Preserving and Enhancing the Responsible Conduct of Research Involving Children and Youth: A Response to Proposed Changes in Federal Regulations and commentaries

Facilitators and Barriers to Participation in PrEP HIV Prevention Trials Involving Transgender Male and Female Adolescents and Emerging Adults

“…The present study thus joins others in highlighting how well-intentioned IRBs that do not apply federal regulations permitting the waiver of guardian permission for sexual health research may contribute to the persistence of health disparities and undermine sexual and transgender minority youth's right to evidence-based interventions essential to their health and wellbeing (Fisher et al, 2016; Fisher et al, 2013; Fisher & Mustanski, 2014; Mustanski & Fisher, 2016). To remedy this situation, investigators can partner with their IRBs in developing materials that enhance youth's ability to give informed and voluntary consent through age appropriate informational materials (Fisher et al, 2016; Ott et al, 2013) and materials that provide transgender appropriate and informative information about levels of risk for HIV given one's gender identity, sexual orientation and risk practices to enable youth to accurately estimate their own risks for invention.…”

An Ethical Frame for Research with Immigrant Families

“…As recently as March 2013, the Society for Research on Child Development published a social policy report addressing the very sensitive issue of responsibility for conduct in research with children (Fisher et al, 2013). These policies pertain to any prospective research participant who could potentially experience harm as a result of a breach of confi dentiality.…”

Enhancing the Responsible Conduct of Sexual Health Prevention Research Across Global and Local Contexts: Training for Evidence-Based Research Ethics

“…Researchers often confront barriers to sexual health prevention programs for adolescents based on cultural mores regarding sexual behavior among youth, IRB/ethics review committee overestimations of risks associated with engaging youth in discussions regarding sexual risk, and disagreements over the extent to which waiver of guardian permission protects or violates the rights of adolescents to participate in health research (Fisher et al, 2013; Fisher & Mustanski, 2014). The article by Thokoane describes barriers and opportunities for implementing an innovative community-based sexual and reproductive health rights program for adolescents in Hammanskraal, South Africa.…”

“…For example, problems encountered during IRB approval of youth consent procedures reflected confusion in South African legal standards that (a) considered youth younger than age 18 legal minors with limited capacity to act independent of adults; (b) permit under the South African Children’s Act (38 of 2005) children 12 years and older to independently consent to medical treatment; (c) make it a criminal offense under the Sexual Offences Act (32 of 2007) to have sexual intercourse at an age younger than 16, even if it is consensual; and (d) grant minors the right to consent independently to certain types of research (Parliament of South Africa, 2005, 2007; Strode, Slack, & Essack, 2010). (Adolescent health researchers in the United States face similar legal challenges when requesting that IRBs extend the sexual health treatment rights of adolescents under state mature minor laws to sexual health research; Fisher et al, 2013; Fisher & Mustanski, 2014; Institute of Medicine of the National Academy, 2006.) Once the project was initiated (with guardian consent required), members of Thokoane’s research team quickly became aware that adolescents were not responsive to oral and written materials and that self-esteem, especially of young women, was a major barrier to open discussion and learning.…”

“…Reasons for this have been postulated to include deep-rooted societal and internalized homophobia, gender and sexual orientation-based discrimination and stigma, and minority stress (Guadamuz et al, 2013). As in the United States (Fisher, 2002, 2003a; Fisher et al, 2013; Fisher & Mustanski, 2014) and South Africa (Thokoane, this issue), laws and cultural mores create reluctance on the part of ethics review committees to waive the requirement for guardian permission for adolescent participation in sexual health research. Although this presents barriers for all youth, it is particularly problematic for sexual minority youth who in many instances may not have informed their parents about their sexual orientation or have suffered physical or social abuse when they have disclosed (D’Augelli, Grossman, & Starks, 2008).…”