What are the risks in conducting a research?

 Potential Risks

 

DescriptionIRB AnalysisWhat IRBs may require

Physical Harms

Research can involve exposure to minor pain, discomfort, or injury from invasive medical procedures or activities designed to test biomechanical or ergonomic performance.Risks are very specific to the study; this is why IRBs need to see a detailed account of all of the tasks investigators will be asking subjects to perform and the environment in which they will be performed. The IRB will want to review supporting evidence of a device’s commercial application and basic operating information from the manufacturer.

Psychological Harms

These run from temporary anxiety and distress to relapse and precipitation of behavioral disorders. Discomfort may be associated with the questions in a survey or interview.  The IRB considers the range of reactions that are possible in response to the research and will ask researchers to design the study in a way that provides an adequate level of protectionGiving subjects information on available counseling services and telephone hotlines.

Deception

Federal regulations permit but establish limitations on the use of deception in research.  Deception in research occurs when subjects are intentionally mislead or when information about the nature of the experiments is withheld.

 

IRBs will require that subjects are fully debriefed after the experiment is conducted.  Investigators will submit a debriefing document for review.  Subjects are given the opportunity to ask questions about the new information and given the chance to withdraw.  It is not permissible to use deception to obtain participants

Invasion of privacy

In the research context, it usually involves either covert observation or "participant" observation of behavior that the subjects consider privateThe IRB must make two determinations:

1. is the invasion of privacy involved acceptable in light of the subjects' reasonable expectations of privacy in the situation under study; and

2. is the research question of sufficient importance to justify the intrusion

 

Breach of confidentiality

Confidentiality of data concerns safeguarding information that has been given voluntarily by one person to another.  A breach of confidentiality may result in psychological harm to individuals (in the form of embarrassment, guilt, stress, and so forth) or in social harm.

 

 

Social and Economic Harms

Some invasions of privacy and breaches of confidentiality may result in embarrassment within one's business or social group, loss of employment, or criminal prosecution.Areas of particular sensitivity are information regarding alcohol or drug abuse, mental illness, illegal activities, and sexual behavior. Some social and behavioral research may yield information about individuals that could "label" or "stigmatize" the subjects. Confidentiality safeguards must be strong in these instances. For example, the fact that a person has participated in HIV-related drug trials or has been hospitalized for treatment of mental illness could adversely affect:

1. present or future employment,
2. eligibility for insurance,
3. standing in the community,
4. relationships with family members

 

All activities pose some level of risk and research participation is no exception. It is generally accepted that participation in research should pose no more than minimal risk to participants, that researchers should assess the potential risks and that participants should be fully informed of these as well as the benefits of taking part in research. In response to the increased ethical regulation of social research, various authors have noted that the risks of harm arising from social research are minimal at most, if not non-existent (see, for example, ; ). Certainly, in comparison with medical research the risks from social research are slight. However, this does not mean that risk of harm does not exist and authors such as and have disputed the assumption that social research is risk-free.

Assessing risk of harm

Assessing risks that might arise as a result of taking part in a research project involves researchers reflecting on the nature of risk and harm 56and the ways in which their research might present risks to participants’ well-being. Assessments of risk involve considerations of the potential for harm, both physical and psychological or emotional, as well as practical issues such as the costs participants might incur as a result of participating in research in terms of money, time and inconvenience. The range of risks that need consideration is discussed below.

The potential benefits of research also need to be considered, both to the research participants themselves and to the community or society more widely, so that research participants and researchers can assess whether the potential risks outweigh the benefits. Balancing possible risks of harm and the potential for benefit is far from straightforward. Risks of harm are generally (but not always) experienced by an individual but benefits are often to groups, communities or society more generally. It is also the case that benefits arising from research, such as a change in policy or provision for a specific group, are often long term and, if they occur at all, may do so some time after the research project has been completed. The Research Ethics Guidebook (http://www.ethicsguidebook.ac.uk/) makes the important point that benefits need to be thought of, and articulated to participants as, ‘hoped for’ outcomes of research rather than those that are guaranteed, noting that this terminology is ‘more honest about the uncertainty underlying all research’. Researchers may, for example, hope that their research brings about a change in the way groups are perceived, or the treatment or provision they receive, but these hoped-for benefits may not occur as a result of one specific research project; indeed it may have no impact on the individual participant's experiences. It is certainly important not to raise participants’ expectations about what the outcomes of the research may be.

Individuals may experience personal benefits as a result of taking part in research, such as feeling listened to, having an opportunity to express their views or feeling that their views will influence policy or practice. Some researchers have reported that their participants have gained considerable benefits as a result of being able to talk about issues or experiences with an independent person that they haven't been able to discuss with anyone else. However, it cannot be assumed that such benefits will occur. It is not the purpose of research to bring about such benefits; if they occur they are perhaps best seen as a side effect of research participation.

Clearly, if risks to participants are greater than minimal and the benefits not evident then there is little justification for the research 57being conducted. However, who should make that decision? Arguably, participants are best placed to make decisions about the risks they are willing to take in relation to participating in research. Researchers, or indeed research ethics committees, who decide on participants’ behalf that a project or method is too risky for participants have been accused of paternalism (, ). Nevertheless, researchers often experience a conflict between seeking to protect study participants on the one hand but allowing them the agency to make decisions about the risks they are willing to take on the other ().

Assessments of risk, harm and benefit are far from straightforward. It is not possible to identify all risks that an individual might encounter from participating in research. A researcher cannot know what an individual might find distressing and even fairly innocuous research topics can result in a research participant becoming distressed. In a study on private health care that I undertook many years ago, one of the first interviews I undertook focused on a man's hospital stay for a minor routine operation and resulted in him crying as he recalled his wife's serious illness twenty years previously. I could not have predicted this response and neither could the interviewee when he agreed to participate. Similarly, Jaimie Ellis, a PhD student, found that what she thought was an activity that was likely to pose little risk to the autistic teenagers taking part in her research resulted in considerable distress for one young person. In her research, the participants were asked to write an essay about their imagined future:

The class started with a discussion each taking it in turns to talk about what they might do as adults. Mrs Morrsion [the teacher] asked the class where they might be living when they are older. Vishal responded with a definite “16. House of my own”. The same question was asked of Ben … Ben burst into a flood of tears. “No, no I don't want to live on my own, I'm just a teenager”. We were all a little surprised by the tears. “Will you leave home when you're older Ben?” asked Mrs Morrison. Ben [said] “No, no I want to stay at school, I'm just a teenager”. He seemed to have forgotten or misunderstood that the task was about the future and not the present. He threw his head into his hands in a panic … and flopped down on the table sobbing into his arm. (, field notes)

Both of these examples illustrate the importance of emergent ethics, of thinking about, and managing, ethical issues and risk throughout the 58lifetime of a research project. The important point to note is that while it is important that researchers think carefully about potential risks and benefits of participating in research and inform participants so that they can decide whether or not they want to take part, neither researchers not participants necessarily know what issues might emerge in the process of the research and how they will be responded to by participants.

A range of potential risks of taking part in qualitative research have been identified. Most risks of social research relate to participants’ psychological or emotional well-being. Risks to participants’ physical well-being are less likely but not unheard of (see ). Risks to well-being have been identified as arising from: an emotional response during data collection; an emotional response to ending involvement with a project; and the effect of the publication of research findings.

Perhaps the most common type of risk arises from a participant's response to a question asked or topic discussed during fieldwork. People becoming upset or distressed is probably a relatively common experience in qualitative research, particularly in research on so called ‘sensitive’ topics (). However, research can also engender other emotional responses in response to researchers’ questions or activities. Embarrassment, humiliation or anxiety can occur in response to insensitive questions, questions or tasks that the research participant feels unable to answer or do, or topics or tasks that explore participants’ underlying fears (see, for example, ). Research participants can feel deceived if they were not, or feel that they were not, told the ‘real’ reasons for undertaking the research. They may also feel devalued if they feel their views are disregarded or not taken seriously.

It has been observed that research participants can feel used by researchers and that they may feel disregarded or devalued as a result of participating in research. Researchers sometimes do engage in various activities to ‘manipulate’ participants to participate in research and to provide rich data, a process referred to by as ‘methodological grooming’. Such activities may leave participants feeling used after the research is completed and the researcher has exited from their lives, particularly if their expectations of benefits are not met. This is particularly the case with longitudinal research when participants 59build up relationships with researchers over prolonged periods. As Iphofen (: 53) notes:

In longer term encounters … the subject may need some ‘closure’ time and some opportunity to come to terms with a relationship that appeared to have friendship at its core but was, in effect, highly instrumental.

Considerable risks to participants can arise from the publication and dissemination of research; many of these issues have been discussed in Chapter 4 on anonymity and confidentiality. Despite anonymisation, people may be upset at how they are portrayed in research reports. review of community studies identified cases where some local residents were deeply unhappy about how they had been portrayed in publications. Such studies may also bring unwanted publicity, and media attention, to a research site given that the anonymisation of specific communities is notoriously difficult. The risk of unwanted media attention is not a risk only in community studies; it may also occur in research on specific groups or institutions or indeed in relation to categories of individuals. Research may result in negative publicity, and the reinforcement of stereotypes, about specific groups such as benefit claimants, young people, homeless people or ethnic minorities. The increasing pressure on researchers to provide evidence of the impact of their research and to get their research findings into the public domain may fuel these sorts of problems given the difficulties that researchers face in controlling how the media report their research findings.

Publication may also pose other risks where an individual's identity is disclosed, such as censure from others which might in some cases result in loss of friendship or employment. In research on political activity or illegal activity more extreme risks, including risk of physical harm or legal sanctions, might be present (see ).

Other risks concern the costs incurred, both financial and personal, from participating in research. These issues are often overlooked but warrant consideration. Such costs might be a loss of earnings incurred by taking time out to participate in research. Participants might also experience inconvenience; the time spent in participating in a project means they have less time to do other things they might want or need to do. Some of these factors can be offset, to some degree, by offering payments to participants in recognition of their contribution.

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Minimising risks of harm

A number of ways have been identified to minimise and manage risks of harm from participating in research. Careful thought needs to be given prior to a study commencing of the possible risks of harm that the research might pose to individuals and/or the communities of which they are part. Research participants should have the risks and benefits of research participation explained to them as part of the consent process and make their own decisions about whether or not they want to participate. As discussed above, risks or harm should also be assessed throughout a research project as they emerge; the publication and dissemination of research are particular points when considerations of risks of harm need to be addressed. Research participants should also be informed, as part of the consent process, about who they can contact should they have a complaint about any aspect of their involvement in a study. Such complaints need to be reviewed and the research changed to take into account complaints as appropriate.

Strategies also need to be in place to manage any distress or discomfort that participants may experience during fieldwork. Research on a wide range of topics can generate emotional responses and researchers need to be sensitive to research participants’ feelings. This may mean monitoring participants’ body language for signs of fatigue or distress and responding to such signs by suggesting that data collection be suspended or stopped. It may also mean enabling people to decline to answer particular questions or discuss specific issues. For some groups, such as children or people in institutional settings, active encouragement for them to refuse to discuss particular issues may be necessary. In our research project on informed consent, researchers working with children reported providing participants with red cards that they could hold up if they didn't want to answer a particular question or didn't want to continue with the interview. They also noted the importance of researchers spending time with participants prior to the research commencing to enable them to ‘rehearse’ this so that they felt confident enough to do it. Another strategy identified was training participants to say ‘pass’ if they did not want to discuss specific topics ().

Involvement in research should mean that participants leave the research process feeling no more unhappy or distressed than they did when they began it. Of course it is not always in a researcher's power 61to ensure this is the case but debriefing after an interview or other data collection activity is an important means of researchers assessing participants’ response to the research. It is often appropriate to provide information or resources about support that people can access if the research has, or might, raise issues that an individual finds distressing. Such support might, for example, be contact numbers for the Citizens Advice Bureau, a counselling service or support groups relevant to the topic of the research.

What is a possible risk that a participant may face during a research experiment?

What are risks and benefits in research?

What are the examples of risks?

What are the risks of qualitative research?