Notice Number: NOT-OD-16-129

Key Dates
Release Date: August 12, 2016

Issued by
National Institutes of Health (NIH))
Agency for Healthcare Research and Quality (AHRQ)
National Institute for Occupational Safety and Health (NIOSH)

Purpose

This Notice alerts the scientific research community of plans to eliminate most appendix materials for applications submitted to the NIH, AHRQ or NIOSH for due dates on or after January 25, 2017. Application instructions will be updated by November 25, 2016 to reflect this change.

The Notice also clarifies:

• Status of appendix materials in peer review
• Allowable appendix materials
• Consequences for submitting disallowed appendix materials

The NIH, AHRQ, and NIOSH strive to ensure fairness in peer review for all grant applicants by specifying the types and amount of application material that are accepted for peer review. At the same time, these agencies appreciate both the need for applications to provide sufficient information to allow for an informed, expert review process and the importance of limiting the burden on peer reviewers.

Elimination of most appendix materials is intended to rectify inequities in the peer review process that can arise from submission of inappropriate or excessive appendix materials by some applicants and consideration of appendix materials in peer review by some, but not all reviewers.

Policy

Appendix materials in peer review
All information submitted with an application except the cover letter, assignment request form and appendix information are assembled into a single application image for funding consideration. The different sections within the application image are specified in the application instructions and correspond to the standard review criteria.

Therefore:

• All information required for the peer review process must be contained within those designated sections of the application image, unless the Funding Opportunity Announcement (FOA) specifies otherwise.
• Information that expands upon or complements information provided in any section of the application -- even if it is not required for the review -- is not allowed in the appendix unless it is listed in the allowed appendix materials (below). (NOT-OD-11-080)
• Unless the FOA requires that certain information be included in the appendix, failure of reviewers to address appendix materials in their reviews is not an acceptable basis for an appeal of initial peer review (NOT-OD-11-064).

Allowable appendix materials
Beginning with applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2017, the only allowable appendix materials are:

For applications proposing clinical trials (unless the FOA provides other instructions for these materials):

• Clinical trial protocols
• Investigator's brochure from Investigational New Drug (IND), as appropriate

For all applications:

• Blank informed consent/assent forms
• Blank surveys, questionnaires, data collection instruments
• FOA-specified items.
  • If appendix materials are required in the FOA, review criteria for that FOA will address those materials, and applications submitted without those appendix materials will be considered incomplete and will not be reviewed.

Consequences for submitting disallowed appendix materials
Applications submitted for due dates on or after January 25, 2017 will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed in this Notice or the FOA as allowed or required.

Inquiries

Please direct all inquiries to:

Division of Receipt and Referral
Center for Scientific Review (CSR)
National Institutes of Health
Telephone: 301-435-0715
Email: csrdrr@mail.nih.gov

Sally A. Amero, Ph.D.
NIH Review Policy Officer
Email: ReviewPolicyOfficer@mail.nih.gov

Francis D. Chesley, Jr., M.D.
Director, Office of Extramural Research, Education, and Priority Populations
Agency for Healthcare Research and Quality
Telephone: 301-427-1521
Email: Francis.Chesley@ahrq.hhs.gov

Viji Potula, Ph.D.
Office of Extramural Programs
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Telephone: 404-498-2551
Email: VPotula@cdc.gov