Harvard Faculty of Medicine Human Subjects Protection Training Certification Requirements

HMS Personnel: Initial training prior to CHS approval; refresher trainings every 3 years.

 

Non-HMS personnel: All non-HMS personnel who interact with study participants and their identifiable specimens or data, and who are working on an approved protocol through another IRB (subcontract or not), must at minimum have taken a human subjects protection training, and we must receive a copy of the training certificate. These individuals will follow their own institutional policies on training (and refreshers), however if the protocol is especially risky or involves a vulnerable population, the CHS reserves the right to request (or require - depending on the situation) that the Investigator or other research personnel take a refresher training or a training elective specific to the situation or population.

 

All non-HMS personnel who interact with study participants and their identifiable specimens or data who work at an institution that does not have an IRB and that institution is relying on the HMS IRB review and approval of the protocol, must follow HMS training policies.

 

The HMS/HSDM Committee on Human Studies accepts training certifications from the Harvard-based HETHR system and those received through other institutions (such as CITI or NIH). If you would like to send a training certificate from a source other than HETHR, please email or fax it to our office so we may update our records.

Harvard Ethics Training in Human Research (HETHR)

The HETHR training is a web-based program which records progress and completion of the training.

For baseline certification: take the six (6) Basic topics plus four (4) Electives, all within 12 months of each other.

For refresher training: take the six (6) Basic topics plus two (2) Electives, all within 12 months of each other.

HETHR Log-In instructions:

• If you have a Harvard University Identification (HUID) Number: Please log in using your HUID number. The option to log-in via PIN should appear on the bottom-left of the log-in screen.

• If you have worked on a protocol reviewed by Harvard in the past: It is likely that you already have a database generated Username and Password. If you are not sure what your Username and Password is, please contact orsp@hms.harvard.edu.

• If you do not have a HUID and you have not worked on a Harvard IRB approved protocol in the past: Please register as a new user by selecting ‘Register’ on the HETHR log-in page.

Updated: 28-Oct-2009