Approvals and Agreements

Q: What approvals are needed to conduct clinical trials in a foreign country?

A: Approvals vary between countries. In general, you will need the same UC San Diego approvals for an international trial as for a domestic trial, including IRB and/or IACUC. The funding agency will also let you know of additional approvals before funds can be distributed. If in doubt, check with your funding agency.

• The UC San Diego Research Compliance Program (RCP) may be able to advise you on the specific reviews and approvals needed for your international, commercially initiated clinical trials. If you cannot open this link with your browser, please e-mail your question to rcp@ucsd.edu.
• You may need to obtain IRB and Ethics approvals in the country where your project will take place. Contact your international collaborators regarding their local requirements.
• Your and your international collaborators may need to obtain Federalwide Assurance, a Memorandum of Understanding (MOU), a Clinical Trial Agreement, or an Affiliation Agreement.
• Your lab and that of your international collaborators may need to demonstrate proof of training in Good Clinical Practices and/or Good Laboratory Practices.
• Your lab and that of your collaborator may also need to document membership in the Immunology Quality Assessment (IQA) and Virology Quality Assurance (VQA) programs.
• Contact the UC San Diego Office of Research Affairs for more information on requirements to conduct research in a foreign country.
• For international collaborators working in your UC San Diego lab, refer to general Guidelines for Non-laboratory Personnel Working in UC San Diego Laboratories.
  Contact your grant’s program officer to obtain a list of requirements specific to your research project.

Q: What approvals are needed to conduct research in animals in a foreign country?

A: Refer to the UC San Diego Institutional Animal Care and Use Program for guidelines.

Q: What is a Federalwide Assurance and do I need one?

A: NIH requires all ethics committees/IRBs to have active Federalwide assurances (FWAs) on file. The FWAs confirm that the ethics committees/IRBs agree to follow accepted international standards for evaluating studies involving human subjects and their specimens or data. The FWAs are established between the ethics committees/IRBs at the institutions and the U.S. Department of Health and Human Services. Contact your institution's ethics/IRB office to determine whether they have an active FWA registration on file. 

Q: What is a Memorandum of Understanding (MOU) and how do I obtain one?

A: A memorandum of understanding (MOU) describes an agreementbetween parties. For example, two institutions may agree to submit grant proposals within a certain time with the goal of establishing a research collaboration. The MOU formalizes the intention of the two parties without a legal commitment. If you need a Memorandum of Understanding to begin a collaboration in another country, Procurement and Contracts can advise you.

Q: What is a Clinical Trial Agreement and how do I obtain one?

A: If you are conducting a clinical trial with collaborators outside UC San Diego, you need a clinical trial agreement. The agreement details each party’s responsibilities. If you receive an award from NIH or similar Federal agency to conduct international research, Procurement and Contracts can arrange subcontracts with each of your international collaborators. If you receive an award from another institution; i.e., if you are a subcontractor, go to the UC San Diego Office of Contract and Grant Administration site, then search on Clinical Trial Agreement.

Q: What is an Affiliation Agreement and do I need one?

A: An Affiliation Agreement is a nonbinding, formal statement of collaboration between institutions. For example, a medical school may establish an agreement with a hospital for training medical students and residents. Or two universities may agree to share responsibilities in offering a joint degree program. You do not need an Affiliation Agreement to conduct research with your colleagues at an international institution.