International IRB Guidance

Conducting research in an international setting poses unique challenges. The information below provides guidance to Penn students, trainees, and faculty designing and implementing research in foreign countries. For more information on IRB submission, please contact the Penn IRB.

Penn students, trainees, and faculty conducting research on human subjects in foreign countries must obtain IRB approval from the Penn IRB prior to beginning any research activities at an international site. As additional review and documentation may be needed, the application timeline can be lengthy. It is advised to start the process early (6+ months before anticipated start date) and expect delays.

Submission to the Penn IRB and Determination of Human Subjects Research

Refer to the Penn IRB tools under the heading ‘Human Research – Is IRB Review Required?’ to determine if the study qualifies as human subjects research. If the study meets the regulatory definition of human research, IRB approval must be received before conducting any research. Submission guidance is available online here: https://irb.upenn.edu/how-submit-penn-irb. If a study is determined to be human subjects research requiring IRB review, publication of the research is contingent on IRB approval. 

Submission to an International Ethics Committee (EC) or Ministry of Health

Investigators must consider local cultural and religious norms when designing an international research study as well as any special conditions of the population being targeted for recruitment.  Therefore, partnering with a local collaborator is highly recommended by the Penn IRB. Research studies must be reviewed by a local Ethics Committee or Ministry of Health. All CGH supported projects require engagement with a partner institution, however. If one is unable to obtain local ethics committee review, contact the Penn IRB to discuss other options.

Submission to a local institution should precede or be concurrent with the submission to the Penn IRB. Note that processing time for human subjects research approval can vary widely from country to country. In order to plan your research timeline, you should seek advice about this timeframe from your in-country collaborator.

The US Office of Human Research Protections compiles a listing of research standards in 130+ countries. This document enumerates country-level laws, regulations, and guidelines that govern human subject protections.  Investigators must comply with both US and foreign regulations.

Guidance for Penn FacultY

In rare circumstances, faculty members conducting research outside of their Penn responsibilities, such as with NGOs, should appropriately represent that work through either the Penn IRB or the NGO’s IRB.  Penn IRB approval or a Data Use Agreement may be needed if the research will continue at Penn. For more information on what constitutes engagement in human subjects research, please refer to the Office for Human Research Protections’ guide. If questions remain regarding your role, please contact the Penn IRB.

Guidance for Penn students and trainees

To determine if submission to the Penn or local IRB is needed, please consult with the study’s Principal Investigator (PI) and review the information above. If you would like to discuss way to engage in research in order to fulfill a requirement (e.g. capstone), reach or out CGH staff or your advisor to discuss opportunities and timing.

 Training in Human Subjects Research curriculum (CITI Training) is required for anyone engaged in human subjects research at Penn. More information on these requirements can be found on the Penn IRB website.

In order for a student or trainee to carry out certain research procedures on a pre-existing non-exempt study, a study modification should be submitted to the Penn IRB and the local ethics committee. The study modification must be approved before new study personnel begins any study involvement including consenting, conducting research procedures and/or interacting with participants, and/or having access to identifiable data/specimens. Guidance is available for how and when to submit modifications to the Penn IRB: https://irb.upenn.edu/how-submit-penn-irb/how-submit-modifications.

Penn students and trainees working with a PI at another institution (US or international) do not need to seek IRB approval from the Penn IRB but should be added to the study by the PI at the other institution. Contact the primary institution to be added to the study.

Data Security

A Data Use Agreement (DUA) or Business Associates Agreement (BAA) may be needed if Protected Health Information (PHI) is transferred. Please contact Penn’s Office of Research Support Services for more information.

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