Office of Regulatory Affairs and Research Compliance
Welcome to the Office of Regulatory Affairs and Research Compliance (ORARC).
Our mission is to ensure the quality and integrity of research conducted at Harvard Chan School.
90 Smith Street
3rd Floor, Suite 338 Boston, MA 02120
Human Research Training
Overview
Human research training must be completed by anyone working directly with human subjects or with data or biospecimens when it can be linked back to individual subjects. All Principal Investigators (PIs), Co-Investigators, and those meeting the NIH definition of “Key Personnel” must complete training regardless of whether or not they have access to identifiable data/biospecimens or direct contact with subjects. Human research training must be completed every three years.
Harvard University recognizes the following options fulfill the human subjects training requirement.
To satisfy this requirement, Harvard University offers human subjects training through CITI (Collaborative IRB Training Initiative). If you do not have an HUID, you will need to have a Harvard affiliate/sponsor request one for you per the Harvard University Person of Interest (POI) Policy. The Office of Regulatory Affairs and Research Compliance does not sponsor researchers or submit this on behalf of POIs.
The HLC IRB accepts the following courses:
- Human Subject Research Biomedical Research
- Human Subject Research Social & Behavioral Research
The following courses do not satisfy the requirement to complete human research training: Conflicts of Interest, Export Compliance, Good Clinical Practice Course, Information Privacy and Security, Responsible Conduct of Research, IRB Members, IRB Chairs.
Harvard University’s CITI training includes both basic and refresher training curriculum. Basic training consists of 7 required modules and 3 electives, and is valid for 3 years. Refresher training includes 5 elective modules and is also valid for 3 years.
The HLC IRB will accept any Organization’s CITI curriculum in the accepted modules in lieu of its own to satisfy either basic or refresher training. Refresher training credit may also be obtained by attending three or more Education Series Sessions during the academic calendar year.
IRB approval may not be granted for proposed Human Research where any staff member’s human research training remains incomplete.
Log into CITI using single sign-on (SSO) here.
New CITI Users
For individuals who do not have a CITI account (either through Harvard or another organization), visit CITI at www.citiprogram.org and click on the “Register” button. Follow these instructions for registering as a new learner.
As part of the registration process, you will be asked to “Select Your Organization Affiliation.” Please select “Harvard University SSO.” If you need to fulfill training requirements for more than one institution, you may affiliate with multiple institutions. Once registered, you may indicate your preference for completing either the Biomedical or Social & Behavioral education modules.
Once you select “Continue to SSO Login/Instructions,” the page will direct you to the Harvard Key log in.
Existing CITI Users
If you have previously completed CITI training through another organization, you may continue to log in under this account and complete CITI to satisfy Harvard’s human subjects training requirements, as needed. You will not be required to complete Harvard’s CITI curriculum. You may choose to select “Harvard University” as an affiliate organization under “Select Your Organization Affiliation.” Doing so will allow the HLC IRB to access your CITI training certificate.
Questions
To access your CITI completion certificates, you may log in to your record here.
For help accessing your account, the password reset is available here.
For technical questions about CITI, contact CITI Support at support@citiprogram.org; U.S. toll-free at 888-529-5929; or international at 1-305-907-3100.
The Office for Human Research Protections (OHRP) Human Research Protection Training provide foundational knowledge on protecting human subjects in research funded by the U.S. Department of Health and Human Services (HHS). Access is free and viewers can print a completion certificate upon completing each of the 4 lessons. This alternative to Harvard University’s CITI curriculum is most appropriate for those study staff members who are not Harvard-affiliated and cannot access Harvard University’s CITI curriculum. If unsure whether this alternative training is appropriate for baseline or refresher credit, contact your IRB Review Specialist.
HLC IRB accepts MGB Human Research Affairs (HRA) human subjects training, which consists of two courses (each available as live webinar or pre-recorded on-demand). Both courses must be completed every 3 years:
• MGB HRA Clinical Research Boot Camp (2.5 hrs.)
• MGB HRA Good Clinical Practice Guidelines (1.5 hrs.)
To upload human subjects training certification into the ESTR record, follow the instructions here for submitting a ‘Study team member information’ Modification: https://estrsupport.fss.harvard.edu/mod-smartform
Other Training & Requirements
Sponsors and/or funders may require investigators and study staff complete additional training.
The National Institutes of Health’s (NIH) “Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials” establishes the expectation that all NIH funded researchers, investigators, and/or study staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP). As such, Office of Regulatory Affairs and Research Compliance requires all researchers involved in the conduct, oversight, or management of an NIH-funded clinical trial to complete ICH-GCP training (e.g., CITI “Good Clinical Practice” online course, NIH GCP online modules for Social Behavioral Research or Harvard’s GCP for Social and Behavioral Research Field Guide.) These courses are separate from the “Human Research (Protection of Human Subjects)” course. Completed ICH-GCP training certificates should be submitted to the IRB in the ESTR record.