Human Participants Challenges in Youth-Focused Research: Perspectives and Practices of IRB Administrators

Abstract

The purpose of this research was to understand institutional review board (IRB) challenges regarding youth-focused research submissions and to present advice from administrators. Semistructured self-report questionnaires were sent via e-mail to administrators identified using published lists of universities and hospitals and Internet searches. Of 183 eligible institutions, 49 responded. One half indicated they never granted parental waivers. Among those considering waivers, decision factors in-

Understanding the Ethical Requirement for Parental Consent When Engaging Youth in Research

“…Ethics committees in general are said to favor active or opt-in consent procedures (Graham and Fitzgerald, 2010). Evidence of this was found in the Wagener et al (2004) study. Their research, conducted with IRBs in the United States, found that over half of the participating IRBs do not allow for passive consent.…”

“…While these Federal Regulations do not provide any detailed guidance on when a waiver can be applied, a study by American academics has shed some light on the practice of IRBs (Wagener et al, 2004). The study participants comprised 49 IRBs, primarily associated with university or academic institutions.…”

Ethical Review and Children's Research in Ireland

“…There is evidence of great variability in decision-making on adolescent consent and a general tendency to favour cautious approaches to the matter (Mammel and Kaplan, 1995;Piercy and hargate, 2004;Rogers et al, 1999;Wagener et al, 2004). There certainly seems to be a need to clarify the scope that RECs have in waiving parental informed consent requirements (Wagener et al, 2004) and there is an acknowledgement of the ethical weight of arguments in favour of full adolescent consent for at least certain categories of research (Levine, 1995;Mammel and Kaplan, 1995). Some proposals for ethical guidance for adolescent research have been made, highlighting the need for facilitating research to increase knowledge of adolescent health (Rogers et al, 1994;Santelli et al, 1995 and.…”

“…It is notoriously difficult to assess psychological risks and, as pointed out by researchers and REC members, there is evidence not only of significant conservatism and risk adversity in relation to identified psychological risks (Corbin and Morse, 2003), but also of a lack of awareness of certain psychological risks or harms (hadjistavropoulos and Smythe, 2001). There is also some evidence that risk may be determined merely by reference to the subject area that is going to be researched (Wagener et al, 2004): it seems that the risk of participants being upset by research in sensitive areas is often overestimated by REC members and can be perceived as much less problematic by research participants (Cromer et al, 2006;Scott et al, 2002).…”

“…adolescent health research frequently addresses adolescents' health risks due to risky behaviour, such as substance abuse or sexual behaviour. One question in this regard is whether such research could be considered relatively harmless or whether any research in such sensitive areas should be considered as more than minimal risk due to its subject area (Wagener et al, 2004).…”