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FIRCA FAQs: Instructions for FIRCA Current Grantees

There has been some confusion in the past regarding policies for FIRCA grants. Following these guidelines can help prevent future problems in making awards.

1. Change of Foreign Collaborator or Foreign Institution
2. Change of Principal Investigator or U.S. Institution
3. Human Subjects
4. Animal Subjects
5. Notice of Grant Award (NGA)
6. Progress Reports
7. NIH's Study Section Rosters and ICP Review Committees

I. Change of Foreign Collaborator or Foreign Institution

These require prior approval from Fogarty. Please submit the following:

• A letter from the foreign institution saying they agree to support the new investigator's work on the FIRCA

• The biosketch

• And a request from the PI at the U.S. institution (co-signed by business office) requesting the change of foreign collaborator.

II. Change of Principal Investigator or U.S. Institution

These require prior approval from Fogarty. Prior approval instructions:

A request for a change of grantee organization must include submission of a Relinquishing Statement and a Final Invention Statement and Certification from the original grantee as well as submission of an application (PHS-398) from the proposed grantee. The application from the proposed grantee should be sent to the grants management specialist and should include, at a minimum:

• A face page;

• Budget pages (current and future years);

• An updated biographical sketch;

• A statement indicating whether the overall research plans/aims have changed from the original submission, and, if so, providing updated information;

• An updated "other support" page(s), if necessary;

• A resources page;

• A checklist page;

• An approved IRB/IACUC assurance, if applicable; and

• If the change includes the transfer of equipment purchased with grant funds, the application must include a detailed list. This list, as part of a transfer application, serves as an acceptance of title by the new organization.

The required forms can be found on the following web page. http://grants.nih.gov/grants/forms.htm

III. Human Subjects

The policy has changed regarding human subjects and single project assurances (SPAs).

The new Federalwide Assurance of Protection for Human Subjects (FWA) has just been established. This simplified Assurance covers all of the institution's Federally-supported human subject research, and eliminates the need for other types of Assurance documents. In anticipation of the new Assurance, OHRP has suspended processing of MPA and CPA renewals. All existing MPAs and CPAs will remain in force until further notice. OHRP will continue to accept new CPAs and SPAs until approximately March 1, 2001.

More information regarding human research protections:

• US Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) - information on the international FWA application process can be found here.

• Instructions for the international FWA application form.

• Instructions for a developing institution to get its own IRB/IEC registered with OHRP can be found at http://www.hhs.gov/ohrp/assurances/index.html

• Developing country institutions must apply for their own international FWA with OHRP. They cannot borrow or use a temporary FWA from another institution.

• For more general IRB information, you can take the NIH online IRB education program at http://cme.nci.nih.gov

You must visit the OHRP website to register the IRB for the U.S. and foreign sites or to check whether they have already been registered. Submit the institutional assurance to OHRP. Send IRB approvals (for U.S. and foreign sites) to the grants management specialist when you know your grant is likely to be funded, and with every progress report each year. IRB approvals must be reviewed annually.

Please also remember to submit the required Gender and Minority Inclusion information as part of the progress report (Inclusion chart in PHS 2590 form).

If you are not using human subjects at the foreign site, and only at the U.S. site, be sure to state this clearly to the grants management specialist at the Fogarty International Center to avoid delay in making an award. If this is the case, please inform the grants management specialist so time is not wasted pursuing IRB approval or assurances which are not necessary. (When human subjects are only being used at the foreign site, the U.S. site still needs IRB registration and approval.) OHRP must approve an assurance at every site using human subjects before such involvement may commence. If you submit the required information to OHRP and do not hear anything from them for two months, you need to contact them regarding the status. Once you receive OHRP approval, please fax the approval to 301-594-1211, Attn: Randolph Williams, Grants Specialist, and the human subjects restriction will be lifted from your award as soon as possible.

IV. Animal Subjects

If you are using animal subjects in your research, you will be contacted by the Office of Laboratory Animal Welfare if the U.S. or foreign site does not already have assurance. You must have a current IACUC approval at BOTH the U.S. site (within three years) and at the foreign site (within five years) before you may use animals, unless you clearly state that animals will only be used at the U.S. site.

For more information: http://grants.nih.gov/grants/olaw/olaw.htm

V. Notice of Grant Award (NGA)

Please read your NGA carefully for important messages, restrictions, and reminders.

VI. Progress Reports

NIH is not routinely sending out the face page of the PHS 2590 "Application for Continuation Grant". If you do not receive a preprinted face page from NIH, the progress report is still due on time. Progress reports are due two months before the budget start date and must be submitted using the PHS 2590 form, NOT the PHS 398 form. Include current U.S. and foreign IRB approvals (see "Human Subjects" section above). Please copy and paste the text of your progress report in an e-mail to FIRCA@nih.gov. We would also appreciate reprints of any publications related to the FIRCA project, although this is not required.

For more information and to print the 2590 form: http://grants.nih.gov/grants/funding/2590/2590.htm

VII. NIH's Study Section Rosters and ICP Review Committees

You can get information about who is on the current ICP (International Cooperative Projects) Review Committee (or any other NIH Review Committee) at: http://www.csr.nih.gov - go to study section rosters then scroll down until you find the desired study section. Note that the SRA often brings in special or ad hoc reviewers as well who are not on the regular study section list.