![]() ![]() Learn the procedures investigators must follow in order to protect human subjects who participate in clinical research studies. OHRP and General Human Subjects Regulations NIH Certificates of Confidentiality (CoC) - Human Subjects.Impact of the HIPAA Privacy Rule on NIH Processes.HIPAA Administrative Simplification Statute and Rules.The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.Learn more about the policies and guidance for ensuring the confidentiality of individuals who participant in clinical research studies. NIH Frequently Asked Questions (FAQs) on Human Subjects Education.Society of Behavioral Medicine GCP Training for Social and Behavioral Research.National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) GCP Course.National Institute of Allergy and Infectious Diseases (NIAID) GCP Learning Center.Training Resources in the Responsible Conduct of Research (RCR) – HHS ORI.NIH Human Subjects Protections Training & Resources.Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials.Here are some useful resources that investigators can refer to which will help them understand the education and training requirements and offer resources to gain knowledge in the various topics related to the safe and ethical conduct of human subjects research. NIH investigators and those involved with conducting NIH supported clinical research are expected to be trained and maintain up to date certification on human subjects protection education and good clinical practice (GCP). Human Subjects Education, Training and Resources for Investigators Conducting Clinical Research FDA Guidance for Clinical Trial Data Monitoring Committees – March 2006.Guidance on Reporting Incidents to Office for Human Research Protections.Office for Human Research Protections (OHRP) Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events.NIAMS Safety Reporting Assessment Flowchart.NIAMS Reportable Events Requirements and Guidelines for Investigators Conducting NIAMS-funded Clinical Research Studies.NIAMS Data and Safety Monitoring Guidelines and Policies.Further Guidance on Data and Safety Monitoring for Phase I and II Clinical Trials – June 2000.NIH Policy for Data and Safety Monitoring – June 1998.NIH Data and Safety Monitoring Policies.Learn the NIAMS requirements and guidelines for reportable events as well as reviewing and reporting unanticipated problems involving risks to human subjects or others and adverse events. Review the NIH and other federal agency policies for data and safety monitoring in the conduct of clinical trials to ensure the safety of research participants and the appropriate and ethical conduct of the study. Policies and Guidelines for Monitoring Clinical Research Frequently Asked Questions (FAQs), General Questions about Human Subjects.Single IRB (sIRB) Policy for Multi-site Research.NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.NIH Inclusion Across the Lifespan Policy.Annotated Forms Set for NIH Grant Applications-FORMS-F-Series (Human Subjects on ).NIH Grant Application and Proposal Considerations for Human Subjects Research.Requirements for Registering Clinical Trials into.NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information.Removal of the Requirement for IRB Review of NIH Grant Applications Contract.NIH Listing of Select Human Subjects Policy Statement Notices.Additionally, this section contains information about single Institutional Review Board (sIRB) and requirements for registering clinical trials on. We encourage you to review the following guidelines for human subjects research and policies for inclusion of women, children, and individuals across the lifespan in studies. The NIH has policies that govern the conduct of studies that involve human subjects. Gene Therapy, Stem Cells and Fetal Tissue.Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials Office for Human Research Protections and General Human Subjects Guidelines.Education and Training for Investigators Conducting Clinical Research.Policies and Guidelines for Monitoring Clinical Research.For further guidance or questions, reach out to the NIAMS Clinical Management Team at NIH Human Subjects Policy and Guidance This page provides information that includes but is not limited to federal and NIH human subjects research policies and guidelines for monitoring clinical research, education and training for investigators, and privacy and protecting confidentiality. The NIH and other federal agencies have developed policies, regulations, and guidelines for investigators to follow for conducting safe, ethical, and high-quality clinical research. NIH Policies & Guidelines and Other Federal Regulations for Clinical Research ![]()
0 Comments
Leave a Reply. |