Purpose

The purpose is to collect sufficient information for the Institutional Review Board (IRB) to assess risks to human subjects and approve or exempt applications accordingly, specifically for research protocols that include all of the following criteria:

  • Human subjects physically located in international settings, and
  • Undergraduate students as study personnel who conduct one or more of the following activities while physically located in an international setting:
    • Intervene for research purposes with any human subjects by performing invasive or noninvasive procedures.
    • Intervene for research purposes by manipulating the environment.
    • Interact with a human subject for research purposes.
    • Obtain consent of human subjects.
Process
  • All IRB applications meeting the criteria listed above must be received at least six weeks in advance of the date of the researchers’ first day in-country. This is the case regardless of level of review requested by the PI.
    • Lehigh’s International Travel Advisory Committee (ITAC) provides the Office of Research Integrity (ORI) with the date of the researchers’ first date in-country, and it is confirmed in the IRB application process.
    • ORI notifies ITAC and the research team when ITAC-approved projects involving human subjects research (HSR) do not submit their IRB applications by this deadline.
  • IRB approval, conditional approval, or exemption must be granted at least five days in advance of the researchers’ first day in-country. PIs must be aware that the IRB review process often requires multiple rounds of revisions. Revisions must be submitted in a timely fashion in order to meet the approval deadline of a minimum of 5 days before the researchers are in-country.
    • If by that deadline, approval / exemption has not been granted, the IRB and ORI stops reviewing the pending application and ORI notifies the PI that they are not approved to conduct HSR. Conducting HSR without IRB approval or exemption is a violation of Lehigh policy.
    • Exceptions are made only for applications where the Lehigh IRB has granted conditional approval pending submission of documentation of the local context review. No other exceptions will be made.
  • All Lehigh-sanctioned activity involving international travel with undergraduate students must be reviewed by the Lehigh University ITAC.
    • ITAC provides the ORI with a list of projects that will involve undergraduates traveling internationally and conducting HSR. ORI staff reaches out to the PIs on those projects to notify them that the ITAC application indicated their work involves HSR and of the IRB application requirements outlined above.
Requirements on the IRB application form / International Research Appendix
  • Date on which researchers arrive in-country must be indicated.
  • Researchers must indicate whether the PI or co-PI conducted HSR within this community, participant pool, population, etc. in the past five years. If yes, researchers provide the corresponding IRBNet ID(s) of previously IRB-reviewed protocol(s). Researchers must describe how/why this population is not being over-burdened with research participation, and describe whether there are benefits to the population.
  •  Researchers must provide a precise description of the study endpoints. Endpoints are a specific measurement or observation used to assess whether the study has assessed the scientific question(s) posed.
  • When individuals listed in the Personnel section are undergraduate students, the PI must provide additional narrative descriptions of the HSR methods training that the PI has personally provided to the individual, in addition to the IRB-required CITI training (which is the minimum requirement). The committee reviewer(s) will judge sufficiency based on the study details. Undergraduate students must receive training on the conduct and design of human subjects research, including: the scientific method, research design, with a focus on the type of research design used in the study (i.e., correlational research, qualitative research, experimental research), project/population-specific research ethics, and informed consent. The PI must upload relevant syllabi or other training materials to the package in IRBNet.