#4 ETHICAL RULES TRIAL#

The Committee understands that Rule 4.2 poses perplexing questions for many in the bar regarding who is protected by the Rule and under what circumstances a lawyer may contact an agent or employee of an organization who may have information about a matter. Individuals 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.Rule 4.2 Communication with Person Represented by Counsel Guidance Respect for potential and enrolled participants 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. Potential participants should make their own decision about whether they want to participate or continue participating in research.

#4 ETHICAL RULES TRIAL#

To 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 riskвЂ“benefit ratio favorable? The panel also monitors a study while it is ongoing. 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. Risks can be physical, psychological, economic, or social. Research risks may be trivial or serious, transient or long-term. Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. 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. Participants who accept the risks of research should be in a position to enjoy its benefits. The primary basis for recruiting participants should be the scientific goals of the study - not vulnerability, privilege, or other unrelated factors. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose Fair subject selection 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. Scientific validityДЄ study should be designed in a way that will get an understandable answer to the important research question. 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. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. Respect for potential and enrolled subjectsД®very research study is designed to answer a specific question.NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research: Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science. There are precautions researchers can take вЂ“ in the planning, implementation and follow-up of studies вЂ“ to protect these participants in research. However, it is important to remember the individuals who volunteer to participate in research. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in aВ podcast.Д¬linical research advances the understanding of science and promotes human health. вЂњWhen 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,вЂќ said Dr.

4 ethical rules