A notice was issued on Aug. 12, 2016 detailing plans to eliminate most appendix materials for applications submitted to the NIH, AHRQ or NIOSH on or after Jan., 2017. According to the notice, the new policy is “intended 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.”
New application instructions will be issued by Nov. 25, 2016 to reflect the following:
All information required for the peer review process except the cover letter, assignment request form and allowable appendix materials must be assembled in a single application image. Allowable appendix materials are as follows:
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.
Applications submitted for due dates on or after January 25, 2017 will be withdrawn and not reviewed if they are submitted with appendix materials that are not specifically listed above or as allowed in the FOA.
Clarification of this new policy may follow in the coming months; we’ll keep you updated.