Here is a list of items we would need to submit to NIH, along with the regular pilot materials, if a pilot project with a foreign component were selected for funding:
- Foreign collaborators’ name and email
- Foreign institution’s name and full address
- Estimated total cost, if any, of foreign collaboration or resources
- A description, in lay terms, of the scope and objectives of the research to be performed in the foreign country, or a description of the materials to be acquired (1-3 sentences)
- A description of the activities that will be carried out at the foreign site (1-2 paragraphs)
If the collaboration involves the use of human subjects, expect to submit:
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- Demographics, such as age range or gender
- Number of subjects and how they will be recruited if known
- What participation will entail, (e.g., clinic visits, questionnaires, blood samples)
- How long subjects will participate (e.g. one clinic visit a month for a year)
- Statement on protection of welfare of human subjects. This should describe informed consent and confidentiality procedures to be used. Applicants may use a general statement if suitable (e.g., “Informed consent for participation will be obtained from all human subjects and confidentiality of subjects will be protected, in compliance with NIH and in-country guidelines under the assurance number provided.”)
If the collaboration involves human subjects data or samples are pre-collected, expect to confirm:
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- If data/samples were collected under another project
- If data/samples are not anonymous, state how confidentiality will be ensured
- If data/samples are anonymous, state that the study is not considered “human subjects research” because data/samples were previously collected and anonymous
2) Financially speaking, we would create a subcontract with your institution and then you would be beholden to all your institution’s usual requirements for documenting the usage of federal funds. Then, your institution would likely invoice UM on a monthly basis.