C.Investigators must obtain informed consent if the study involves collection of privateinformation from or about research participants.D.All of the above8.True or False: After informed consent for a research study is given, a research participantmust complete the study. Show
Get answer to your question and much more 9.True or False: In general, informed consent should be a process rather than a one-time event. Get answer to your question and much more 10.In order to participate in research, children must …A.Provide written informed consentB.Provide written permissionC.Provide assent, unless the IRB determines that they are too youngD.Sign, or put an “X” on the assent document 11.For research involving pregnant women, participation requires ... Get answer to your question and much more 12.Why might an individual have diminished autonomy? Get answer to your question and much more 13.True or False: Risks to research participants must be completely eliminated for the study tobe considered ethical. Get answer to your question and much more The IRB is responsible for evaluating the potential risks and weighing the probability of the risk occurring and the magnitude of harm that may result. It must then judge whether the anticipated benefit, either of new knowledge or of improved health for the research subjects, justifies inviting any person to undertake the risks. The IRB cannot approve research in which the risks are judged
unreasonable in relation to the anticipated benefits. In This Section 45 CFR
46.111 (a) (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk,
and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment
purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those
risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those
research risks that fall within the purview of its responsibility. Initial Review Application You will be asked to select all procedures that will be conducted for research purposes as
directed by the study protocol: Your selection will assist in routing the application for the
appropriate level of review. Research Protocol Describe the known risks related to participation in research. Describe any actions taken to minimize risk. Clearly state which procedures are being done specifically for research purposes and which are done as standard of care or normal practice. Describe any anticipated benefits the research subjects may receive from participation in the research. For minimal risk research, there is no requirement of direct benefit to research subjects; it is acceptable to state that there is no anticipated benefit to subjects. When research is greater than minimal risk, the anticipated benefits must justify the known risks. Please note that compensation for participation in research may not be listed as a benefit. Consent Documents Describe the known risks and anticipated benefits in laypersons terms. List all risks and benefits that are described in the research protocol. Ethical ConsiderationsWhen making this determination in research with adult populations, the IRB weighs the risks to participants against the anticipated benefits (either direct or indirect) of the research. When vulnerable subjects take part, the regulations place limits on the extent of risk permitted. Children may only participate in greater than minimal risk research when there is a prospect for direct benefit. The IRB will:
Risk GuidanceIn human subject research, research is categorized into in two categories:
Research is considered minimal risk when the risks of the research are not greater than those experienced in regular daily life. Researchers are responsible for identifying any possible risks of the research and minimizing risks to subjects whenever possible. Some common types of risks are:
Strategies for Minimizing Risks Eliminating Risks Risks are eliminated by limiting research procedures or data collection to those that are necessary for the research. Some examples:
When risks cannot be eliminated, there are often opportunities to decrease the risk to research subjects. Some examples:
Combining research procedures with clinical care If procedures can be timed to take place at the same time as a clinically indicated procedure or if clinical test results can be used instead of repeating the measurements, the risks are often greatly reduced. Some examples:
Benefits GuidanceNancy King has defined three types of benefit that may occur in the context of clinical research (J Law Med Ethics. 2000 Winter;28(4):332-43) Direct Benefit: A benefit arising from receiving the intervention being studied. Indirect Benefits
Research with a direct benefitAny study that involves an intervention could have an anticipated direct benefit. In these studies, participants may receive some intervention (medical, behavioral, or other), that they would not otherwise receive. The purpose of the research is typically to test the effectiveness of the intervention. When describing the anticipated benefits of research in the consent document, it is important that researchers make subjects aware that the benefits of the intervention are not known, and that the research is being conducted to evaluate the effectiveness of the intervention. Whenever possible, the researcher should provide any known information about the probability and magnitude of the anticipated benefit. Research with an indirect benefitWhen research does not involve an intervention there is little opportunity for direct benefit. When the risks of the research are no greater than those encountered in the everyday life, there is no requirement for direct benefit. When the research risks are greater than minimal risk, then the researcher must provide justification that explains how the anticipated benefits of the research justify the risks to the subjects. DefinitionsBenefit is a valued or desired outcome; an advantage. Minimal Risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Resources
What are the three ethical principles from the Belmont Report that constitute the basis for the HHS human subjects regulations 45 CFR 46 )?The Belmont Report identifies three fundamental ethical principles for all human subjects research -- respect for persons, beneficence, and justice.
What is an appropriate method for maintaining confidentiality?What is an appropriate method for maintaining confidentiality of private information obtained from human subjects? Keeping data in a password-protected database. Storing data in a secured cabinet. Coding data or specimens and keeping the key to the code in a separate location.
Is a set of 10 guidelines for the ethical treatment of human participants in research?The following is a general summary of some ethical principles:. Honesty: Honestly report data, results, methods and procedures, and publication status. ... . Objectivity: ... . Integrity: ... . Carefulness: ... . Openness: ... . Respect for Intellectual Property: ... . Confidentiality: ... . Responsible Publication:. What are recommendations for ethical practice of research quizlet?Three core principles are identified: respect for persons, beneficence, and justice.. Minimization of risk to participants.. Reasonable risk in relation to benefits.. Equitable selection.. Informed consent.. Documentation of Informed consent.. Data monitoring.. Privacy and confidentiality.. |