Institutional Review boards: Ethics, regulations and the research agenda

Authors


Abstract

Information Science researchers and designers are well-positioned to become active participants in scholarly and institutional conversations concerning the protection of human subjects. The overall goals of this panel are: 1) to extend the discourse within the Information Science field concerning the protection of human subjects in research; 2) to explore new ways to improve the relationship between researchers and Institutional Review Boards; and 3) to advance current Institutional Review Board policies and procedures concerning the use of iterative, culturally appropriate, qualitative methods within social science research. This panel will stimulate conversations through which “IRBs and investigators accept their common charge to meet the needs of subjects and to improve the quality of research.” (Burke, 2005, p. 921)

Introduction

In response to a series of ethical breaches in research practice (e.g., Milgram, 1963; Rockwell, Yobbs, et. al., 1964) research institutions that receive funding from federal agencies in the United States are required to have Institutional Review Boards(IRBs). IRBs review, modify, reject or approve research to which the “Common Rule” applies (AAUP, 2001). The Common Rule includes the following requirements for research involving human subjects:

  • 1Risks to subjects are minimized
  • 2Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may be reasonably expected to result
  • 3Selection of subjects is equitable
  • 4Informed consent [has been] sought from each prospective subject or the subject's legally authorized representative (45 CFR 46.111)

The professed goal of human subjects regulations is to protect research participants from ethically compromised situations (Burke, 2005). However, for researchers, IRB procedures and regulations are often viewed as adding layers of bureaucracy and administrative paperwork. Researchers frustrated by the process claim that IRBs are more concerned with legal liability and institutional reputation than protecting human subjects (Lincoln, 2005). IRB's can influence: 1) which populations are studied, 2) what methods are employed, and 3) what constitutes research (Burke, 2005; Lincoln, 2005).

Information Science and IRBs

Information Science researchers draw from a plurality of research methods and place a high value on triangulation. However, methodological choices (e.g., in-depth ethnographies, web-based data collection, iterative experimental protocols) can add daunting complexity to the IRB application process. In addition, many Information Science researchers investigate and design “cutting edge” technologies, interactions with these technologies can push against existing ethical norms and standards. There is a recognized need for research that explores the implications of these new interactions, especially for vulnerable populations. Yet, this type of research is especially difficult to negotiate through the IRB process. It has become commonplace to hear researchers justifying their subject population (e.g., high school students rather than elementary students) because of fears of the label “High Risk” and its associated IRB challenges.

Agenda

  • a.15 min: Brief introductory remarks by each of the panelists
  • b.40 min: The Director of Research Services will respond to specific compliance challenges introduced by each of the panelists using a lens of regulatory compliance
  • c.35 min: The conversation will be opened up for interaction with the audience

To encourage audience participation, the following question will be displayed during the final section of the panel:

  • How should IRBs handle specific methodologies which do not conform to a priori standards of documentation and structure? In particular, how should IRBs work with inductive research designs?

Participants

This panel is comprised of four individuals who share a deep concern for ensuring the ethical treatment of research participants while supporting rigorous, uncompromised research agendas. Three panelists are actively involved in conducting research and teaching. The fourth panelist is a qualitative researcher who works as an administrator (Director of Research Services) in faculty advancement and compliance.

Promoting IRB Compliance, Ethical Reflexivity, and Research

Alpha S. DeLap

Dr. Alpha Selene DeLap, is the Director of Research Services at the University of Washington's Information School and an instructor of research ethics. She is responsible for pre-award research administration and research compliance. Working to promote and foster research at the University of Washington's Information School, her responsibilities include: ensuring ethical compliance with federal and state regulations and University policy and serving as a liaison between researchers and various institutional review boards. Trained as a feminist social scientist in American cultural studies, for this panel, Dr. DeLap will explore the problems and possibilities of ethical reflexivity for social scientists using qualitative methodologies. In addition, she will draw upon her own experience doing ethnographic fieldwork within domestic violence shelters in Northern Colorado to map selected arguments within social and behavioral realms.

The Value Sensitive Design of Children's Information Systems and the Protection of Human Subjects

Nathan G. Freier

Value Sensitive Design is an established method of accounting for human ethical values in the design of information systems across various populations. As with a number of user-centered design methodologies, the Value Sensitive Design approach emphasizes the importance of iterating design processes with user evaluation procedures. Children are a particularly vulnerable population and this is increasingly true for their interactions with information systems. This panelist's research efforts include investigations designed to identify the ethical and psychological implications of children's interactions with information systems. The empirical aspect of this work, grounded in social-cognitive domain theory from developmental psychology, includes a study of children's judgments and reasoning about the moral standing of a personified software agent (i.e., a 3D graphical character that looks and behaves like a human).

Individual and institutional concerns for protecting human subjects and, in particular, vulnerable populations such as children appropriately places a burden on the researcher to submit him or herself to the review procedures of an Institutional Review Board (IRB). In many institutions such as the Rensselaer Polytechnic Institute, such IRB human subjects reviews can extend anywhere from three weeks to three months and no human subjects data can be collected prior to IRB approval. The review procedures are a necessary and appropriate level of protection for human subjects. Unfortunately, the timeliness of review procedures can significantly limit the number of iterative cycles in the design and evaluation process, potentially comprising an important aspect of user-centered design.

Therefore, this panelist's contribution to the discussion will be a reflection on the impact that IRB review procedures can have on information system design and evaluation methodologies with a focus on the specific problems faced in the development of his research program.

IRB Procedures and International Court Protocols: Conflicting Norms and Regulations

Lisa P. Nathan

Cross-cultural research, especially in politically-charged contexts, demands sensitivity and flexibility. Lisa spent six weeks during 2008 in Rwanda and Tanzania as co-project lead of a cross-disciplinary team interviewing members of the United Nations Criminal Tribunal for Rwanda (UNICTR). Recognizing the weighty mandate, sensitive topics, and complex international politics of the UNICTR, her university's IRB set a series of tight constraints on the research project. As one example, recruitment procedures were tightly scripted in an effort to prevent individuals from feeling coerced into participation. However, when the team arrived in Tanzania, a series of events made apparent that a strong Western bias was undermining the recruitment procedures. Ironically, the IRB's efforts to protect participants conflicted with unwritten, but well established protocols of the international court. The project was in serious jeopardy as potential subjects, expecting to be asked to participate manner appropriate to the unwritten protocols of the UNICTR were bemused by what they interpreted as the team's lack of interest. Lisa will discuss how the team worked with their institution's IRB to overcome these challenges in 2008. She will also draw out lessons learned and applied when the team planned a follow up trip to Rwanda during the summer of 2009. She will highlight ongoing issues facing research teams working in contexts geographically, culturally, and technologically removed from their institutions' IRB.

Ethical Research Behaviors as Individual Responsibilities, Social Constructions, and Regulated Activities

Phillip M. Edwards

At the University of North Carolina at Chapel Hill, graduate students from master's programs in library science (MSLS) and information science (MSIS) complete a final research project as part of the requirements for graduation. Many of these students pose research questions and associated methods which would involve collecting data from study participants. Students' study protocols are reviewed internally before advancing to the campus-wide IRB for approval, but most of the mentoring of students occurs at the level of individual faculty advisors. Dr. Edwards will present a framework of ethical research behaviors from three complementary perspectives—the researcher's practices, socially constructed professional consensus, and the regulated oversight of IRBs—and will reflect upon the utility of such a framework for mentoring students and engaging in dialogue about ethical issues related to student-generated research projects. This will not a discussion of ‘ethics’ per se, and the end product will not be an enumeration of what is or is not an ethical research behavior; rather, this is an inclusive endeavor to represent the diversity of methodological approaches adopted within our field.

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