NOTE: THIS GUIDANCE DOCUMENT HAS BEEN ARCHIVED BECAUSE MORE CURRENT INFORMATION CAN BE FOUND ON THE NIH WEBSITE AT http://grants.nih.gov/grants/peer/hs_review_inst.pdf [PDF FORMAT].
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
CODE |
|
|
|
E1* |
YES |
|
SRA |
E2* |
|
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 |
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 |
|
|
|
45 |
NO |
|
SRA |
|
|
H.S. involved - No assurance - No IRG concerns - IRG comments. |
|
49** |
|
H.S. involved - No assurance - IRG concerns. |
|
|
|
Previously coded as 44 - H.S. concerns received (awards) or transmitted (non-awards). |
|
|
|
Previously coded as 45 - Assurance and certification received. |
|
|
|
Previously coded as 47 - Assurance and certification received. |
|
|
|
Previously coded as 49 - H.S. concerns resolved (awards) or transmitted (non-awards) and, if an award will be made, Assurance and certification received. |
|
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 |