What Do you Mean by “Informed Consent”? Ethics in Economic Development Research^†

Introduction

The ethical conduct of research requires the informed consent and voluntary participation of research participants. As such, much effort goes into ensuring that informed consent is practiced in research, particularly in survey and experimental work (Barrett and Carter 2020). Institutional Review Boards (IRB)1 guarantee that relevant regulations are followed and that researchers are familiar with the process of obtaining informed consent. However, though ethical principles are clearly defined at most Western institutions, including those in the United States, Canada, Australia, New Zealand, the United Kingdom, and across the European Union, discrepancies still exist across countries and regions (Israel 2015). In the field of agricultural and applied economics, Josephson and Michler (2018) identify two limitations to the ethical review of study design and implementation. First is the discrepancy between requirements and practice: there may be differences in the de facto reality of ethical standards practiced and de jure stipulations from IRBs. Second is the use of institutional review primarily within Western universities, which results in a significant number of economists engaged in human subject research who have no requirement to obtain ethical approval of new studies.

We use these two limitations to motivate and frame this article. We specifically focus on the process of informed consent, as most economic studies are “exempt”2 and approval requires only that research participants are informed of all of their rights as research subjects and they consent to participation voluntarily. Our purpose is not to review all ethical standards that researchers face in the process of obtaining IRB approval; we instead seek to highlight recent issues germane to informed consent. Specifically, we focus on these topics in an international context, for research in the field in low-income or developing countries. A large amount of applied economics work is conducted in these contexts and there are associated complexities of ensuring ethical treatment of subjects in these environments.

In this article, we explore informed consent as required by IRBs and practiced by researchers in the United States. Although (of course) not all agricultural and applied economics researchers are located in the United States, as Schrag (2010) observes, the standards of research ethics are by and large set in the United States. To this end, we focus on the standards as set by institutions and the government in the United States. We review informed consent material on IRB websites of land grant universities in the United States. To extend this analysis for international development economics work, we also review material at the centers of the CGIAR and other development research organizations. We find heterogeneity in requirements: most, though not all, public universities (though few CGIAR centers) have IRBs. The lack of IRBs in some contexts and, for those that exist, the emphasis on process, raises questions about whether research participants are adequately protected and if the regulations imposed by IRBs achieve their stated goals. To further study this finding, we survey researchers at universities to evaluate informed consent practices of researchers. We find that though regulations are clear, modifications may be needed to adapt standard practices to be appropriate for the context of the work.

The specific regulation and practice of interest in this article is that of informed consent. Informed consent advises research participants of their rights as research participants. Of these rights, perhaps the most important are that participation is voluntary and that the research participant can withdraw at any time. In the United States, the standards for conducting ethical research and obtaining consent are rooted in longstanding issues with different application of IRB standards to vulnerable groups. Historically, women, children, those not in power, and other marginalized research participants have faced abuse, mistreatment, and violation of their rights. A number of specific cases have shaped the relevant regulations and practices. Perhaps the most infamous case is that of the Tuskegee Syphilis Study, in which researchers deliberately did not treat African American men for syphilis, so that they could study the disease's progression. More cases of mistreatment of research participants occur in Native American populations, including the specific case of the Havasupai Tribe.3 While these cases are largely within the medical discipline, social scientists have also perpetrated mistreatment, including on LGBTQ populations (Humphreys 1970). In all cases, the mistreatment is focused on marginalized groups or individuals. These marginalized peoples are often referred to as “vulnerable populations,” indicating some disadvantage of the group, in comparison with the broader population (Caballero 2002). The freedom and capability of vulnerable individuals to protect themselves from intended or inherent risks may be abbreviated (Shivayogi 2013). By extension, research participants outside the US have comparable limits on their ability to secure their rights in accordance with regulations from IRBs located a continent or more away. Due to these vulnerabilities, diligent attention is needed to ensure that individuals are made aware of and are secure in their rights.

In addition, there may be further considerations for researchers that may complicate working in contexts in low-income or developing countries. Populations may not be literate, their language may not be written, or they may have conceptions of the self that extend beyond an individual making the typical wet signature.4 Additionally, the consent process may not be viable if enumerators in charge of data collection do not have training relevant for obtaining informed consent and thus not see its value and role in the research process. Further, it may be the case that researchers are able to “get away with” research in developing countries that would be impermissible in high-income countries in the modern era.5

Following the evolution of thought on this topic, ethical research must not only meet codified standards, but should also consider potential harms and benefits, equity, and autonomy. Ethical research is not satisfied by completing forms that can be read and distributed, but is an ongoing process, extending from the genesis of an idea, through data collection and analysis, and through publication itself (Lybbert and Buccola 2020; Michler, Masters, and Josephson 2020). These practices must be culturally appropriate and recognize the rights of the individuals and groups involved.

In this article, we attempt to provide a thorough discussion on informed consent, though our coverage and the associated ethical considerations are far from exhaustive. We address several sensitive issues and make recommendations for adapting informed consent procedures based on these complications, but we do not claim to hold all the answers to the problems discussed, nor do we claim to be the ethical arbiters of the profession or of survey work broadly. The goal of this article is to engage agricultural and applied economists in a discussion about the current structure of the IRB system, specifically our use of informed consent and the ethical considerations, best practices, and procedures of our economic development work.

Background and Status of IRB

The protection of individuals has long been inherent to scientific, in particular biomedical, practice. However, such standards were only codified following World War II. At that time, internationally recognized declarations formalized regulations on the conduct of research with human participants. Chief among these is the Nuremberg Code, which states that “the voluntary consent of the human subject is absolutely essential” in any experiment involving humans. According to the Code, voluntary consent means that.

the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements involved as to enable him to make an understanding and enlightened decision” (USGPO 1949: pp. 181–182).

The key elements of this definition are both “free choice” and “sufficient knowledge and comprehension.” Though the Nuremberg Code was and is not legally binding, it influenced the formation of national guidelines, rules and regulations on the conduct of research. The Helsinki Code, created by the World Medical Association (WMA) in 1964, further codified ethical behavior in biomedical science, building on provisions of the Nuremberg Code (WMA 2018).

In 1974, regulations were formalized and codified in law in the United States. The United States Congress established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research following revelations of abuse of humans by the U.S. Public Health Service at Tuskegee University. The Commission issued the Belmont Report in 1978, which defined the basic principles of the US system of ethical research (Childress, Meslin, and Shaprio 2005; Israel 2015). Three core principles were identified: respect for persons, beneficence, and justice (Belmont 1978). Belmont (1978) also defined three areas of application of these principles: informed consent (respect for persons), assessment of risks and benefits (beneficence), and recruitment and selection of participants (justice).

The Belmont Report does not explicitly specify rules for application in economics research specifically, though the profession has adopted many of the rules and regulations, including those related to informed consent.6 The presence of IRBs at universities ensures the de jure application of the ethical principles of the Belmont Report in economics research (Josephson and Michler 2018). Field guides written to assist economists and social scientists in designing research projects and the increasing use of preanalysis plans in specifying research projects before approval and implementation of research also serve to dictate norms in the profession.7 Applied economists at universities typically obtain approval of study design and survey instruments prior to fieldwork. Through the Belmont Report the United States government plays an important role in regulating the treatment of research participants; if an organization receives federal funding of any kind, the Common Rule (Federal Policy for the Protection of Human Subjects, Title 45 of the Code of Federal Regulations, Part 46) stipulates that an IRB approval be obtained before undertaking research involving human subjects.

The Common Rule likewise effectively enforces the practices and standards associated with informed consent procedures. This requires that researchers explain any risks of harm associated with participation in a study to those involved. The researcher must also obtain consent from the study participants, after informing them of the risks associated, but before proceeding with research activities. The requirement of a signed consent form may be waived under particular conditions, e.g., if the only record linking the subject and the research would be the consent document and the principle risk would be potential harm resulting from a breach of confidentiality; and/or if the research presents no more than minimal risk of harm to the participants and involves no procedures for which written consent is normally required outside the research context. However, even if the IRB approves a waiver of written documentation, other accommodations may be stipulated. For example, an oral statement may be required at the outset of each interview or a cover letter that includes the essential elements of informed consent may be necessary when introducing a web or mail survey. Further, such waivers of writing documentation are increasingly rare (Schrag 2010).

Although the standards for informed consent seem straightforward, the process itself can be complex. Such complications arise, for example, when a service is provided to an entire community, in the interest of research, as an individual may be unable to opt-out of participation (Hutton, Eccles, and Grimshaw 2008; Glennerster 2017).8 Extending this, there may be negative externalities from an experiment even when participants have been appropriately given an opportunity to engage in informed consent. An example of this is case of Bertrand et al. (2007), in which drivers were encouraged to secure drivers licenses, resulting in a number of potential drivers engaging in extralegal payments and thus obtaining licenses without actually knowing how to drive. These individuals may cause damage outside the scope of the experiment, to others who are unaware of the experiment and did not consent to participate. These community-level effects can result in unintended harm and thus may confound the meaning and practice of informed consent.

Further, it is possible to violate participants’ rights, despite adherence to the written regulations of informed consent. An example of this is demonstrated in a case of medical research undertaken on the Kenyan Coast: Molyneux, Peshu, and Marsh (2004) reported that parents signed consent for over 4,000 children to be involved in ongoing research each year, ranging from observational studies to testing of new drugs. Additionally, thousands more community members consented to interviews and sometimes invasive procedures. Despite the review of study design and consent forms by national and international committees, Molyneux, Peshu, and Marsh (2004) found that the study participants were not appropriately treated. Compliance with IRB regulations and informed consent procedures still failed adequately protect subjects, as such regulations purport to achieve.

The problems associated with informed consent and research ethics generally are well documented in the biomedical profession.9 As the roots of ethical standards are set in this field, this is not surprising (Childress, Meslin, and Shaprio 2005; Schrag 2010; Israel 2015). However, less is said in the field of applied and agricultural economics. Some of this is due to the nature of the questions at hand: for applied economists, the research questions of interest are generally of low risk10 to participants. Yet some of it may also be attributable to a minimal discussion of ethics within the field generally (Josephson and Michler 2018). With this article, we hope to broadly encourage the discussion of the ethical considerations and to specifically stimulate discussion on the process of obtaining IRB approval and engaging with informed consent procedures.

Method

The issues surrounding IRB are generally discussed and studied qualitatively, with case studies or anecdotes from the field. So, to contribute some empirical evidence to discussions on this topic, we make efforts to include quantitative perspectives. To gain an understanding of the current status of informed consent practice and policies with agricultural and applied economics profession, we conduct a layered search. We follow the issues raised by Josephson and Michler (2018), including: (i) the discrepancy between regulations and practice, and (ii) the use of IRBs primarily within Western universities.

To address this first issue of discrepancies between practice and regulation, we conduct a university search. We downloaded a list of universities from the National Institute of Food and Agriculture's list of land grant universities or (LGUs; USDA-NIFA n.d.).11 NIFA has lists of 1862, 1890, and 1994 LGUs. Of these, there are 191890 LGUs, 311994 LGUs12, and 501862 LGUs, excluding the District of Columbia and the territories of the United States. We excluded our home universities, leaving us with 481862 LGUs. From this list of 108 universities, we collect details on their ethical review policies. We screened universities according to whether a search of their main website with the letters “IRB” (or permutations thereof) led to information about ethics review and/or research protocols. If the IRB location resulted, we then searched for informed consent language in the policy documents or online tools provided for researchers. Finally, we searched for language about the waiver of informed consent. The information from this search gives us an overall picture of the expectations for ethical review across universities.

Based on the findings of this search, and to examine how researchers at universities actually practice research ethics in agricultural and applied economics, we distributed a survey to agricultural and applied economics researchers. Our target respondent currently had work in the field somewhere outside of the United States. On October 9, 2018, a survey and short message13 were sent to 283 researchers across the United States.14 On October 18, 2018, the survey was distributed again, through the listserv of the International Section of AAEA, with the objective of reaching additional researchers who were missed in the initial search process. Fifty-five researchers ultimately responded to the survey. Although this gives us limited capacity to make inferences, we discuss briefly the practices and some of the perspectives of respondent researchers.

To consider the second issue, the use of IRB primarily within universities, the next component of our search focused on nonuniversity research institutions. These included the fifteen CGIAR centers, as well as organizations such as the Abdul Latif Jameel Poverty Action Lab (J-PAL) and Innovations for Poverty Action (IPA). As in the case of land-grant universities, we screened each center or organization with a search of their main website to see if using the terms “IRB,” “Research Ethics,” or “Protection of Human Subjects” led to information about the Institutional Review Board or research protocols. We also searched for informed consent language in the policy documents or online tools provided to researchers. The information from this part of our search gives us a picture of the expectations for ethical review outside of universities by institutions that are often partners in research conducted by university faculty or students.

Status of Ethical Review across Academic Institutions in the United States

We review the IRB procedures for land grant universities or LGUs, including the 1862, 1890, and 1994 LGUs. We focus our discussion on the 1862 LGUs, due to the emphasis within these institutions on research.

Status of Ethical Review within Other Development Institutions

In low-income and/or developing countries, a great deal of research in agricultural and applied economics is conducted in the CGIAR system, by other research organizations such as J-PAL and IPA, or in projects that are jointly implemented by these institutions and universities. Using a similar search procedure from the search of the LGUs, adapted for these other institutional systems, we perform another search for IRBs. Table 2 presents relevant information about IRB requirements and status of development within these CGIAR institutions and the other development research organizations of interest.

Both J-PAL and IPA post detailed procedures, akin to those at 1862 universities, which are easily found on their websites. However, the lack of review boards is acute within the CGIAR system. During our initial search in December of 2018, only eight of the fifteen CGIAR centers require research involving human participants to be cleared by an ethical review board. Broadening our scope and re-conducting the search in July of 2020, we found that ten of the fifteen CGIAR centers either had IRBs in place for social science research or ethical research policies. The latter does not imply that approval for research with human subjects is required, however. Because of the disparate nature among the conditions of the IRBs in the CGIAR, compared with J-PAL and IPA, we focus our discussion on the CGIAR institutions in this section.

In an examination of the websites for these eight institutions only IFPRI's 2003 document “Principles, Policies and Procedures for the Protection of Human Research Subjects” and CIFOR's 2015 document “Research Ethics Review (RER) Policy and Toolkit” were easily obtained on websites. We found ILRI's research compliance website, with information about the research process with animal and human participants. Additionally, policies on research ethics were available and easily found from CIMMYT, ICARDA, and ICRAF. Codes of conduct, which include references to research ethics, were often available on CGIAR institution websites, as well.

This is not the first time that IRB status within the CGIAR system has been surveyed. The Stripe Review of the Social Sciences in the CGIAR (Barrett et al. 2009) found that CGIAR social scientists were often unaware of IRBs and routinely failed to adhere to current international practices for the ethical protection of human participants in data collection. In response to a survey distributed by the review team, only IFPRI and WorldFish had a form of Institutional Review Board to “clear ethical issues as a routine part of project approval.” Barrett et al. (2009) note that several Centers stated that “this is not an issue,” or that they “are not really ‘using’ human participants in research,” or that “researchers are responsible enough to know the level of confidentiality of the data that they are collecting.” At that time, the Science Council had commissioned earlier studies that made clear recommendations for the use of IRBs by Centers, but the team found “the ethical review of CGIAR research processes is deficient in many instances” (Barrett et al. 2009).21 Though often known for their applied research in the agricultural sciences rather than social science, the system as a whole and cross-center, multidisciplinary projects include a sizeable number of social science researchers. Particularly due to recent emphasis on impact assessment, the role of social science within the CGIAR is increasing, but without attention to human subjects in the process of research. Similarly, there is increasing attention to ethics review and the creation of related boards, but the process is slow.

There is a continued to push for use of IRBs within the CGIAR. Doug Gollin of Oxford University, long-term research partner and advisor to the CGIAR, observes that though individuals working in the CGIARs are not quite in the same role as individuals working in the medical profession, there are “… genuine ethical issues associated with introducing new agricultural technologies to people when you don't know how/whether they will work” (Gollin 2018). He further observes that, within these complex technologies, interventions do not all have decidedly positive impacts: “Indeed, it is rare for a technology to have unambiguous effects; most technologies create losers as well as winners. So the potential for doing harm is real” (Gollin 2018). Of course, this holds for many interventions of interest in economic studies, not just agricultural technologies.

Much of the impetus for IRBs within universities is motivated by regulations and the CGIAR must take similar protections. An IRB process could provide both legal and moral protection so that if a technology or intervention developed and/or distributed by the CGIAR causes harm, the institution is able to show that it is not through a failure of oversight or a lack of attempts to minimize risk. Due to existing synergies, the CGIAR system would be well suited to a centralized IRB system, which could serve all the centers in a consistent manner.

Conclusion and Recommendations

In this article, we investigated the process and practice of informed consent, particularly as implemented in the developing country context by researchers based in the United States. We consider informed consent material on IRB websites of LGUs in the United States, as well as at the centers of the CGIAR and other development research organizations. We also use a survey of researchers at universities to evaluate informed consent practices. We find heterogeneity in the presence of IRBs among LGUs in the United States and within the CGIAR centers. Without well-developed systems for tracking research conducted with federal funds, many 1890 and 1994 LGUs, as compared to the 1862 LGUs, have weak IRBs. Further, IRB systems often do not exist in well-funded CGIAR institutions.

Currently, innovations to IRB are focused on reducing burdens or requirements on researchers, with the objective of decreasing the administrative weight on universities and decreasing the time between submission of projects and their final approval. However, such innovations fail to address a basic query: is the IRB process working?22 IRBs and informed consent procedures are largely motivated by the protection of university interests and focus attention on issues of confidentiality and data privacy, rather than the protection of participants themselves. This is an acceptable incentive: good can come from impure motives. Still, it underscores existing concern for research participants.

IRBs take a deontological approach to ethics requirements: the rules exist prior and we must undertake them for our research to be ethical. This system simply provides a checklist for researchers to go through, rather than a goal of rights and protection to work to ensure. This checklist of requirements is simply a lower bound on researchers' ethical obligations. Moreover, many researchers and institutions fail to even achieve and respect that lower bound. We, as a discipline, can and must do better to conduct research ethically, particularly with respect to ensuring the protection of research participants through procedures like securing informed consent. It is imperative that we acknowledge and practice research and informed consent as ongoing processes, which are culturally appropriate and recognize the rights of the individuals and groups involved (Michler, Masters, and Josephson 2020). To this end, more attention should be given to research participants: how do they perceive the current regulations; how do they perceive the researchers; how do they perceive the outcomes of the research? Though we hope the motives of most researchers are likely ethical, we, in the field of agricultural and applied economics, should turn our attention more closely to the participants—the individuals, households, and communities with whom we interact in our research. This will give us a better understanding of what is meant, what is understood, and how we can improve in the process of informed consent in our work around the world.