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,...
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