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The terms anonymity and confidentiality are frequently confused in human subjects research. The distinction between the two terms, however, is critical in the design of protocols that protect participant privacy and provide for adequate informed consent. Confidentiality refers to a condition in which the researcher knows the identity of a research subject, but takes steps to protect that identity from being discovered by others. Most human subjects research requires the collection of a signed consent agreement from participants, and the collection of other personally identifiable data, and thus researchers are aware of the identity of their subjects. In such cases, maintaining confidentiality is a key measure to ensure the protection of private information. Researchers employ a number of methods to keep their subjects' identity confidential. Foremost, they keep their records secure through the use of password protected files, encryption when sending information over the internet, and even old-fashioned locked doors and drawers. They frequently do not record information in a way that links subject responses with identifying information (usually by use of a code known only to them). And because subjects may not be identified by names alone, but by other identifiers or by combinations of information about subjects, researchers will often only report aggregate findings, not individual-level data, to the public. Anonymity is a condition in which the identity of individual subjects is not known to researchers. Because most human subjects research requires signed documentation of consent, subject anonymity is not as common in human subjects research. Federal law does allow an IRB to waive the requirement for signed consent documents in cases where the collection of that document is the only identifying information linking the subject to the project. Such documentation is most often waived for projects such as online survey that present no more than minimal risk to subjects. As you develop your human subjects review application, please be certain you understand the distinction between confidentiality and anonymity, and that you use the appropriate terms in your project description and consent documents. Pursuing Potential Research Participants Protections “When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast. Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science. NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:
Social and clinical valueEvery research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research. Scientific validityA study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose Fair subject selectionThe primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk. Favorable risk-benefit ratioUncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks. Independent reviewTo minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing. Informed consentPotential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate. Respect for potential and enrolled participantsIndividuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:
More information on these seven guiding principles and on bioethics in general
Liberty University EDUC 750 QUIZ 1 3 out of 3 points Triangulation implies that viewing a situation from different perspectives will help the researcher gain a clearer picture of the educational situation being studied. 3 out of 3 points Which type of research attempts to answer the question “what is going on here?” 3 out of 3 points A researcher who is interested in studying bullying primarily because of his own childhood experience as a target of bullying is probably motivated by _____ reasons. 3 out of 3 points The _____ philosophy is closely linked to qualitative research approaches. 3 out of 3 points The increasing influence of interpretivist approaches on educational research is referred to as: 3 out of 3 points Which statement accurately summarizes findings from the U. S. Department of Health and Human Services study on the impact of the Early Head Start program? 3 out of 3 points Educational research relies on _____ thinking. 3 out of 3 points Ms. Lake has been teaching first grade for four years. Each year, she has found that many of her curly-haired students are shy. Therefore, she has concluded that all children with curly hair are shy. She is displaying an error of: 0 out of 3 points Our questions about various research topics are answered by educational theory. 3 out of 3 points Which aspect of a research proposal involves identifying human subjects' issues? 3 out of 3 points Which one of the following characteristics is NOT a criterion for a good educational research question? 3 out of 3 points No Child Left Behind and the popularity of classroom-based research methods have raised awareness about the goal of : 3 out of 3 points An educational research question may be answered through the _____ of empirical data. 3 out of 3 points Qualitative researchers often employ a deductive reasoning process. 3 out of 3 points What do the authors recommend researchers do to avoid becoming overwhelmed by the task of formulating a research question? 3 out of 3 points When we consider whether or not the answer to a research question will make a difference for society we are addressing: 3 out of 3 points When assessing the validity of a study, it is important to: 3 out of 3 points The standard of confidentiality does not apply to information available in public records. 3 out of 3 points Diana Baumrind and Stanley Milgram agreed that obedience to authority could be studied in a laboratory setting. 3 out of 3 points Why did Amos Hatch reportedly feel guilty following his six-month study of social interactions in kindergarteners? 3 out of 3 points Assessing a study from the perspective of the subject(s) is central to research ethics. 3 out of 3 points In order for an experiment to be considered valid, the research methods must be kept confidential. 3 out of 3 points Minimizing possible harm to subjects and maximizing benefits are cornerstones of the ethical principle referred to as: 3 out of 3 points How many of Milgram's 40 subjects shocked the Learner at the highest level (XXX)? 3 out of 3 points The primary focus of research ethics is: |
In order for an experiment to be considered valid, the research methods must be kept confidential.
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