PROTECTION OF HUMAN SUBJECTS IN BIOMEDICAL RESEARCH AND INTERNATIONAL FIELDWORK

The normative standards by IRBs at US institutions are drawn primarily from the psychological sciences and are based on addressing problems faced by medical practitioners (Carapico Reference Carapico2006; Carpenter Reference Carpenter2012). Cassell (Reference Cassell1980) correctly pointed out that relationships between those who study and those who are studied are not fixed but instead vary with the type of research. The context and location of the research are important factors that affect the relationship between the researcher and those who are studied. Anthropologists and other social scientists often are concerned about how the IRBs apply an inappropriate level of scrutiny to minimal-risk research in which investigators use methods such as surveys, structured and unstructured interviews, ethnographic participant observation, oral histories, and analysis of existing datasets (Marshall Reference Marshall2003). At the other end of the spectrum are certain research topics—for example, political conflict, especially terrorism—that by their very nature raise questions from the human-research perspectives (Dolnik Reference Dolnik2011). Some of the existing regulations related to obtaining informed consent are practically impossible to fulfill when conducting research on topics such as terrorism. There is a twofold problem: (1) the sensitivity of the issue, and (2) the geographical location. For my proposed fieldwork on the Maoist conflict in India, as mentioned previously, I had to make several revisions and delete certain segments of the population to be interviewed. Despite my background and thorough knowledge of the regional language and culture, the IRB did not allow me to conduct interviews with the local population. The local population was critical to my research, which analyzed levels of civilian support for insurgent groups. Even after multiple submissions and presentations of my revised documents and restating my knowledge of the area and my acquaintances there, the IRB did not allow me to continue with my original project. Part of this rigidity was because existing regulations do not fully apply to international field research. Also, I found a general lack of knowledge among the IRB members about the local and regional cultures in Eastern India. As stated by Dolnik (Reference Dolnik2011), members of the IRB committees are rarely active researchers, and there is an almost “unofficial” norm of identifying problems with any proposal; this naturally has a perverse effect when applied to proposals on political conflict set overseas. Two of the major areas of concern are informed consent and assessment of risk. I use my specific case and experience with the IRB to illustrate common concerns and not to generalize. In many cases, IRBs reach different conclusions about similar studies (Stark Reference Stark2012); therefore, it is not fair to conclude that all studies of this nature are assessed similarly.

In international field research, the sociocultural and political atmosphere is completely different than in the United States. The population to be studied can be illiterate or uneducated. The subjects often lack adequate knowledge to understand the entire content of the research, and they are intimidated by written documents that require a signature. This can lead to an initial mistrust between the researcher and those who would be studied. In ethnographic field research involving indirect observation, individual informed consent would be unrealistic (Marshall Reference Marshall2003). Many IRBs apply ethical-research principles rather mechanically following protocols that are applicable to medical research or studies that include clinical trials. A foreign country with active conflict, weak institutions, and corruption presents a different reality. These changing contexts should be considered to redefine protocols for international fieldwork. In the international context, it is important to develop culturally meaningful approaches to obtain informed consent. Obtaining consent should be a process—a series of interactions that familiarizes the subject with the researcher to understand the concept of consent (Marshall Reference Marshall2006). The pros and cons of using consent forms in these areas should be evaluated. When necessary, the provision of oral consent should be discussed. Kass and Hyder (Reference Kass and Hyder2001) mentioned from personal experience that informed consent during their own research was seen as culturally insensitive but was accepted mechanically to satisfy the funding agency and government regulations. ^{Footnote 1} Hyder and Wali (Reference Hyder and Wali2006) surveyed more than 200 researchers involved in international studies and found that 40% did not use written consent. ^{Footnote 2}

The protocols as presented by the IRBs make the process of obtaining informed consent the foremost concern for ethical research. However, research ethics does not end after obtaining consent forms. There is a lack of concern about how these consents are obtained. In foreign cultures and dangerous political conditions, obtaining signatures on consent forms is difficult. Subjects, especially women, often undergo emotional stress before signing a document that is not understood. In patriarchal societies, women have little choice and their choices often are voiced through their father or husband. The review process should be sensitive to these cultural variations, assessing research protocols based on the particular sociocultural and political context.

“PROCEDURAL ETHICS” AND “ETHICS IN PRACTICE”

Regulations to protect human subjects of social science research are a set of rules, procedures, and ethical standards that aim to protect the dignity and rights of individuals who are involved in research. It follows naturally that preexisting conditions and environments in which the individuals reside and communication procedures with which they are most familiar are recognized and protected. However, no such attempt is made by the IRBs. The ethical process becomes simply a set of rules that must be implemented. The adherence to and approval of the protocols do not safeguard ethical judgment; the protocols cannot anticipate the various dilemmas other than informed-consent and data-security issues that arise during research in conflict zones (Wood Reference Wood2006). During the review process for my research, I eventually learned—as did many others in the profession—that the fundamental function of the process is not to protect human subjects but rather to protect universities from malpractice suits (Carpenter Reference Carpenter2012). ^{Footnote 3}

Guillemin and Gillam (Reference Guillemin and Gillam2004) pointed out that procedural ethics alone cannot provide all that is needed for dealing with ethically important moments in qualitative research. Procedural ethics is one-dimensional, emphasizing the set of rules and their application more than an actual assessment of ethical reality. In this sense, procedural ethics becomes simply a set of technicalities. Ethics in practice, conversely, has two levels: (1) recognizing the set of ethical rules, and (2) implementing them in the context of ethical reality. Procedural ethics emphasizes the importance of individual ethics along with the set of rules. There often is a divide between “procedural ethics” and “ethics in practice.” However, Guillemin and Gillam (Reference Guillemin and Gillam2004) indicated a process that bridges the gap between procedural ethics and ethics in practice: that is, reflexivity. McGraw, Zvonkovic, and Walker defined reflexivity as a process whereby researchers place themselves and their practices under scrutiny, acknowledging the ethical dilemmas that permeate the research process and impinge on the creation of knowledge (2000, 68). Indeed, reflexivity goes a long way in understanding and evaluating the ethical purpose of the research being conducted. However, Guillemin and Gillam (Reference Guillemin and Gillam2004) placed the entire onus on the researcher. The IRB also should be an active part of this reflexive process. The institution must share equal and, in some cases, greater responsibility in being reflexive about “how” individuals should be involved in research, especially in politically vulnerable areas across the world.

COMMUNICATION GAP BETWEEN THE RESEARCHER AND THE IRB

One of the main problems in the ethical-review process is the lack of communication and dialogue between the researcher and the IRB. To increase my understanding of the process, I communicated with IRB members even before I started writing the proposal. I asked questions and sought guidelines. However, other than the reiteration of standard protocols, I learned little from these interactions. After the initial rejection of my proposal, I met in person with the committee chair to discuss the prospect of my research and revisions to my proposal. During the conversation, the feasibility of the research was questioned and, on several occasions, I had to repeat the justification for my topic. Although my experience is specific to only one institution, it raises questions about ethics in the context of the researcher and the research. There is evidence of researchers who are able to conduct field research on sensitive topics internationally. This evidence indicates that IRBs vary, but it also should offer insights to successful completion of research that can serve as a model.

My research analyzed civilian support for the Maoist rebel groups in India. To collect data, I needed interviews and oral histories from civilians residing in the peripheries of Maoist-affected areas. I had definite advantages in conducting this research because I am Indian and I resided in the same location for several years. Also, I had acquaintances in the government and police departments, who conveyed their interest in providing security for me; they also helped me in the initial selection of areas (i.e., predominantly low-conflict zones). Despite having these resources and regularly updating the IRB and sharing information about them, I could not conduct my initial research project. However, it was difficult to convey this to the IRB about my research project, and it continually failed to acknowledge my expertise in the area of study and my knowledge of the geographical location. After several revisions, I could include only government officials as my interviewees. I spent several painstaking hours carefully selecting specific government officials for my interviews. In addition to government documents and newspaper archives, I expanded my secondary-document analysis to include rare journal entries from ex-activists and Maoist prisoners. I also communicated with several scholars who had prior field-research experience abroad in conflict zones and similar locations; most of them quickly understood the issues and warned me about the IRB process. A few shared their approved research protocols with me to demonstrate that research in conflict zones, riskier than the location I chose, was indeed possible. ^{Footnote 4} Subsequently, I shared these protocols with the IRB, but this did not immediately help facilitate the approval process of my research.

The communication gap between the researcher and the IRB should not be a reason to impede social science research. The IRBs should expand their ethical concerns to include the issue of a communication gap between the researcher and the committee. The communication gap is heightened by the fact that few committee members have actual knowledge about several geographical areas chosen for fieldwork. Also, they do not have adequate information about particular topics and they apply general rules to evaluate a research proposal.

ASSESSING INTERNATIONAL FIELD RESEARCH

Unlike experimental research, field-research design is concerned with access to settings, people, and research-relevant documents. For this reason, it often requires amending the research design to accommodate sudden changes and/or unavailability of certain people (Yanow and Schwartz-Shea Reference Yanow and Schwartz-Shea2008). Not many ethnographers start with specific hypotheses that later will be systematically tested. As a primary data-gathering technique, ethnographers often rely on the relationships that they have established with potential subjects (Bosk and de Vries Reference Bosk and de Vries2004).

International field research is fraught with uncertainties that are specific to a region and the sociopolitical context within the region. This leads to significant differences between experimental research and field research. The differences have implications for three of the fundamental IRB processes: informed consent, understanding potential harms and risks, and confidentiality. For instance, observation of public behavior as a part of ethnographic research does not necessarily require informed consent (Marshall Reference Marshall2003). ^{Footnote 5} Furthermore, for various reasons, ethnographers cannot particularly inform the subjects of the risks and benefits of cooperating. In developing countries, the mere mention of benefits—especially in rural areas—is related to monetary incentives. After a researcher convinces the subjects that there are no financial benefits for them or their families, there is general disappointment. ^{Footnote 6} This behavioral shift can have a direct impact on further communication with the researcher. Also, discussing the risks from an academic perspective is too difficult for the subjects to understand. Before delving into directed questions related to the research, the process of explaining risk and benefits may deter the subjects from establishing a rapport with the researcher. In addition, it is difficult to specify risks because the findings are not known (Bosk and de Vries, Reference Bosk and de Vries2004).

In many non-Western countries, the concept of ethical review for the social sciences is relatively unexplored and few mechanisms are in place to oversee or approve any proposed field research. At times, IRBs in the United States propose that a researcher obtain a “go-ahead” from the country where the research will be conducted. In nonmedical fields, this approval from the foreign country is almost impossible. The administrative setup varies among countries, which often is ignored by IRBs. These uncertainties are real problems that must be discussed at length. Instead, IRBs are more concerned with “the procedural and bureaucratic” (Bosk and de Vries Reference Bosk and de Vries2004, 260).

Indeed, there are serious ethical dilemmas when conducting research in international regions that have either a history of conflict or an ongoing conflict. Does this automatically lead to the conclusion that all ethnographic research in conflict areas is to be abandoned? “Fieldwork is possible even in the most dangerous contexts” (Sluka Reference Sluka, Nordstorm and Robben1995, 293). Fortunately, several researchers have successfully completed field research in conflict zones; however, almost all of them raise concerns about the IRB process. Again, the fundamental issue in conducting research in conflict zones is related to uncertainties and heightened by the possible occurrence of violence. This issue can be resolved in the following ways: careful selection of the location (i.e., not all areas are equally violence prone), careful selection of subjects, choice of questions to be asked, and method of observation. Another aspect is the breadth of knowledge of the researchers and their academic, professional, or family ties to the region to be studied—all of which helped in my research on Maoist conflict in Eastern India.

RECOMMENDATIONS

The tensions in the IRB process cannot be resolved by a single set of actions (Fujii Reference Fujii2012). I recommend a multilayered course of action in which both the researcher and the IRB members engage actively to encourage ethnographic field research in general and international field research involving challenging topics in particular. This research is important to learn about causes and consequences of complex issues (e.g., political conflict). These recommendations are not restricted to ethnographic field research in conflict zones but rather field research in general. They include (1) bridging the gap between the researcher and IRB members, (2) reducing delays in the IRB approval and revision process, (3) encouraging collaboration and dialogue among researchers, and (4) advocating a proactive stance by academic associations.