iv) Education
Human Subjects Protection Training
Federal requirements for education in the Protection of Human Subjects in Research currently are met according to Rockefeller University Hospital policy by of completion of one of two options for training. All investigators must complete Human Subject Protection training prior to participating in research in accord with federal regulations, and IRB policy. Draft hospital policy has been proposed which creates tiered training according to the research staff's level of interaction with human subjects in clinical research. This policy was drafted by a committee consisting of the Director of the Office for Protection of Human Subjects, the Clinical Research Officer (RSA), and representatives from Research Nursing, The Office of Regulatory Affairs, and the IRB. The highest level of training, for investigators, medical and nursing staff, and others with extensive interactions with research participants, consists of four choices: including completing the NIH On-line course, OHRP's Investigator 101 also available for load from the CRSO staff, reading the book Protecting Study Volunteers in Research, by Dunn and Chadwick and completing the quiz, or completing a series of on-line training modules hosted by the University of Miami-sponsored CITIprogram including 14 required modules covering:
- History & Ethical Principles;
- Basic Institutional Review Board [IRB];
- Regulations and Review Process;
- Informed Consent;
- Records-Based Research;
- Genetic Research in Human Populations;
- Research with Protected Populations-Overview;
- Research with Protected Populations--Minors;
- Research with Protected Populations-Research Involving Pregnant Women and Fetuses Group Harms:
- Research with Culturally or Medically Vulnerable Groups;
- FDA-Regulated Research;
- HIPAA & Human Subjects Research;
- Workers as Research Subjects-A Vulnerable Population;
- Conflict of Interest in Human Subjects Research, the NIH on-line course.
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
CITIprogram also offers a 10 module on-line self-study course in Good Clinical Practices.
A formal curriculum for Good Clinical Practice, organized around a half-day course taught in the media resource room in the University library, is under development. All professional research staff will be required to take the course and demonstrate proficiency in understanding GCP. The didactic course, taught by a teaching pair consisting of an MD/investigator/research administrator and by a nurse/NP/coordinator will be offered on a monthly basis until all existing staff are trained, then quarterly to train new staff. The teaching materials will include the CITIprogram GCP course (developed by the Trials Monitoring Committee at Duke University), Human Subject Protection Training modules (CITIprogram, and Rockefeller curriculum), as well as the historical perspectives, philosophy and rationale behind many of the practices. Training will also include demonstration of the resources of the Rockefeller Program of IND Assistance, and review of the Rockefeller University Hospital and Center and IRB.
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 the 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.
