The simple (but not particularly satisfying) answer to the question posed above is 'perhaps'. Uncertainty in this case stems from the fact that we have asked an ethical rather than a regulatory question.
There is no simple formula for determining how much can or should be paid to compensate for a particular level of risk. Most would agree that it is unethical to offer levels of payment that would incline healthy young individuals to put their lives seriously at risk, but that it is ethical to offer some payment for loss of time, travel and minor inconveniences. The extremes of right/wrong or ethical/unethical situations are usually clear, but in less extreme cases it is not always easy to figure out where the line should be drawn – which is why the decision is left to research ethics committees. They are supposed to have the balance, skill and knowledge needed to make an informed decision when there is ethical uncertainty. Society provides guidance on prevailing moral views, such as the 'principles' outlined in the Belmont Report (see the box on the right of the screen), but leaves specific judgements about ethics to these broad and representative committees.
The remainder of this screen explores three issues that are particularly important to research ethics committees but that can also raise difficult ethical questions for researchers. If you are planning to do research that raises these or other controversial issues, you might want to consider taking a formal ethics course.
Informed consent
A critical aspect of the protection of human participants is gaining proper consent. This is more difficult than it may appear. Of course participants must be fully informed, but this must be done in a way that does not overwhelm them. Consent should pay attention to three issues, summarised as the 'three Cs'. Good consent must be:
- Clear: use plain, understandable language
- Concise: don't overwhelm the potential participant with unnecessary information
- Continuous: don't assume consent is a one-time event. Check in with participants as the research progresses to confirm that they wish to continue.
In practice, a number of obstacles can hinder your ability to follow the three Cs, potentially challenging both the ethics and the integrity of your project.
In the UK there is no national standard but each institution will have its own detailed policy relating to informed consent, some of which may be very detailed It is not expected that researchers will need obtain this in every situation – although there needs to be clear justification if informed consent is not obtained.
In the following activity, classify some of these obstacles according to the way in which they are most likely to compromise proper informed consent by dragging and dropping the statements at the top into the appropriate columns.
Assessing and managing risks and benefits
The process of assessing and managing risks and benefits in research with human participants is complex. Although the REC has primary authority, the responsibility for the welfare of participants begins early in the planning process and carries through to the end of the project. Responsibility also extends to everyone engaged in the research.
The many ways in which problems arise is illustrated by one widely publicised 'first in human' trial that went dramatically wrong: the case of TGN1412.
In the following activity, click through the screens to read about the case of TGN1412, and ask yourself whether some of the problems could have been avoided. At the end of the case, you will be asked a series of questions to help you reflect further.
Source: Based on Ho & Cummins (2006) and Wikipedia.
Unforeseen events
No one can anticipate all the problems that may emerge during a research project, but there are some 'expected unexpected' problems that should be addressed as part of the planning process. The following case study highlights a number of these. Read the case and then complete the activity.
A PhD student in social work is studying how 16- to 18-year-olds make plans for the next stage of their education. The research plan was approved by the REC and, after acquiring the appropriate consents, the student began the interviews.
Although it was not one of the interview questions, one research participant told the PhD researcher about several years of struggle with self-destructive 'cutting' behaviour.
This unforeseen event raised immediate questions about what do to next. Should the information be shared with others? If so, with whom? The REC? The participant's school? Fearing both for the young person's welfare and possible personal liability should anything happen to them, the PhD student found a number for the research participant's parents in the telephone book and called.
Was this the proper course of action? Read the definitions and explanations in the box to the right of the screen then, in the following activity, assess the appropriateness of the PhD student's actions by selecting the tick or the cross next to each statement.
As this case study illustrates, the challenges thrown up during the course of research are not always easy to deal with. But research ethics committees have been established to safeguard the health and well-being of those who volunteer to be in research. Although the approval process is rigorous, researchers cannot assume that simply getting approval marks the end of their responsibilities. In response to participants' gift of volunteering for research, you must treat them as you would expect members of your own family to be treated should they participate in research.
If and when you begin your work on a research project involving human participants, you must supplement what you have learned here with more thorough training.