Notice Number: NOT-OD-17-006

Key Dates
Release Date: October 6, 2016
Response Date: November 29, 2016

Issued by
National Institutes of Health (NIH)

Purpose

The NIH seeks input on the use of interim research products in NIH applications and reports, and the standards for reporting them. We want to know if interim research products can increase the rigor and impact of NIH funded research. We also want to know how to ensure that interim research products arising from NIH funds can be created and used with integrity. We invite comments from any interested parties.

Background

Interim research products are complete research products that are made public before they are final. They are created in order to increase the impact and rigor of a research study. They might be in draft form, like a preprint, or they may be a step in an ongoing study made public, like a preregistered study protocol.

Examples of interim research products and their impacts
Preprints
A preprint is a complete and public draft of a scientific document. Preprints are often intended to be submitted to journals for peer-review and subsequent publication. However, they are public and permanent in a way that journal submissions under review are not.

Preprints give their authors a fast way to disseminate their work, establish priority of their discoveries, and obtain feedback ¹ . Early-career scientists can also use preprints as evidence of independence and productivity ² .

Other interim research products, including preregistration of protocols
Preprints are not the only form of interim research products. There are other complete scientific products that capture part of the scientific process or may be revised after they are made public.

For example, one interim research product that captures part of the scientific process is preregistration. Preregistration is publicly declaring key elements of a research project in advance, such as hypotheses, measures, confirmatory research protocols and analysis plans. Preregistration can reduce bias in analyses, distinguish between exploratory and confirmatory findings, and provide context for any eventual findings ³ .

In this RFI, the NIH seeks input on whether preprints and other interim research products should be included in NIH applications and reports, and how investigators could report them.

Implications for NIH applications and reports
If a scientist wants to cite an interim research product in an NIH application or report, the citation should meet certain standards. These standards might include:

• Ensuring the document is preserved, findable, and freely accessible to people and machines
• Links to other versions and associate data and resources
• Attribution and disclosure of authorship, funding, competing interests, licensing, and other issues used in high-quality scholarly publication
• A clear statement that the product is preliminary, and the level of peer-review it has received (if any)

Note, NIH does not intend to require awardees to create interim research products. Also, this RFI does not apply to research products, interim or otherwise, already addressed in other NIH policies. These other policies include, but are not limited to:

• data sharing
• clinical trials
• public access
• genomic data sharing
• model organisms
• invention reporting

Information Requested

Please send us any:
1. Types of interim research products your or your organization create/and or host.
2. Feedback on what are considered to be interim research products, and how they are used in your field.
3. Insight on how particular types of interim research products might impact the advancement of science.
4. Feedback on potential citation standards.
5. Insight on the possible need and potential impact of citing interim products on peer review of NIH applications.
6. Advice on how NIH reviewers might evaluate citations of interim research products in applications.
7. Any other relevant information

How to Submit a Response

Responses to this RFI must be submitted electronically on the submission website by November 29, 2016. We do not require you to provide your name with the response.

Responses to this RFI are voluntary. This RFI is for planning purposes only and should not be construed as a solicitation or as an obligation on the part of the Federal Government, the National Institutes of Health, or individual NIH Institutes or Centers. The NIH does not intend to make any type of award based on responses to this RFI or to pay for either the preparation of information submitted or the Government’s use of such information.

The NIH will use the information submitted in response to the RFI at its discretion. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information provided and will not provide feedback to respondents. The information submitted will be analyzed and may be shared publicly. Proprietary, classified, confidential, or sensitive information should not be included in your response.

Inquiries

Please direct all inquiries to:

Interim Research Product RFI
Office of Extramural Research
National Institutes of Health
6705 Rockledge Boulevard
Room 5102
Bethesda MD 20817

Email: [email protected]