This is carried out by carefully considering the risk to benefit ratio, using all available information to make an appropriate assessment and continually monitoring the research as it proceeds.
The scientific researcher must obtain informed consent from each research participant. This should be attained in writing although oral consents are sometimes acceptable after the participant has had the chance to carefully consider the risks and benefits and to ask any pertinent questions. Informed consent ought to be seen as an ongoing process, not a singular event or a mere formality.
The researcher must list how privacy and confidentiality concerns will be approached. Researchers must be receptive to not only how information is protected from unauthorized observation, but also if and how participants are to be notified of any unexpected findings from the research that they may or may not want to know.
The researcher must consider how unfavorable events will be handled. They must know who will supply care for a participant injured in a study and who will pay for that care.
Before enrolling subjects in an experimental trial, the investigator should be aware that if a new intervention is being tested against the currently accepted treatment, the investigator should be truly uncertain which approach is superior. A true null hypothesis needs to exist at the beginning in regards to the outcome of the trial (Research Ethics, 2008).
When the research involves children there is an entirely new set of issues that must be looked at and considered. Respect for the research participants includes respect for autonomous decision-making. It requires awareness to the three main elements of informed consent -- adequate information, voluntariness and capacity to understand the information. Accountability for consent for participation in research by children who are unable to provide full consent themselves is vested in parents or guardians, who are assumed to have the best interests of the child in mind. Children, however, may develop the ability to fully consent during the course of a study or be able to consent to some aspects of the research (Ethical issues in health research in children, 2008).
While there is a chance that children can be potentially compromised in each of the elements of informed consent, it is important to acknowledge that they live in an evolving context that may assist or hinder capacity by virtue of their illness and experience. Issues that may influence the sufficiency of consent include information that is too complex or overwhelming in volume, parental or familial pressures that may limit voluntariness and capacity related to neuro-cognitive development. The socioeconomic and multicultural circumstance and language of the population under study must also be considered in making sure that all elements of informed consent are met. The difficulty and severity of potential outcomes of a study should also be considered in assessing whether a child has the capacity to understand the consequences of participation in a study (Ethical issues in health research in children, 2008).
There is indication that consent for research by adults for themselves is often faulty, with poor understanding of the voluntary nature of participation, the meaning of randomization and other issues. These errors also apply to substitute decision-making by parents for their child. Decisions may be clouded by emotional distress and medical acuity, dependent relationships when clinicians assume a dual role as researchers, and the interdependent nature of parent and child. Some research has identified factors that enhance parental understanding. For example, in pediatric oncology research, involvement of nursing support, encouragement of questions and the use of audiovisual aids have been effective. It is imperative that a critical view be taken of the consent documents that support and document the process of consent to ensure that they are not overly long or complex (Ethical issues in health research in children, 2008).
Assent is the notion of providing agreement to participation in research where full consent is not possible by virtue of compromise of one of the three main elements of consent. It is suggested that assent be sought for participation in research at an age-appropriate level, and as suitable to the complexity of the project under consideration. Children ought to be involved in the decision to take part in research as their developmental capacity allows. Undoubtedly, as the complexities and consequences of a research study increases, the need for more sophisticated reasoning and understanding of consequences will also need to increase for a child to provide full consent (Ethical issues in health research in children, 2008).
Wherever public health is involved and deals with groups and communities as opposed to individuals,...
Similarly, there are comparable distinctions between ethical issues related to public health research compared with biomedical research. When conducting public health research, the focus is generally on groups of individuals and on communities rather than on single individuals. While the rights of the individuals in those groups and communities need to be scrupulously protected, consideration needs to be given to the protection of the rights of the groups and communities as a whole. Planning within the field of public health has addressed how to incorporate ethical precepts into practice and research and recognition of the need for increased dialogue (Paulson, 2006).
Due to the fact that public health research engages communities, it has been argued that communities must be involved in public health research. Community advisory boards have been recommended as one means of achieving this end. In many instances, the actions undertaken by public health researchers and those undertaken by public health practitioners are identical in that they both collect data about communities. One way to distinguish between the two and thus determine whether the additional ethical constraints applied to research should apply is whether the information is to be used for generalization or to be applied to a specific issue. Many experts have recommended that the development of alternative methods of oversight for public health investigations that are less dependent on the research vs. practice distinction and more geared to assessing the level of risk and ensuring ethical conduct (Paulson, 2006).
Justice in health care is a recurring and often problematic issue. It is known that the burdens of ill health are unevenly distributed both within and across populations, and that the benefits of health care are not always available to all those who need them. Evidence-based medicine (EBM) has been launched into this already complex situation, with some implied promise of greater fairness than previously existed. This promise operates in at least two ways. The procedures of EBM are committed to objectivity through the use of strictly standardized methods, thereby eliminating opportunities for subjective decisions and possible discrimination. The findings of EBM can be used to make sure fair distribution of effective interventions across the population, at the individual level through the use of evidence-based practice, and at the population level through the use of evidence informed health policy and purchasing decisions (Rogers, 2006).
Keeping away from discrimination and ensuring fair distribution of effective treatments are potentially powerful tools in achieving greater justice in health care. One of the main statements of evidence-based medicine is that it provides objective evidence about the effectiveness of interventions. This is attained through the use of research methods that aim to minimize the risk of bias, such as randomized controlled trials (RCTs). Results from multiple RCTs are collected, using systematic reviews and meta-analysis to give an overall result that is considered to be the definitive best available evidence about a specific intervention. Evidence synthesized in this way can be used to inform treatment decisions for individual patients, or policy decisions about the provision of interventions at a population level. In theory this should bring about fair and equal decisions about treatments, so that individuals with the same illnesses receive the same interventions. Founding treatment decisions solely upon effectiveness may provide the opportunity to eliminate more subjective and possibly discriminatory reasons for giving or withholding treatments. Before looking at the application of EBM it is worth looking in more detail at the way that evidence is generated (Rogers, 2006).
Disadvantaged groups hardly ever have a voice in commissioning and designing research, and have limited participation in trials of new interventions. This usually results in a lack of research evidence about useful interventions for this group. As the occurrence of evidence of effectiveness is increasingly a requirement for the provision of health care, this is a serious matter. Those who fund health care research, both government and private, are responsible for their spending. Funding interventions that are of proven effectiveness are seen as part of this accountability. Aside from the intuitive attractiveness of funding interventions that work, no health care provider wants to be accused of wasting resources on interventions that do not work. In order to receive the newest and best treatments requires evidence, but exclusion from research prevents the generation of evidence and hence access to treatments. The obstacles to performing research with disadvantaged groups are considerable, but…
