Clinical Terms of Award

Purpose

To strengthen NIAID oversight of clinical trials and studies by requiring applicants to provide additional information with their competing and noncompeting renewal applications.

Procedure

Incorporated into the Notice of Award, the NIAID Clinical Terms of Award specify a grantee's responsibilities and deadlines for providing documentation and approvals when starting and during a study. We may ask applicants to send us some or all of this information.

The terms apply to all NIAID-supported grants conducting human subjects research. There may be additional terms for certain countries; for example, see the NIAID Clinical Terms of Award Restriction for China.

Grant applications must follow human subjects instructions in either the Grant Application Guide (for an electronic application)or PHS 398 (for a paper application).

NIAID can award applications only if they provide information showing that they comply with all policies.

For grants, certain human subjects codes, 20 or 44, in IMPAC II and on an application's summary statement indicate a bar to award that must be resolved before funding. Bars are placed on grants if no assurance exists or if applicants did not clearly follow the application instructions. For a list of codes, go to Human Subjects Inclusion Codes.

Find more information on human subjects requirements at NIAID human subjects resources on the Funding Web site.

Applicant and PI

• Read the NIAID Clinical Terms of Award for details on what to do.
• Contact the program officer early on. Before you can begin patient accrual, you will need to send NIAID some or all of the information listed in the terms document.
• Before and during your award, you'll need to provide information to your program officer.
• Make sure you are gathering the data you will need for reporting during the award.

Program Staff

• Indicate on the program officer checklist or program officer worksheets whether the Clinical Terms of Award should be part of the Notice of Award. Include any country-specific restrictions, such as the NIAID Clinical Terms of Award Restriction for China.
• Negotiate with grantees what documentation is required and track information provided in response to the terms. Before patient accrual can begin, you will need to get some or all of the information listed in the terms.
• Send a negotiated response to grantees within three weeks of receiving their information.

Grants Staff

• Add the Clinical Terms of Award to the Notice of Award. Include any country-specific restrictions, such as the NIAID Clinical Terms of Award Restriction for China.

Contacts

If you have questions, contact your Contact Staff for Help.

See GMP Assignments by Geographic Region and Program Code for the appropriate GMP specialist.

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Electronic Application Resources

Grant Application, Electronic SOP

Grant Application, Paper SOP

How to Write a Human Subjects Application Web page

Human Subjects SOPs

IMPAC and CRISP SOP

NIH Guide notice, NIH policy on reporting race and ethnicity data: subjects in clinical research, August 8, 2001

Noncompeting Progress Reports and Program Officer Approval SOP

Program Officer Checklist SOP

Protection of Human Subjects: Assurance Identification/IRB Certification/Declaration of Exemption Form

Required Clinical Training -- Frequently Asked Questions Web page

Trans NIAID Clinical Research Toolkit