Codes for conduct in research came out of atrocious abuses that came to light during the Nuremberg war crime trials at the end of World War II. When the biomedical experiments conducted by physicians and scientists on prisoners in concentration camps were exposed, there was a startling new awareness of the vulnerability of those held captive, who were subjected to experiments they never consented to, conducted by those in power or in positions of authority.
The result was the Nuremberg Code, which “became the prototype of many later codes . . . intended to assure that research involving human subjects would be carried out in an ethical manner” (National Commission, 1979, p. 1).
In the U.S., several landmark cases of research that exploited particularly vulnerable populations laid the groundwork for the federal protections that were developed to minimize risk to human subjects participating in research (LeCompte & Schensul, 1999). These primarily involved abuses by the medical community that were publicly exposed in the mid-1960s and the early 1970s.
Some of the more infamous cases included hepatitis vaccine research carried out on institutionalized, developmentally disabled children at the Willowbrook State School in New York and the Tuskegee Syphilis Study involving African-American male prisoners from whom effective treatment for syphilis was withheld to track the progression of the disease (Mastroianni & Kahn, 2001). Mastroianni and Kahn point out that these examples of exploitive practices in research
contributed to a sense that human subjects research in the US permitted scandalous practices—inadequate attempts to inform subjects about research and obtain their consent, exploitive recruitment strategies, the use of vulnerable subject populations, and a willingness to expose subjects to significant risk without any potential for direct medical benefit. Further, there was a sense that the risk and benefits of the research were split apart—the risks were borne by subjects, the benefits accrued to others. (p. 22)
This history of research abuses led to the creation of ethics policies focusing on the protection of human subjects from exploitation or exposure to unac-ceptable levels of risk through their participation in research. In addition, some populations, such as prisoners and children, were declared in need of special protections. Federal regulations to address these ethical concerns have their origins in the Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979.
This report set out the basic ethical premises that are embodied in current reg-ulations (Hammack, 1997) and are reflected both in professional associations’
codes of ethics and in the establishment of IRBs. While created in an era of heightened awareness and concern about the ethics and abuses of biomedical
research, the guidelines in the Belmont Report also apply to any field of research involving human subjects.
THE BELMONT REPORT
While the Belmont Report has been codified into working rules of sorts, implemented and enforced by entities such as IRBs, it is acknowledged in the report itself that it was intended as a guide rather than a clear-cut blueprint.
The creators indicate that the rules “often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply” (National Commission, 1979, p. 3).
Three basic principles are set forth in the Belmont Report to provide an analytical framework toward the resolution of ethical problems that develop with research involving human subjects: (a) respect of persons, (b) benefi-cence, and (c) justice. The principles provide a framework within which to think about risks to human subjects participating in research; in addition, they
“provide a basis on which specific rules may be formulated, criticized and interpreted” (National Commission, 1979, p. 3). Key here is that the principles offer an approach or guide rather than a grid that can be applied to resolve beyond dispute any ethical problem; with the ongoing development of action research, we must continue to push to understand the application of these principles to these emergent designs.
Respect for persons represents flip sides of the same idea: that individuals are autonomous persons, capable and entitled to personal decision making in terms of participating or not in the research process; conversely, if their auton-omy is diminished, they are persons in need of protection in terms of their possible participation in the research process (National Commission, 1979, p. 4). Autonomous persons in this context are those who are seen as capable of deliberating and then acting upon this deliberation in terms of freely consent-ing or declinconsent-ing to participate in the proposed research. In other words, when approached, they freely consent or decline based on their weighing of the options and choices in front of them; part of this weighing is their considera-tion of whether they run the risk of being harmed in any way through or by the research and whether they are willing to assume such a risk.
In terms of respecting potential research participants, the researcher is obliged to be forthcoming in terms of imparting the information necessary whereby the potential participant can consent to participate based on being apprised of relevant information; part of the relevant information is a complete description of what the participant might expect if agreeing to be involved in the research. This has typically involved a spelling-out of the procedures of the research—observations, interviews, anything that the participant will be asked to do as part of the research. The idea is that the potential participant is fully
informed as to what to expect in the research process. While this information may be conveyed verbally, it must also be laid out in written form; participants must agree in writing to the terms of the research via signing an informed con-sent form. Most IRBs supply a template of sorts that delineates what needs to be included in the consent form.
Some individuals are not seen as capable of self-determination—that is, able to give their own consent to participate in a research endeavor—and there-fore are offered special protections based on their possible vulnerability (Tisdale, 2003). Diminished autonomy may be temporary, dependent on the maturation process of the individual or the life circumstances, or it may be per-manent. For example, children are a population requiring special protection because they are seen as too young and immature to consent for themselves until they reach the age of 18. Others, such as the severely developmentally dis-abled or the mentally ill, no matter what age, may be seen as permanently not capable of self-determination and others—parents or guardians—may be asked to consent for them in terms of their participation in the research.
Those persons in life circumstances where they may be subtly coerced or unduly influenced to participate in the research, that is, perhaps not freely and voluntarily consenting, are also entitled to consideration regarding special protections. Prisoners are offered as a common example of those who may face coercion. In their circumstances, prisoners may fear some sort of repercussion should they refuse to participate or anticipate some kind of benefit should they agree; in either case, their ability to freely consent or decline may be compro-mised. These same concerns are often raised when teachers propose study-ing their own students or administrators their own employees. In these cases, the issue is one of deciding whether to allow them to “volunteer” at all or to “protect”
them from even facing such a decision.
The principle of justice in research speaks to the fair distribution of the burdens and benefits of research in the selection and recruitment of partici-pants (Mastroianni & Kahn, 2001; Pritchard, 2002). Mastroianni and Kahn (2001) point out that in practice this has also come to mean preventing any further exploitation of vulnerable groups; much was staked on protection and singling out particular groups (prisoners, children, pregnant women, and fetuses) for particular protections. The Belmont Report drew attention to the consideration of the preexisting vulnerability of potential participants based, in part, on past abuses. For example, prisoners were considered vulnerable because of their living environment and the constrained autonomy that came with it;
in addition, they had been a population made easily available to researchers, in part because they, historically, had been viewed as less than “desirable”
(Tisdale, 2003). Policies remain in place today that prevent research on prison populations unless there is a direct medical benefit to the individuals them-selves, such as in clinical trials for HIV, or aims at better understanding or
improving the prison environment such that the research would potentially benefit the prison population generally (Mastroianni & Kahn, 2001). Similarly, because of previous abuses such as the Willowbrook case mentioned previously, research involving children was limited to studies involving either minimal risk or direct medical benefits.
Some have argued that “deviant” people fit the category of vulnerable pop-ulations as defined by the Belmont Report. The reasoning is, deviant behavior is outside the accepted norm and those exhibiting such behaviors fall into the undesirable category delineated in the report; O’Connor (1979, cited in Tisdale, 2003) suggests that illicit drug users and “sexual deviants” deserve special pro-tections because they can be considered vulnerable if researchers place “further burdens on already burdened persons” (O’Connor, 1979, p. 18, cited in Tisdale, 2003, p. 21). The Belmont Report directs that researchers not select only “unde-sirable” persons for risky research (Tisdale, 2003). In addition, it stipulates that when selecting participants, care must be given to avoid systematically selecting those who are easily available (persons confined to institutions, welfare clients, etc.), easily manipulated, or in a compromised position; instead, the selection of subjects must directly relate to the research problem being studied. In addition, the principle of justice demands that, in the development of therapeutic devices, interventions, and procedures, these not advantage only those who can afford them and also that this kind of research not unduly involve persons from groups unlikely to benefit from the applications of the research.
The principle of beneficence speaks to the maximizing of benefits and the minimizing of risks in the research process. According to the Belmont Report, researchers are to adhere to two general rules: (a) do no harm and (b) maximize possible benefits and minimize possible harms (National Commission, 1979, p. 6).
Essentially, “we must actively attempt not only to avoid harms, but to benefit those studied, to augment, not merely respect, their autonomy” (Cassell, 1982, p. 27).
However, as the report points out, to avoid harm requires learning what is harmful and, in the process of determining this, some may be exposed to risk of harm.
Learning what will, in fact, benefit may require exposing persons to risk.
The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks (National Commission, 1979, p. 7).
The principle of beneficence applies to individual research projects and the entire enterprise of research; by this we mean that researchers and IRBs must consider how to maximize benefits and reduce risks in the individual’s research process but this also must be done within the context of the longer-term benefits and risks that may result “from the improvement of knowledge and from the development of novel medical, psycho therapeutic, and social procedures”
(National Commission, 1979, p. 7).
Researchers and the institutions designed to review research are asked to perform a balancing act; they are asked to take into consideration the possible risks and benefits of a course of research and make difficult decisions when the principle of beneficence cannot be unambiguously applied. Just as the Belmont Report reiterates an expectation that physicians are guided by the Hippocratic oath, requiring them to “do no harm,” “according to their best judgment,” this same sense of exercising professional judgment is required of us as action researchers.