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Mental Health Wiki > Research ethics: participant distress in psychiatric research

Research ethics: participant distress in psychiatric research

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1. Major findings from research on participant distress
2. Factors associated with distress
3. Positive reactions to participation in research
4. Recommendations for conducting psychiatric research
5. References

Psychiatric research often involves participants who have a mental disorder or have had emotionally charge experiences like traumatic life events. There has been ethical concern that participation in research which asks about the person’s mental state or their experiences could be distressing and cause harm. Concerns about potential harms may lead ethics committees and institution review boards (IRBs) to restrict some research projects. On the other hand, some useful research may not be carried out on important topics like traumatic experiences. A number of research projects have been carried out to investigate the potential short- and long-term harms of participating in various types of psychiatric research. ¹ This work can help guide ethical decision making on future projects.

Major findings from research on participant distress

Only a minority of participants become distressed from participation, typically less than 10%. This applies to both studies involving clinical samples of patients and studies of community samples consisting predominantly of well individuals. However, distress is more common in studies asking people about traumatic experiences. Most research has only looked at immediate distress from participation. While there is less evidence on long-term harms, studies show no evidence of longer-term distress, increases in health service use following participation or unwillingness to participate in further research.

Factors associated with distress

When participants are asked what caused them distress, there is wide variation in what they report. However, topics more often nominated as causing distress are questions about substance use in children, testing of cognitive impairment in older people, and questions on finances and income. Individuals more prone to distress from participation are those who are more mentally unwell and those with more risk factors for mental disorders (e.g. more adverse life events).

Very few studies have used control groups where people who are involved in answering psychiatric questions are compared to another group which is not. Where this has been done, there appears to be little difference in distress. For example, asking high school students about suicidal thoughts and actions does not appear to have any ill effect on their mental state and does not produce an increase in suicidality. ² If anything, there is some benefit to the participants.

Positive reactions to participation in research

When participants are asked about both positive and negative effects, positive reactions are more common than negative ones. In fact, positive and negative reactions can occur in the same person. For example, a person could be asked about traumatic experiences and find this upsetting, but at the same time find this beneficial and be glad that they participated.

Recommendations for conducting psychiatric research

Researchers on participant distress have made many recommendations to ethics committees/ IRBs and to researchers about how to deal with these issues. ¹ These recommendations include:

Recommendations that have been made to ethics committees/ IRBs on psychiatric research

There needs to be a balance between minimizing distress and the benefits of new knowledge.
Committees should focus on the overall outcome, rather than just on avoiding distress.

Recommendations that have been made to ethics committees/ IRBs on trauma research

People suffering from trauma can still give meaningful consent.
After a large-scale disaster, there is a need to coordinate research efforts so that people are not approached multiple times by different researchers.

Informed consent guidelines for research for psychiatric research

Participants need to know that the research can be upsetting, but that most people find it rewarding nevertheless.
Consent forms should be easy to read, use simple language, and take into account the developmental level of the participants.

Informed consent guidelines for research for trauma research

Depending on the focus of the research and the type of participants, consent procedures may need to include the following:

examples of sensitive or potentially upsetting questions
whether the intention of the research is therapeutic
that the interview can be stopped at any time and spread over several sessions if necessary
that the participant can contact the researcher if they are troubled by the experience.

When consent is being obtained, the participant should be in a safe controlled environment (not a disaster site) and the initial information should be given in writing rather than on the phone.

Minimizing distress during psychiatric research

Research staff should be trained in how to support participants who become distressed.
Participants who are thought to be vulnerable to distress should not be excluded from participation, but should be treated with care.
In longer-term projects, participants may need reminders of the purpose of the study and be given opportunities to ask questions at any time.

Minimizing distress during trauma research

There needs to be a suitable time gap between the traumatic event and the interview.
Participants need to be given some control over aspects of the interview, such as when and where to meet, the duration of the interview, whether the interview is spread over multiple sessions.

Responding to distress when it arises

If a participant becomes distressed, the researcher should ask how they are feeling and respond in a supportive manner.
An interview may need to be terminated if a participant becomes overly distressed. Counselling or other appropriate support should be available if needed.

Debriefing/termination of psychiatric research

Participants should be informed of the results of studies in which they are involved.
Where appropriate, participants should be offered information on appropriate services or supports available to them.
Participants should be able to contact research staff if their distress increases following the interview.

Debriefing/termination of trauma research

Participants should be informed of the results of studies in which they are involved.
Where appropriate, participants should be offered information on appropriate services or supports available to them.
Participants should be able to contact research staff if their distress increases following the interview.
Researchers should have a debriefing procedure and assess the emotional impact of participation.
When research is conducted soon after a traumatic event, back-up mental health services should be available.

References

1. ↑Jorm, A.F., Kelly, C.M. & Morgan, A.J. (2007). Participant distress in psychiatric research: A systematic review. Psychological Medicine, 37, 917-926.

2. ↑Gould, M.S., Marrocco, F.A., Kleinman, M., Thomas, J.G., Mostkoff, K, Cote, J. & Davies, M. (2005). Evaluating iatrogenic risk of youth suicide screening programs: a randomized controlled trial. Journal of the American Medical Association, 293, 1635-1643.

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