Refer to the following NIH announcements for more information:
NOT-OD-17-068 – ‘Reminder: Authentication of Key Biological and/or Chemical Resources’
NOT-OD-16-011 – ‘Implementing Rigor and Transparency in NIH & AHRQ Research Grant Applications’
NOT-OD-16-012 – ‘Implementing Rigor and Transparency in NIH & AHRQ Career Development Award Applications’
Resources for the authentication of cell lines
- International Cell Line Authentication Committee (ICLAC) Cell Line Checklist (updated May 16, 2019). This checklist was written as a resource for scientists that write or review manuscripts and grant applications. This list can be used to determine if the cell lines used for this work meet acceptable quality requirements.
- Guidelines for the use of cell lines in biomedical research. RJ Geraghty et al. British Journal of Cancer (2014) 111, 1021-1046 I doi:10.1038/bjc.2014.166
Definition of Human Subjects Research
Human subjects = a living individual about whom an investigator conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens
Try Decision Tool if you are not sure if your project involves Human Subjects
Walk-through video of PHS Human Subjects and Clinical Trials Information Form
PHS Human Subjects and Clinical Trials Information (Application Guide)
Resources for Human Subjects Research
- Human Subjects Research (NIH)
- Research Using Human Subjects (NIAID)
- Human Subjects Research (NIDDK)
- Frequently asked Questions (NIH)
- Human Subjects Research Requirements SOP (NIAID)
Vertebrate Animal Section Checklist (overview of requirements, checklist, detailed instruction, and example)
If the work proposed in a grant application, contract proposal, or cooperative agreement involves live vertebrate animals, federal policy requires applicants and offerors to address the criteria in the checklist.
This includes work involving:
- Animals obtained or euthanized for tissue harvest
- Generation of custom antibodies
Refer to the following NIH announcements for more information:
NOT-OD-16-006 ‘Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals’
Resources for Vertebrate Animals
- Vertebrate Animals Section (NIH OLAW)
- Template (Duke ORA)
- Example(Duke Pediatrics)
- Research Using Vertebrate Animals (NIAID)
- Vertebrate Animals (NIH)
A Select Agent is a biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.
Include a ” Select Agent Research” PDF attachment if your proposed activities involve the use of select agents at any time during the proposed project period, either at the applicant organization or at any performance site.
Select Agent Research (Application Guide)
Check Select Agents and Toxins list, to figure out if you are using them. You also can check Select Agents and Toxins Exclusion list.
Resources for Select Agents
- Research Using Select Agents (NIAID)
- Select Agent Awards SOP (NIAID)
- Policy on Select Agent (NIAID Funding News)
