All JHSPH faculty, staff, and students, who are “engaged” in human subjects research (see Guidance When is an institution or PI "engaged" in Human Subjects Research?) must complete successfully an online human subjects research ethics training program through CITI, the Collaborative Institutional Training Initiative (CITI). The successful completion of the basic course will satisfy institutional requirements for 5 years, after which time a refresher course is required. Investigators on new PHIRST applications must satisfy these ethics training requirements, or the IRB will not approve their inclusion on the research team. Certain specialized research requirements have been added for investigators conducting clinical trials, working on Native American reservations, using Protected Health Information (PHI), and/or funded by the Department of the Navy. Please review the entire chart below to identify your personal training requirements. Here are the ethics and other compliance training requirements, depending upon research type and funding source; all certificates of completion may be uploaded to your personal profile page in PHIRST: JHSPH Learner Groups | Training Courses Required | All JHSPH investigators, study staff, and students who have not previously completed CITI human subjects research ethics training | - JHSPH Human Subjects Research Basic Course
OR (For DoD funded research) - Department of the Navy CITI Human Subjects Research Ethics Training for “Extramural Performers and Collaborators.” (Register through DoN CITI account)
| Non-JHSPH co-investigators who have not completed human subjects research ethics training elsewhere and need training to register in PHIRST | - JHSPH Human Subjects Research Basic Course
OR - Family Health International (FHI), NIH, etc.
| JHSPH investigators, study staff, and students who previously completed CITI human subjects research training 5 years (or more) ago and need to renew certification | - JHSPH Human Subjects Research Refresher Course 1, 2, or 3
OR (For DoD funded research) - Department of the Navy CITI Human Subjects Research Ethics Training for “Extramural Performers and Collaborators.”
| JHSPH investigator, study staff, and students conducting research on Native American reservations. | - Satisfaction of the JHSPH IRB Human Subjects Research requirement, above
AND - CITI Native American Module
| JHSPH investigator, study staff, and students conducting clinical trials with drugs/devices | - Satisfaction of the JHSPH IRB Human Subjects Research requirement, above
AND - CITI Good Clinical Practices (GCP) Training
| Additional Requirement Through JHU MyLearning System | JHSPH investigators, study staff, and students using Protected Health Information in Research | MyLearning Module: HIPAA & Research -01 You will find this course in the MyLearning Course Catalog under “Compliance > Research Compliance and Ethics > HIPAA & Research.” It will NOT be listed under “HIPAA.” You do not need to take the “General Privacy Issues” course as a prerequisite. |
CITI FAQs Click to access the training module For purposes of PHIRST registration, the JHSPH IRB will accept certification of completion of human subjects research ethics training from sources other than CITI for non-JHSPH investigators and study team members. We recommend the Family Health International (FHI) computer based “Research Ethics Training Curriculum, 2/e” (http://www.fhi.org/training/en/RETC2/index.html) , which uses a case-study approach, and which provides a training curriculum for community representatives. This program is only available in English. Field TrainingThe "JHSPH HUMAN SUBJECTS RESEARCH ETHICS FIELD TRAINING GUIDE" is intended to be used as a tool for training individuals who will be “engaged” in some aspect of a human subject research interaction or intervention. It is directed, in particular, to Johns Hopkins principal investigators who are responsible for training of study team members who will (1) obtain informed consent from research participants, or (2) collect data from human subjects through individual or focus group interviews, testing, physical measurements, or other procedures involving direct contact, hereafter called a “data collector." The content and language level of this guide is specifically worded to help the investigator convey basic research principles and behavior that accords with those principles to data collectors. We encourage users who translate the document into local languages to submit those translations (with certifications of the translator’s qualifications) to our office (irboffice@jhsph.edu) so we can make them available to other investigators. Click Here to see article on the development of the Training Guide Field Training Guide Field Training Guide, Bangla translation, Courtesy of Abdullah Baqui and Abdullah Mahmud Field Training Guide, Chinese translation. Courtesy of Youfa Wang Field Training Guide, Dari translation. Courtesy of Linda Bartlett and the staff of the RAMOS II project in the JHSPH Kabul office Field Training Guide, French translation. Courtesy of the PI Orin Levine. translated by TransPerfect Translations Field Training Guide, Nepali translation. Courtesy of Joanne Katz and Sudeep Shrestha Field Training Guide, Swahili translation, Courtesy of Alison Norris, and translated by Shemsa Mohammed and Amani Kitali Field training Guide, Thai translation. Courtesy of David Celentano and Louise Walshe |
