Grievance Procedures As Assurance for the HIV-Infected Clinical Trial Participant

Legal and Ethical Values in the Resolution of Research-Related Disputes: How Can IRBs Respond to Participant Complaints?

“…Each of the two available articles has mentioned a grievance procedure specific to biomedical HIV research. For example, the Richmond AIDS Consortium instituted a three-step approach to resolving complaints brought by participants in clinical trials for AIDS treatment (Cox & Kerkering, 1993). This process was guided by the policy that the study participant “ha[d] the right to be treated with dignity as a human being at all times, regardless of [his or her] need for testing, treatment, or other services” (Cox & Kerkering, 1993, p. 20).…”

“…For example, the Richmond AIDS Consortium instituted a three-step approach to resolving complaints brought by participants in clinical trials for AIDS treatment (Cox & Kerkering, 1993). This process was guided by the policy that the study participant “ha[d] the right to be treated with dignity as a human being at all times, regardless of [his or her] need for testing, treatment, or other services” (Cox & Kerkering, 1993, p. 20). The process first required participants to express their complaints verbally and in writing, followed by the option of speaking with a social worker who reported directly to the Consortium panel.…”

“…The panel issued written decisions about disputes within 10 days, and participants could then appeal to the full IRB for a final resolution. Data were not reported regarding the uptake or outcomes of the system, but the authors suggested that such a grievance procedure “may foster better patient-physician relationships,” compared to conducting the trials without a formal process (Cox & Kerkering, 1993). …”

“…Community-led activism and advocacy in HIV/AIDS have set precedents for community consultation and research involvement at every stage (Harrington, 2009). Even some of the earliest clinical trials suggested that “AIDS clinical trial study participants prefer to be active participants rather than passive participants … [who] want to process their concerns and experiences about participating in clinical trials” (Cox & Kerkering, 1993, p. 20). Empirical research has since examined practices for engaging participant populations in community-based research (Harris, 2006; Logie, James, Tharao, & Loutfy, 2012; Rhodes, Malow, & Jolly, 2010; Ross et al, 2010), clinical trials (Essack et al, 2010; Newman et al, 2011; Sahay & Mehendale, 2011; Shagi et al, 2008; White et al, 2011), and outreach-based recruitment (Alvarez, Vasquez, Mayorga, Feaster, & Mitrani, 2006), to cite just a few papers.…”