Cases in Bioethics: Health Research Ethics in Southeast Asia
Keywords

privacy, confidentiality, consent, assent, children, return of results and study findings, computer-based research, children

Although electronic nicotine delivery systems, including electronic cigarettes (e-cigarettes), have been touted as a way to help tobacco users quit smoking, evidence from research is inconclusive.1 E-cigarette use is becoming more prevalent and is particularly popular among adolescents and smokers of conventional cigarettes. Components of e-cigarette vapor have known cytotoxic, genotoxic, and carcinogenic properties.2 While the oral health sequelae of smoking conventional cigarettes are well-established, the impact of e-cigarettes on oral health is still unknown. Scant research has addressed the influences of e-cigarette use among early teens.3

A researcher with a wide range of experience in conducting community-based research designed a study using a validated online questionnaire to explore e-cigarette awareness, knowledge, attitudes, and use among secondary school–aged children. The researcher recruited participants from either urban or rural public secondary schools. To be eligible for the study, children were required to be 1) enrolled in lower secondary school, 2) able to understand both Malay and English, and 3) able to answer questions independently. Children enrolled in special education schools or who were absent during the data collection period were excluded from recruitment. The school administration provided the research team with lists of all eligible lower secondary school-aged children. Designated contacts at each school collected parental consent forms prior to data collection. Students with parental consent were assembled in the school computer room and provided with a log-in code to take the online-based questionnaire.

International ethics guidelines clearly emphasise that children who are incapable of giving informed consent should be included in research investigations, provided that appropriate safeguards are in place.

Questions

  1. Do you think involvement of children in this study is justified?

  2. Did the researcher take appropriate measures to ensure children were protected from harm and provided with relevant care and resources? If not, what else might they have done?

  3. From which children should the researchers be expected to obtain assent?

  4. What are your thoughts about having the students complete the survey together in a computer room?

  5. Who, if anyone, should have access to the individual-level study data aside from the researchers? Parents? School administrators? A school nurse? Others? What about aggregate study results? Would it be OK for the researchers to include the name of the school when publishing their findings?

References

Pentz, Mary Ann, HeeSung Shin, Nathaniel Riggs, Jennifer B. Unger, Katherine L. Collison, and Chih-Ping Chou. “Parent, Peer, and Executive Function Relationships to Early Adolescent E-Cigarette Use: a Substance Use Pathway?Addictive Behaviors 42 (March 2015): 73–78. https://doi.org/10.1016/j.addbeh.2014.10.040.
World Health Organization. “E-Cigarettes Are Harmful to Health.” World Health Organization. February 5, 2020. https://www.who.int/news/item/05-02-2020-e-cigarettes-are-harmful-to-health.
Yang, Irene, Shelly Sandeep, and Jeannie Rodriguez. “The Oral Health Impact of Electronic Cigarette Use: a Systematic Review.” Critical Reviews in Toxicology 50, no. 2 (February 11, 2020): 1–30. https://doi.org/10.1080/10408444.2020.1713726.

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