Medical Atrocities, Legal and Ethic Mandates and the Application to Cross-Cultural Research in Criminal Justice: Research on Mexico and Mexicans

Rodrigo Murataya, ABD and J.Michael Olivero, Ph.D.

Professor Murataya is an assistant professor in the Department of Law and Justice at Central Washington University. He holds a master’s degree in public administration of the University of Washington and is ABD in the doctoral program in educational leadership at Gonzaga University.

Professor Olivero is a full professor in law and Justice at Central Washington Univerity. He holds an MSW from Eastern Washington University, an MS in Criminal Justice Sciences from Illinois State University and a Ph.D. in sociology form southern Illinois University. He has published numerous articles and chapters on the Mexican criminal justice system.

Professors Murataya and Olivero can be reached at the Department of Law and Justice, Central Washington University, Ellensburg, WA 98926, Murataya@cwu.edu or Olivero@cwu.edu

Introduction

Medical atrocities resulted in ethical and legal frameworks guiding research with human subjects in an effort to protect human rights. The federal government followed suite by creating policies mandating human subject internal review boards among institutions receiving federal funding. New bureaucracies have sprung up at various universities across the nation to review research protocol to assure that it meets federal and ethical mandates. These mandates are constructed out of issues relevant to medical experimentation and do not necessarily meet the realities of social scientific research. We examine the application of ethical and legal guidelines for research on criminal justice related issues with cross-cultural studies on Mexico or Mexicans in the United States.

We will begin with a brief introduction to a history of prominent medical atrocities. Following this, we will outline ethical and legal frameworks for guiding research with human subjects. We will then discuss technical problems associated with the implementation of the process of review. Finally, we will analyze the application of federal and ethical guidelines in the research and analysis of criminal justice related studies focusing on or Mexico or Mexicans in the United States.

A Brief History of Prominent Medical Atrocities

Present human subjects concerns are based upon a history of abuses and atrocities committed in the name of science that were primarily medical in nature. During World War II Nazi physicians under the guise of "medical experiments" were performed on thousands of concentration camp prisoners and included deadly studies and tortures such as injecting people with gasoline and immersing people in ice water (Garnett. 1996) for up to thirty-six hours, and forcing people to ingest poisons (Lippman, 1996). Healthy inmates at Dachau were infected with malaria and were treated with various experimental drugs and vaccines. Inmates were purposely infected with poison gas or bacteria to simulate battlefield injuries.  Sometimes wood shavings and ground glass were placed in incisions to test the impact of drugs on infection. They were also burned with phosphorus and treated with various novel preparations (Lippman, 1996).

Also during World War II, the Japanese Army's "Unit 731," killed thousands of Chinese in medical and germ-warfare experiments, including dissecting live prisoners, dropping "plague bombs" on entire villages, gassing mothers and children while timing their convulsions, and pickled humans in six-foot jars of formaldehyde (Fong, 2000; Garnett, 1996). Chinese people in the thousands of were killed in these experiments during 1932-1945 (Gilman, 2003). The experimenters were never prosecuted because the United States granted immunity in exchange for the research data (Garnett, 1996).

The United States has not been immune to these kinds of experiments. In the 1930s researchers with the Tuskegee Syphilis Experiment watched the progress of untreated syphilis in several hundred black men until 1972. During this time it became obvious that they were dying off at a higher rate than the control group and antibiotics were known to be effective in the treatment of syphilis as far back as the 1940s (Garnett, 1996).

The Clinton administration investigated experiments at Vanderbilt University in the 1940's in which pregnant women were given radioactive iron (Garnett, 1996). It is alleged that research doctors at Vanderbilt University Hospital fed 829 pregnant women a tracer dose of radioactive iron and then followed up to find out the morbidity and mortality experiences of the mothers and their children (Hawk, 1995).

In 1972, twenty women, mostly poor, young, and Black, were bused from Chicago to Philadelphia to receive abortions using an experimental device. The device caused problems and complications. A complication of using the devise was uncontrollable bleeding that lead to shock and a total abdominal hysterectomy (Randall, 1996).

In 1994 a UCLA undergraduate who volunteered for experimental schizophrenia treatment alleged that researchers foresaw and even conspired to produce his and others' schizophrenic relapses (Garnett, 1996). Patients with schizophrenia were taken off medications and put on placebos, as part of an attempt to recognize predictors of relapse among patients who stop taking their medications. A patient off medication committed suicide and another hitchhiked to Washington, D.C. in an attempt to assassinate the President (Coleman, 2004).

Consequential Legal and Ethical Frameworks

In response to medical atrocities, various legal and ethical frameworks have been developed to protect human subjects in research, and consent has become the foundation for ethical medical research. Modern law regarding human experimentation developed from the Nuremburg Code (Hafemeister and Petrila, 1994). In response to Nazi human experimentation during World War II, the Nuremberg court established the Nuremberg Code which set standards for medical experimentation on humans (See www.hhs.gov/ohrp/references/nurcode.htm for the Nuremburg Code in its entirety) . The Nuremberg Code stated that the voluntary consent of a human subject in research was absolutely essential (Garnett, 1996).

Expanding upon the Nuremburg Code, members of the World Medical Association wrote the Declaration of Helsinki, which held the voluntary consent requirement, and further added that voluntary participation must be an informed one (Ziker, 2003) and that subjects had a right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal (See www.fda.gov/oc/ohrt/IRB/helsinki83.html for the Declaration of Helsinki in its entirety) (Caulfield and Ries, 2004). . It also required that each potential subject be adequately informed of the research aims, methods used, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, and the likely benefits and potential risks of the study. Further, every precaution was to be taken to respect the privacy of the subject, the confidentiality of the patient's information and to minimize the impact of the study on the subject (Caulfield and Nola, 2004).

In 1979, the National Commission on Ethical Principles and Guidelines for the Protection of Human Subjects of Research wrote what is known as the Belmont Report that provided further ethical principles and guidelines for research involving human subjects (See www.fda.gov/oc/ohrt/IRB/ belmont.html for the Belmont Report in its entirety). The Belmont Report stated that risks and benefits of research with humans must be balanced and stand in an acceptable ratio (Rajczi, 2004).

In 1991, the federal government passed Title 45, CFR Part 46 Protection of Human Subjects. This legislation required that each institution engaged in research which is conducted or supported by a Federal Department or Agency must comply with the requirements set forth in this policy. If a research activity involves human subject, there must be a review by an institutional review boards and obligation of certain standards for informed consent. Part A of the policy is known as the "Common Rule." Part B addresses additional protections extended to research involving fetuses, etc. Part C pertains to research with prisoners. Finally, Part D addresses research with children and their protection (See www.hhs.gov/ohrp/humansubjects/ guidance/ 45cfr46.htm#46.103 for the statute in its entirety).

Technical Impact on Research in the University Setting

Universities across the country have now formed human subject committees and internal review boards to review research to make certain that it fits the criteria developed by federal legislative statute. To do otherwise would be to leave universities without federal funding. The result has produced a number of problems in doing cross-cultural and international research in criminal justice as ethical issues created for medical experimental procedures are construed and applied in the sphere of social science.

Technically, this has raised a number of problematic issues. For example, our host university had created policy that we were unaware of that applied to our research. A Human Subjects Review Committee (HSRC) had been formed to assure the U.S. Department of Health and Human Services (DHHS) that human research subjects would be protected and that our university would comply with DHHS Regulations for the Protection of Human Research Subjects (Title 45 Code of Federal Regulations, Part 46). As a consequence a fledgling bureaucracy had developed with time consuming regulations that appear to be ill fitted to social science endeavors.

The university now required that all student and faculty principal investigators and all co-investigators complete training in the responsible conduct of research prior to submitting applications to the Human Subjects Review Committee. The RCR training was delivered in two modes: (1) an on-line (web-based) tutorial and (2) an on-campus workshop. The on-line tutorial was provided through the Continuing Cancer Education Curriculum site and took one and a half hours to complete. A significant amount of the material did not apply to our research interests.

In addition, it is far from clear that a training module is a factor likely to make a significant difference to research protocol, performing the informed consent process properly, and carrying out research in a manner that minimizes risks to participants. Macklin (2002) in her article, “Mistaking Procedural  Requirements for Ethical Standards,” points out that a researcher could complete a web-based training and still jeopardize the welfare of participants. On the other hand, a researcher could also not take the training and exercise significant regard for participants through out the course of the research. Just because a web-based tutorial is official does not mean that it is good.

Other technical problems were associated with the review process. This included a six week review process or longer, the filling out of a lengthy questionnaire designed to cover issues from a variety of research endeavors, a questionnaire or interview script, confidentiality requirements such as assurances of a locked file cabinet, data disposal procedures, informed consent procedures, respondent identity procedures, etc. We sometimes use indigenous assistants to collect information and had to provide information on issues surrounding how they were to be trained. It further requires specifics about how the questionnaire would be handed out and where, as well as support from other entities (such as the population being researched). The process of completing the required fields is time consuming and possibly frustrating granted questions were far removed from our concerns and focus.

Human Subjects Concerns When Researching Criminal Justice Related Issues in Mexico or Mexicans in the United States

We have reviewed the literature on human subjects and found numerous issues that need to be addressed or might cause problems with an internal review board review on research on Mexican criminal justice issues or undocumented Mexicans in the United States.

Internal Review Board Committee Credentials

A number of issues rise with the issue of internal review board committee credentials. Ethically sound research is said to require an internal review board review to assure that application of the principles of respect for persons, beneficence and justice. Procedural requirements mandate review by a competent body to assess compliance with these substantive principles. The primary objective of the internal review board is to protect research participants from risk (White, 1999).

Few sponsoring researchers or internal review board members are more than superficially acquainted with the cultural context of foreign subject populations. Some have suggested lay members on internal review board committees who represent the culture where the research is to be done provide insight. Members of the community to be studied should be participants at all phases of the research process, beginning with the research design. This should provide a culturally competent advocate to assist the internal review board to illuminate issues of concern unique to the community to be researchers (Kelly, 2002).

We are uncertain how this could be accomplished when studying undocumented immigrants, or people living in another country due to the distance, etc. Moreover, even if the internal review board were to pay for the travel, or overcome the problem of acknowledging undocumented immigrants there are other problems. One issue would be who would represent the culture being represented and who would select them. Would the internal review board independently find someone, which may be a problem, or should the researchers provide one who may not be objective (White, 1999)?

There might also be issues in reading the materials, which in our case would be written in Spanish. There is also the issue of translating surveys or questionnaires. The questionnaire or informed consent procedure must be translated from Spanish into English so that the internal review board can understand what is being said. One international research project went as far as to translate their survey from English, into the research country’s language (Chinese) and then had it translated back in English to make certain that it was comparable (White, 1999). Legalistic language contained in an informed risk might be greatly difficult to translate or comprehend (Kelly, 2002).

Risk to Respondents

One of the major complaints is that internal review board s are over scrutinizing minimal risk types of research (surveys, questionnaires, etc.)(Marshall, 2003). Macklin stated (2002:378) that, ”It is unfortunate but true that internal review board in the United States are inexperienced and inflexible when it comes to reviewing and approving collaborative research in developing countries.” Informed consent litigation relating to medical treatment took off in the 1960s and 1970s. Claims alleging a negligent failure to obtain informed consent continue today. Attorneys have now diversified these suits into several approaches, and defendants now include universities. The concern is that now that the courts have begun to second-guess internal review board decisions, resulting in the natural tendency for internal review board to become more conservative. They may take on a legalistic mode in which attention to regulatory detail crowds out reviewers' ability to ask real questions about the risks and benefits of research studies. Research that has long been considered acceptable in terms of risk-benefit ratio may no longer be approved (Mello, Studdert and Brennan, 2003).

Informed consent can be seen by internal review board legalistically. Informed consent includes: a) the purpose of the study; b) risks and harms associated with the study; c) benefits; d) disclosure of alternatives to study participation, including available treatments if it is clinical research; e) the protection of confidentiality; f) compensation in case of injury; g) who to contact if there are questions or concerns; and h) a statement indicating that participation is voluntary, refusal will not have negative consequences, and withdrawal from the study is possible (Marshall, 2003).

Drafting this up on a survey is problematic. The sound of it may not be conducive to the participation of some potential respondents. People who are vulnerable, such as those involved in illegal activities (such as undocumented immigrants in the United States) or those that may be oppressed by law enforcement officials may be reluctant to participate due to a misunderstanding of what is being said. People who have been exploited in the past from signing legal looking documents may also not wish to sign or be involved (Marshall, 2003).

Kelley (2002:373) stated that “In authoritarian cultures or societies where there exists mistrust of government officials due to political unrest or atrocities, providing a signature to an official document may be seen as a potentially dangerous act, thus placing a participant in harms way.” Macklin (1989:379) stated that, “Even in some societies where there is a high degree of literacy, people are reluctant to sign documents because of a fear that they will be used against them, in some way. Most often these are societies in which there have been oppressive regimes, corrupt governments or both. That is the case in several countries in Latin America, where literacy rates are high but people do not trust ruling authorities.” He went on to say, “Although there may be no objective grounds for such fears in the signing of informed consent documents in U.S. sponsored research, the subjective reality for these individuals stems from having lived under oppressive governments.”

It is possible that if we were to work with Mexican university officials or officials in general in a country with widespread corruption in all facets of life, would result in people who do not wish to participate. An internal review board, such as the one at our host university, may want support from organizations or individuals in Mexico, which may raise problems with gaining respondents.

Researching the criminal justice systems in Mexico and the United States is problematic due to the risk to respondents. To be excluded from review, the risks of harm anticipated in the proposed research need to be no greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. We have written elsewhere that Mexican officials are sensitive to criticisms concerning their system and operations. We have also commented upon all levels of corruption and violence perpetrated by Mexican police and officials. Many people could be placed at risk from responding to surveys or interviewing, including the respondent, the interviewer, the researchers, etc.

However, the question of informed consent is not, in our opinion, one that should be addressed by the internal review board. The respondent, interviewer, etc., if they are indigenous people, know the risks associated with their participation or conduct. It should be up to them to discern the risks and benefits, and they are in the best position to know.

There is also concern for work with undocumented immigrants in the United States. Under concerns about terrorism, the U.S. government has stepped up efforts to manage undocumented access to the United States. In a recent publication, we have stated that the U.S. government has focused on undocumented aliens as a means to show the public that it is doing something about terrorism (Olivero, Trevino, Murataya and Capitillo, 2004). It is possible that materials, names, locations, etc., might be used to the government to the detriment of research respondents. It might also be construed in some fashion that researchers are co-conspirators due to their knowledge or failure to report issues to authorities on both sides of the border.

With respect to vulnerable people in the United States, such as undocumented immigrants, there may be some protections that materials, names, locations, etc., might be used to the government to the detriment of research respondents. Under Federal law, and some state laws, researchers can obtain a Certificate of Confidentiality. This will protect the researcher from the obligation to provide information as the result of a subpoena (Ebsbensen, 1991).

Extreme Internal Review Board Position

Some have argued that merely questioning might rise top the level of an ethical breech. MacQueen and Sugarman (2003) suggest that the risk part of the equation is being minutely scrutinized for any potential or conceivable risk. Under this perspective, psychological harm can arise from simply thinking or talking about one’s own behavior or attitudes on sensitive topics or from filling out a questionnaire. Psychological harm is defined as undesirable changes in cognition and emotion, such as feelings of stress, depression, guilt, embarrassment, or loss of self-esteem (Michigan Tech, 2004).4 An internal review board might hold researchers responsible for rendering aid to someone who suffered as the result of the “psychological harm” resulting in participation.

Based upon medical research, research has been considered to be ethical insofar as the general good to be gained from the research findings outweighed the risks to the participants. Further, the physician's relationship to the patient was accepted as the analogy for the investigator's relationship to the research subject. Just as the physician must be committed to protecting the welfare of the patient he or she is treating, the researcher must be committed to protecting the welfare of the research subject (Brennan, 1999). As such, it is conceivable that an internal review board might require that researchers have a therapeutic component following the simple completion of a questionnaire.

Subjects should not be pressed to provide information that they are uncomfortable or re-traumatized by sharing. However, we feel that in ethnographic research involving observation of anonymous public behavior (e.g, a public park, a restaurant, a theater) individual informed consent would be unrealistic and unnecessary and concerns about trauma are too extreme for consideration.

Conclusion

A new bureaucracy has developed nationally on college campuses. The official role of the bureaucracy is to review human subjects’ research for the protection of human rights. In actuality, this bureaucracy may function as a means to thwart possible litigation. Internal review boards have developed out of the field of medicine and atrocious abuses of humanity in the name of science. Much of the real abuses appear to have come from the sphere of medical research. The present ethical concern in medical cross-cultural research is the use of poor and disadvantaged people to develop medical procedures that might benefit the elite, without noticeable application to the population that bore the brunt of experimentation. Taking the issues of medical research and applying them to social scientific research is problematic.

Cross cultural research in Mexico as well as researching Mexican undocumented immigrants raise a host of problems, besides the application of medical research to social research. A host of safeguards are now in place to protect respondents. At the same time over-reactive internal review board reviews and the process itself will hinder the process of research and in the long run adversely impact those they are designed to protect. If the research does not take place because of the presumed risks, necessary issues will not be addressed and allowed to continue.

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