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

P.T. 34


  Human Subjects Policy 

  Grants Administration/Policy+ 

National Institutes of Health

The Common [Federal] Rule for the Protection of Human Subjects

(56FR28002-32, June 18, 1991) requires Federal Departments and

Agencies conducting or supporting research activities involving human

subjects to obtain certification from applicant organizations that an

appropriate Institutional Review Board (IRB) has reviewed and

approved each proposed activity.  On behalf of participating

Departments and Agencies, the Office for Protection from Research

Risks (OPRR) has received Office of Management and Budget approval of

the OPTIONAL FORM 310 for use by applicant organizations in

fulfilling the requirements for certification under the Common

[Federal] Rule.  Each Department and Agency may implement specific

instructions for the use of this form.

The purpose of this notice is to introduce the OPTIONAL FORM 310 and

to provide specific guidance ONLY as it relates to research

activities conducted or supported by components of the Department of

Health and Human Services (DHHS) (e.g., National Institutes of


For DHHS-supported activities, certification requirements and

procedures are carefully detailed in the instructions found in the

application for Public Health Service (PHS) Grant (PHS 398), the

application for PHS Individual National Research Service Award

(PHS-416-1), and in the following Notice which updates instructions

for follow-up certification.  The face page of the appropriate

application, PHS 398 or PHS 416-1, continues to be the primary

vehicle for providing certification of IRB review and approval when

the applicant organization with a Multiple Project Assurance (MPA) on

file with OPRR chooses to conduct IRB review and approval prior to

submission of an application.  In this case, follow-up certification

is not necessary, and use of the OPTIONAL FORM 310 is inappropriate.

An MPA applicant organization may use the OPTIONAL FORM 310 to

provide follow-up certification when:  (1) the organization elects to

delay certification submission for up to 60 days after the competing

application receipt date deadline and has inserted "pending" in place

of the required IRB date of approval; or (2) the organization, for

competing or continuation applications, has inserted "indefinite" in

place of the IRB date of approval because plans for involving human

subjects were so indefinite that IRB review and approval was not

feasible (see 45 CFR 46.118 and PHS 416-1 and 416-9).

Non-assured applicant organizations (No MPA on file with OPRR) are

not required to submit certification in conjunction with an

application.  Specific instructions in the appropriate application

package must be followed.

There may be other elective uses for the OPTIONAL FORM 310, such as a

means for documenting IRB approvals within multi-center clinical

trials.  Also, MPA organizations receiving a research contract that

proposes human subject involvement may elect to use the OPTIONAL FORM

310 for certification purposes.


Requests for single copies of the form may be made to:

Division of Research Grants

Office of Grants Inquiries

Westwood Building, Room 449

Bethesda, MD  20892

Telephone:  (301) 496-7441

Requests for bulk orders may be addressed to:

Division of Research Grants

Administrative Office

Westwood Building, Room 436

Bethesda, MD  20892

Telephone:  (301) 496-9797


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