NURS 521
Discussion Assignment Instructions
The student will post one thread of at least 500 words. For each thread, students must support their assertions with at least 3 scholarly citations and 1 Bible verse in APA format. Each reply must incorporate at least 2 scholarly citations in APA format. Any sources cited must have been published within the last five years. Acceptable sources include nursing or medical textbooks, scholarly, peer-reviewed research journal articles published in the past 5 years, reliable websites (generally .org, .gov., or .edu sites are acceptable; avoid .com sites, blogs, social media), and the Bible.
Topic:
Review the information in Gray & Grove Chapter 9.
Read the three articles that provide examples of occasions where unethical research happened or may happen. The 2 attached and the link:
https://journalofethics-ama-assn-org.ezproxy.liberty.edu/article/genetic-research-among-havasupai-cautionary-tale/2011-02
·
Watch the video about bias in research or read the transcript for the video.
· In your initial post identify commonalities in the unethical practices or attitudes of each of the articles if any.
· What ethical principles were violated?
· What are the lessons to be learned from these examples?
· What guidance, practices or policies would you use to avoid these errors in the future.
· How would a Christian worldview and Biblical principles apply? Support with Scripture.
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Ethics & Behavior
ISSN: 1050-8422 (Print) 1532-7019 (Online) Journal homepage: https://www.tandfonline.com/loi/hebh20
No Meaningful Apology for American Indian
Unethical Research Abuses
Felicia Schanche Hodge
To cite this article: Felicia Schanche Hodge (2012) No Meaningful Apology for
American Indian Unethical Research Abuses, Ethics & Behavior, 22:6, 431-444, DOI:
10.1080/10508422.2012.730788
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ETHICS & BEHAVIOR, 22(6), 431–444
Copyright © 2012 Taylor & Francis Group, LLC
ISSN: 1050-8422 print / 1532-7019 online
DOI: 10.1080/10508422.2012.730788
No Meaningful Apology for American Indian
Unethical Research Abuses
Felicia Schanche Hodge
Health Promotion Services, UCLA School of Nursing Health Services, UCLA School of Public
Health Center for American Indian/Indigenous Research and Education
This article reviews the history of medical and research abuses experienced by American Indians since
European colonization. This article examines the unethical research of American Indians/Alaska
Natives in light of the Tuskegee Study of Untreated Syphilis in the Negro Male. Literature cita-
tions indicate that significant unethical research and medical care incidents occurred both before and
after the Tuskegee Syphilis Study among American Indians/Alaska Natives. The majority of these
unethical abuses were committed by the federal government and within the historical context of a
long-term contentious relationship between American Indians and the federal government. Although
President Clinton issued a highly visible public apology to the African American survivors of the
Tuskegee syphilis experiment in 1997, American Indians have yet to experience such visible federal
acknowledgment. To ensure ethical research in which benefits outweigh risks and findings are not
value-laden or misrepresented, tribes have instituted their own Institutional Review Boards coupled
with community-participatory activities.
Keywords: American Indians, Legacy of Tuskegee Syphilis Experiment, research distrust, bioethics,
minority participation in research, Tribal IRB
INTRODUCTION
The Tuskegee Study of Untreated Syphilis in the Negro Male (1932–1972) could have been a
story of American Indian/Alaska Native research abuses. As in the Tuskegee Syphilis Study,
research with American Indian/Alaska Native populations was generally implemented by gov-
ernmental researchers with the aid of a trusted member of the community, often an indigenous
nurse or elder recruited participants who acted as translators (Foulks, 1989; National Research
Council, 1996). Much like research in the Tuskegee Study of Untreated Syphilis in the Negro
Male, harm outweighed benefit, producing great damage to American Indian participants, their
families, and community/tribes. American Indians/Alaska Natives and the Tuskegee Study of
Untreated Syphilis in the Negro Male participants share a troubling history of scientific racism
that has led to multiple research abuses; violations of basic human rights; and, in some cases,
genocidal tactics against American Indians (Stiffarm & Lane, 1992; Thornton, 1987).
Correspondence should be addressed to Felicia Schanche Hodge, UCLA School of Nursing, 700 Tiverton Avenue,
5-940 Factor Building, Los Angeles, CA 90095. E-mail: fhodge@sonnet.ucla.edu
432 SCHANCHE HODGE
Given the lengthy history of these unethical abuses, it is not surprising that distrust of research
and reluctance to participate in research studies have evolved over the years among indigenous
groups. Multiple research insults occurred before and after the Tuskegee Syphilis Study, occur-
ring within a historical context of a long-term, contentious relationship between tribes and the
federal government. Concern over these abuses has given birth to tools and methods designed to
control research and to protect individual American Indians/Alaskan Natives and the collective
tribal communities. Tribes have taken advantage of legislation and other tools to advance control
over research, thereby protecting their tribal members and community from the potential research
abuses. Since President Clinton’s Apology 15 years ago to the Tuskegee Study participants, the
lack of a direct apology to tribes that have endured a lengthy history of medical and research
abuses at the hands of the federal government has become apparent. This article traces the history
of medical and research abuse experienced by American Indians/Alaskan Natives through an
examination of some of the most egregious and well-documented cases of abuse and illustrates
the approaches that tribes have undertaken in response to these abuses.
MEDICAL ABUSES EXPERIENCED BY AMERICAN INDIANS
The lives of today’s American Indians are influenced by a history of oppression, repression,
and intergenerational trauma experienced since Europeans colonized North America more than
500 years ago (Braveheart & DeBruyn, 1998; O’Nell, 1994). From the beginning of coloniza-
tion, there was little room for the indigenous population in the plans of European newcomers.
Military campaigns and assimilation efforts were responsible for destruction of tribal struc-
tures and dramatic population losses for American Indians. But it was the lack of immunity
to the diseases that accompanied European colonizers and their rapid and sometimes deliberate
introduction into American Indian communities that proved to be the most damaging. A well-
known example occurred during the French and Indian War of 1756 to 1763 when the British
military commanders advised that small-pox-infected blankets be distributed among American
Indian communities as a means to “Extirpate this Execrable Race” (Parkman, 1994; Patterson &
Runge, 2002). In other regions, small pox eliminated half the Huron and Iroquois confederations
(Duffy, 1951), half the Cherokees and Catawbas (Duffy, 1951), and two thirds of the Omahas
(Stearn & Stearn, 1945). The subsequent spreading of whooping cough, influenza, tuberculo-
sis, and pneumonia decimated the American Indian population and brought numerous tribes to
the brink of extinction (Crosby, 1976; Thornton, 2000). In addition to disease, the health sta-
tus of many American Indians was threatened by rotting meat and bug-infested food supplies
that were distributed with rank drinking water at forced and guarded military encampments with
poor sanitation. These encampments became reservations (Berzok, 2005). By the turn of the 20th
century, the American Indian population, estimated to number in the millions before the arrival
of Europeans, was reduced to a paltry 120,000 in the contiguous United States—a significant
reduction that threatened the extinction of all tribes (Thornton, 1987).
As diseases continued to devastate tribal communities, many abusive medical practices were
documented (Meriam, 1928). Government doctors stationed at military sites (where most reser-
vations were located) practiced on Indians with impunity. Trachoma, an infectious eye disease,
became a serious health threat in 1897, particularly with the influx of immigrants to the United
States. In the 1900s, rates of infection were high in the “Trachoma Belt” stretching from Virginia
UNETHICAL ABUSES IN AMERICAN INDIAN RESEARCH 433
to Oklahoma, and the prevalence of trachoma reached 90% on some American Indian reserva-
tions (Edwards, 1998; McMullen, 1917). To treat trachoma, Indian Health Service (IHS) doctors
surgically removed the upper and lower eyelids of men, women and children, “a serious radi-
cal operation” called a tarsectomy (Allen & Semba, 2002), a supposed cure, “without carefully
watching results and checking the degree of success achieved” (Meriam, 1928, p. 11). Although
trachoma was epidemic throughout the world at various times, treatments in past years included
bloodletting (cuts to the eyelids), rupturing of the granules, and various eyewashes. The more
serious procedure used on American Indians (removal of the eyelids) was radical and not widely
used on other populations. Tarsectomy was used from the 1900s to 1930s as a treatment, as well
as a preventative measure on nonsymptomatic individuals in several American Indian communi-
ties. This disfiguring and untested medical procedure continued until sulfa drugs were discovered
in the 1930s. (Thygeson, 1939).
Perhaps among the most traumatizing and illegal of assaults was the sterilization of American
Indian women and girls without their knowledge or consent. American Indians were targeted for
this extreme form of family planning due to their high birth rate compared to other populations
(Lawrence, 2000). In the 1970s, rumors were circulating about American Indian females undergo-
ing sterilization (tubal ligations and hysterectomies) at the hands of the federal IHS. Complaints
by an American Indian physician to the federal government resulted in a study by the General
Accounting Office (Carpio, 2004; Torpy, 2000). The General Accounting Office reported that
3,406 American Indian females between the ages of 15 and 44 who received healthcare services
in four of the 12 IHS regions were sterilized by IHS doctors or IHS “contract” doctors between
1973 and 1976 (Chicago Committee to End Sterilization Abuse, 1977; Comptroller General of
the United States, 1976). This report indicates that the medical consent forms were inadequate,
illegally obtained, and not in compliance with IHS regulations. For instance, it is reported that
36 women younger than 21 had been sterilized from 1973 to 1976 despite a court-ordered mora-
torium on sterilizations of women younger than 21 (Comptroller General of the United States,
1976). It was reported that physicians obtained “verbal consent” for sterilization, and in many
cases coercion was evident, as women were reportedly led to believe that they “would lose BIA
[Bureau of Indian Affairs] benefits, access to services, or custody over their other children if
they refused to do the procedure . . . and IHS personnel did not correct this perception” (Rutecki,
2011).
It was the practice of the IHS to contract out to non-IHS physicians when healthcare services
were not available at local reservations. Over the period of 1972 to 1976 the IHS reimbursed
fully or at a rate of 90% for sterilizations compared to less than one half for abortions (U.S.
Department of Health, Education and Welfare, 1978). Many American Indian women were ster-
ilized following childbirth or during another procedure (such as appendectomy). At least two
15-year-old girls awoke from what they believed to be surgeries removing their tonsils to find
that their ovaries had been excised instead. Compensation, explanations, or corrective action by
the IHS to the victimized individuals and their families were never obtained (Rutecki, 2011).
A 1973 study conducted by the Health Research Group, as well as interviews with physi-
cians who carried out sterilizations on American Indian women, reveals the troubling reasoning
behind the practice (Rosenfeld, Wolfe, & McGarrah, 1973). Aside from the physicians’ views
that this practice helped society through population control and reducing racial/ethnic tensions,
they reasoned that it reduced the financial burden on government social programs and lessened
their personal tax burden to support social programs. In addition, American Indian women,
434 SCHANCHE HODGE
they reasoned, were not intelligent enough to effectively use birth control methods, and fur-
ther, the procedure allowed physicians to gain more specialization in gynecology and obstetrics
(Lawrence, 2000). The federal government has been legally and morally entrusted with safe-
guarding the health and welfare of American Indian tribes (Cherokee Nation v. Georgia, 1930).
The same ill-guided views that allowed the federal government to breach its trust responsibility
in medical care also permitted abuses in the research domain.
RESEARCH ABUSES EXPERIENCED BY AMERICAN INDIANS
Long before the Tuskegee Study, American Indians/Alaska Natives were subjects of research that
was often supported by pseudoscientific methods, resulting in risk to health and disfigurement,
and running contrary to cultural beliefs and practices. For instance, in the 17th and 18th cen-
turies, military doctors collected American Indian body parts from battlesites and army hospitals
for phrenological purposes, a pseudoscientific study of the shape and protuberances of the skull
in the discredited belief that skulls could reveal character and mental capacity (Thomas, 2000).
These practices were traumatic, as many tribes believe one cannot go into the spirit world with-
out an intact body, or that disturbed spirits will potentially cause harm to the living (Gulliford,
1996; Riding In, 1996; Thomas, 2000). Disposal or reburial of the body parts from the desecrated
gravesites was never reported.
In a 1950s study, the U.S. Air Force’s former Arctic Aeromedical Laboratory attempted to
identify the role of the thyroid gland in human acclimatization to cold weather. With the assistance
of Native elders, Alaska Natives were recruited into the study, which entailed ingesting a radioac-
tive isotopic (National Research Council, 1996; Shore, 1989). Radioactive Iodine (Iodine131), also
called Radioiodine I-131, an isotope of iodine that emits radiation, was given to Alaska Natives
as a part of the study. Generally used for medical purposes (such as a treatment for an overactive
thyroid), when ingested I-131 is absorbed in the bloodstream and then concentrates in the thyroid,
where it destroys the gland’s cells. Two hundred doses of the radioisotope Iodine131 were admin-
istered to 120 Alaska Natives and Eskimos (men, women, and children) residing in villages in the
northern and central portions of Alaska. Most doses were 50 microcuries, which exceed the cur-
rent recommended dosage limits for such use as cancer screening purposes (Advisory Committee
on Human Radiation Experiments, 1995). Current standards for safely ingesting Iodine131, which
are more restrictive than the standards used in the 1950s, would preclude use of minors, lac-
tating women, and potentially pregnant women; however, subjects in these categories were not
excluded. Many of the Alaskan subjects were non-English-speaking individuals and children,
who were unable to provide proper consent at the time. Adequate records, such as participant
demographic characteristics, residence, date and per-person amount of iodine dosage, pregnancy
status, consenting of individuals or guardians of children were not obtained or retained. Medical
follow-up for iodine exposure health risk assessments of the subjects and their offspring is there-
fore not possible. In additions, records detailing methods and procedures used that would ensure
that coercive tactics were not employed in the recruitment and retention of subjects were not col-
lected. It is speculated that the villagers believed they were trading their participation for much
needed medical treatment in their rural villages (Shore, 1989).
In the 1970s, controversial studies continued to abuse and stigmatize tribes. Inupiat natives
of Barrows, Alaska, age 15 and older participated in a study of alcohol use (Foulks, 1989).
UNETHICAL ABUSES IN AMERICAN INDIAN RESEARCH 435
Commissioned by the city’s Department of Public Safety, the study’s aim was to assess the role
of alcohol use in traumatic deaths to facilitate the design of beneficial interventions for the com-
munity. Among the charges levied against the study by Inupiat critics were the study’s lack of
proper consenting of Native youth and adults and the use of “Western, lower-48” standards and
measures on the Inupiat society (Foulks, 1989). The sensational “findings” were leaked to a major
news source prior to consultation with the studied community (Wolf, 1989). As a result of the
negative media portrayal of Barrow, the bond rating for the city dropped, undermining economic
development (Noe et al., 2006).
In a special edition of the National Journal (Manson, 1989), several researchers assessed the
implementation of the Barrows study and the resulting conflict between the community and
researchers. Beauvais (1989) noted that the “one-dimensional model” focus, coupled with the
complete lack of Inupiat participation in the research (although a Native steering committee was
convened in the later stages of the research), led to the ill-fated results of the study. These results
highlighted the problem of alcohol consumption and subsequent health and social problems expe-
rienced by the Inupiat community members instead of focusing on intervention options targeting
traumatic deaths (due to accidents and hyperthermia). Further, the report was published widely to
the non-Indian communities without the opportunity for the Native group to review and respond
to its validity or comment on its potential harm by stigmatizing the community. Westermeyer
(1989) addressed the stumbling blocks faced by researching stigmatizing conditions stating that
research cannot be guided by the funders and that if the research is important, someone will
either be disturbed or enraged. Wolf (1989), however, reminded the reader that the research has
had some impact as a number of Alaskan communities (including Barrow) have voted to become
“dry” communities to reduce the effects of heavy drinking. These communities have noticed a
marked decrease in both violence and drinking.
In the 1990s and shortly after the turn of the 21st century, tribes were given additional rea-
sons for distrusting research and researchers. Although the Tuskegee Syphilis Study and the
Belmont Report (guidelines for the protection of human subjects in research) aid the groundwork
for Institutional Review Boards (IRBs), which enforce protections for human research subjects,
research abuses continued. University IRBs were in force when the Havasupai Indian tribe of
Arizona agreed in 1990 to participate in an Arizona State University (ASU) type 2 diabetes study
(Couzin-Frankel, 2010). A researcher entered the reservation and drew more than 200 blood
samples from Havasupai members. These samples were removed from the study site at Havasupai
without the tribe’s knowledge, stored at ASU, and used for other non-diabetes-related studies (and
non-IRB-approved studies), such as the genetic basis of schizophrenia and inbreeding (Dalton,
2004; Mello & Wolf, 2010; Santos, 2008; Sterling, 2011). Numerous publications were produced
and a doctoral thesis resulted (Caplan & Moreno, 2010; Rimmer, 2007). Blood samples were
sent overseas to other researchers and their whereabouts remain unknown. This was particularly
troubling to the tribe, as their cultural belief is that all biological human material must be intact
in order for an individual’s spirit to travel to the afterlife, making the return of the blood sam-
ples extremely important to the Havasupai (Drabak-Syed, 2010). ASU had promised to return the
sample as part of their original research agreement.
Years of discussions the about return of the biological samples, the data, and the unapproved
research between the tribe and the university produced few results, so the tribe sued ASU in
2004 alleging fraud, breach of fiduciary duty, negligence, and trespass (Potkonjak, 2004). After
several years, the college agreed to return what remained of the blood samples and to settle out of
436 SCHANCHE HODGE
court. The Principal Investigator of the study was fired for operating a lax research program. ASU
formally apologized to the Havasupai and set out a plan to work with the tribe on issues of health,
education, and economic development. The results of these promises are yet to be determined
(Gulliford, 1996).
Meanwhile, the student researcher who received a doctoral degree for a dissertation on the
Havasupai data subsequently obtained a faculty position at a large university. No publications
based on research using the samples were withdrawn from peer-reviewed journals. The Havasupai
case illustrates that even though changes have been made to promote ethical research practices
since the Tuskegee Study and implementation of the Belmont Report, there is still a need for
tribes to monitor research and assure the mutually beneficial nature of their collaborations with
researchers, federal and otherwise (as even respected academic institutions have caused abuse).
SELF-DETERMINATION AND AMERICAN INDIANS
Since the Tuskegee Study, policies and laws have been enacted to support American Indian con-
trol of healthcare, social services, education, and research. The most seminal piece was the federal
Indian Self-Determination and Education Assistance Act of 1975 (Public Law 93–638). It was
a reaction to federal efforts to assimilate tribes into Western society and to terminate tribes as
sovereign nations and eliminate federal responsibility for the health and welfare of American
Indians. Termination would have meant the end of all treaties and the end of the recognition of
tribes as sovereign entities. Self-determination gives tribes the ability to make choices in their
future, to run programs, which in essence is the determination of their destiny and direction. The
Act encouraged “maximum Indian participation in the government and education of the Indian
people” (Cornell, 1984, p. 53). Tribes now had the authority to negotiate contracts, administer
their own education and social service programs, and participate on school boards. Later amend-
ments provided direct grants to help tribes develop plans to assume responsibility for federal
programs (Dean & Webster, 2000), thus tribes have the ability to assume the implementation and
management of various grants and programs previously headed by federal officials. These grants
and programs include health care clinics, dental clinics, training and education programs, and
support services (Glazer, 2004).
In the 1980s and 1990s, amendments to the Indian Self-Determination and Education
Assistance Act provided for tribal self-governance, thereby launching tools and approaches to
regulate research. In 1995, the Navajo Nation became the first tribe to establish its own IRB
(Brugge & Missaghian, 2006). Tribes and urban Indian organizations have since developed
IRB research training programs for Indian and non-Indian researchers (Research Ethnics and
Institutional Review Board (IRB) Resources for Tribes and Researchers, 2005). Some tribal IRBs
enforce additional conditions that the researcher provides progress reports, a final report, presen-
tation at an annual conference and community feedback at the conclusion of the study and prior
to publication (Maldonado, n.d.). This is important, as failure to organize research in a collab-
orative fashion often results in published data that are not trusted as authentic and is viewed as
not valuable by the community (Mohatt & Thomas, 2005). Failure to organize research in a col-
laborative fashion often results in published data that are viewed as useless by the community,
therefore leaving them with little benefit (Mohatt & Thomas, 2005). Additional requirements
can be instituted; for instance, the Navajo Nation Health Research Review Board can require
UNETHICAL ABUSES IN AMERICAN INDIAN RESEARCH 437
the employment of tribal members who are subject to their labor laws, assert ownership over all
equipment used in the research at the conclusion of the research, and oversight and ownership of
the data specific to its members (Manson, 2004). The Cherokee Nation of Oklahoma, on the other
hand, can require that the investigator spend a couple of weeks at the tribal healthcare clinic prior
to the start of the research (Manson, 2004), further underscoring the right of American Indian
communities to govern themselves. Tribally controlled and operated IRBs and research commit-
tees have rapidly become a reality with many tribes across the nation who either develop their
own IRBs or coordinate the placement of multitribal IRBs in Indian organizations, tribal colleges,
or at local Indian clinics (Aberdeen Area Tribal Chairmen’s Health Board, 2005).
An important distinction of Tribal IRBs is the attention and inclusion afforded to tribes as
a collective society. Where university or governmental IRBs focus on the individual with steps
designed to protect the individual study subject, Tribal IRBs extend this protection to groups,
such as tribes, clans, urban Indian cohorts, and special groups, such as healers, elders, and chil-
dren. As a collective society, American Indians place emphasis on responsibility within the
family, community, and the tribe (Harrison, Wilson, Pine, Chan, & Buriel, 1990). Tribal iden-
tity is formidable and is identifiable in language, clothing, ceremonies, and place (reservation or
region). Perceptions may be influenced by tribal identity, and research groupings and measures
need to take these cultural factors into consideration (Brugge & Missaghian, 2006).
Community-Based Participatory Research (CBPR), a process that encourages targeted
research communities to participate in the development, implementation, and evaluation of
research (Minkler, 2005; Trimble, Scharron-del Rio, & Bernal, 2010), has recently been imple-
mented in tribal communities. However, difficulties in the design and implementation of CBPR
in American Indian communities have arisen. Mohatt and Thomas (2005) emphasized the need
for researchers to understand the influence of culture in the formulation of research ques-
tions, methods, and interpretation. Wallerstein and Duran (2010) and others (Christopher, Watts,
McCormick, & Young, 2008; Fisher & Ball, 2003, 2005) have discussed key challenges for
American Indian equal participation in the CBPR process: (a) translating research findings to
populations who may have high variability in culture, resources, organizational factors, and
research acceptance; (b) listening to and incorporating cultural practices, beliefs, and theories;
(c) translating language, which includes “incompatible discourse between the academy and the
community,” and the use such powerful research terms as “institutionalization” or “collabora-
tors” that may trigger “resistance and historical memories of assimilationist policies or betrayal”
(Wallerstein & Duran, 2010); (d) control of the research process by academics that may impose
research prescriptions or employ tactics to increase minority enrollment; (5) insufficient attention
to implementation within the organizational culture and lack of resources as a barrier; and (6) lack
of trust between researchers and underrepresented communities.
Community-Based Participatory Research, as operationalized by American Indian communi-
ties, means that tribes are equal partners, participating fully in the identification of the problem,
the research design, the selection of measures, subjects and findings. As American Indians are
a collective society whose decisions are made by the group or by elders, and not on an indi-
vidual basis, this dynamic is an important cultural process to consider in designing research.
One or more individuals may be selected from the community to provide representation on an
advisory board; however, the equal participation of both parties may be compromised in cases
where the American Indian individual whom the researchers have selected is not an acceptable
choice to the community. Indeed, the researcher may feel ownership of the research, data, and
438 SCHANCHE HODGE
resulting reports. Too little consideration is given to a culture that operates and views the world
as a collective society.
Community involvement in research can present in several forms. For many American Indians
and Alaska Natives, participatory research has taken the form of partnerships, contracts, or
consultancy with tribal advisory councils, and tribal council stewardship. Indeed, tribes are
(a) beginning to assert ownership over research data, voice their interpretation of research find-
ings, and control publications by guiding publication topics, and (b) having the authority to
approve or disapprove publications (Maldonado, n.d.). Ensuring that interpretation of the research
data reflects the tribal culture and that value-laden measures are not used or reported are impor-
tant functions of Tribal IRBs and CBPRs. In addition, many tribes are starting to require that
research teams provide training workshops/meetings in the tribal community prior, during and
after the research (Maldonado, n.d.; Navajo Human Research Review Board, 2007). These work-
shops provide some interaction with the community and help to educate members on various
research topics. Videos and publications on the history of the tribe or the urban community may
be exchanged so that the research team can expand their knowledge and understanding of the
tribal culture and community.
DISTRUST OF RESEARCH AND RESEARCHERS
The history of medical abuses left scars among American Indians that were never fully healed.
Western medical providers and researchers continue to be uninformed of American Indian cul-
tural constructs of illnesses and the need to observe customs and traditions. For instance, many are
unaware of the need for the return of body parts, so that the individual can pass into the next world
whole, as is the custom for many tribes (Riding In, 1996). Further, tribes may not approve of stud-
ies (or complete the consenting process) that contradict their origin beliefs. Research on sensitive
topics, such as genetic studies or DNA analysis, is often rejected, as most tribes have origin sto-
ries as to where they came from and how they were created that contradict scientific studies that
base their findings on DNA or genetic studies (Maldonado, n.d.; Sterling, 2011). Origin stories
have been told and retold through generations and are an important part of tribal traditions, cer-
emonies, and myths; their veracity may be brought into question by research findings. Research
to examine tribal origins is often denied by Tribal IRBs as it is seen as threatening to tribes and
not of benefit to tribal members (Harmon, 2010). In addition, research on psychological issues,
such as depression, mental illness, and the use of certain substances, is controversial, as differ-
ences in definitions, the cultural constructs of measures, and the value-laden interpretation of
results can be problematic (Kinzie & Manson, 1987; Trimble et al., 2010), leading to stigmati-
zation of the community and its members (Foulks, 1989). Also, words such as “depressed” and
“anxious” can be absent from some American Indian and Alaska Native languages (Manson,
Shore, & Bloom, 1985), making study of these issues sensitive. In addition, the importance of
addressing the intersection of gender and culture in research cannot be ignored in order to protect
the research findings from being interpreted from the dominant, male-centric perspective (Reid,
2002).
Researchers targeting American Indian populations must be cognizant of the restrictions they
face in designing and conducting their research. Although many may question the potential loss
UNETHICAL ABUSES IN AMERICAN INDIAN RESEARCH 439
of research knowledge and benefit to American Indian communities/tribes when DNA and stud-
ies of origin are restricted, however, the value tribes place on culture and identity, past experience
with harmful research, and their concern over the use of value-laden measures that are inappro-
priately used compel many to urge researchers to better understand these issues and to design
research appropriately. The rights of tribes to approve or disapprove research must be honored
given past abuses and concern over poorly designed research. This does not mean that all research
on origin and DNA are restricted, as tribes have maintained the right to selectively approve and
to participate in research that they deem valuable.
Distrust of research and of researchers have colored the American Indian perspective of
research; however, by placing research within the control and supervision of tribes (through
tribally controlled IRBs and research committees), research can be developed to truly benefit
tribes and society at large. Tribal IRBs require respect from researchers, as they must demon-
strate an understanding of the research subjects’/community’s culture(s), and they may also
require that benefits would outweigh the risks of research (Maldonado, n.d.) and comply with
review and approval/disapproval of research measures (Aberdeen Area Tribal Chairmen’s Health
Board, 2012). In addition, tribes have the opportunity to require community-wide presentations
of findings through oral and written reports and as well as workshops or training sessions on
some aspects of the study. Prior approval of research findings and publications that report par-
ticipating tribes by name or give an accounting on study subjects or community can be denied
(Burhansstipanov, Christopher, & Schumaker, 2005; Christopher, 2005) because of privacy con-
cerns. Generally, tribal approval or disapproval of publications is required before final publication
in a research journal.
Tribal IRBs have the full strength of the law because tribes are sovereign nations with special
rights that enable them to set a course for self-determination. The use and ownership of data,
findings, and products of research may be held under the purview of the tribe (Burhansstipanov
et al., 2005; Christopher, 2005). Inclusion of authorship may also be a requirement, especially
if tribal members work on the research project or provide sustentative input or analysis, such as
translation of focus group recordings, validation of research interpretation, and coding or data
analysis.
IS AN APOLOGY REAL IF IT IS NOT PRESENTED TO TRIBES?
In 1997, President Clinton issued an apology to the African American survivors of the Tuskegee
Syphilis Study for the abuses they suffered (Capriccioso, 2010). President Ronald Reagan also
made a formal statement when he signed the Japanese Internment Apology law in 1988, which
carried with it financial restitution (Capriccioso, 2010). Indeed, President Obama recently called
his Guatemalan counterpart to apologize for the 1946–48 research study conducted by U.S.
researchers in which people in Guatemala were intentionally infected with sexually transmitted
diseases to test the effectiveness of penicillin (“U.S. Apologizes,” 2010). Yet no apology of sig-
nificance has been offered to American Indians and Alaska Natives for past research abuses other
than a weak statement buried in a defense appropriations spending bill in 2009. The Apology
Resolution was included as Section 8113 in the 2010 Defense Appropriations Act, H.R. 3326,
Public Law No.111-118, and reads as follows:
440 SCHANCHE HODGE
H.R. 3326, PUBLIC LAW 111–118—DEC. 19, 2009 123 STAT. 3409 123 STAT. 3454 – Section 8113
APOLOGY TO NATIVE PEOPLES OF THE UNITED STATES SEC. 8113.
(a). ACKNOWLEDGMENT AND APOLOGY.
—The United States, acting through Congress—
1. recognizes the special legal and political relationship Indian tribes have with the United
States and the solemn covenant with the land we share;
2. commends and honors Native Peoples for the thousands of years that they have stewarded
and protected this land;
3. recognizes that there have been years of official depredations, ill-conceived policies, and
the breaking of covenants by the Federal Government regarding Indian tribes;
4. apologizes on behalf of the people of the United States to all Native Peoples for the many
instances of violence, maltreatment, and neglect inflicted on Native Peoples by citizens
of the United States;
5. expresses its regret for the ramifications of former wrongs and its commitment to build
on the positive relationships of the past and present to move toward a brighter future
where all the people of this land live reconciled as brothers and sisters, and harmoniously
steward and protect this land together;
6. urges the President to acknowledge the wrongs of the United States against Indian tribes
in the history of the United States in order to bring healing to this land; and
7. commends the State governments that have begun reconciliation efforts with recognized
Indian tribes located in their boundaries and encourages all State governments similarly
to work toward reconciling relationships with Indian tribes within their boundaries.
(b). DISCLAIMER.—Nothing in this section—
1. authorizes or supports any claim against the United States; or
2. serves as a settlement of any claim against the United States.
The resolution does not specify medical or research abuses; it simply states regret for many
wrongs and apologizes for many instances of violence, maltreatment, and neglect. These words,
however, are lost in the volumes of a defense-spending bill. Of note are the two statements that
follow this “apology” serving as a disclaimer, that “nothing in this section (1) authorizes or sup-
ports any claim against the United States; or (2) serves as a settlement of any claim against the
United States.” Few Americans are aware of this resolution because a formal apology was not
voiced, presented, or disseminated to American Indians.
Other countries have issued strong, extensively disseminated apologies for travesties against
their indigenous groups. In June 2008, Canadian prime minister Stephen Harper gave a widely
published speech apologizing to Native survivors of the country’s residential boarding school sys-
tem (Capriccioso, 2010). Prior to that, the Australian prime minister Kevin Rudd apologized to all
aboriginals for laws and policies that “inflicted profound grief, suffering and loss” (Capriccioso,
2010).
Can an apology that was not verbalized or disseminated to tribes and not directed at the
American Indian victims of governmental research abuses suffice as a meaningful apology? For
American Indians, federally sponsored research is a double-edged sword, having both benefi-
cial and unfavorable outcomes. As indicated in this article, a great majority of the medical and
UNETHICAL ABUSES IN AMERICAN INDIAN RESEARCH 441
research abuses perpetrated upon American Indians were conducted at the hands of the U.S. gov-
ernment or those charged with the health and welfare of American Indians. As wards of the federal
government, American Indians are under the stewardship of the government whose charge it is to
raise the health status of American Indians to the highest level possible. Still, American Indians
continue to report severe disparities in health status, education, and poverty rates. As many IHS
healthcare providers are commissioned officers, their appearance on reservations in military uni-
form can be a strong reminder of past federal scientific and medical abuses. Yet the relationship
between tribes and the federal government cannot be severed, as American Indian communities
continue to require healthcare services in rural and urban areas.
CONCLUSION
Following a long history of governmental unethical behaviors, tribes have become distrustful
of government-sponsored research and of researchers, fueling their reluctance to participate in
research studies (Burhansstipanov et al., 2005; Christopher, 2005, Trimble et al., 2010). The
Tuskegee Syphilis Study and the subsequent Belmont Report were the impetus for the develop-
ment of research protective measures, such as IRBs for the protection of human subjects. Tribal
and urban Indian groups have taken control of research by establishing IRBs under the supervi-
sion of tribes or tribal organizations. Further, American Indian cultures are now reflected in the
Tribal IRBs, as consideration of the individual human subject is expanded to include consider-
ation and protection of the collective tribal society. Tribes have undertaken publication review
and approval and have instituted a hybrid, community-based participatory research methodology
that takes tribal culture, in terms of group process and the cultural constructs of concepts and
perceptions, into consideration (Burhansstipanov et al., 2005; Christopher, 2005). In the face of
overwhelming health problems coupled with the fears and distrust of research and researchers,
American Indian tribes have taken these steps in an attempt to heal (Braveheart & DeBruyn,
1998) and to protect their communities from the abuses of research. Current Tribal IRBs have
been developed to respond to the collective structure of tribes and ensure the culturally appro-
priate interpretation of research data and security of research findings. Researchers should take
steps to collaborate with communities, share research findings, follow conditions imposed by
communities in order to enter, and gain access to respondents (Trimble et al., 2010).
President Obama’s Apology to acknowledge abuses suffered by American Indians is magni-
fied by the placement of the written apology within the Defense Appropriation Act. The wounds
of prior medical and research abuses will not heal without a meaningful apology that is delivered
in a respectful, direct manner. Multiple research insults on American Indians, especially those that
violated basic human rights and, in some cases, resulted in what many American Indians/Alaska
Natives consider as genocide (Grenke, 2005; Rubinstein; 2004; Stannard, 1992) cannot be easily
forgotten. A respectful apology would begin the path toward healing for American Indians and
tribal communities. Until then, tribes have secured tools and developed more effective ways
to protect their members and their communities. Implementing tribally controlled IRBs and
American Indian research committees are examples of resiliency, self-determination, and forward
thinking that can be viewed as positive steps by tribes to control of their future, by controlling
research.
442 SCHANCHE HODGE
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Exportation of unethical practices to low and middle income countries in biomedical research – Germán Novoa-Heckel, Rosemarie Bernabe, Jorge Linares
Rev Bio y Der. 2017; 40: 167-177
* Germán Novoa-Heckel. MD PhD, National Autonomous University of Mexico (UNAM). Bioethics Universitary Program.
México City. E-mail: heckelg@prodigy.net.mx.
* Rosemarie Bernabe: MA PhD, Julius Center for Health Sciences and Primary Care, University Medical Center U trecht
(Netherlands). E-mail: r_bernabe@yahoo.com.
* Jorge Linares: PhD, National Autonomous University of Mexico (UNAM). Bioethics Universitary Program. México City.
E-mail: lisjor@unam.mx.
Revista de Bioética y Derecho
Perspectivas Bioéticas
www.bioeticayderecho.ub.edu – ISSN 1886-5887
ARTICLE
Exportation of unethical practices to low and middle income
countries in biomedical research
Exportación de prácticas éticas deficientes de investigación
biomédica hacia países con menor grado de desarrollo
GERMÁN NOVOA-HECKEL, ROSEMARIE BERNABE, JORGE LINARES *
OBSERVATORI DE BIOÈTICA I DRET DE LA UNIVERSITAT DE BARCELONA
Revista de Bioética y Derecho was established in 2004 at the initiative of the Bioethics and Law Observatory (OBD, initials
in Spanish) with the support of the Master in Bioethics and Law at the University of Barcelona:
www.bioethicsandlaw.es/master. In 2016 the journal Perspectivas Bioéticas from the Bioethics’ Program at the Latin
American Faculty of Social Sciences (FLACSO, initials in Spanish) merged with Revista de Bioética y Derecho.
This is an electronic open access journal which means that all content is freely available at no cost to the user or his/her
institution. Users can read, download, copy, distribute, print or link to the full texts of the articles in this journal without
previous permission of the publisher or the author, provided there is no profit in such transactions, and provided that
the source is always cited. This is consistent with the BOAI definition of open access.
Exportation of unethical practices to low and middle income countries in biomedical research
– Germán Novoa-Heckel, Rosemarie Bernabe, Jorge Linares
Rev Bio y Der. 2017; 40: 167-177
www.bioeticayderecho.ub.edu – ISSN 1886-5887
| 168
Abstract
Substandard ethical practices in biomedical research have been exported from more developed
countries to less developed countries worldwide. The term for this practice is called ethics
dumping, which can be described as exporting, in clinical research, sensitive ethical practices from
more developed to less developed countries, with subpar requirements and other economic or
operational advantages that would be inadmissible in developed countries. Examples for this
practice are described, as well as its origin, receptivity, and perpetuation, together with some
preliminary guidance and advice in order to work towards possible solutions for this ethically
sensitive issue in the future.
Keywords: clinical research; ethics; ethics dumping; research ethics; research bioethics.
Resumen
En la investigación biomédica se han exportado prácticas éticas deficientes desde los países con
mayor grado de desarrollo hacia países con menor grado de desarrollo a nivel mundial. El término
para esta práctica es el de deposición de prácticas éticas (“Ethics Dumping”), que puede
describirse como el hecho de exportar, en la realización de investigación clínica, prácticas éticas
sensibles del tipo de exigencia disminuida y otras ventajas de índole operativa y económica no
aceptables en países desarrollados, hacia países no desarrollados. Se describen ejemplos de esta
práctica, así como su origen, receptividad, y perpetuación, junto con algunas guías preliminares y
recomendaciones, con el fin de trabajar hacia el futuro en busca de posibles soluciones para este
asunto éticamente sensible.
Palabras clave: investigación clínica; ética; deposición ética; ética de la investigación; bioética de
la investigación.
Exportation of unethical practices to low and middle income countries in biomedical research
– Germán Novoa-Heckel, Rosemarie Bernabe, Jorge Linares
Rev Bio y Der. 2017; 40: 167-177
www.bioeticayderecho.ub.edu – ISSN 1886-5887
| 169
1. Introduction
Exporting substandard ethics to developing countries
That substandard ethical practices in biomedical research are continuously exported to the
developing world have been the topic of discussion in the research ethics literature for some time
now.1, 2, 3, 4, 5 It is only recently, however, that the concept of “ethics dumping” has received regulatory
attention.6 The term “dumping” seems to have been borrowed from the realm of commerce and
economics referring to the practice of exporting goods at prices lower than the home -market prices.
It is used in the context of international commerce law where a company fixes for its export goods a
price lower than the cost of producing them in the importing country, thus driving loc al competitors
out of business.7 Even though the term has negative connotations, free-market supporters consider
the practice beneficial for consumers.
In clinical research, “ethics dumping” designates the risk of sensitive ethical issues being
exported from more developed countries (MDCs) to less developed countries (LDCs) in pursuit of
potential economic and operational advantages under conditions deemed unacceptable in MDCs. The
European Commission defines it as “the exportation of research practices that would not be accepted
in Europe on ethical grounds”.6 For more than two decades, some research organizations have been
seeking to conduct their work in LDCs, regardless of whether the drugs tested can be marketed under
local economic and organizational conditions.8, 10 One of the advantages researchers see in these
countries, precisely, are large numbers of patients who are completely new to treatment and
significantly easier to recruit.11
A clearer definition is needed in order to understand what we mean by “ethics dumping”. We
can begin by expanding the definition “exporting ethically unacceptable practices to developing
countries”: in clinical research, this refers to the practice of exporting to developing countries research
practices that may be ethically unacceptable in developed countries. The motivation for this
exportation are usually economic and/or operational advantages.12, 13
What would constitute examples of unethical practices being exported by countries who
commission clinical research abroad? Relatively well-known instances of this would be exerting
undue pressure by offering researchers incentives to recruit patients faster, or individual c ases in
which legal, economic, operational or competitive standards are lowered to the advantage of MDC
organizations dominant in LDCs. Another example would be working with payment rates that fail to
match first-world rates or compensate for the cost of operation for LDC researchers and facilities. Yet
another instance of these practices is the adoption of double standards, as discussed by Macklin, for
Exportation of unethical practices to low and middle income countries in biomedical research
– Germán Novoa-Heckel, Rosemarie Bernabe, Jorge Linares
Rev Bio y Der. 2017; 40: 167-177
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| 170
example.14 What the term implies here is that, with the intention of avoiding the pitfalls associated
with the differences in clinical research between MDCs and LDCs, certain practice standards are
applied in the former, while entirely different standards are applied in the latter. Table 1 shows some
examples of ethics dumping and its consequences. Note that we are not claiming that all practices are
“unethical”. To do so, we would need to make a case for each of these examples. In the table below, we
simply wish to demonstrate the undesirable consequences of the various ethics dumping practices.
Ethics dumping practice
Examples (ethical and unethical)
Undesirable consequences
1. Patient recruitment issues Recruiting babies for epilepsy
studies and taking advantage of
mothers’ commitment to watch over
their children for the 24 to 48 hours
needed to complete the study.
Abusing parents’ and guardians’
availability, good faith and mistaken
beliefs about potential treatment
benefits.
2. Methodological issues Using placebos in cases where lower
treatment standards in LDCs seem
to justify it. The argument is that
patients are not being exploited:
since their condition does not
actually worsen, it is not necessary
to administer active medication.
(8)*)
Abusing the good faith of patients;
denying patient -participants of a
proven intervention even when such
exists.
3. Advantages in dealing with
authorities and Research and
Ethics Committees (RECs)
Studies with varying degrees of risk
can be difficult to carry out in MDCs
due to tighter restrictions. RECs in
LDCs might be less rigorous.
This practice entails increased risk to
participants from LDCs.
4. Recruitment advantages Studies deemed burdensome or
problematic in other countries
because of increased patient
discomfort/burden (e.g. complex
laboratory testing or use of IV
markers).
Abusing patients who often are
unaware of the absence of benefits
and the increase in risks.
5. Advantages due to increased
prevalence of certain diseases
Studies of the antibiotic treatment
of diarrhea conducted in the North
of Mexico. (e.g. Studies in the 90s).
Some diseases are more prevalent in
LDCs. The availability of subjects is
abused, with little compensation or
for
LDCs.
6. Economic advantages Studies are less costly in LDCs,
though the burden of work is the
same.
Taking advantage of the lack of
negotiating power and the
availability of local research teams.
7. Logistical advantages (e.g.
implementation times)
Shorter implementation times,
accelerated patient recruitment
achieved by offering questionable
incentives to researchers, which
may be unacceptable in MDCs.
Inadequate compensation, unethical
in MDCs.
Table 1. Ethics dumping practices and examples of practices.
* The use of placebos has to do with using or not the best methods available worldwide as control treatment. In the Nevirapine
controversy it is shown that the rule of best methods available worldwide and, as a result, the limitation of using placebos to conditions
in which there is no medical alternative under no circumstances are good rules, but there are some exceptions in which research may
be carried out while at the same time participants are not exposed to exploitation” (15).
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An additional manifestation of ethics dumping emerges as a more subtle issue when it
comes to recruiting patients for research. In MDCs, participating in research may be seen as a
moral obligation, a commitment by subjects to help find more and better treatments.16 In the less
developed world, by contrast, the agreement to take part in a study is often predicated on patients’
hope of solving their medical problems or improving their health. This issue has been detailed in
a very comprehensive study17 (See also: International Conference on Harmonization, ICH-E6,
specifically the definition in 1.61: Vulnerable subjects).18 Clinical studies thus make “therapeutic
promises” they may not actually fulfill, but participants may not be fully aware of this when they
sign the informed consent.19 It is the nature of clinical research to not claim expected therapeutic
benefits for the present or future health of patients, with the exception of phase IV clinical trials.20
The phenomenon wherein therapeutic benefit is expected in clinical trials has been described in
the medical literature as “therapeutic misconception”: study participants believe that their
individual therapeutic needs will be considered during clinical trials, a faulty understanding of the
nature of clinical trials coupled with the unreasonable expectation of receiving medical benefits.21
It is worth noting that the many unsolved issues in clinical research (such as the use of placebos,
or justifications unconvincingly rooted in the principle of equipoise)22 only add to the problems
raised by the exportation of substandard ethical practices. This in turn only deepens rifts of
misunderstanding and abuse.
The moral obligation to take part in a trial, as may be understood in MDCs (i.e. the
importance of contributing in the search for more and better treatments23 is invalidated by the
fact that these new therapies might not be available, at least in the short term, to LDCs population.
When they do become available, it is likely that their market price will continue to make them
unavailable for as long as patents are valid. Generic versions, though less expensive, will still be
unaffordable for some. Informed consent requirements and therapeutic promises are thus
unequal, insufficient and surely unjust.
2. Origins of ethics dumping
With the aim of arriving at a viable solution, we must first investigate the causes of ethics dumping.
The answer is many-sided. First, there is an increased demand for clinical services in MDCs. This
puts pressure on existing research capacities to grow, in a context of research saturation and
patient shortage.23 Second, strict requirements and regulations in MDCs are subject to additional
pressure from other, equally urgent factors as are economic and marketing factors. There follows
pressure to conduct research with simpler regulatory requirements and at lower cost.24
Exportation of unethical practices to low and middle income countries in biomedical research
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Next, we should consider the effects of a certain automaticity in southbound exportation.
Together with the exported research, countries where requirements tend to be more flexible and
authorities more lenient also receive the pressure and demands typical of MDCs if LDCs wish to
be competitive hosts of clinical trials.25 The demand for research services in LDCs are increased,
along with the possibility that sponsors or their intermediaries may act unfairly characterized by
uneven commercial interactions between countries and unequal negotiations. The risk is that this
kind of interaction will result in exploitation, i.e.
…when wealthy or powerful individuals or agencies take advantage of the poverty,
powerlessness, or dependency of others by using the latter to serve their own ends (those
of the wealthy and the powerful) without adequate compensating benefits for the less
powerful or disadvantaged individuals or groups.26
To sum up, the context of research is subject to pressure from authorities and corporations.
Many of these demands can be traced back to economic interests, as the term “time-to-market”
denotes. Such pressure can move international clinical researchers to apply double standards
(moral and otherwise) and resort to ethics dumping, a phenomenon in which unequal ethical
practices inadmissible in MDCs are offshored to the developing world. The consequences include
a sense of disappointment, frustration and lack of empathy, and misunderstandings in
transnational clinical research, with a loss of prestige and moral credibility for both sides of the
equation.
Also at the root of ethics dumping are faulty negotiations. LDCs might not be familiar with
the standard of rights and obligations to be observed in specialized transnational research
negotiations. Other issues which perpetuate the exportation of substandard ethical practices will
be discussed in the following sections.
Finally, an allegory extracted from family dynamics might help explain the “natural” course
MDCs follow in the attempt to deal with increased pressure. In some families, one parent is less
strict than the other when it comes to demands like pressure to succeed in school and restrictions
placed on the children’s behavior. The natural course of action for a child seeking to obtain special
permissions or approval will thus be to appeal to the parent that offers less resistance. Though
both parents are equivalent as authority figures, their authority is exercised differently, with one
of them offering less resistance. It can be understood in this same sense that the search for new
research territory “naturally” (also) looks to developing countries.
Exportation of unethical practices to low and middle income countries in biomedical research
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3. Receptivity of LDCs to ethics dumping
LDCs become receptive to ethics dumping for a number of reasons. Some of the most widely
acknowledged include the need for growth and international recognition, economic needs, the
quest for scientific and technological development, and a duty to stay in line with parent
corporations. Other less studied motivations have to do with cultural nuances, such as the
perception of flattery combined with feelings of inferiority, and the resulting pressure to
demonstrate ability, worth and equality.
Receptivity in LDC regions is reinforced by the relaxed regulations we have mentioned, plus
some operational advantages. An undeniable fact is that patient availability is greater in these
regions, together with accommodating management, reduced costs, and qualified, efficient
personnel with unmet economic needs.
We can group all these factors under “LDC receptivity”. Together with “reduced regulatory
and economic demands,” this preserves a relationship that can lead to the exportation of
unacceptable ethical practices. In summary, the pursuit of clinical research shifts from its origins
in the direction of LDCs seeking increased speed, reduced costs and advantages in implementing
and carrying out studies as far as ability (and goodwill) will allow it.
4. Perpetuation of ethics dumping
We will now attempt to surmise on the possible contributing factors to the long-term prevalence
of these practices. Note that a systematic approach to look into the causes for the perpetuation of
ethics dumping would have yet to be done in future research.
Ethics dumping subsists and even change shape over time mainly because the ethics that
MDCs apply outwardly are seldom revised by LDCs. This depends on the perception that practices
of varying acceptability on both sides should be geared towards fulfilling the demands and
priorities of the sponsoring agents. In other words, the idea is to solve a host of different and
varying problems of conducting clinical research. An additional complication is that LDCs often
approach negotiations with little knowledge of accepted and acceptable practices, guidelines and
valid premises in MDCs. Also, there is much to be desired with regard to community engagement
or participant consultation27 in global research. LDCs are thus unable to identify ethics dumping,
its origins and its forms. LDCs place a blind trust on MDCs and adapt to their precepts easily.
Exportation of unethical practices to low and middle income countries in biomedical research
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Rev Bio y Der. 2017; 40: 167-177
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5. Working out our differences
We have seen that there are various issues related to the installment by receptivity of LDCs and
how this leads further to the perpetuation of ethics dumping.
We think that there is a need to intervene on existing norms, both in procedural and tangible
matters (the former being conflict resolution, changes in terms, etc., and the latter compensations,
duties, and performance). Requirements should be regulated to harmonize with the developing
world, encouraging openness and transparency in negotiations, and eliminating the unfair
exportation of ethical practices such as double standards.
We could start by harmonizing our understanding of patient involvement, supporting the
conditions of moral obligation to participate in studies. Though it seems complicated, this is not
impossible. The search for homogenous visions and regulations (as part of a proposed
harmonization conference) could include negotiating the terms of participation by LDCs, as well
as establishing clear guidelines for solving issues of ethics dumping. Additionally, we should
commit to sharing study results and benefits more equitably, so as to ensure fair conditions for
LDCs.
In the recent CIOMS Guidelines28 of mid-2016, in GUIDELINE 2: “Research conducted in low-
resource settings”, there are recommendations in order to tackle different issues partially
discussed already; for instance, the use of comparators provided in our table. In the comments
section “Responsiveness of research to health needs or priorities”, it states: “a question about
responsiveness might arise if a study of a new intervention is planned for a community in which
established effective interventions for a health condition are not locally available and the new
Intervention has features that would make it difficult to implement in that community. In
such cases, researchers and sponsors must consider whether the study could be made more
relevant to local health needs.” It further states: “If the knowledge to be gained from the research
is intended for use primarily for the benefit of populations other than those involved in the
research, the responsiveness requirement is violated”. Further, this last sentence would address
the compliance that is necessary with community interests, brought about in general form
originally by the Declaration of Helsinki. In general, the valuable recommendations brought about
by this last review should help to tackle ethics dumping further in some of its most salient features.
Other recommendations in Guideline 2, as is the building of local research capacity or to ensure
an overall fair distribution of the benefits and burdens of the research, should well serve the
purpose of preventing this phenomenon.
Exportation of unethical practices to low and middle income countries in biomedical research
– Germán Novoa-Heckel, Rosemarie Bernabe, Jorge Linares
Rev Bio y Der. 2017; 40: 167-177
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The issue of informed consent should also be on our agenda. Informed consent needs to be
justified and culturally sensitive to the conditions of LDCs. A “showtime” approach, in which
patients are called upon and dismissed as needed, leaves a community’s real needs unaddressed
when the study concludes. In LDCs, this might be interpreted as abandonment, creating a sense of
emptiness or alienation, with no perceived gain. Such issues could be eliminated with clear
guidelines as to personal and community benefits, in accordance with the latest version of the
Declaration of Helsinki.29
Most importantly, we should endeavor to eradicate ethics dumping to the best of our ability,
through a clear discussion and understanding of existing differences. Practices such as offering
payments to expedite recruitment, for example, might prove too complex to solve in the short
term, but we could outline feasible solutions to correct imbalances wherever possible, without
resorting to unacceptable practices, always seeking to eliminate abusive, unfair or exploitative
behavior.
Technical and methodological aspects should also be on our agenda. In a provocative
review, Contopoulos-Ioannidis30 examines the differences between MDCs and LDCs in relation to
the over or underestimation of risks. The study concludes that there is a need to prioritize and
standardize the documentation and reporting of harms in all randomized trials, both in MDCs and
LDCs.
Our first priority should be instituting a negotiating table guided by a bilaterally established
agenda, with the goal of harmonizing differences. We must keep in mind the need for open, honest
and transparent discussion of the existing differences that have so far been the cause of many
misunderstandings and obstacles (or even disrepute). Such difficulties, however, can and should
be overcome. The ongoing practice of ethics dumping is, undoubtedly, in need of being addressed
and solved as soon as possible. The advice and rules expressed in many ways through different
channels at present should make it more difficult in the future to trespass the desired limits,
getting closer to the ideal of complying with what is feasible, and at the same time what is decent,
fair and just in biomedical research as it is practiced in developing countries.
Exportation of unethical practices to low and middle income countries in biomedical research
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Received for publication: 28 September 2016
Accepted for publication: 6 March 2017
Good morning. For the past three years, I was a researcher at the Edmond J. Safra Center for Ethics at Harvard University, where I examined corrupting influences and hidden biases in their pursuit of knowledge. During this time, I conducted in-depth interviews with professors from medicine, business, law, the natural and life sciences, as well as the humanities and social sciences. My goal was to try to understand the everyday life of scientists and professors across all the disciplines. In the end, I ended up with close to 10 thousand pages of interview transcripts. Today, I would like to share with you some of the ethical dilemmas that professor’s face, in particular, whether they experience an increased risk of bias depending on who is funding their research. Now, why should we be concerned about the ethics of knowledge production? When I first started university, I had this idealistic and perhaps naive view of science. I believe the scientists inquired about the world, practice the scientific method with integrity, and made new discoveries that drive progress forward. But close examination of how scientists conduct research reveals that what we can know depends not only on the scientist, but also on the structures and institutions that gives scientists the means to pursue knowledge. As I interviewed scientists and professors and began to uncover patterns of scientific distortion, or what some might call the corruption of knowledge. However, the majority of these distortions were not produced by bad people behaving unethically or illegally. Although this does happen. But rather by good people, like the people sitting beside you right now, your friends and your family, who in response to the daily pressures of work, may simply begin to rationalize to themselves little ethical lapses here and there. Now. By ethical lapse, I mean scientific integrity lapses that appear to be very small or inconsequential at the time. One of the most common examples of this involves a scientists thinking. Maybe I won’t ask question a when pursuing my research because my funder who may be relying on the results of the study to obtain regulatory approval for potential commercialization may not be too happy with a higher risk of a negative result, which might also affect my future funding. Maybe instead, I’ll self censor myself and ask a different question of the data, where the possible outcome will most likely not ruffle too many feathers. And that will then answer that question honestly and with scientific integrity. Now, these types of rationalizations, these little compromises where we convince ourselves in the moment that what we’re doing is okay, help to neutralize any guilt we might experience and our ethical decision-making. However, over time, the accumulation of these little ethical lapses is leading to a broader system of knowledge production that is becoming increasingly distorted and more difficult to trust. I want you to think about that word for a moment. Trust and how it plays a role in your daily activities. For instance, plastic water bottles. They’re so common that when we pick one up, we’re probably not thinking anything other than, I’m thirsty. We don’t ask ourselves, who does bisphenol a or BPA, a common compound used in hard plastic products lead to cancer, behavior disorders or reproductive problems? No, of course not. We take a drink, we go on with their day. We trust that drinking from the water bottle can’t be bad or at least bad enough to worry about. While on the one hand, you can feel safe. Because every study performed by scientists funded by the industry concludes no harm from BPA. In other words, it’s okay, you can trust BPA. But at the same time, 93% of the non industry funded studies show that there might be cause for concern. And that may be, we should be a little less trusting the next time we pick up a hard plastic water bottle. So who do you trust? And how is it possible that the industry funded scientists studying BPA or so certain that there is no harm, is it’s simply because they’re better. Scientists have bigger data set and know the compound better. Maybe, perhaps. But we see this pattern, often called the funding effect across many different areas of research. From cell phone safety to climate change to soft drinks. In each case, scientists funded by the industry or industry supported think tanks reach conclusions that overall tend to deny or downplay any harm. While non industry funded scientists. Overwhelmingly find evidence of harm. Among the professors I interviewed in food and nutrition. There was acknowledgment of this funding effect biased. One food scientists said, there is a tendency for people in my discipline to develop, sympathize with the food industry. And to say, yeah, this is definitely safe. Rather than to say, okay, here’s this research study and this research study. In this research study. When I interviewed another professor who was also an editor of a scientific journal in nutrition. He said the following to me. So we get some manuscripts that are industry sponsor. And one senses that their story is a little slanted towards the benefit of whatever it might be, their product ID. This, never mind that it didn’t do ten other things. The most frequent scenario, it’s not that the study is done poorly, but that the questions themselves are kind of selective. Now, if a funding effect bias does exist, then surely the regulatory bodies who look out for our safety must be aware of it, right? For instance, what about our prescription drugs? Pharmaceutical companies must first obtain regulatory approval for their products, right? Yes. However, many of the Drug Evaluation and Research Advisory Committee members who vote on whether a drug should be granted regulatory approval also have financial conflicts of interest with the same drug companies. These voting members often serve as consultants and have ownership interests in the same drug companies seeking approval. They also sit on their advisory boards and even receive funding from these firms for their own individual research. In other words, they might be experts, but they’re not independent experts. As you know. In 2008, the world suffered a major financial crisis. The Oscar winning documentary Inside Job suggested that economics professors were being corrupted and blinded through their consulting relationships and conflicts of interest with the financial sector. He was so serious that even an upset Queen of England visited the LSE, the prestigious London School of Economics, and sternly asked her top economics professors if the problem was so widespread than why didn’t anyone notice it? To Director of the LLC’s Management Department who was standing beside the queen at the time, said you are. At every stage, someone was relying on somebody else and everyone thought they were doing the right thing. In my interviews with business and economics professors, it was observed as it was with professors across all the disciplines, that a lack of independence can distort the production of knowledge. One economics professor, researchers, private equity finance told me during an interview, the only way to get the data is to get the private equity firms to give it to you. If you then say These people don’t know what they’re doing, are they only make returns by taking excessive risks. Then there is the potential. You simply will not get data going forward and you will be forced to leave the field of economics. So you have to worry that the research that comes out is more favorable to the private equity industry than otherwise, it would be. Now, despite all these cautionary examples of corrupting influences and hidden biases, some of you out there, I’m certain, are still thinking to yourself. Okay, Gary, I hear what you’re saying. But I would never distort my work and no conflict differentiates would change how I pursue my research. Fair enough. Many of us do believe that we can manage any conflict of interest and still maintain our own personal integrity. However, we should never forget that the power to rationalize our own little ethical lapses is remarkable. Consider this everyday example. Statistics demonstrate that there are disturbingly high rates of accidents and deaths due to cell phone related distracted driving. Yet, despite knowing this, many of us will continue to use cell phones when we dry after we leave here today. Studies show that more than half of us believe that when we use cell phones and drive, it makes no real difference on our own individual driving performance. Yet, we switch from being the driver to the passenger. 90 percent of us now will suddenly stay. I would feel very unsafe if I observe my driver using a cell phone. So saying you have integrity is easy. Practicing integrity is not easy. And recognizing our own little ethical lapses and rationalizations is even more difficult. So what does this all mean in the context of knowledge production? First, we should be aware that funders increasingly want more influence over what questions scientists can ask, what findings that can share, and ultimately what kind of knowledge is produced. So ask yourself, what are the strings attached when we accept funding? Or the strings visible where the scientist is told that she cannot publish your work until given approval to do so by the funder? Or does the funder require that the data remains confidential so that the research conclusions can never be verified within the scientific community. Are the strings invisible? Increasingly, scientists and professors are self-censoring their work in order to appeal to funders. And in so doing, our sidestepping important questions that may be critical to the public good and society as a whole. My interviews made clear that the funding effect bias is real. And if left unchecked, will continue to have a real impact on what we can know. So next time you pick up a book or a research article, check to see who is funding the author’s work. And pay close attention to the author’s affiliations. In order to be informed in this information age, we need to take extra measures to vet the legitimacy of the content that we rely on to develop a critical eye for independence and to value scientific integrity above anything else. Information and knowledge requires science, unfettered and unbiased. And it’s time we all take measures to demand it. Thank you.
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