The Federal Regulations - SBE (ID 502) Latest Update Already Passed

The Federal Regulations - SBE (ID 502) Latest Update Already Passed What is the significance of the Common Rule in federal regulations? The significance of the Common Rule lies in its establishment of ethical guidelines and requirements for institutions conducting research involving human subjects, promoting consistent protections across studies. What are the key components required for informed consent under federal regulations? Key components of informed consent include providing information about the study, ensuring comprehension, and allowing voluntary participation without coercion or undue influence. How often must institutional review boards (IRBs) review ongoing research studies? Institutional review boards (IRBs) must review ongoing research studies at least annually to ensure continued compliance with ethical standards and regulations. What are the potential consequences of non-compliance with federal regulations in research? Potential consequences of non-compliance may include legal penalties, loss of federal funding, suspension of research activities, and damage to the institution's reputation. 2 What is the role of the Office for Human Research Protections (OHRP)? The role of the Office for Human Research Protections (OHRP) is to oversee and ensure compliance with federal regulations regarding the protection of human subjects in research. What are "exempt" categories of research under federal regulations? "Exempt" categories of research refer to specific types of studies that may not require full IRB review, typically involving minimal risk to participants, such as surveys or educational tests. How do federal regulations define "minimal risk" in research studies? Federal regulations define "minimal risk" as the probability and magnitude of harm or discomfort anticipated in the research being no greater than that encountered in daily life or routine physical or psychological examinations. What is the purpose of the Federalwide Assurance (FWA) in research? The purpose of the Federalwide Assurance (FWA) is to provide a formal agreement that institutions will comply with federal regulations governing the protection of human subjects in research. 3 How can researchers ensure the confidentiality of participant data under federal regulations? Researchers can ensure the confidentiality of participant data by implementing secure data management practices, anonymizing data, and restricting access to authorized personnel only. What is required for researchers to make changes to an approved study protocol? Researchers must submit