Institutional Review Boards at Very High Research Activity Universities

Background

IRBs were created to protect human subjects involved in academic research. Historically, they formed in reaction to a series of infamous research studies. The Nuremberg Trials brought to light the abusive research experiments performed by the Nazis on prisoners during World War II. Further oversight was also warranted after such notorious research cases in the United States as the Tuskegee experiment, Stanford prison experiment, and the Milgram experiment. In the Tuskegee experiment (1932–1972), a group of African American men with syphilis were given free medical exams but not informed of their medical condition, and even when a cure became readily available in the 1950s, they were not treated with it. Several of the men died due to complications associated with the disease (Heintzelman, 2003). In the Stanford prison experiment, a group of Stanford students were assigned to be either guards or inmates in a mock prison that resulted in the trauma created by the brutal treatment of the students as guards on the students as prisoners. In the Milgram experiment, which sought to study the obedience of participants, the participant was told to shock another person if that person answered a question incorrectly. Although the experiment was staged and no one was shocked, participants were led to believe they were, in fact, shocking another person, which caused them psychological harm. Taken together, these experiments raised professional, safety, and ethical concerns over the twin needs of protecting human subjects from such abuse and creating a process of informed consent.

In order to prevent such abuse in future research and to ensure the rights of participants, IRBs were created to maximize the responsibility of the researcher to conduct research with minimal harm to participants. The passage of the National Research Act (1974) established IRBs as the responsible party that provides oversight to ensure protections of human subjects. To that end, this legislation also sponsored the Belmont Report (1979), which continues to provide ethical and practical guidance for the protection of human subjects involved in academic research. Emphasizing the values of justice, beneficence, and respect, it does so through the use of informed consent, assessment of risks and benefits, and subject selection. The National Research Act requires all U.S. institutions conducting research with human subjects (e.g. universities, hospitals, foundations) to have an IRB. IRBs are comprised of both members from the institution and nonaffiliated community members. The community members must include both lay people and professionals to ensure that the full range of views of community residents are being adequately represented and voiced in research decisions. For example, any proposed research being conducted on prisoners must have the prisoner representative from the community (a former prisoner) participate in the decision making. For many academic institutions, review boards are typically divided into biomedical research and social–behavioral. Biomedical review boards tend to oversee research conducted in the medical sciences, while social–behavioral review boards tend to oversee research conducted in the social sciences. In order to conduct research on human subjects, researchers must obtain IRB approval for their proposed study prior to conducting research activities.

VHRA universities, formerly referred to as research-intensive, or R-I, universities according to the Carnegie Foundation, were selected as the sample for this study since they generate a great deal of research in the United States. Further, as social scientists who conduct social–behavioral research requiring IRB approval, we sought to investigate to what degree chairs of social–behavioral IRBs come from social work. We focused on this question for two reasons. First, given social work is the most holistic approach of the social sciences, in that social work scholars are trained in theories and methods at the individual, family, and macro levels, it stands to reason that there would be many IRB chairs from social work. This would also seem logical because social work training provides a broad range of experiences with diverse research populations, which has obvious benefits in the oversight of such diverse submissions as the IRB receives. Second, as members of the social work discipline, we were genuinely curious about how many IRB chairs come from our discipline.

Method

Of the 108 VHRA research universities in the United States listed by the Carnegie Foundation (2014), we have data for 104 universities or 96% of the total cases. Data were collected in two ways. First, we contacted the Federal Office of Human Research Protections, the regulatory office of the federal government that provides oversight and assistance for research with human subjects and obtained the current roster of IRB members for every IRB filed with that office (over 11,000). From these data, we determined the discipline of the social–behavioral IRB chair for 97 VHRA universities. We gathered the remaining data from the social–behavioral IRB websites of the missing schools and e-mailed schools for which rosters were not immediately available. One university keeps IRB members confidential. Using these methods, we were able to collect 104 of the 108 VHRA universities. We found only 4 of the 104 universities have IRB chairs from social work or 3.8% of all social–behavioral IRB chairs come from social work. Given this low percentage, we argue that universities can benefit from having more social work scholars serve on IRBs for several reasons elaborated subsequently.

Discussion

Social workers, as social workers, bring an important and unique perspective to IRBs in three main ways, namely, their holistic training, commitment to ethical standards, and focus on social justice. Historically, social work began as a response, in the form of evidence-based research and informed policy recommendations, to structural causes of poverty and injustice (Trattner, 1998). Given social workers’ ethical commitment to the well-being of individuals and society (National Association of Social Workers [NASW], 2008), universities could benefit from more social workers serving as chairs of social–behavioral IRBs because social workers bring a unique perspective to the protection of human subjects. Social workers have a professional responsibility to justice, beneficence, and respect for clients and research subjects alike (Council on Social Work Education [CSWE], 2006). As the only social science that trains researchers in theories and methods that address individual, family, and macro levels of analysis, social workers are exceptionally situated to have deep insight into a wide range of research projects and topics. Social workers often must deftly navigate academic, policy, and research demands. Doing so provides them valuable experience that could be used to address concerns faced by IRBs. For example, IRB submissions cover a wide range of academic (e.g., does this research make a unique contribution to knowledge?), policy (e.g., does this research have implications for policy?), and research concerns (e.g., does this project constitute a meaningful contribution to the knowledge base and are the methods safe for subjects?) that must be adequately addressed for approval. Further, submissions to social–behavioral IRBs come from disciplines as diverse as anthropology and public health, which typically focus on different levels of society (e.g., individual and community) and utilize a wide range of methodologies (e.g., ethnography and program evaluation). Experiences and insights garnered by social workers from their training at multiple levels of analysis in multiple methodologies, ranging from ethnography to program evaluation to quantitative analysis, uniquely situates them to inform and guide the IRB process.

Since social workers must abide by strict ethical commitments in accordance with their professional values, often termed responsible conduct of research, they are primed for overseeing ethical guidelines established and promoted by IRBs. This attitude extends not only to research but also to all professional responsibilities (Anastas, 2008). By ethics we mean the rules people use to differentiate between right and wrong. Ethical guidelines for social workers are laid out in the NASW’s Code of Ethics (2008). Such guidelines include engaging in research with careful consideration for the potential consequences of subjects; with informed, voluntary consent; that protects participants from any harm; and that is confidential (NASW, 2008). This training in ethics and the professional commitment to it is another reason social workers are uniquely situated to responsibly and effectively chair social–behavioral IRBs.

Third, social work, with its emphasis on social justice (see Gasker & Fischer, 2014; Reamer, 2014), brings an important orientation to IRBs. This focus helps to ensure potential subjects not only are fully protected but also will have just and fair participation experiences. This is especially true for vulnerable populations (e.g., pregnant women, children, and prisoners) who require greater protection from possible research abuses. Social work teaching and research not only values culturally sensitive research but also works to discover and cultivate better ways of conducting sensitive research that are more beneficial for individuals (see Bowles & Hopps, 2014; Jackson, 2010). Such an orientation provides both skills and a vantage point with which to assist other members of the academic research community to develop more sensitive and just studies. In recognizing these major concerns and social work prioritizing the core values of beneficence, justice, and respect, the CSWE, the accrediting body for schools of social work, calls for social work researchers to join university bodies that design and distribute research regulations and policies (CSWE, 2006). Specifically, the CSWE calls on social work professors to join their local IRBs in order to protect the interests of human subjects (CSWE, 2006). Accordingly, social work researchers, through their professional experiences and obligations to beneficence, justice, and respect, have much to offer IRBs. Following this call, one of the authors, as a social worker and chair of a social–behavioral IRB at a VHRA university, has cultivated several best practices for preparing an IRB submission.

Based on experiences chairing the social–behavioral IRB at a VHRA university, we offer some best practices for preparing an IRB submission. At our university, like many VHRAs, we subscribe to an online software platform that generates the submission electronically and that is broken into several, individual parts required by federal guidelines (e.g., Parts I & II, the Protocol, Informed Consent forms, etc). IRB submissions (or packages) have five parts and come to 27 single-spaced pages. IRB submissions usually require at least 20 hr of preparation. Key concerns for IRBs, and thus researchers, are informed consent, confidentiality, privacy, physical/emotional harm to participants, conflict of interests, and sound scientific enquiry. IRBs help researchers design studies that respect all of these elements. First and most importantly, do not treat the IRB as an afterthought. Instead, this is an opportunity to think through the research design, develop research instruments, cultivate a manageable scope, and advance the unique contributions this research will create. Second, make sure to proofread the several components of the IRB submission, including the protocol, research instruments, and application Part II. Proofreading ensures not only that all portions of the submission are accurately and completely communicated but also gives researchers a chance to double check their research design. It is important to be consistent throughout each part of the IRB submission, otherwise the package will be sent back to researchers for corrections and clarity. For example, a common mistake is to have discrepancies between Part II and the protocol (e.g., amount subjects will be compensated for their time, total number of subjects to be enrolled and where, and the specific person who will actually be collecting the data) and such differences will delay approval since the IRB will have to ask the researcher for clarity on which procedures they will actually use. We find it is better to spend more time constructing and proofreading the IRB package before submission in order to cut down on review time. Finally, take advantage of the in-house resources offered by your university’s Human Research Protection Office. These offices have in-house IRB analysts who check submissions for completion and accuracy before sending the packages on for review. Call and make an appointment with them ahead of the submission to have them walk you through the application process and point out typical pitfalls. The benefit of following this suggestion is the amount of time this is likely to save applicants in the turnaround time for review and approval of their IRB package.

In conclusion, our finding that only 3.8% of social–behavioral IRBs at VHRA universities are chaired by social workers is distressing. Given their holistic training, commitment to high ethical standards, and central focus on social justice, social workers should be more involved in stewarding IRBs at VHRAs. Their leadership and guidance will have significant benefits to research subjects, especially vulnerable populations, and their commitment to social justice will increase the probability that “bad” or “unethical” research practices can be avoided.