Garden City, MI5 days ago
Risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes; Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result; Selection of human subjects and patients for research participation is equitable; Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by company policies and federal regulations; Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by company policies and federal regulations; Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects; The privacy of human research subjects is protected and the confidentiality of data is maintained; Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons). Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation; Reporting promptly any internal or external adverse event that is considered to be unexpected, serious, and possibly or definitely related to the study; Reporting promptly any significant changes in the risk/benefit of study participation; Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible; Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study; Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable company required training modules; Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines.