In addition, research that is regulated by the FDA must adhere to its regulations for the protection of human subjects and other relevant FDA regulations (e.g., 21 CFR 50, 54, 56, 312, 314, 812, and 814). 5. Human subjects. Vulnerable populations may require surrogate consent. As we move to re-starting research at Harvard University, research studies that involve human participant interactions will include screening procedures prior to contact with participants, as well as the use of Personal Protective Equipment (PPE) to minimize the risk of contracting or spreading COVID-19. Research on humans must be scientifically sound and carried out by qualified persons. This includes research done in Tribal or Urban facilities since IHS, Tribal, and Urban sites fall under the IHS federal-wide assurance (FWA) #00008894. The IRB must conduct periodic reviews of research to ensure continued protection of the welfare of human subjects and compliance with relevant regulations. Information must be individually identifiable to constitute human subjects research. Professor Kwan studies violence and designs a study of the effects of video game violence on children. For example, this would include research on living persons using: In addition, the IRB must review and approve or disapprove the investigator for the research. It must be voluntary and informed, with consent and ability to withdraw documented. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects. Click here for updated information on changes to Human Subjects regulations. Research using human specimens or data. Research that is funded by the federal government must meet all of the requirements of the Common Rule. Human subjects research involving individually identifiable human specimens or data and subject to federal and state regulatory requirements. 7. Another important provision that came out of the National Research Act was the requirement that all human subjects’ research must be reviewed and approved by an Institutional Review Board (IRB). All ASU and research related projects involving humans as subjects must be reviewed and approved by ASU’s Institutional Review Board (IRB) prior to implementing studies, … The research protocol must have been scrutinized and approved by an 4. Human subjects research is defined as follows (click here for regulatory definitions): Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. 6. Once approved, the IRB must monitor the progress of the ongoing research and, if necessary, terminate a research project. Human participant research conducted in IHS facilities or with IHS staff or resources must be approved by an IHS Institutional Review Board (IRB). FEEDBACK: Animal Research (Standard 8.09) — Research involving animals must be approved by an Institutional Animal Care and Use Committee (IACUC). requirements for research on humans. All research involving human subjects proposed by EPA staff or EPA supported researchers must be approved by the EPA Human Subjects Research Review Official (HSRRO) before human subjects work may begin. Important information regarding recent IRB changes Before you implement research that involves the use of human subjects, your project must be reviewed and approved by the Kent State Institutional Review Board (IRB).The IRB is responsible for ensuring that the research adequately protects the rights and welfare of study participants.