Human Subjects Protection Training
Federal requirements for education in the Protection of Human Subjects in Research currently are met through The Rockefeller University Human Research Protection Program and Hospital policy requiring completion of a series of on-line training modules hosted by the CITIprogram. The course modules include:
- History and Ethics of Human Subjects Research;
- Basic Institutional Review Board [IRB] Regulations and Review Process;
- Informed Consent;
- Social and Behavioral Research (SBR) for Biomedical Researchers;
- Records-Based Research;
- Genetic Research in Human Populations;
- Populations in Research requiring Additional Considerations and/or Protections
- Vulnerable Subjects - Research Involving Children;
- Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates;
- Avoiding Group Harms - U.S. Research Perspectives;
- FDA-Regulated Research;
- Recognizing and Reporting unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research
- Research and HIPAA & Human Subjects Research;
- Conflict of Interest in Human Subjects Research.
The basic CITIprogram modules are supplemented by 12 modules authored by Rockefeller University personnel from the Clinical Research Support Office using the research funds made available to Rockefeller under an S07 grant in 2003-2004. These modules are also available on the CITIprogram site by agreement between the CITIprogram and Rockefeller University. These modules cover topics on the protection of human subjects, as well as topics that introduce many aspects of Good Clinical Practice, including:
- Informed Consent: An Introduction;
- Addressing Therapeutic Misconceptions and Psychological Barriers during the Informed Consent Process;
- Improving the Readability of the Informed Consent Document;
- Recruiting Members of Minorities as Participants in Research;
- Culturally Competent Informed Consent; Bridging Language Barriers:
- Communicating Effectively Through an Interpreter;
- IRB Policies on the Use of Translations and Interpreters;
- Pediatric Research Ethics: An Introduction;
- Pediatric Informed Consent;
- Quality Assurance in Data Management;
- Reporting and Managing Adverse Events;
- Research Using Stored Tissue and Samples.
The Rockefeller specific modules are used for focused learning, and for continuing education in Human Subject Protection.
Good Clinical Practices Training
Investigators, coordinators, research nurses and other team members are also required to complete training in Good Clinical Practices through the modules offered in the CITIprogram. Recertification is required every 3 years. Certificates must be submitted to the IRB as a condition of study approval.
Training in GCP is also provided by the Clinical and Translational Research Facilitation Office staff through the Translational Research Navigation Program (TRN). In TRN, a semi-structured series of one-on-one and interdisciplinary meetings with the investigator and other content experts are facilitated by an experienced senior research coordinator throughout the development of a protocol, introducing the reinforcing principles and practices of GCP. The customized iRIS-based protocol writing application in which the protocol design is documented was designed intentionally to reinforce principles of GCP throughout its use.
The GCP modules offered through the CITI Good Clinical Practice Course for Clinical Trials Involving Drugs and Devices, include:
- Overview of New Drug Development;
- Overview of ICH GCP;
- CH – Comparison Between ICH GCP E6 and U.S. FDA Regulations;
- Conducting Investigator-Initiated Studies According to FDA Regulations and GCP;
- Investigator Obligations in FDA-Regulated Research;
- Managing Investigational Agents According to GCP Requirements;
- Overview of U.S. FDA Regulations for Medical Devices;
- Informed Consent in Clinical Trials of Drugs, Biologics, and Devices;
- Detecting and Evaluating Adverse Events;
- Reporting Serious Adverse Events;
- Monitoring of Clinical Trials by Industry Sponsors;
- Audits and Inspections of Clinical Trials;
- Completing the CITI GCP Course.
Research Ethics Training
Research Ethics Training Research Ethics Training encompasses education in the standards of scientific conduct, and in the ethics of clinical research. Ethical scientific conduct is taught as part of the core curriculum for Clinical Scholars as part of the Tri-Institutional course in Responsible Conduct of Research. Clinical research-specific ethics is reviewed in Human Subjects Protection Training, in the Pediatric Research Ethics modules hosted on www.citiprogram.org , and in presentations to the research staff hosted by the Ethics Committee.