maybe hadn't considered, or raise aspects of their recruitment strategy or some other dimension of the project that they just had not looked at, and often are very happy to go back and re-look at things, sometimes agree with us, sometimes they don't, and come back and explain why that might be the case.
But we also do have others who feel like the process has become too bureaucratic, who have concerns that we're asking questions that really are not relevant to their methodologies. What we seek to put forward is that we are trying to facilitate good research, that we are trying to raise questions that, maybe from our multi-disciplinary backgrounds on the committee, that some of the researchers might not have considered. We do have two lay members on the committee also, and sometimes they can provide feedback as to the level of comprehension for the patient information leaflets or the informed consent form.
Dr. Karen Melham: Often, people, when they come to the research ethics committee and are involved in discussion, they're also able to benefit from the expertise of the committee, because we've seen so many projects and the ways people have been able to undertake their work effectively. We're often able to give suggestions or provide advice about what would be best for recruitment, how best to communicate with participants, that sort of thing. The mandate of the research ethics committee is both to protect the dignity and well-being of patients, participants, but it's also to facilitate good research, and we do take that part seriously.
What is your own experience of ethics review?
Dr. Sofia Merajver, Director, Center for Global Health, University of Michigan: I have submitted multiple protocols to ethics review committees over the years, of all types of studies: Phase I, Phase II, Phase III, prevention studies, bio-repository studies, genetic studies, so the full gamut. There have always been challenges, for each type of research has its own special types of challenges, but in general, what I have found is that research ethics committees have always been my friends in helping me understand what those challenges are, and how to conduct research in the most ethical, proper form, and how to consult with them. They have been open. They have been nothing but most helpful to me.
I can say this with complete humbleness, including one protocol that took me four years to work on until it was fit to be approved, because it was so innovative, that it really didn't fit into any previously-used paradigm, but the research ethics committee worked with me. I was frustrated at the time that they were taking so long in making different decisions and asking me to do different things, but I don't regret for a moment how well it turned out.
The review process for research with human particpants can be frustrating. For example, it is well known that different research ethics committees reach different conclusions, even when reviewing the same project (Stair et al, 2001). This may be due in part to different local circumstances but it is also due to the fact that ethical decision-making is not an exact science. You and your research ethics committee may see things differently, but the committee's decision is the one that matters.
Reference - Stair et al, 2001
Stair, T. O., Reed, C. R., Radeos, M. S., Koski, G., Camargo, C. A. and THE MARC* (2001) 'Variation in institutional review board responses to a standard protocol for a multicenter clinical trial', in Academic Emergency Medicine, 8: pp.636–641.)
As a final note, remember that research ethics committees have full and final authority over approval and disapproval. Their decisions cannot be appealed to central administration on substantive grounds. That said, most RECs willingly interact with researchers, listen to their concerns and work to find reasonable ways to allow research to proceed. But their primary task is to protect human participants, not researchers, and they will not approve any projects that are deemed by their membership to be unethical.