Some Ethical Considerations for Health Research in Sensitive Communities
Response to "Compilation of Environmental Health Research Ethics Issues with Native
Communities"
By Sheldon Krimsky
June 15, 2001
Research ethics is an evolving field of study and policy most prominently in Western
industrialized societies. The Nuremberg Code, the United Nations Declaration of Human Rights,
and the Geneva Convention are several important milestones in the 20th Century that provide the
guiding principles on which the ethics of human experimentation was built. Much has been
accomplished in the past thirty years to insure that human subjects are properly informed and
protected from unethical experiments.
The system of ethical rules and guidelines developed in Western nations has, for the most
part, been based on the concept of individual rights and the respect for persons. The cases that
symbolize the most egregious transgressions of those rights are well documented in the historical
record: the Tuskegee syphilis studies, experimentation with mentally retarded patients, and
human radiation experiments carried out on children at state institutions.
As a consequence of these and other violations of the rights of human subjects, great
advances were made in establishing safeguards for participants in human subject experiments.
Two fundamental premises behind these safeguards are informed consent and accountability of
testing protocols to a duly constituted authority beyond those participating in the research. Each
human subject must be fully informed about the nature of the experiment including the risks and
benefits (if there are any). The procedures are established by the federal government and
implemented by institutional review boards required of all institutions that receive funding from
federal sources or that submit drug applications to the Food and Drug Administration.
The protocols for setting up institutional review board (IRBs) are uniform across all
agencies of government that either support human subject experiments or that regulate products
(drugs and medical devices) that are administered to or used by human subjects.
The individualistic paradigm for human subject experiments remains open to negotiation
on several issues including the nature of informed consent and the breadth of its application on
questions of privacy and intellectual property.
Recently, in response to the death of Jessie Gelsinger, the result of a gene therapy clinical
trial carried out at the University of Pennsylvania, two issues became the subjects of intense
policy discussions. First, the Gelsinger family only learned after the young Gelsinger's death that
the person who supervised his clinical trial had a financial interest. Questions were raised
whether such information should have been available to young Gelsinger and the family before
the clinical trial began. Health and Human Services secretary Donna Shalla held hearings to
address whether the Gelsinger case illustrates the need for change in the informed consent rules.
Another issue raised by the Gelsinger death was whether adverse effects of drugs or
therapeutic procedures should be afforded proprietary status. When clinical trials are carried out
at multiple sites and under different sponsorship, investigators at one site are not privy to the
adverse drug effects at another since pharmaceutical companies do not want other companies to
know anything about their drugs, including adverse effects. The open reporting of these effects
can help investigators make mid-course corrections on drug delivery or take precautions against
effects they may not have anticipated.
Thirdly, the rules of informed consent face new challenges for disclosing intellectual
property that may result from cells, DNA, including DNA polymorphisms, or tissues taken from a
human subject. The courts have rules that without informed consent the exploitation of a
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person's biological matter could constitute a "taking" without fair compensation. The tradition
that there be no economic markets for body parts flies in the face of the commercial value that
physicians and biotechnology companies could receive from tissues and cell cultures.
The rules of informed consent must be used in conjunction with, rather than to the
exclusion of, other ethical rules that are substantive in their instructions, not simply formal. In
general, human subjects can only be used in research that involves risks, physical or
psychological, when the study offers the potential of contributing to the health of persons,
especially, but not necessarily the subject. Paying human subjects attractive sums to engage in
risky research that has no health benefits (e.g., to solve a toxic tort case) is unlikely to be
approved by the current standards of ethical conduct of research. However, in a recent human
trial subjects were paid $1000.00 each to participate in an experiment, which involved their
exposure to a toxic substance to determine how they were affected at low doses. This substance
was the subject of a tort case and the research was funded by a company that was a party in the
case.
Current standards in medical ethics does not exclude healthy people from taking risks in
clinical trials for which they would receive no benefits--except the knowledge that their
participation supports the progress. Recently, a healthy woman volunteer died in a "challenge"
experiment involving a drug that was known to cause airways of the lung to constrict. She was a
healthy 19-year-old student who volunteered for an experiment testing the effects of air pollution.
These experiments are the most controversial in biomedical ethics because their goal is not to test
a treatment, but rather to test the mechanism of an irritant or toxic chemical.
The limits of the individualistic paradigm of research ethics become evident when the
object of research moves from individuals to groupings of people based on race, ethnicity, or
geography/demography. Beyond the traditional rights of individuals, other consideration come
into play such as the interests, rights and cultural values of ethnic and/or racial groupings, where
religious values, historical traditions, group identity, and cultural perspectives are relevant
factors. The following discussion applies to collective interests and values discussed in the report
"Summary of issues on environmental health research ethics with native communities."
Groups vs. Individuals as the Object of Study
Applied to individuals, the concept of informed consent has a reasonably clear meaning,
even if its implementation criteria are vague. The individual or his/her health care proxy, must
understand the nature of the research, its purpose and the types of procedures and interventions
involved, the potential risks, and the extent to which the experimental clinical interventions, the
survey, or the information obtained might benefit the individual and the extent to which other
individuals, present or future, might benefit from the study. Individuals assigned to a blind
placebo would not have any immediate benefit in a drug study (unless the placebo effect is
demonstrated to be real) but could be placed off the placebo and on to a pharmico-active
experimental drug even before the trial is complete, if the drug's success and life saving capacity
are obvious.
There is still much to be debated about the implementation of informed consent.
Investigators have given the forms to people in advanced stages of Alzheimer's disease and claim
that they satisfied the ethical guidelines. And how much should a prospective human subject be
told about the study when the telling of details can affect their psychological states and provide
another variable in the study.
But the concept of informed consent applied to a community is far more nuanced and
complex than its application to individuals. Some communities are organized into well-defined
socio-political structures such as tribal communities. All types of social apolitical decisions are
made through tribal councils. Depending on the types of studies and interventions under
consideration, informed consent may have to operate at three levels. If individuals are solicited
for study (surveys, health assessment, clinical trials), institutional IRBs and human subjects
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consent forms will have to come into play. In addition, those with experience in these matters
cite the importance of gaining consent through a representative council. This level of consent
gains ethical legitimacy on two grounds. First, the political or social council operates
democratically. Second, the appeal for council consent stimulates a community dialogue and
public education that surpasses what is usually considered minimally acceptable through the
standard declarations of consent forms and the investigator's communications with the human
subject. In the case where communities do not have social or political representative structures,
community informed consent can only be ethically justified when such structures are created.
Some interventions are justifiably left to the representative council while others may
require two levels of consent, namely both the council and the individual. For example, in the
case where health professionals wish to study the impact of PCBs on tribal communities, they
will need the approval from individuals for obtaining new born (umbilical cord) blood samples as
well as the approval from the tribal council for undertaking the study in the community. In other
cases the study may involve taking environmental samples (samples of water) which do not
involve the consent of individuals.
In non-tribal communities, consent for environmental studies (collection of
environmental data) is usually left in the hands of some bureaucrat and is quite separate from
studies involving human subjects.
Participatory Research Models
The recommendations for meeting new standards of research ethics in culturally sensitive
communities suggested by the cited authors include the concept of participatory research models.
This is an area that has no analog in the individualist paradigm, in the way that confidentiality,
building trust and informed consent do. What are the ethical grounds for community-scientist
partnership in research? Will it produce better research? I suspect sometimes it would contribute
to the quality of the research, especially in cases where indigenous knowledge is relevant. It also
adds to community empowerment and builds trust in the research. But sometimes it can backfire.
In Woburn, Massachusetts, local citizens were involved in health surveys to determine whether
proximity to contaminated wells correlated with adverse health outcomes. When local residents
were used for the interviews, the results were criticized for introducing interviewer bias since the
surveyors had a point of view on the danger of the contamination. Also, when does hiring
community members on a study appear to be co-optation of the local residents to buy into the
study?
There are many ways that community partnership in research may be defined including
hiring members of the community, shared responsibility for defining the scope and methodology
of the research, and shared responsibility for interpreting the results. Cases where community
health research is carried out without community partnership in any of the above would not
necessarily be considered unethical. Such partnerships do not a priori discredit or diminish such
research and might enrich it. Where a community is in a position to negotiate for a communityresearch partnership, the question for the researcher is: will this partnership in any way
compromise the integrity of the science. In science, the highest ethical standard is the integrity
of the research. Some view this goal as beyond compromise. Of course, research ethics
establishes accountability for research protocols based on standards other than the nature of the
methodology and the pursuit of truth. Therefore, it cannot be said that integrity of research takes
precedence over everything else. If the best research protocol to answer a question involves an
unethical treatment of a human subject (an increasing of animal subjects) then some lesser
protocol must be used if the experiment is to proceed.
Once communities establish the standards of research conduct, then it is likely the
protocols will adapt to those standards, in the same way the researchers in clinical trials have
adapted to the review of protocols by human subject committees. Perhaps the one area where the
universality of the ethical principle is uncompromising is that whatever the nature of the protocol
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and the conditions of informed consent are, the pursuit of truth is a categorical imperative.
Researchers are ethically bound to follow the direction of the results, wherever it leads. For
example, if a community-research partnership results in distortion of truth to meet community
concerns about the outcome of results, the researchers are ethically bound to reject such
distortions, even if they would please the community.
Obligations of Researchers to the Community
What do researchers owe the community they study? The broad ethical obligations of
researchers to a community are not established in a body of research canon. Professional societies
in disciplines like archeology and anthropology developed guidelines for researchers out of
necessity growing out of tribal opposition to research interventions and to the appropriation of
artifacts and human remains.
Health research in communities raises a new set of concerns. For example, are
researchers who study communities and discover communities at risk obligated to help after the
study is complete? Are they obligated to prevent stigmatization from studies? Almost any
generalization based on racial or ethnic divisions may result in stigmatization? How can it be
prevented? What about studies that may affect the economic interests of the community, such as
environmental health information that depresses housing values? Are health researchers
obligated or should they be amenable to downplaying results in community health studies, which
can be used in discriminatory ways? Are researchers obligated or should they be amenable to
adjusting their write-up of results to avoid offending communities on culturally sensitive issues
(e.g., sacred knowledge)?
Many scientists would feel uneasy about any constraints in the way they report results. If
the same issue were presented within the context of industrial sponsors, many in the scientific
community would consider it unethical to adjust the interpretation of results to meet the interests
of the corporate sponsor. On the other hand, we know this type of thing happens. Some contracts
between university researchers and corporate funders contain clauses that allow corporate
sponsors to review and make recommendations about the interpretation of data. However, once
these agreements are disclosed, the responses among other scientists and the public to such
clauses are quite unfavorable.
Some researchers recommend that studies in culturally sensitive communities should
invite members of those communities with professional standing to peer review the project. The
ethics of such involvement can be defended if these individuals have something to contribute to
the process but cannot be defended on ethical grounds if the participation is likely to restrict the
researchers from pursuing the truth--e.g., any form of censorship.
Ownership of Data
Some authors report that their canons of research ethics require that the raw data of their
research belong to the community. The research group is appointed "guardians of the research
data" for the duration of the experiment and then the data must be returned to the community,
which will decide its future uses.
The ownership of data and its availability to the public has been a subject of intense
controversy in the research community. In drug research sponsored by pharmaceutical
companies, the companies own and control the data, for which they paid. Sometimes the
company claims ownership of the data that is generated from an academic study, if it funded the
study. There is no single ethical standard regarding the control and ownership of research data.
Scientific professional societies would like the data to remain with the researchers who
supervised its acquisition rather than the sponsor who supported the research or some group of
human subjects that were the source of the data.
In most cases, government sponsorship of research does not give the government the
right of ownership of the data. This has been the trend in the past two decades with genomic
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data, which is patented and commercially developed by researchers who have been solely
supported by government grants.
Among the range of negotiated approaches to the ownership of research data, ethics
demands consistency, honesty in handling and interpreting data, and protection of privacy and in
some cases proprietary information.
Helping the Communities Under Study
Do researchers have an obligation to help the citizenry when they discover a community
at risk? Suppose a research team of health scientists is undertaking an environmental health study
and learns that there is a high body burden of a dangerous chemical in the serum of children.
Moreover, they have also determined the source of the exposure.
It would seem that at the very minimum the team would have an obligation as health
professionals to inform authorities and persist until the source of the contamination is removed.
Failure to do so might cast the research team as uncaring and self-serving. The "obligation to
inform" has not been a part of ethical instruction to researchers. The law has conflicting doctrines
on the "obligation to inform." Citizens are not legally obligated to inform authorities when they
observe a crime or an accident. However, certain health professionals are both morally and
legally bound to inform when people are at risk (e.g., child abuse; psychiatric patients who make
violent threats; infectious diseases).
There are no established and agreed-upon obligations that the researcher has to the
community beyond meeting informed consent and privacy considerations. Communities are
accustomed to dealing with researchers who court their participation, complete their
investigations, publish their results, and leave the problems behind. In some instances, the
community might decide it is better for the citizenry not to know than to be left with risks that
cannot be addressed.
Beyond the obligation to inform is a stronger obligation to help solve the problems
discovered by the research. This is a noble goal for research, but realistically few research teams
are in a position to carry out changes that would improve the health of the community. However,
members of the research team can make themselves available to community organizers in their
search for funding to make the requisite changes. They can provide important information to
community leaders about federal and state agencies that could implement preventative programs
that break the cycle of risk.
Risks and Benefits to the Subjects of Experiments
In an article by Fred Beauvais he states that among the conditions of informed consent is:
"The research must involve minimal risk to the subjects. The risks that exist should be
outweighed by the benefits."
This leaves open the questions of whether the risks and benefits are directed at the same
individual and who makes the determination on the balance of risks and benefits. Healthy human
subjects do enroll in experiments that will not yield than any benefits. Some of these are called
"challenge experiments" because they are designed to determine what exposures to a substance
produce a biological effect on a healthy subject. In a recent case at Johns Hopkins Medical
School, a healthy young volunteer died in an experiment designed to help physicians better
understand asthma attacks. The volunteer did not have asthma. On the ethical grounds that the
benefits to the subject must outweigh the risks, this experiment cannot be justified. But people do
wish to volunteer in scientific experiments knowing that they are taking risks without benefits to
their physical health. This is the tradition in the ethics of human experimentation termed
"philanthropic subjects." They take physical risks for the expectation of psychological benefits,
namely the knowledge that they have contributed to the understanding or treatment of an illness.
For philanthropic human subjects the burden of safety must be high since they have everything to
lose and nothing to gain in their physical health from the experiment.
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Potential Conflicts between Tribal Sovereignty and Federal/State Statutes
The conflicts between tribal sovereignty and state laws regarding health and safety
regulations have been reported in the press and have been a source of litigation. In particular,
tribal decisions about land use have sometimes been in conflict with state laws and policies. The
tribe may be willing to use reservation land for storing nuclear waste materials, whereas the state
in which the reservation is located is opposed to such uses. The legal doctrine of tribal
sovereignty within reservations has been challenged in the courts. It is not a doctrine of unlimited
power.
In a similar matter, one might imagine a pharmaceutical company that offers a
reservation an attractive payment for soliciting residents to participate in a set of human trials.
Does the tribe have the right under the tribal sovereignty doctrine to establish conditions for such
human trials when they do not meet minimal federal standards. The ethical conditions would not
be problematic if the tribe accepted the federal guidelines as a minimum standard and simply
added conditions.
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