Harvard Institutional Requirements
Harvard policies require that all individuals who are involved in human subjects research complete training in the ethical conduct of human research. This includes investigators and all study team members who have contact with human subjects or their identifiable data. Faculty sponsors of non-exempt research must also complete the training. The requirement may be satisfied by obtaining CITI or NIH certification online. Certification is valid for three years. Undergraduates have the alternative of attending one of several in-person training sessions delivered by CUHS staff throughout the year.
All individuals who complete an online training program should download and save a copy of the certificate for their records. Some certificates must also be submitted to CUHS.
NIH Good Clinical Practice Requirements
In effect since January 1, 2017, NIH's Good Clinical Practice (GCP) policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of NIH clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).
The policy can be found here:
How to Take the Training
Finding the Social & Behavioral Courses on the CITI (Collaborative Institutional Training Initiative) web site
Finding the BASIC course:
- If you have an existing CITI account, enter your Username and Password. If not, choose Register under Create an account (not “Log in through my institution”), then under Select Your Organization Affiliation, type in Harvard and select Harvard University (Cambridge/Allston campus) from the choices that appear. Note that Harvard does not currently participate in the “Single Sign On” program (“SSO”).
- Your CITI login is not connected to your HUID, but be sure to enter your HUID in the HUID or XID field in your CITI profile - without it, your training will not be automatically imported to ESTR.
- At Main Menu > Add a course... > Human Research (Protection of Human Subjects) > Social & Behavioral Research Investigators > Stage 1: Basic
- The requirements include completing the set of eight fundamental modules, as well as three additional modules that the investigator selects from a list of choices.
Finding the REFRESHER course:
- Enter your Username and Password; choose Harvard University (Cambridge/Allston campus). Make sure that the correct HUID is entered in the HUID or XID field in your CITI profile.
- The refresher course consists of completing five modules that the investigator selects from a list of options.
How To Download Your CITI Completion Report:
- Log in to CITI
- Click on Harvard University (Cambridge/Allston Campus)
- Click on View Previously Completed Coursework
- Click on "View" under Completion Report in the table
- The certificate will open in a new window. Save or print it as a pdf
Note: If your report doesn't show up, you have not completed the training
For technical questions about CITI, contact CITI Support at firstname.lastname@example.org; U.S. toll-free at 888-529-5929; or international at 1-305-907-3100.
Finding the Protecting Human Research Participants course on the NIH (National Institutes of Health) web site:
Use the following link to create an account and then sign in to complete the NIH-PHRP training:
NIH Good Clinical Practice (GCP)
Please see the following link to gain access to the training modules that have been developed for social and behavioral science researchers:
Submitting certification for research ethics training
1. Certificates that do not need to be submitted:
CITI training carried out through Harvard University affiliation if a valid HUID was entered into the CITI “employee number” field. (Updates on completion of CITI training are uploaded automatically every Friday into ESTR.)
CUHS-led undergraduate training. (CUHS will enter the information into ESTR.)
2. Certificates that must be submitted:
CITI training carried out without an HUID or through another affiliation.
NIH Ethics Training.
The first time the individual is listed on a study in part 2 in the Study Team Members section of the Smartform, attach the certificate to this section. Please contact CUHS if you have any questions.