Conducting research in international locations is challenging in a number of ways: working with foreign governments, additional regulations and policies, and lack of infrastructure (such as internet accessibility) to name just a few. Based on your feedback we recognize that the human subject training requirements for foreign enumerators, who are part of the study team, have been challenging and that the content of the current training is not practical or easily understood by those who are not familiar with U.S. federal regulations.
In response, the IRB office has developed a paper-based human subjects research training guide for use with international enumerators when it is not feasible to undertake online human subjects protection training such as CITI. As specified in the guide, “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 enumerators and/or field workers.”
Starting on August 25, 2017, the Harvard University-Area IRB will consider this training and documentation as acceptable for the fulfillment of the University human subjects training requirement.
The training guide may be found on the IRB website under the Training tab or at: https://cuhs.harvard.edu/required-ethics-training?admin_panel=1
Some items to note:
- The training is for foreign enumerators not affiliated with Harvard University.
- If the enumerators are affiliated with an institution that holds a FWA, proof of their institutional training would be acceptable as an alternative.
- The training does not satisfy NIH funded study training requirements for clinical trials (Good Clinical Practice). We are also developing a similar guidance document that should be available soon.
- The training must be documented by completing a training completion sheet that includes name and signature of those that received the training as well as the person that provided the training.
- The training completion sheet must be appended to the ESTR study record.
- The training is valid for three years.