NIH Just-in-Time (JIT)

• If the proposal survives study section review, NIH will request certification of IACUC approval.
• Provide the current protocol number and approval date to the analyst who originally reviewed the proposal, and they will have IACUC review your proposal and compare it to the approved protocol.
• IACUC will then generate the official Certification/Approval Letter.

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IRB congruency is the responsibility of the PI.  The PI must send an email to the Sponsored Projects Office (SPO) Officer where they confirm the appropriate IRB Protocol #(s). Once the SPO has received the protocol #(s) and email, they can then verify the approval and dates in Kuali Protocols. 

Email language:

• "I confirm this/these IRB approval(s) is/are associated with this application/grant. This/these protocol(s) represents the research being performed in this application/grant."

Human Subjects Training Certification and Sample letter

• Provide letters from the UCSD Principal Investigator and any subcontract PIs certifying that the key personnel listed have received the required training.
• These letters must be signed by the appropriate institutional official before they are sent to NIH, unless they are being submitted via the eRA Commons.

Please Note: Do not include the actual training certificates; they should remain in the department files.

NIH requires education on the protection of human research participants for all key personnel working with human subjects on projects funded by NIH.

• This does not include trainees on training grants.
• Certification of this training will be required with the Just-in-Time (JIT) documents for competing proposals.
• For non-competing progress reports, only include training certification if new key personnel are added to the grant.

UCSD IRBs now require completion of the appropriate Collaborative Institutional Training Initiative (CITI) Training Module regarding the protection of human subjects in research. These CITI course certifications are good for three years at which time the course may be re-taken.

• You must choose between the CITI IRB Biomedical, Protection of Human Research Subjects module or the CITI IRB Social-Behavioral, Protection of Human Research Subjects module.
• For either course, log on to the CITI Program’s home page.

UCSD Implementation Procedures

• The Principal Investigator (PI) will be responsible for:
  1. Assuring that all key personnel have completed a training course, and
  2. Providing a copy of the certification to the Department/ORU, and
  3. Generating a letter to NIH, upon their request, to be routed through the Sponsored Projects Office (SPO). The letter should be generated by the PI/Department/ORU in the format provided below.
  4. If the Training Assurance is submitted via SPO endorsement will occur electronically during submission to NIH.
• The Department will be responsible for:
  1. Retaining copies of the certifications for audit purpose
• The SPO will be responsible for:
  1. Notifying the Department/ORU when NIH contacts our office requesting a letter certifying that Key research personnel have completed the training, and
  2. Endorsing and forwarding the letter to the appropriate NIH Grant Management Office.

When certification is required that the key personnel have completed human subjects training please use the template provided below. We do not provide the CITI certificates to the NIH, though the PI should keep copies in his or her award files; instead, the template below should be utilized and all Key Personnel who have completed the required training should be listed. Please note if personnel have completed training other than CITI, information regarding the specific training they have completed should be included.

Sample Training Certification Letter

• When requested by NIH at the JIT stage, provide letters to the SPO from the UCSD PI and any subcontract PIs certifying that the listed key personnel have received the required training.
• These letters must be signed by an institutional official if a fax or hard copy is being sent to NIH. Otherwise, electronic endorsement by the SPO will occur if an electronic submission of these letters via the eRA Commons is made.

Please Note:

• Do not include the actual training certificates; they should remain in the department/ORU files.
• Do not include this training certification letter with the original proposal submission.
• When this information is requested as part of the Just-in-Time documents, upload a PDF version of the completed letter to the eRA Commons.

Sample Letter: (modify the course title and one-sentence description for personnel who have taken other training programs)

UCSD#
Date
NIH Grants Management Specialist [or other requestor]

[address and/or fax number if applicable]

Subject: Human Subjects Training Certification

[NIH Grant or Assignment Number and PI's name]

This letter is to provide certification of training as required by the June 5, 2000, NIH Guide announcement on Required Education in the Protection of Human Research Participants.

The Key Personnel on this project as listed below have completed the CITI IRB Biomedical [or substitute Social-Behavioral] Protection of Human Research Subjects course. This course was developed to instruct research staff in the basic principles and special requirements associated with research involving human subjects.

Key Personnel:

PI’s name, then a list of all other Key Personnel who have taken this training tutorial.

Sincerely,

[Name and title of PI]

Other Support is ONLY submitted to NIH when requested. Most typically, it is requested during the Just-In-Time (JIT) Information phase. The Other Support document assists NIH in clarifying that each person listed as Senior/Key Personnel on the Senior/Key Person Profile tab in the grant application is NOT over the allowable 12 person-months of effort per year (AKA 100% effort) on all of their combined funded research projects, including the NIH grant to be funded. If a person is over or about to go over the allowable 12-person months, then that person will need to make reductions either on the grant to be funded or other currently funded research grants; in most cases, prior approval will be required before these reductions can be done. You will need to work with your Central SPO on these prior approvals. 

Note: do not provide Other Support documentation for Other Significant Contributors, such as consultants, unless their participation in the project has or will move them to the level of Key Personnel.

The NIH GPS 2.5.1, states that Oether Support includes all resources made available to a researcher in support of and/or related to all of their research endeavors, regardless of whether or not they have monetary value and regardless of whether they are based at the institution the researcher identifies for the current grant. This includes:

What if you have a key person with a 9-month Academic Appointment? A 12-month appointment is pretty easy to figure out what the effort is, but what about a 9-month academic appointment? To figure out person months for someone on an academic year faculty appointment: take their 9-month salary appointment divide it by nine and then multiply that by 12. That will give you their hypothetical 12-calendar month appointment. You then multiply this by their budgeted % of effort in the project and this gives you the proper person-months that they are working on any specific grant.