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Initiated Clinical Research

Publications

Protecting Intellectual Property

Patent Considerations

Before you publish, consider whether your results are an invention that might benefit patients. Journal publications, website publications, and presentations at conferences constitute public disclosure of intellectual property. Once the invention has been publicly disclosed, a patent usually cannot be obtained.

Questions - Contact MSIP.

Consolidated Standards of Reporting Trials (CONSORT)

Consolidated Standards of Reporting Trials (CONSORT) – documents and resources to facilitate reporting of randomized trials

Requirements for Acknowledging NIH-Supported Research

Acknowledging ISMMS ConduITS CTSA Support - NIH Requirement

What

The NIH requires publications, posters, grants arising from research projects receiving support from the ConduITS CTSA to acknowledge grant support.

Who

This is applicable to all faculty and research staff within the MSHS who have received ConduITS support (including consultations, training, workshops, funding) through the use of the following ConduITS resources and services:

  • Biostatistics, Epidemiology & Research Design (BERD)
  • ConduITS Community Engagement
  • Biobanking Resources
    • LabVantage Biorepository Management System
    • Biospecimen storage
  • International Center for Health Outcomes and Innovation Research (InCHOIR)
  • Office of Research Services (ORS)
    • Clinical Trials.gov
    • Investigational New Drug (IND) / Investigational Device Exemption Consults
    • OnCore CTMS (Clinical Trial Management System)
    • Pre-Protocol Development Consults
    • Recruitment Consult
    • EPIC Participant Recruitment for Clinical Research
    • ResearchMatch Consults and Support
  • Research Information Technology
    • Mount Sinai Data Warehouse (MSDW)
    • Mount Sinai Imaging Research Warehouse (MS-IRW)
    • REDCap
    • NCATS National COVID Cohort Collaborative (N3C) Data Enclave
  • Career Development Funding
    • KL2 Scholars
    • TL1 Scholars
  • Pilot Project Funding

How

Include this recommended language in your publication:

 "Supported by grant UL1TR004419 from the National Center for Advancing Translational Sciences, National Institutes of Health."

Questions

Not sure if you should acknowledge the CTSA, ask here: Research 411 ticket.

NIH Public Access Policy

What

The National Institutes of Health (NIH) Public Access Policy requires that all investigators funded by the NIH, upon acceptance for publication, must submit an electronic version of their final peer-reviewed manuscripts to National Library of Medicine’s PubMed Central.

Who

The NIH Public Access Policy applies to any manuscript that:

  • Is peer-reviewed
  • And, is accepted for publication in a journal on or after April 7, 2008
  • And, arises from:
    • Any direct funding from an NIH grant or cooperative agreement active in Fiscal Year 2008 or beyond, or;
    • Any direct funding from an NIH contract signed on or after April 7, 2008, or;
    • Any direct funding from the NIH Intramural Program, or;
    • An NIH employee.

Why

In 2013, the NIH established New Compliance Requirements whereby NIH will delay processing of non-competing continuation awards if publications arising from that award are not in compliance with the NIH Public Access Policy.

Compliance is being tracked through Research Performance Progress Reports (RPPRs). These interface with the My Bibliography feature of My NCBI to alert researchers and authors of non-compliant publications.

When

Manuscripts must be submitted to PubMed Central no later than 12 months after the official date of publication.

How

Download the detailed instructions for How to Monitor Compliance.

Institutional Policies

Scientific Illustration

Instructional Technology Group (ITG)

Resources

Research 411 Portal

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