Reminder: Updated Appendix Policy Eliminates Clinical Trial-Related Materials for NIH/AHRQ/NIOSH Applications Submitted to Due Dates on or After January 25, 2018.

Notice Number: NOT-OD-18-126

Key Dates
Release Date:  January 12, 2018

Related Announcements
NOT-OD-16-129
NOT-OD-17-035
NOT-OD-17-098

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

Purpose

This Notice reminds the scientific research community of plans to eliminate Appendix materials related to clinical trials for applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2018 unless they are otherwise specified as required in the funding opportunity announcement (FOA).  Clinical trial-related materials will be specified and required in the new PHS Human Subjects and Clinical Trials Information Form and no longer allowed in the Appendix unless specifically stated as required in Section IV.2, Appendix of the funding opportunity announcement (FOA).   See NOT-OD-17-098 for full details.

Policy

Allowable Appendix Materials

The following information applies to all competing NIH, AHRQ, and NIOSH applications and activity codes.

Beginning with applications submitted to the NIH, AHRQ, or NIOSH for due dates on or after January 25, 2018, unless specified otherwise in the FOA, the only allowable Appendix materials are:

  • Blank data collection forms, blank survey forms and blank questionnaire forms -- or screenshots thereof. 
  • Simple lists of interview questions. 
    • For clarification, these blank forms and lists are not and do not include items such as:  data, data compilations, lists of variables or acronyms, data analyses, publications, manuals, instructions, descriptions or drawings/figures/diagrams of data collection methods or machines/devices.
  • Blank informed consent/assent forms
  • Other items only if they are specified in the FOA as allowable Appendix materials

Some FOAs further restrict allowable appendix materials and/or may specify that some materials listed above must be provided in another part of the application.  Applications submitted to those FOAs must follow instructions in the FOA and must not put those items in the Appendix.

No other items are allowed in the Appendix.  Simply relocating disallowed materials to other parts of the application will result in a noncompliant application unless they are items specified in the FOA as optional or required for those other sections of the application.

Consequence for Submitting Disallowed Materials:

Applications submitted for due dates on or after January 25, 2018 will be withdrawn as noncompliant if they are submitted with Appendix materials that are not specified in this Notice or specified in the individual FOA as allowed or required.
Please see our Frequently Asked Questions resource for additional information
FAQs on the NIH/AHRQ/NIOSH Appendix Policy

Inquiries

Please direct all inquiries to:

Division of Receipt and Referral
Center for Scientific Review
Telephone: 301-435-0715
Email: csrdrr@mail.nih.gov

Sally A. Amero, Ph.D.
NIH Office of Extramural Research
Email: ReviewPolicyOfficer@mail.nih.gov

Lisa Scott-Morring, M.S., M.S.H.S., C.R.A.
Agency for Healthcare Research and Quality
Telephone:  301-427-1555
Email: Lisa.Scott@ahrq.hhs.gov

Viji Potula, Ph.D.
National Institute for Occupational Safety and Health
Centers for Disease Control and Prevention
Telephone:  404-498-2551
Email: vbp6@cdc.gov