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. Author manuscript; available in PMC: 2017 Jul 1.
Published in final edited form as: J Adolesc Health. 2016 May 13;59(1):44–49. doi: 10.1016/j.jadohealth.2016.03.020

Table 1.

Potential Ethical Issues and How Guy2Guy Addressed Them.

Belmont Report components Potential ethical issue How Guy2Guy addressed them
Respect for Persons Obtaining informed assent with an online recruitment protocol Enrollment occurred over the phone so that research staff could gauge whether the participant understood the assent.
Obtaining informed assent from a group with diminished autonomy (i.e., children) The assent form was written in easy-to-understand language, and the capacity to consent ensured that all children who enrolled understood the risks and voluntariness.
Beneficence Risks and benefits Requiring parental permission can potentially harm sexual minority youth, due to discrimination and stigma We requested and were granted a waiver of parental permission by both IRBs involved in the study.
Privacy and confidentiality If youths' phones are lost or intercepted, the text messages on the phone could result in a loss of confidentiality of their sexual identity We created a self-safety assessment to help youth determine whether they could take part in the study safely. We also provided how-to instructions to help youth change the settings on their phone to increase their privacy (e.g., adding a password).
Justice Fair distribution of benefits and burdens The choice of participants needs to be considered carefully to ensure that groups are not selected for inclusion mainly because of easy availability, compromised position, or manipulability Although we used Facebook as our main recruitment source, which means we attracted youth who were easily available and perhaps manipulable (e.g., they clicked on our advertisement), we developed a complex and rigorous safety protocol.
Equity: The digital divide may mean that those who are least likely to have access to HIV prevention programming designed for AGBM are also least likely to be in the recruitment pool We used Facebook, the most popular social network among adolescents, to increase the likelihood of reaching a wide pool of AGBM.
When research leads to the development of new treatments, procedures, or devices, justice demands both that:

  • These advancements are provided to those who can benefit from them, and

  • The research should involve persons from groups who are likely to benefit from subsequent applications of the research

 Our hypothesis is that text messaging represents an opportunity to put sexual health and HIV prevention programming in the hands of youth. As such, we thought it important to develop and test the program among those most likely to take part in a similar program in the “real world”: those who currently own their own phone, use text messaging, and are enrolled in an unlimited text messaging plan.
Inclusion of women, minorities, and children in research Ensuring a racially diverse sample, particularly the inclusion of Black and African American males given the epidemiology of HIV in the U.S. The enrollment algorithm also set targets based upon race and ethnicity.
The need to include youth under 16 years old, which has been the youngest age group included in YMSM intervention studies to date We included participants as young as 14 years old, and our enrollment algorithm ensured that 14- to 15-year-olds represented 40% of the study sample.

The descriptions of Belmont Report components and the potential ethical issues were based upon those presented in the NIH online human subjects research course [34].