NEW REQUIREMENTS FOR A CONTRACTS AND GRANTS REVIEW FOR HUMAN SUBJECT APPROVAL COMPLIANCE

Just-in-time Proposals (For NIH applications only)

If CHR review will occur "Just-in-Time" (JIT) as announced in the NIH Guide for Grants and Contracts dated May 1, 2000, check "yes" on the PHS 398 application face page and write "JIT" in the space where one would otherwise insert either the CHR Approval Date or "pending." Pending for the NIH signifies that a CHR application is under review and therefore should not be listed on a "Just-In-Time" application.

"Just-in-Time" rules also apply to applications made to the Agency for HealthCare Research and Quality (AHRQ) (announced in the NIH Guide for Grants and Contracts dated September 29, 2000). When requested by the NIH to provide just-in-time certification of CHR approval forward a copy of the CHR Approval Letter (along with the grant number, title, PI name and NIH contact name and address) to C&G to support the certification of approval that will be sent by C&G to NIH.

Proposals that are not under Just-in-time Procedures

For PHS agencies other than NIH, or for special NIH programs that are not under the NIH "just-in-time" rules, certify at the time of proposal submission that there is either a current CHR Approval or that an application is under review by the CHR (pending). For these proposals attach a copy of the current CHR Approval Letter or, if approval is pending, a copy of the CHR application cover page to the C&G Approval Form. If the CHR Approval Letter is issued to someone other than the Principal Investigator of the related grant application provide evidence that the Principal Investigator is cited in the CHR application.

The major Public Health Service funding components are:

• Assistant Secretary for Health



• Agency for HealthCare Research and Quality (AHRQ)



• Centers for Disease Control and Prevention (CDC)



• Food and Drug Administration (FDA)



• Health Care Financing Administration (HCFA)



• Health Resources and Services Administration (HRSA)
  


• Bureau of Health Professions



• Bureau of Health Resources Development



• Maternal and Child Health Bureau


• National Institutes of Health (NIH)



• Substance Abuse and Mental Health Services Administration (SAMHSA)