Projects may be performed at any qualified facility, as long as this is defined in the proposal and approved by the Committee. when an off-campus research adviser will be responsible for the actual supervision of the project, the student must also have an on-campus sponsor (this can be your academic adviser); the role of the on-campus sponsor is to help ensure that your project will meet the MSR requirements, and serve as a first point of contact if your research adviser has questions. Note that if your project involves human subjects in any way, then human subjects research approval is required from the IRB at the research site, AND from the Penn State College of Medicine IRB. You will need to provide the IRB abstract from your research adviser and a copy of your sponsor's approval letter to our IRB for approval. Approval MUST be granted by the University IRB before beginning involvement with the human subjects as part of MSR. You can find more about human subjects in the MSR Guidelines.

The easiest way to identify an on-campus adviser would be to choose someone who is familiar with the kind of work you will be doing at an external institution (someone who can actually advise you, for example, on whether you are taking on a manageable role in a project, or whether your effort is suitable for an MSR). If you already have someone you work closely with here, and they are comfortable serving this additional role, that is also fine.

Your research adviser is the person who has expertise in your chosen area of research, and who actually provides day-to-day supervision of your research project.

Yes! Human research is any interaction with humans that involves data collection and analysis. This includes questionnaires, surveys, interviews, focus groups, etc., as well as scientific studies of normal or abnormal physiology and development, studies that evaluate the safety, effectiveness, or usefulness of a medical product, procedure, or intervention, and studies that involve any invasive procedures. Any research in medical education that you intend to report publicly (for example, in an MSR Final Report) requires IRB approval. You can find more about human subjects in the MSR Guidelines.

Yes! The IRB must review and approve research conducted outside the United States by Penn State employees or students, even if the foreign research receives no U.S. governmental funding. Such collaborative research activities must meet ethical standards similar to those required at PSU. The IRB may approve such research, provided it determines that

1. the research conforms to proper codes of ethics (e.g., the Declaration of Helsinki or the Belmont Report) and

2. the research is approved by the local ethical review authority.

Requirements for the informed consent process will follow the laws and customs of the country in which the research is being conducted. If a U.S. department or agency funds the research, then it is probable that the foreign research site will need to file a Federal Wide Assurance (FWA) application through OHRP.

Guidance on important IRB issues in international human subjects research can be found in the University Park Office of Research Protections "Guideline II, International Research Involving Human Participants." You can find more about human subjects in the MSR Guidelines.

Academic credit is available, but not required, when a student uses specific elective time to conduct their research. To obtain academic credit, the student should register for course "Subject 596 Individual Studies" in basic science departments or "Subject 796 Individual Studies" in clinical departments. The number of credits will be determined by the sponsor and will depend on the number of hours committed to the project.

Data acquisition and data reduction for a MSR project while abroad requires a considerable time commitment to the research project on the part of the student. While Penn State supports students spending time abroad in clinical settings to acquire international perspectives on health care, it is very difficult for a student to do an international clinical rotation and an acceptable MSR project simultaneously.

The decision to pay you while working on your MSR project is at the discretion of your research supervisor. Research funding is extremely difficult to obtain, and research supervisors may not have research funds to pay you. Students working on their MSR project typically are working on their project full-time during the summer after the first year of medical school. Most projects at Penn State can be supported by federal work study positions for summer work, but both you and your adviser must fill out forms by April 1 to qualify. Work study funds will pay for three-quarters of the salary of a student. The department or adviser is responsible for the remainder. Research at sites other than Penn State cannot be supported by work study. Students may not be paid while enrolled in research electives for academic credit.