NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE MORE CURRENT INFORMATION CAN BE FOUND ON THE NIH WEBSITE AT http://grants.nih.gov/grants/peer/hs_review_inst.pdf [PDF FORMAT].

OPRR BULLETIN


June 15, 1994

Subject: SUMMARY STATEMENT CODES FOR HUMAN SUBJECTS

Dear Colleague:

This bulletin is being forwarded to ICDs at NIH that are involved in research activities that include human subjects. Its purpose is to clarify the use of human subjects codes on summary statements (see Attachments).

The Office for Protection from Research Risks (OPRR) staff has observed the miscoding of a large number of summary statements, especially SBIRs. Miscoding with respect to the involvement of human subjects causes subsequent problems that include funding of a project without obtaining an Assurance from the awardee, failure of program to resolve concerns identified by the peer review group, and failure to alert the assurance coordinator to the existence of performance sites for an awardee that holds an approved Multiple Project Assurance (MPA) with OPRR. The code most often used inappropriately is 30, especially for many SBIR summary statements. Code 30 is appropriate only for institutions having MPAs. With only one known exception, awardees of SBIRs almost never have an MPA with OPRR.

The coding system described in the NIH MANUAL was devised to aid and expedite the processes of obtaining Assurances for compliance with the human subject regulations, the resolution of concerns identified by the peer review group, and identification of exempt research. We request that you review these codes and train those employees assigned to apply them to summary statements.

The present MPA list can be found in Wylbur. OPRR updates this list continuously with respect to the various components of MPA institutions as well as newly approved MPA institutions. Furthermore, we are preparing a list of institutions that have Inter-Institutional Amendments (IIAs) with MPA institutions and will make that list available through Wylbur when it is complete. An IIA allows an institution to be covered by the MPA of the institution to which it is affiliated, but only if the MPA institution is formally involved in the implementation of the grant, contract, or cooperative agreement, and the IIA institution is a performance site for the project. If the awardee is the IIA institution, the MPA does hot apply and the IIA institution must get a Single Project Assurance (SPA). Often, IIA institutions apply for grants as the awardee and improperly claim coverage by the MPA of another institution. Unless carefully checked, this error may lead to miscoding of the summary statement and the funding of a project without the appropriate Assurances in place.

Your attention to this important matter is greatly appreciated. 


Melody Lin, Ph. D.
Director
Division of Human Subject Protections
Office for Protection from Research Risks
Gary Ellis, Ph.D.
Director Office for Protection from Research Risks



SUMMARY OF HUMAN-SUBJECT CODES (IMPAC Item 44)

 CODE

 CAN AWARD BE PROCESSED?

DESCRIPTION

 ASSIGNED BY

 
E1*


 YES

 
H.S. involved- Exemption category 1 designated.

 SRA
 E2*

 YES

H.S. involved - Exemption category 2 designated.

 SRA
E3*  YES
H.S. involved - Exemption category 3 designated.

 SRA
 E4*  YES
H.S involved - Exemption category 4 designated.

 SRA
 E5*  YES
H.S. involved - Exemption category 5 designated.

 SRA
 E6*  YES
H.S. involved - Exemption category 6 designated.

 SRA
 E7  YES
H.S. involved - Multiple exemption categories designated.

 SRA
 E8  YES
H.S. involved - Applicability of H.S. regulations waived by
the Secretary, HHS.

 SRA
 20  NO
H.S. involved - No exemption designated.

 SRA
 30  YES
H.S. involved - MPA certified - No IRG concerns or comments

 SRA
 32  YES
H.S. involved - MPA certified - No IRG concerns - IRG comments, or unassured performance site.

 SRA
 44**  NO
H.S. involved - MPA certified IRG concerns.
 SRA



 * Exemption categories refer to paragraph (1) through (6) of 45 CFR 46.101 (b) as amended and effective August 19, 1991.

 ** OPRR must be notified by program administrator when IRG concerns are identified.




 CODE

 CAN AWARD BE PROCESSED?

 DESCRIPTION

 ASSIGNED BY


 45

 
NO


H.S. involved - No assurance - No IRG concerns or comments.

 
SRA

 47

 NO

H.S. involved - No assurance - No IRG concerns - IRG comments.

 SRA

  49**

 NO

H.S. involved - No assurance - IRG concerns.

 SRA

 54

YES

Previously coded as 44 - H.S. concerns received (awards) or transmitted (non-awards).

 OPRR

 55

 YES

Previously coded as 45 - Assurance and certification received.

 OPRR

 57

 YES

Previously coded as 47 - Assurance and certification received.

 OPRR

 59

 YES

Previously coded as 49 - H.S. concerns resolved (awards) or transmitted (non-awards) and, if an award will be made, Assurance and certification received.

 OPRR



 NOTE  - IF AN INSTITUTION HAS AN APPROPRIATE ASSURANCE ON FILE AND HAS NOT FILED THE REQUIRED CERTIFICATION OF IRB REVIEW, IRG REVIEW MUST BE DEFERRED AND THE H.S. CODE SHALL REMAIN 20 UNTIL IRG REVIEW.

 SRA  - Scientific Review Administrator

 OPRR  - Office for Protection from Research Risks