Social Work Research & Current IRB Issues : Minimal Risk, Global, Vulnerable, Waivers of Consent

Since 1966, when the first Institutional Review Board (IRB) appeared for clinical trials in medical centers, the impact of human subjects protections regulations on social, behavioral & educational research (SBER) has not been well elucidated, understood or, some would say, implemented. This has contributed to tensions and an adversarial relationship between SBER IRBs and investigators. Numerous articles, proceedings, and conference presentations across the social sciences detail dissatisfaction and foment with IRBs and assumedly, with the Common Rule and the current OHRP regulations concerning human subjects' protections. As social work research becomes more complex, client problems, methodology and venues (domestic and international) increase exponentially. From an IRB perspective, social work research represents some of the most time-consuming and worrisome, albeit worthwhile and important, work to be done. Bridging the distance here is in the best interests of social work researchers and educators.

Fortunately, over the past 15 years, a small but growing body of evidence-based knowledge has grown to inform investigator–IRB relations, IRB burden, and issues of most frequent concern to both researchers and IRB administrators. Social work research needs to be fully informed of this body of knowledge. Research center directors, faculty researchers, and aspiring social work researchers will benefit from attending this roundtable.

The five issues addressed in this round table are: 1) What is minimal risk research and how does this look different in social work research; 2) Conducting minimal risk research with vulnerable populations and/or social work clients 3) Global social work research; 4) Waivers of consent or of elements of consent; and 5) Methods of improving relations with the IRB to facilitate research. More concretely, we will examine the following: 1) The definition of minimal risk research is often not fully understood and needs to be better clarified –for both the population under study and to distinguish who is not under study 2) “Vulnerability” is a subject category covered most clearly under CFR 45 46, Subpart B which refers to b) pregnant women/neonates/fetuses; c)prisoners, and; d) children, but can also be extended to studies which result in over-identifying-- situationally, and even momentarily-- based sources of vulnerability which need to be more carefully examined. 3) Global research includes a myriad of participant, situational, social and systemic variables that require examination within the cultural context in which the research is carried out. 4) Waivers of some or all elements of the informed consent process are possible and should be pursued more vigorously in minimal risk research 5) The capacity to educate and influence your IRB will increase the likelihood of positive response to the above recommendations and directions for change.

Roundtable members include Chairs of University social and behavioral IRBs, members of University IRBs, and social work faculty and doctoral student investigators, all with significant experience in navigating protections of human research participants.