NIH Guide, Volume 22, Number 12, March 26, 1993

P.T. 34


  Human Subjects Policy 

  Grants Administration/Policy+ 

National Institutes of Health

The instructions for completing form PHS 398 (rev. 9/91) from an

applicant organization that has an appropriate approved Multiple

Project Assurance of Compliance on file with the Office for

Protection from Research Risks, and that proposes non-exempt research

involving human subjects, includes the following:

The "information in Items 4a and 4b and the signatures on the face

page fulfill the requirement for certification of IRB approval.  To

ensure against delays in the review of the application, institutional

review board (IRB) review is best completed prior to submission of

the application.  However, if the IRB review is unavoidably delayed

beyond the submission of the application, enter 'pending' at Item 4a.

A follow-up certification of IRB approval from an official signing

for the applicant organization must then be sent to and received by

the Scientific Review Administrator of the initial review group

within 60 days after the receipt date for which the application is

submitted.  Any modifications in the Research Plan section of the

application required by the IRB must be submitted with the follow-up

certification.  Occasionally, PHS initial review may be scheduled to

occur before the end of the 60-day grace period.  In these special

cases of accelerated review, the follow-up certification will be

requested earlier.  Otherwise, it is the responsibility of the

applicant organization to submit the follow-up certification.  The

PHS does not guarantee that it will remind the applicant organization

or the Principal Investigator/Program Director to provide this

missing information.  If certification of IRB approval is not

received prior to the scheduled PHS initial review date, the

application will be considered incomplete and deferred to the next

review cycle."

If a follow-up certification of IRB approval has to be sent to the

Scientific Review Administrator of the initial review group, an

appropriately completed and signed OPTIONAL FORM 310 (available on

request from DRG), a letter prepared on organizational letterhead

stationery, or a revised face page of PHS 398 is acceptable provided

that all of the following required information is included:  title of

project, application number, name of investigator and institution,

Multiple Project Assurance number, date of IRB approval, and

appropriate signatures.  The OPTIONAL FORM 310, the organizational

letter, or the revised Face Page with an attachment must contain any

changes or modifications required by the IRB and, if none, a

statement to that effect.

The name and address of the Scientific Review Administrator of the

initial review group will be sent to the Principal Investigator/

Program Director as soon as possible after the receipt date, usually

within six weeks.  To avoid delays in review, do not send the

follow-up information to any other addressee.


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