Since the U.S. adopted regulations governing research with human subjects in the 1970s, most of the ethical debates about research with human subjects have focused on questions relating to clinical research, such as management of risks, using placebos in control groups, randomization, informed consent, reporting adverse events, recruitment of subjects, and research on vulnerable populations. Most of the infamous or controversial cases discussed in the literature on human experimentation-the Nazi Experiments, the Tuskegee Syphilis Study, the Department of Energy’s secret human radiation experiments, and HIV research in developing nations-have been about medical research conducted in a clinical setting (Coleman et al. 2005; Emanuel et al. 2008; Levine 1988).
During the last five years, there have been various ethical issues that arise especially in the field of environmental health research as well as the usage of the Internet. Most of the ethical issues that occur in environmental health research are similar to those that arise in clinical research, but since there are important scientific, social, and political differences between environmental health research and clinical research, these familiar issues appear under a new light.
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This paper shall tackle all the ethical issues concerning the environmental health research as well as the use of the Internet. At the end of the paper, all the issues shall be summarized and recommendations shall be made in order to ensure that the proper ethics and guidelines can be followed at all times
Research Methods Used in Health research Using Human Subjects
Environmental health research methods involving human subjects can be classified as either observational or experimental. Observational studies gather information about human subjects in their natural environment, whereas experiments gather information on human subjects under controlled conditions. Some of the designs commonly used in observational research include case-control studies, cohort studies, field studies, and cross-sectional studies. These study designs are commonly used in epidemiological and medical research. In a retrospective case control study, investigators collect information on the environmental exposures of a group of people with a disease or condition (cases) over a period of time and a group of people similar to the cases but who do not have the disease or condition in question. In a prospective cohort study, investigators follow one group of people (the cohort) who have a particular characteristic (such as an environmental exposure) for a long period of time (10 years or more). Investigators also follow a comparison group of people (the control group) who do not have the characteristic. Field studies are similar to prospective cohort studies, except the observational period is much shorter: a field study may involve observation of subjects over a period involving days, weeks, or months. In a cross-sectional study, investigators make observations of a population at a single point in time. In all of these methods, investigators attempt to determine whether observed differences between the groups (e.g. cases vs. controls or cohort vs. control) are due to differences in environmental exposures (Gertsman, 2003).
Ethical Issues in the Environmental Health Research
The ethical issues that arise in environmental health research with human subjects are similar to those that arise in clinical research, but there are some situations unique to environmental health researches that create dilemmas rarely encountered by clinical researchers. Many of these novel ethical dilemmas occur when investigators collect data or conduct interventions in the home environment or intentionally expose human subjects to dangerous environmental agents, such as pesticides. It is likely that other novel issues will emerge in environmental health research. Environmental scientists-and ethicists-should prepare to deal with them as they arise.
It is important to note that although subjects usually receive some payment for risk research that does not provide any medical benefits; most government agencies do not consider money to be a benefit (Shamoo and Resnik 2006).
Another ethical issue is the allegedly safe dosages. A “safe” dosage would be one that is not expected to cause any permanent harm to the research subject. Some substances that are harmful in larger doses, such as ozone, may cause little harm in very small doses. Some substances may cause permanent harm even in small doses. For example, known carcinogens, such as benzene and asbestos can cause permanent damage at very small exposures. It makes no difference whether the unsafe expose might occur in normal life. For example, a construction worker might inhale asbestos dust when helping to demolish an old building, but this would not justify intentionally exposing a human subject to inhaled asbestos (Resnik 2006).
Ethical Issues in Researches for the Virtual World
During the recent years, virtual worlds have become a focus of multiple disciplines in research as the researchers begin in tapping the potential of these so called virtual worlds (Bainbridge 2007). With the emergence of new technologies and methodologies in research, concerns for setting new ethical standards, or at least the re-evaluation of current ones, have as well arise. However, current researchers do not see any harm in doing research for the virtual world. This is viewed as one of the advantages in engaging in this kind of research. It is being rationalized by the researchers that there is fair game in the virtual world because of various reasons. Though other deemed these reasons questionable. The rationalizations are created by the oversimplification of the many reasons as to why people are participating for researches for the virtual world.
As demonstrated in the analysis of virtual world research and from the discussion abstracted, there is a clear need for more in depth ethical analysis when conducting human subjects research virtual worlds. While there has been much discussion and debate in the academic world of the potential and validity of virtual world research, there has been very little discussion of the ethical implications of such research. While this debate of validity will continue into the foreseeable future, research in virtual worlds is occurring now and needs to be addressed accordingly in a consistent and concise manner.
Due to the number of disciplines and various types of research involved, one all-encompassing set of ethical guidelines for virtual world research would seem impractical, if not impossible. In addition, virtual worlds themselves can vary greatly from each other in intended use, practice, and experience. Therefore, a recommendation for the creation of a standalone ethical code of conduct to apply to all virtual world research would not be feasible or practicable.
Beyond the impractically of universal guidelines, such work may be ultimately unnecessary. The majority of the research ethics developed for human subjects’ research is still applicable and usable in the virtual world context. The basic tenants of properly respecting the participant and the structural oversight in the form of IRB review boards can be utilized to address or mitigate much of the existing concern. The core problem is that the IRB process is done on a case by case basis, which can create inconsistent results. Further, when relatively new technologies are implemented, there is a genuine possibility for an IRB not to understand the full ramifications of certain actions.
The solution to the IRB awareness problem might come from the creation of a document that illuminates ethical issues of conducting human subjects’ research in virtual worlds. Potential stakeholders of virtual world research could collaborate to create such a document, similar to what the Association of Internet Researchers have done in their ethical guidelines. This bottom-up process is more likely to result in standards for ethical research that all stakeholders agree with and will actively work to uphold, much as a bottom-up process is preferable for other forms of standards-building such as educational standards (Fleischmann, 2007). Such a document would allow more flexibility in terms of scope, and research, than a rigid and finite all-in-one ethical code. The document would illustrate the unique ethical issues that exist in conducting human subjects’ research in virtual worlds, and the further expand on the potential for harm and abuse.
An increased focus on personal responsibility should be introduced with respects to virtual worlds, to cover areas where IRBs might fail. Just because a research proposal passed approval does not absolve you of additional ethical and legal responsibilities (Sales & Folkman, 2000). There should always be considerable focus on personal responsibility in terms of research ethics.
Human Subjects on the Internet
Internet research raises a number of complex issues for the scientific community, research subjects, and policy makers. The preliminary discussions begun at the AAAS-OPRR workshop need to continue, with greater focus on the extent to which the issues take on different qualities on the Internet than they do in the physical world, and what that means for policies and guidelines intended to protect human subjects. In order for these discussions to be most useful, they must be firmly grounded in an understanding of Internet technology and its impact on human subjects’ research. The Internet as an evolving medium for research can be viewed as a paradigm of the larger question of how we deal with value-laden questions associated with technological advances and the capabilities they confer. This powerful technology needs to be better understood if we are to ensure that effective mechanisms are in place to protect human subjects (Frankel and Siang 2005).
Workshop participants developed a set of recommendations related to research and education as well as for action that should be considered as part of a general strategy for dealing with the challenges posed by Internet research. They are presented here as a basis for galvanizing further dialogue on these important issues (Frankel and Siang 2005).
Ensuring anonymity in the Internet survey was relatively simple because data collection through the Internet usually originated as an anonymous communication with the researchers and respondents typically lacking any knowledge of each other (Fawcett & Buhle. 1995). When the participants transferred inputs through the Internet, the only information that could be linked to personal identity was the Internet Protocol address (IP address). One can find the person’s identity that uses the IP address only if the network manager who manages the IP address discloses the identity of the user, which does not frequently happen. Therefore, during the Internet survey, the participants were anonymous. However, there had difficulties in ensuring anonymity in e-mail group discussions even though we did not use their real names and any other identities in the e-mail list. Some participants used their real names in the messages that they sent to other participants (e.g., from Jane Doe in Sydney). They seemed to want to disclose themselves to make contributions to the discussions and connect to nursing colleagues in different countries.
Research participants can more easily ask questions and get answers by e-mail compared with traditional quantitative research methods including self-administered questionnaires (Im & Chee. 200l; Lakeman. 1997). In this regard, data collection through the Internet and e-mail may provide better opportunities for research participants to become informed about the research and self determine their participation. Indeed, in the study presented here, potential participants promptly responded to the invitation to the study and asked questions related to the study (e.g., payment for participation, unclear inclusion criteria, risk and benefits from the study, safety issues). Also, after each topic was sent to the research participants, they could determine the time of their participation at their convenience within a week.
Research assumes authentic interactions between researchers and research participants, but it is questionable how authentic the interactions and the phenomenon reported and/or explored through the Internet can be in reality (Frankel & Siang. 1999). Validating that the participants were the real persons the researchers were looking for was an issue. The researchers contacted each school of nursing identified through several Internet search engines, including Yahoo.com and AltaVista.com, and obtained lists of faculty members through the institutions’ home pages. Then, faculty members were contacted through their e-mail addresses identified through the Internet. While the researchers could ensure that all the potential participants were faculty members of the schools of nursing, they could not ensure that all the potential participants were experts in oncology because some of the institutions did not disclose the expertise of their faculty members and the participants were recruited based on their self-reports about their expertise.
Ethics and Incentives
A recent debate over payment for research subjects illustrates the differences in the ethical issues that emerge when wages are substituted for incentives. Anderson and Weijer (2002) challenged Dickert and Grady’s (1999) recommendation that research subjects be paid an hourly wage equivalent to the wages paid to unskilled laborers. They argued that wage earners are entitled to an array of rights associated with their status as workers, including the right to overtime compensation, the right to organize, and the right to a standard work week. This would mean that the human subjects used in research shall be treated the same as that of ordinary workers and should have the same rights.
In general, then, while incentives are always employed to induce someone to do what they otherwise might not, the ethically suspect situation is one in which an incentive is used to induce someone to do something to which they are averse. This is the kind of manipulation, pressure or seduction captured in the colloquial phrase, “against my better judgment.” A choice that involves an aversion is different, for example, from the choice between one car and another when I already have decided that I want to buy a car. And the ethical problem is multiplied where the aversion is a principled one or a matter of moral scruple. To deliberately induce religious people to work on the Sabbath by offering large incentives would involve an attempt to get them to act against what they see as their duties; it would be a form of bribery.
Well-designed and well-conducted medical research can provide critically important public benefits. For this reason, protocols that make it unlikely that research will take place due to a shortage of subjects carry an ethical burden. And conversely, an incentives program that can provide the important public benefits of medical research has a strong ethical claim on its side. Of course, voluntary participation in sound medical research has the fewest ethical problems associated with it. In fact it is an admirable forms of altruism, a free gift to unknown others. But the supply of volunteers is unlikely to be sufficient to meet the needs of medical research.
Incentives can be used to recruit subjects in many situations without any ethical qualms where all other ethical criteria are met-that is to say, incentives themselves are not the ethical problem here, generally speaking. If the research meets the usual ethical criteria for human subjects’ research, the introduction of incentives will generally be benign. Rarely would there be a case that could be classified as bribery or blackmail, for example. However, under certain conditions, incentives are implicated in problems of manipulation in the form of undue influence and in problems of respect for personal dignity. What, then, are those conditions?
It was argued that the use of incentives would be problematic, that is either when joined by the following factors. The subject is in a dependent relationship with the researcher, where there is a high risk that is very particular, the research is degrading, wherein the subject will only participate because of the high incentive at stake, and the aversion is principal. If one of the mentioned conditions are present, the use of incentives are questionable.
Consider the Belmont Report’s (1979) condemnation of “excessive” and “unwarranted” incentives cited above. Actually, the size of the incentive is not important in itself. If a researcher were to offer $1000 to a prospective participant to complete a psychological questionnaire, one would consider it a foolish incentive, but certainly not unethical because “excessive” and “unwarranted.” Large incentives only become problematic in the presence of the other sorts of factors that we have identified. The question is one of the types of choice that is being made. Undue influence occurs when an incentive is attractive enough to tempt people to participate in a research study “against their better judgment.” Thus, the analysis differs from others because we do not conclude either that large incentives ought to be rejected as coercive or that all incentives ought to be permitted as opportunities for free choice. An alternative analysis is offered.
Summary, Conclusion and Recommendations
In closing, it needs to be stressed that according to some analysis, most of the time for most research studies, it is innocuous to use incentives in recruiting and retaining subjects for research. But there are some areas where it is not. It follows that there will be some research studies that should not be done on account of ethics requirements with respect to incentives. So be it. The ethical responsibility to improve medical care must be balanced against the ethical responsibility to treat research subjects as autonomous individuals deserving of respect. Incentives used in an ethically appropriate manner can play an important role in striking that balance.
The following generalization and recommendation is in place with regards to the improvement of ethical considerations towards human subjects that are being used in research:
First, the current system has a coverage that is inadequate. This is in the sense that all of the human subjects do not fall under the protection of either the Common Rule or the FDA regulations. Given that there are no federal funds involved, there is no system of oversight at all. This leaves that there are uncertain number of investigators as well as subjects that are unprotected.
Secondly, clinical research has become a vast enterprise. The IRB’s and those involved in the system oversight are too overburdened in fulfilling their role effectively. It should not be surprising that there are ethical lapses. Until all the partners in the enterprise of medical research can devote more resources, no human subject can be assured of protection that is appropriate. In the long run, the failure in addressing this issue shall begin undermining public support for the entire clinical research enterprise.
Thirdly, the critical process of informed consent has become a rather legalistic document-oriented event rather than a serious process of sustaining a meaningful level of understanding between the human subject and the research team.
Fourth, even those areas that are covered by already existing regulations, there is no single uniform set of requirements or a single source of authoritative guidance to turn to.
Fifth, it is difficult to change the current system that is already unable to adapt to the changing realities of medical science.
Sixth, the current system ignores the fact that the integrity of a decentralized system depends on the education and training of all those involved in the research enterprise level. They must not only have a working knowledge of the oversight system, but as well as that of their own ethical responsibility.
Seventh, there should be a compensation system for the human subjects that are injured as a result of their participation of the research. Perhaps the compensation system can be financed in a manner similar to that of the Federal Deposit Insurance.
Despite international, national, and institutional efforts to develop standardized guidelines for human subjects protection in electronic transmission including the Health Insurance Portability and Accountability Act (HIPAA) (Frankel & Siang. 1999; United States Department of Health and Human Services, 2001), very few standardized guidelines for human subjects protection in Internet research are currently available. Researchers need to be active in developing ethical guidelines and educating researchers on Internet ethics, and develop a national resource network to respond to inquiries from IRB members, nurse researchers, and research participants regarding the technical and ethical components of Internet research. Also, researchers should consult with their academic communities and potential research participants about perceived benefits and harms, expectations of privacy, and the information that potential research participants need to make decisions about their participation.
Second, we suggest the use of investigator triangulation in Internet research to conduct technically secure and ethically sound research. Investigator triangulation means that two or more investigators with diverse research training backgrounds examine the same phenomenon in a Single Study (Duffy, 1987; Kimchi, Polivka, & Stevenson, 1991, Mitchell, 1986). Using investigator triangulation to include an expert in computer system management as a research team member would certainly help conduct an Internet study. At least, researchers need to consult with their institutions’ computer system administrators (or network administrators) regarding the technical aspects of their research.
Finally, respecting the autonomy of research participants requires a conscious, sustained effort by researchers (Nelson-Marten & Rich, 1999). We propose that workshops, panel discussions, conference presentations, and/or special seminars on protection of human subjects in Internet research be held to inform and educate nurse researchers in this topic. Also, researchers should tell participants how their messages and communications will be used and that interception of messages is possible. Complete anonymity, confidentiality, or security is impossible and full disclosure is not always possible on the Internet.
