Contract table of contents

ARTICLE H.24. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND TRANSPARENCY

Contractors shall adhere to the NIH policy of enhancing reproducibility through rigor and transparency by addressing each of the four areas of the policy in performance of the Statement of Work and in publications, as applicable: 1) Scientific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables, including Sex; and 4) Authentication of Key Biological and/or Chemical Resources. This policy applies to all NIH funded research and development, from basic through advanced clinical studies. See NIH Guide Notice, NOT-OD-15-103 , "Enhancing Reproducibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable in NIH-funded Research" for more information. In addition, publications are expected to follow the guidance at http://www.nih.gov/research-training/rigor-reproducibility/principles-guidelines-reporting-preclinical-research , whether preclinical or otherwise, as appropriate. More information is available at http://grants.nih.gov/reproducibility/index.htm , including FAQs and a General Policy Overview.
 

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****(USE BELOW IN ALL SOLICITATIONS AND CONTRACTS INVOLVING GENOME-WIDE ASSOCIATION STUDIES (GWAS) CONDUCTED ON OR AFTER JANUARY 25, 2008.)****

ARTICLE H.25. DATA SHARING IN GENOME-WIDE ASSOCIATION STUDIES (GWAS)

The Contractor shall submit and certify data obtained in the genome-wide association study to the NIH GWAS data repository in accordance with the NIH "Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)" located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html .  All data and information shall be submitted to a high security network within the National Center for Biotechnology Information (NCBI), National Library of Medicine, through a secure transmission process.  Data submitted to the database for genotypes and phenotypes (dbGaP) shall include the following basic study information:

• 
  the protocol,
  
• 
  questionnaires,
  
• 
  study manuals,
  
• 
  variables measured, and
  
• 
  other supporting documentation
  

 

The curated and coded phenotype, exposure, genotype, and pedigree data, as appropriate, should be submitted to the NIH GWAS data repository as soon as quality control procedures have been completed by the Contractor. Information on submitting data to dbGaP is available at: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=HowToSubmit.pdf . Additional information about GWAS can be found at:  http://gwas.nih.gov .

 

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****FOR USE IN ALL SOLICITATIONS AND CONTRACTS THAT INCLUDE HeLa CELL WHOLE GENOME SEQUENCE DATA****

ARTICLE H.26. SHARING HeLa CELL WHOLE GENOME SEQUENCE DATA AND FAMILY ACKNOWLEDGEMENT

All research conducted using HeLa Cell Whole Genome Sequence data shall be in accordance with  NIH notice NOT-OD-13-099, entitled, "Notice of NIH Guidance on the Family Acknowledgement and Use of HeLa Cell Whole Genome Sequence Data located at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-13-099.html .

 

The Contractor shall submit HeLa Whole Genome Sequence Data generated under this contract tothe database of Genotypes and Phenotypes (dbGaP) available at: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/study.cgi?study_id=phs000640.v1.p1 , in accordance with the HeLa Genome Data Use Agreement available at: https://dbgap.ncbi.nlm.nih.gov/aa/wga.cgi?view_pdf&stacc=phs000640.v1.p1 ."

 

The Contractor shall acknowledge Henrietta Lacks and her family in all publications, presentations, or other public reporting of research when HeLa Whole Genome Sequence Data that is under controlled access in dbGaP has been used and/or generated under this contract. Sample language (or similar) for data submitters and users and is located at: http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=HeLaAcknowledgement.pdf .     

 

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****(INCLUDE THE FOLLOWING IN ALL SOLICITATIONS AND CONTRACTS FOR R&D REQUIREMENTS.)****

ARTICLE H.27. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. NIH defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and NIH. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov .

Additional information is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-071.html and http://publicaccess.nih.gov .

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****(USE BELOW IN SOLICITATIONS AND CONTRACTS WHEN CONTRACT PERFORMANCE MAY INVOLVE AN AGENT OR TOXIN THAT IS LISTED IN THE UNITED STATES GOVERNMENT POLICY FOR OVERSIGHT OF LIFE SCIENCES DUAL USE RESEARCH OF CONCERN (DURC). ADDITIONAL INFORMATION ABOUT THIS ITEM: • For a list of applicable agents or toxins, refer to Section 6 of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf .)****