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NIH Institutional NRSA Applications:
Instructions for Entering Protocol Information in the WISPER Record

NIH Requirements

The instructions on preparing institutional NRSA (National Research Service Award) applications are included in the PHS 398 packet, and instructions for annual progress reports on existing institutional NRSAs are included in the PHS 2590 packet.   These instructions require that appropriate research protocol information is included in applications/reports if trainee research involves human subjects or vertebrate animals.  In addition, information on the use of human embryonic stem cells must be provided for grants supporting trainees using stem cells.

Current Situation using WISPER

All proposals, including institutional NRSA competing proposals and non-competing progress reports, are required to be entered as a WISPER record and routed accordingly.  However, WISPER currently limits the number of protocols that can be input for each WISPER record:  15 for human subjects, 9 for vertebrate animals, 5 for bio-safety, and 3 for stem cells.  For institutional NRSA applications and for many center and program-project grants, the number of applicable protocols is far greater than the maximum number currently allowed by WISPER.  Furthermore, it is a burden for administrators to type a large number of applicable protocol numbers twice – once for the NIH application, and a second time for the WISPER record. 

Instructions

I.         Training Proposals Involving Human Subjects

II.       Training Proposals Involving Vertebrate Animals

III.      Training Proposals Involving Biological Materials

IV.      Training Proposals Involving Human Pluripotent Stem Cells

V.        At the Time of Award (Competing or Non-competing)

VI.       At the Time of Trainee Appointment

VII.     Resources

 

Training Proposals Involving Human Subjects

1. Read the instructions on preparing Institutional NRSA applications in the PHS 398 packet.  A description of the requirements for human subjects information is included in the specific instructions for the face page.
2. If any training plans include or potentially will include work with human subjects, check “Yes” on the face page and proceed with this section.  If not, check “No” and proceed to Section II below.
3. Include the Human Subjects Assurance Number (also referred to as a Federalwide Assurance Number) for the University of Wisconsin-Madison listed on RSP’s Frequently Needed Data webpage on the face page of the application. 
4. UW human subject protocol numbers are listed in the PLuS (Protocol Lookup System), a database developed by the Graduate School. While the database is not currently open to all UW-Madison personnel, access is currently being piloted with the T32 administrators. To request access to this database, contact Heather McFadden in the Graduate School's office of Research Policy.  This database will provide you with protocol numbers and approval dates for your PIs. You may use this resource, as well as communication with your trainers regarding trainee involvement in human subjects research, to determine the list of protocol details to be provided to NIH and entered in WISPER.
5. Create a table in Microsoft Excel of protocol information to be included in the training plan as indicated in the PHS 398 instructions.  (Click here for sample table)
6. In the WISPER record, check "Yes" for the use of human subjects or human tissue.  You can either list protocols associated with the training grant at this point or wait until the time of award (when just-in-time information is requested by NIH). 

• Do NOT enter any information in the protocol certification details link; rather, attach the Excel file with all of the protocols to the Attachments tab in your WISPER record. 
• As a reminder, all faculty and students engaged in Human Subjects research must complete the UW-Madison Human Subjects training requirements.  In addition, the PI of the training grant must also complete the requirements.  The training can be taken online. 

Training Proposals Involving Vertebrate Animals

1. Read the instructions on preparing Institutional NRSA applications in the PHS 398 packet.  A description of the requirements for vertebrate animals information is included in the specific instructions for the face page. 
2. If any training plans include or potentially will include work with vertebrate animals, check “Yes” on the face page and proceed with this section.  If not, check “No” and proceed to Section III below.
3. Include the Animal Welfare Assurance Number for the University of Wisconsin-Madison listed on RSP’s Frequently Needed Data webpage on the face page of the application.
4. UW vertebrate animal protocol numbers are listed in the PLuS (Protocol Lookup System), a database developed by the Graduate School. While the database is not currently open to all UW-Madison personnel, access is currently being piloted with the T32 administrators. To request access to this database, contact Heather McFadden in the Graduate School's office of Research Policy.  This database will provide you with protocol numbers and approval dates for your PIs. You may use this resource, as well as communication with your trainers regarding trainee involvement in vertebrate animal research, to determine the list of protocol details to be provided to NIH and entered in WISPER."Umbrella" animal protocols for training grants are no longer required.
5. Create a table in Microsoft Excel of protocol information to be included in the training plan as indicated in the PHS 398 instructions. (Click here for a sample table)
6. In the WISPER record, check "Yes" for the use of vertebrate animals.  You can either list protocols associated with the training grant at this point or wait until the time of award (when just-in-time information is requested by NIH). 

• Do NOT enter any information in the protocol certification details link; rather, attach the Excel file with all of the protocols to the Attachments tab in your WISPER record. 

Training Proposals Involving Biological Materials

1. If any training plans include or potentially will include work with biological materials including toxic, infectious or carcinogenic/mutagenic material of proven or potential hazard to humans, other animals or plants, or the use of recombinant DNA , proceed with this section.  If not, proceed to Section IV below.
2. Trainers must obtain approval of a biosafety protocol if their trainee will be working on research activities involving any of the six criteria listed on the Office of Biological Safety’s web site.  You may contact the Office of Biological Safety with any questions regarding the requirements for protocol review.
3. Biological materials protocol numbers are listed in the PLuS (Protocol Lookup System), a database developed by the Graduate School. While the database is not open to all UW-Madison personnel, access is currently being piloted with the T32 administrators. To request access to this database, contact Heather McFadden in the Graduate School's office of Research Policy.  This database will provide you with protocol numbers and approval dates for your PIs. You may use this resource, as well as communication with your trainers regarding training involvement in research using these biological materials, to determine the list of protocol details to be identified in the WISPER record.
4. Create a table in Microsoft Excel of relevant protocol information.  (Click here for sample table)
5. In the WISPER record, check "Yes" for the use of toxic, infectious or carcinogenic/mutagenic material of proven or potential hazard to humans, other animals or plants, or the use of recombinant DNA.  You can either list protocols associated with the training grant at this point or wait until the time of award. 

• Do NOT enter any information in the protocol certification details link; rather, attach the Excel file with all of the protocols to the Attachments tab in your WISPER record. 

Training Proposals Involving Human Embryonic Stem Cells OR Transplantation of Human Pluripotent Stem Cells into Animals with Possible CNS Integration or Germline Transmission

1. Read the instructions on preparing Institutional NRSA applications in the PHS 398 packet.  A description of the requirements for human stem cell information is included in the specific instructions for Form Page 2.  NIH requires that the following information be included for each trainee using human pluripotent stem cells:
   • Project title
   • Mentor
   • Specific cell line registration number(s)
2. If any training plans include or potentially will include work with human pluripotent stem cells, you must check "Yes" on form page 2 and proceed with this section..  If not, check “No”.
3. Ask your faculty trainers whether the training projects will use human pluripotent stem cells in their research.  For those who do, request cell line registration number(s), protocol title, agency and grant number with which it is associated, approval date, and approval number.
4. UW stem cell protocol numbers are listed in the PLuS (Protocol Lookup System), a database developed by the Graduate School. While the database is not currently open to all UW-Madison personnel, access is currently being piloted with the T32 administrators. To request access to this database, contact Heather McFadden in the Graduate School's office of Research Policy.  This database will provide you with protocol numbers and approval dates for your PIs. You may use this resource, as well as communication with your trainers regarding trainee involvement in stem cell research, to determine the list of protocol details to be provided to NIH and entered in WISPER.
5. Create a table in Microsoft Excel of protocol information to be included in the training plan as indicated in the PHS 398 instructions. (Click here for sample table)
6. In the WISPER record, check "Yes" for the use of human pluripotent stem cells.  You can either list protocols associated with the training grant at this point or wait until the time of award (when just-in-time information is requested by NIH). 

• Do NOT enter any information in the protocol certification details link; rather, attach the Excel file with all of the protocols to the Attachments tab in your WISPER record. 

At the Time of Competing or Non-competing Award for Projects Involving Human Subjects, Vertebrate Animals, Biological Materials, or Human Pluripotent Stem Cells

1. In the WISPER record, enter protocols for projects on which appointed trainees are working.  Remove any expired protocols, and enter any new protocols, approval numbers and approval & expiration dates.

• For Human Subjects Research
• Do NOT enter any information in the protocol certification details link (note: you will need to enter a protocol listing in the details link to avoid an error when forwarding the WISPER record); rather, attach the Excel file with all of the updated protocols to the Attachments tab in your WISPER record. 
• For Vertebrate Animals Research
• Do NOT enter any information in the protocol certification details link (note: you will need to enter a protocol listing in the details link to avoid an error when forwarding the WISPER record); rather, attach the Excel file with all of the updated protocols to the Attachments tab in your WISPER record. 
• For the Use of Biological Materials
• Do NOT enter any information in the protocol certification details link (note: you will need to enter a protocol listing in the details link to avoid an error when forwarding the WISPER record); rather, attach the Excel file with all of the updated protocols to the Attachments tab in your WISPER record. 
• For the Use of Human Pluripotent Stem Cells
• Do NOT enter any information in the protocol certification details link (note: you will need to enter a protocol listing in the details link to avoid an error when forwarding the WISPER record); rather, attach the Excel file with all of the updated protocols to the Attachments tab in your WISPER record. 

At the Time of Trainee Appointment

The training grant PI or the training grant administrator will check to ensure that protocols related to the trainee’s project are identified and that they have not expired. 

Resources

            Human Research Protection Institutional Review Boards

            Research Animal Resources Center

            Office of Biological Safety

            Stem Cell Research Oversight Committee

 

 

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