Harvard Students Conducting Degree Requirement Research at Another Institution
 

1. Are you a Harvard University Area Student (i.e., degree conferred through Harvard GSAS or FAS)?

2.  Does your study meet the threshold for research that requires IRB review? (Please see Do You Need IRB Review and Why)

If YES, IRB oversight of this activity is to be conducted by the Harvard University Area IRB (HUA IRB), the IRB that is identified on the Harvard University Area Federal Wide Assurance (FWA). In the capacity of a student of Harvard doing work for a Harvard degree, you are an agent of Harvard University. 

Data collected as part of a degree requirement at Harvard may be collected at various locations beyond Harvard University.  Be aware that IRB approval may be required by the non-Harvard institution as well as the HUA IRB. Agency may be two-fold. 

Why is there IRB oversight at more than one institution? Some examples: if the data are HIPAA protected; if you need access to institutional resources; if you will work on a particular research study that is taking place at the institution by the institution’s agents – these will require the institution to have their own IRB review that does not cover your research activities for your Harvard degree.

Working as Study Staff on a Research Study: Agency and Activities
 

When you work on another investigator’s research study, your purpose may be two-fold: to gain experience as a study team member and to use the data collected under this research in support of your degree requirement.

You are both a study team member conducting research AND you are a Harvard student conducting research.  IRB oversight is required for each of these roles, separately.

If the research takes place at Harvard University Area, both roles are covered by the HUA IRB.  It gets complicated when your work is as a Harvard student and as a study team member at a non-Harvard University Area location. Agency (and subsequent IRB review) will depend on what activities are covered under that institution’s IRB submission AND under what agency that institution’s IRB added you to the study.

Some IRBs would prefer to include you on a research study under their purview as their own agent, regardless of your status as student at Harvard University Area. When this is done, you would be added to their study with an Individual Investigator Agreement (IIA), sometimes referred to as an Individual Student Investigator Agreement (ISIA). This would make you, in your role as study team member at another institution, an agent of that institution for the purpose of that research study.

If you are also using data from that research study to support your degree requirement, the research activity that uses that data falls under the agency of Harvard University Area. In this situation, a separate Harvard University Area IRB review would be required.  Or, a reliance agreement between the institutions could be completed if the degree requirement activities were also included in the other institution’s IRB approval.

Next Steps

If you are conducting your degree requirement activities at another institution, please contact the Harvard University Area IRB at cuhs@harvard.edu or 617-496-2847