News You Can Use

This monthly newsletter includes links to trainings in multiple subjects, such as grantwriting, implementation science, HIV and Aging, and other topics. Email SDCFAR-i-g@ucsd.edu to subscribe.

FWA REGISTRATION AND WHY IT MATTERS

When you receive an SD CFAR International Pilot grant, our administrative team will confirm that institutions involved in your study have Federalwide Assurance (FWA). If not, or if the assurances have expired, we will follow up with you about obtaining or renewing this registration.

Although FWA seems complex, it is simply an affirmation that the institution(s) involved in your study agree to follow accepted principles for protecting human subjects and safeguarding their confidentiality.

All institutions that receive U.S. federal funds for research in human subjects must have an FWA on file. Because the SD CFAR is supported by federal funds through the National Institutes of Health (NIH), the institutions that contribute to our grant recipients’ research must also have an FWA.

FWA registration is a two-part process. Each step is completed online via the U.S. Office of Human Research Protections (OHRP).

1. Each institution involved in your study needs to be associated with an IRB, and each IRB needs to be registered with OHRP.

2. After IRBs are registered, each institution needs to submit its FWA. IRB and FWA registrations are each good for five years. After that, they must be renewed.

Institutions’ IRB Offices or Ethics Committees are usually responsible for registering and renewing their IRB and FWA registrations. We will go into more detail on the registration procedures in upcoming issues of News You Can Use. Meanwhile if you have questions, please email cfar@ucsd.edu.

CRITICAL SUBCONTRACT UPDATE

Those of you whose research is supported by the U.S. National Institutes of Health (NIH) will soon see an important update in your subcontracts. This update applies to all research funded by the NIH, not only HIV research. Many U.S. institutions use NIH funds to issue subcontracts with universities or agencies outside the U.S. For example, all of you who received SD CFAR International Pilot grants have or will have your studies supported by subcontracts between your institution and UC San Diego. The NIH is the funding source for these subcontracts, and we are required to follow NIH rules.

Starting in January 2024, all researchers outside the U.S. whose studies are supported by subcontracts using NIH funds must make all records related to their NIH-funded research available to their U.S. colleagues at least once a year for inspection. The records include copies of lab notebooks, deidentified patient data, and all other documents related to NIH-supported studies. You must do this for each NIH-supported study at your institution. SD CFAR administrative staff will confirm that your records have been uploaded, but we will only view them in detail and share with your SD CFAR collaborators and mentors if the NIH requests an audit. Although audits rarely occur, the study records must be available on very short notice—a few days or a week at most.

Read more about it in the January 2024 Issue!

O-K REVIEW FOR INTERNATIONAL RESEARCH IN INFECTIOUS DISEASES

The U.S. National Institutes of Health (NIH) is offering grants in International Research in Infectious Diseases (R01 Clinical Trial Not Allowed). The Principal Investigator must be based outside the U.S. in a low- or middle-income country. The proposed research should focus on infectious disease. If you choose to apply for research in HIV (we hope you will!), your proposal must address NIH HIV priorities. 

SD CFAR will be offering an O-K Review mock study section to assist applicants in refining their proposals. For more information, and to view the proposed timeline, please see the O-K Review for Special Programs website. 

Please see the full FOA here: RFA-AI-23-023: International Research in Infectious Diseases. We encourage SD CFAR members to collaborate with foreign investigators to respond to this funding opportunity.

SD CFAR MAILING LIST

Our Center publishes a weekly online newsletter including information about education and professional development, funding opportunities, and other activities relevant to HIV research. Many of the events and offerings are online and recorded for later viewing. If you are not already receiving our weekly newsletter, the best way to start is to sign up for SD CFAR Membership. International investigators and administrators are eligible for community membership. SD CFAR collaborators have additional options. In addition to our newsletter, members receive all announcements of upcoming grant opportunities, seminars, and other programs.

CLICK HERE TO BECOME A MEMBER TODAY