NIH Senior Key Personnel and Other Significant Contributors

GUIDANCE

NIH Senior/Key Personnel & Other Significant Contributors ?

Related to PHRS Training Requirements

Section G: Training, Education & Outreach

Version 1.0

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Definition: Senior/Key Personnel

The National Institutes of Health (NIH) replaced the term "key personnel" with "senior/key personnel" in September, 2010. In addition to the program director/principal investigator (PD/PI), senior/key personnel are defined as individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries or compensation are requested. In addition, an NIH Funding Opportunity Announcement (e.g., RFA, PA) may instruct certain types of personnel to be identified as senior/key. Other defining characteristics include:

? Where on the grant application they are listed: ? SF 424 (R&R) application: Senior/Key Person Profile (Expanded) component ? PHS 398 application: Scientific/Key Personnel on Form Page 2 (continued).

? If a biosketch must be provided in the grant application. ? The level of effort described in the grant application is greater than zero person months. ? If identified as senior/key personnel by NIH in the Notice of Award.

Note: While all personnel identified as such on the Notice of Award are considered senior/key personnel, not all senior/key personnel are listed on the Notice of Award.

NIH has provided information/guidance regarding Senior/Key Personnel and a new category called Other Significant Contributors: ? (near the bottom) ? The requirement for protection of human research subjects (PHRS) training applies only to senior/key personnel, as described on NIH's website in conjunction with grant instructions.

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Guidance: Senior/Key Personnel

2.1 Characteristics and criteria for who is considered to be senior/key personnel: 2.1.1 Typically, individuals who are considered to be senior/key personnel have doctoral or other professional degrees, although individuals at the masters or baccalaureate level should be included if their involvement meets the definition (above). 2.1.2 Consultants should also be included if they meet the same definition. 2.1.3 Senior/key personnel must devote measurable effort to the project whether or not salaries are requested. "Zero percent" effort or "as needed" are not acceptable levels of involvement for those designated as key personnel. 2.1.4 Anyone who could be replaced without significantly affecting the direction or conduct of the project should not be listed as key personnel. 2.1.5 NIH program officials use discretion in identifying in the Notice of Award senior/key personnel other than the PD/PI(s), and may identify individuals that are considered critical to the project (i.e., their absence from the project would have a significant impact on the approved scope of the project). 2.1.6 Limiting the number of individuals that are named in the Notice of Award does not diminish the scientific contribution to the project of the senior/key personnel who are not named in the Notice of Award.

2.2 Requirements for senior/key personnel: 2.2.1 Completion of Training in the Protection of Human Research Subjects. 2.2.2 Prior written approval for change in status. The NIH grants management officer must provide prior written approval before changing the status of senior/key personnel named on the Notice of Award. Examples: withdrawal from the project, absence from the project for any continuous period of three months or more, or reduction of time devoted to the project by 25% or more from the level that was approved at the time of the initial competing year award.

Audience: HSD Staff, IRB Members, Researchers 5-25-11

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Other Support Information. For applications reviewed under the NIH Just-in-Time process, the PI will need to submit Other Research Support information for all personnel identified as senior/key personnel in the application, when the PI is notified that funding is likely. IRB Authority ? Senior/Key Personnel & PHRS Training ? The IRB does not have the authority to determine who are senior/key personnel.

This designation is the responsibility of the lead researcher and NIH. ? However, the IRB may require that specific individuals who are not senior/key

personnel take Training in the Protection of Human Research Subjects.

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Definition: Other Significant Contributors

Other Significant Contributors (OSC) is a new NIH classification, as of September, 2010. It refers to

individuals who commit to contribute to the scientific development or execution of the project, but do

not commit any specified measurable effort (in person months) to the project. These individuals are

typically presented at "effort of zero person months" or "as needed." Other defining characteristics

include:

? A biosketch must be provided in the grant application. ? The level of effort described in the grant application is zero person months or "as needed."

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Guidance: Other Significant Contributors

4.1 Characteristics and criteria for who is considered to be other significant contributors: 4.1.1 Individuals with measurable effort cannot be listed as other significant contributors. 4.1.2 Consultants should be included if they meet this definition. 4.1.3 This would also be an appropriate designation for mentors on Career awards.

4.2 Requirements for other significant contributors: 4.2.1 Completion of Training in the Protection of Human Research Subjects is not required by NIH for other significant contributors. 4.2.2 Prior approval (written or verbal) from the NIH grants management officer is not required for change in status of other significant contributors. 4.2.3 Other Support Information not required. For applications reviewed under the NIH Just-in-Time process, the PI does not need to submit Other Research Support information for all personnel identified as other significant contributors in the application, when the PI is notified that funding is likely.

Audience: HSD Staff, IRB Members, Researchers 5-25-11

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