The research proposal considers the most effective treatment options for depression in a sample size of 80 patients. The researchers state that there is a scarcity of studies that provide comparative review of the effectiveness of medication versus different forms of Psychotherapy. Whilst they propose their goals, they do not detail how this information will be used and whether there is a conflict of interest in them conducting this research. In this regard the ethical standards set by the British Psychological Society (BPS) of Scientific value (2.2) and Social responsibility (2.3) are not being fully met.

Furthermore, the proposal does not outline how informed consent will be obtained and how the participant may withdraw if they so wish as required by standard 3.10 and 10.1 for Therapy of the American Psychological Association (APA) ethical guidelines and section 4 of the BPS guidelines. Moreover, the methodology does not refer to how participants will be debriefed following the conclusion of the study according to 8.08 (APA). There is no information about how the study is communicated to participants and whether details are provided as required by the BPS (p.18) and 8.02 of the APA breaching the standards of Honesty and Integrity.

Principle A (APA) and section 2.4 of the BPS ethics code requires that research should not cause harm.  Whilst widely available, the use of Imipramine Hydrochloride has been associated with detrimental side effects (Le Noury, Nardo and Healy et Al, 2016). Avoidance of risk is stipulated by the BPS (3.0) and there is no evidence that this has been assessed risk or participants informed on what the potential risks could be. BPS guidelines state that additional caution should be taken with participants who can be viewed as vulnerable. Research that involves psychiatric patients should be assessed to ensure no harm is presented and that this is considered when designing the study (Yanos, Stanley and Green, 2009). Pharmocogenic testing could also be considered to determine which antidepressant medication best suits the patient. This is an emerging research area based on the knowledge that different persons respond to different forms of treatment (Fabbri, Zohar and Serretti, 2018).

The evaluation of patients is due to occur at the start of the study and after 16 weeks despite the knowledge that antidepressants can have harmful side effects.  The assessment gap is potentially too long to assess the impact of treatment and neither allows for this to be halted if there are issues. 10.10 of the APA ethics code state that therapy must be discontinued by the psychotherapist if the patient is suffering as a result of the intervention.

Inclusion of a Placebo in research studies is controversial even more so in this case whereby the proposal does not state whether the participant is aware of a placebo. Whilst some argue that it qualifies as Deception (Section 8.07, APA) Lichtenberg, Heresco-Levy and Nitzan (2004) argue that this is not always the case but should not be offered when a more effective solution is present. However, Brim and Miller (2005) contend that placebo use in scientific research, particularly in the area of neurological disease, has shown considerable benefits.

In conclusion, the research proposal should be revised based on the above issues and modified accordingly. Further consideration might also be given to the choice of antidepressant to avoid drawing erroneous conclusions regarding the merits of drug-based treatment.

References

American Psychological Association. (2017). Ethical Principles of Psychologists and Code of Conduct. Retrieved from https://www.apa.org/ethics/code/index.aspx.

Brim, R. L., & Miller, F. G. (2013). The potential benefit of the placebo effect in sham-controlled trials: Implications for risk-benefit assessments and informed consent. Journal of Medical Ethics, 39(11), 703. doi:http://dx.doi.org.liverpool.idm.oclc.org/10.1136/medethics-2012-101045

British Psychological Society. (2014). Code of Human Research Ethics. Retrieved from https://www1.bps.org.uk/system/files/Public%20files/inf180_web.pdf.

Fabbri, C., Zohar, J., & Serretti, A. (2018). Pharmacogenetic tests to guide drug treatment in depression: Comparison of the available testing kits and clinical trials. Progress in Neuropsychopharmacology & Biological Psychiatry, 86, 36–44. https://doi-org.liverpool.idm.oclc.org/10.1016/j.pnpbp.2018.05.00

Le Noury, J., Nardo, J. M., Healy, D., Jureidini, J., Raven, M., Tufanaru, C., & Abi-Jaoude, E. (2016). Study 329 continuation phase: Safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression. International Journal of Risk & Safety in Medicine, 28(3), 143–161. https://doi-

Lichtenberg P, Heresco-Levy U, Nitzan U (2004). The ethics of the placebo in clinical practice. Journal of Medical Ethics 2004;30:551-554. Retrieved from: https://jme.bmj.com/content/30/6/551

Yanos, P. T., Stanley, B. S., & Greene, C. S. (2009). Research risk for persons with psychiatric disorders: a decisional framework to meet the ethical challenge. Psychiatric services (Washington, D.C.), 60(3), 374-83.