References Abstract As social and behavioral research expands to involve diverse populations, contexts, and sensitive topics, it raises many complex issues of privacy and confidentiality. These issues go beyond what is contained in textbooks or known to most researchers and Institutional Review Board IRB members.
Case 3 The atrocities committed by Nazi physicians on Jewish prisoners during World War II prompted an international tribunal, convened in the city of Nuremberg, Germany betweento elaborate 10 principles, called the Nuremberg Code, by which research involving human subjects should be governed.
Publication of the Nuremburg Code in ushered in the modern era of research ethics, which mandated balancing the advancement of science with the rights and welfare of humans who serve as research subjects. Since Nuremburg, a multitude of regulations and policy statements have been developed by domestic and international bodies.
Within institutions where clinical research is conducted, responsibility for the interpretation and application of these ethical principles and regulations rests with committees comprised of scientist and non-scientists, called Institutional Review Boards for the Protection of Human Subjects IRBs.
General ethical principles applied to research with human subjects. The Belmont Report, which provides the ethical foundation for research regulations and guides IRB deliberations, was generated by a federally commissioned group of scientists, physicians, ethicists, and philosophers and published in The three primary ethical principles cited in Belmont are: Autonomy refers to the right of an individual to determine what activities they will or will not participate in.
Implicitly, full autonomy requires that an individual be able to understand what they are being asked to do, make a reasoned judgment about the effect participation will have on them, and make a choice to participate free from coercive influence.
The cornerstone of protecting autonomy is the informed consent process, whereby an investigator provides a potential research participant with full disclosure about the nature of the study, the risks, benefits and alternatives, and an extended opportunity to ask questions before deciding whether or not to participate.
Populations presumed to have diminished autonomy, by virtue of impaired cognition for example, children, cognitively-impaired elderly, or mentally ill subjects or of circumstance for example prisoners or seriously ill people are considered to be vulnerable populations. In some of these cases children and prisoners special safeguards to protect their autonomy are required by regulation.
Maximizing potential benefits is predicated on sound experimental design, thus research proposals must undergo rigorous scientific review before proceeding to the IRB for ethical review. Justice demands equitable selection of participants, i. The principle of justice requires that those who undertake the burdens of research must be likely to benefit from the research, and is a principle often violated by the export of clinical trials to underdeveloped countries.
Designing ethical research studies. The primary concern of the investigator should be the safety of the research participant. Protecting subject safety requires the investigator to use all available information to identify potential risks to the subject, to establish means of minimizing those risks, and to continually monitor the ongoing research for adverse events experienced by subjects.
The investigator must be prepared to stop the study if serious unanticipated risks are manifest. The scientific investigator must obtain informed consent from each research participant. This should be obtained in writing although oral consents are sometimes acceptable after the participant has had the opportunity to carefully consider the risks and benefits and to ask any pertinent questions.
Informed consent should be seen as an ongoing process, not a single event or a mere formality. There are regulations and guidance documents that govern exceptions to the requirement to obtain informed consent, for example in cases of emergency or if the subject is unconscious and thereby unable to give consent.
The investigator must consider how adverse events will be handled. In particular, it must be established a priori who will provide care for a participant injured in a study and who will pay for that care. The investigator must strive for clinical equipoise. A true null hypothesis should exist at the onset regarding the outcome of the trial, that is, if a new intervention is being tested against the currently accepted treatment, the investigator should be genuinely uncertain which approach is superior.
Components of ethically valid informed consent for research. Given the appreciation that informed consent is at the crux of human subjects protection, it is not surprising that the regulations reflect extensively upon the necessary elements of the consent document itself as well as on the informed consent process.
For an informed consent to be ethically valid, the following components must be present: The informed consent document must make clear that the study is a research study, and not clinical therapy. There should also be a statement that describes procedures in place to ensure the confidentiality of data and anonymity of the participant.
The informed consent document must also disclose what compensation and medical treatment are available in the case of a research-related injury. The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by someone fully conversant in the study particulars.
The informed consent document must be written in lay language, avoiding any technical jargon. Consent forms for multinational research must be translated into the respective language for each participating country and back-translated to verify accuracy.
Care should be taken that the consent form is administered by someone who does not hold authority over the participant. Ideally, the potential participant is given the opportunity to discuss their participation in the study with family, trusted friends, or their physician before reaching a decision.
The participant must be competent to give consent. In certain emergency cases, consent may be waived due to the lack of competence of the participant and absence of an appropriate surrogate.This directory introduces newcomers to the field of children and childhood studies with the current periodical literature.
It also aims to assist scholars and other researchers from various disciplines in selecting appropriate journals as they seek to publish their work.
But Deming tracked children for a longer period, beyond just their school years, and he found that the program’s positive influence is evident in later years in various important areas of children’s lives such as high school completion, college enrollment, health status, and being either employed or in school.
The atrocities committed by Nazi physicians on Jewish prisoners during World War II prompted an international tribunal, convened in the city of Nuremberg, Germany between , to elaborate 10 principles, called the Nuremberg Code, by which research involving human subjects should be governed.
Table of Contents Research Ethics in Australia Donald Chalmers, University of Tasmania Location of the Office for Protection from Research Risks Within the National Institutes of.
When a proposed research study involves children and is supported or conducted by HHS, the research institution's Institutional Review Board (IRB) must take into consideration the special regulatory requirements that provide additional protection for the children who would be involved in the research.
Determining which type of research method to use in a study is an important part of developing a research question in the scientific method. false __________ research is a type of research that describes various types of data collected through observational research methods.