FellowshipWorkshopDocuments

Supporting Documents

Slides for today can be found here.

You will need several supporting documents, which we will work on all together. This includes the following

Letters of Reference

Letters of reference are confidential and submitted directly by your referees — they are not part of your application package and you will not see them. You will request them through the NIH system, which sends referees a link to upload their letters directly.

Choose referees who can speak specifically to your scientific qualities (creativity, curiosity, resourcefulness, drive) and your potential as an independent researcher. Reviewers will read these alongside your own candidate statement and your sponsor’s statement, so coordinate with your referees: share your aims, your training goals, and the specific skills and gaps you have described in your Candidate’s Goals, Preparedness, and Potential so that their letters reinforce and add evidence for what you have written.

Review criteria addressed here:

• Assess whether the candidate and sponsor statements as well as the referee letters provide convincing evidence that the candidate possesses qualities (such as scientific understanding, creativity, curiosity, resourcefulness and drive) that will improve the likelihood of a successful research training outcome.

Letters of Support

Letters of support are part of your submitted application and are distinct from letters of reference. These should come from collaborators, core facility directors, consultants, and any other mentors (such as dissertation committee members) who play a role in your research or training plan. Each letter should speak to a specific resource, expertise, or mentoring role described in your Training Activities and Timeline or Sponsor’s Statement — they provide evidence that the support you describe is real and committed.

Facilities and Environment

Describe the key cores, shared resources, and institutional infrastructure available for your research training. This section supports the reviewer’s assessment of whether the scientific environment is adequate for the proposed training plan.

Review criteria addressed here:

• Consider whether the sponsor(s), scientific environment, facilities and resources are adequate and appropriate for the proposed research training plan. (also addressed in Sponsor’s Statement)
• Evaluate the extent to which the sponsor(s) and organizational commitment is appropriate, sufficient and in alignment with the candidate’s research training plan. (also addressed in Sponsor’s Statement)

Key Equipment

Critical equipment needed for your studies.

Human Subjects

If your research involves human subjects you must complete a Human Subjects section. If the research is exempt under 45 CFR Part 46, you must provide the exemption category and justification. If it is not exempt, address all five of the following:

1. Risk to subjects – describe the risks (physical, psychological, financial, legal, social) and their likelihood and severity
2. Adequacy of protection against risks – describe the protections and procedures to minimize risks, including informed consent
3. Potential benefits – describe potential benefits to subjects and to others; risks should be reasonable relative to anticipated benefits
4. Importance of knowledge – explain why the knowledge to be gained justifies any risks to subjects
5. Data and safety monitoring – describe plans for monitoring data to ensure subject safety, particularly for clinical trials

If you are not involving human subjects, you must still address this section by stating that no human subjects are involved and providing a brief justification.

Review consideration (not scored separately): Reviewers will evaluate protections for human subjects as an additional review criterion. The five elements above map directly to what they assess.

Vertebrate Animals

If your research involves live vertebrate animals you must complete a Vertebrate Animals section addressing all three of the following:

1. Description of proposed procedures – provide a complete description including species, strains, ages, sex, and total number of animals to be used
2. Justification – explain why the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model
3. Minimization of pain and distress – describe all interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit unavoidable discomfort, distress, pain, and injury

Methods of euthanasia must also be described in a separate section of the application; if the method is not consistent with AVMA Guidelines, provide justification.

If you are not using vertebrate animals, state this explicitly.

Review consideration (not scored separately): Reviewers will evaluate vertebrate animal use as an additional review criterion. The three elements above map directly to what they assess.

Training in Responsible Conduct of Research

Your RCR instruction description (1 page total) must address the following five aspects:

1. Format – the required format of instruction (face-to-face lectures, coursework, and/or real-time discussion groups; online-only instruction is not acceptable)
2. Subject Matter – the breadth of subject matter (e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics)
3. Faculty Participation – the role of the sponsor(s) and other faculty involvement in the fellow’s instruction
4. Duration of Instruction – the number of contact hours of instruction (at least eight contact hours are required)
5. Frequency of Instruction – instruction must occur during each career stage and at least once every four years

Authentication of Resources

Key resources (mice, antibodies, chemicals) need to be validated. For more details see NOT-OD-17-068

Resource Sharing Plans

How developed resources (mice, tools, computational resources, sequence data) will be shared. For more details see Model Organism Policy and Research Tools Policy

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