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Updates from MUSC's Offices of Research Administration


DO YOU WORK WITH HUMAN PLURIPOTENT STEM CELLS?

Then you should know that MUSC has adopted a new campus policy for the review and approval of human pluripotent stem cell research. The “MUSC Research Using Human Stem Cells Policy” will take effect on July 1, 2017. In order to be compliant, MUSC leadership has charged a new oversight body, the Stem Cell Research Oversight (SCRO) committee, with oversight responsibilities for all research projects that fall under this policy.

Applicability and Scope of Oversight of the SCRO Policy

The scope of the MUSC Research Using Human Stem Cells Policy is limited to a well-defined subset of life sciences research that involves the storage of human embryonic stem cells and the derivation or use of all types of human pluripotent stem cells at MUSC.  The aim of this policy is to help ensure that such research is conducted with the highest ethical and scientific research standards, and in compliance with all applicable federal and state regulations, MUSC policies, and the requirements of extramural research sponsors.  Non-compliance with this Policy may result in suspension, limitation, or termination of Federal research funding.

Principal Investigator Responsibilities

It is the responsibility of the Principal Investigator to identify research involving the derivation or use of human pluripotent stem cells and notify the SCRO for review.  

SCRO Notification of Research with Human Stem Cells

The formal SCRO review starts with the PI submission of a SCRO registration form. Instructions for submitting this form are available on the SCRO website. The SCRO will review the application and determine whether or not the project indeed falls into the scope of human stem cell research oversight. All individuals involved in this scope of research will be required to complete the SCRO training module in the online CITI Human Stem Cell program.   

Researchers with questions are encouraged to talk to the SCRO Program Manager (Dr. Yashmin Karten, 843-792-6521, karteny@musc.edu).

 

Resources:

MUSC website on SCRO

http://research.musc.edu/ori/SCRO  

MUSC Research Using Human Stem Cells Policy

http://research.musc.edu/ori/SCRO/Policies%20and%20Procedures.html

National Academies of Sciences Guidelines  

https://doi.org/10.17226/11278

NIH Guidelines on Human Stem Cell Research

https://stemcells.nih.gov/policy/2009-guidelines.htm 

NIH Human Embryonic Stem Cell Registry

http://stemcells.nih.gov/research/registry/ 

International Society for Stem Cell Research

http://www.isscr.org/ 

 


Final Research Performance Progress Reports (Final RPPR)

NIH Notice NOT-OD-17-022 announced NIH’s implementation of Final Research Performance Progress Reports (Final RPPR or F-RPPR) effective January 1, 2017.

The Final RPPR will replace the Final Progress Report (FPR) and will be submitted via a new eRA Commons module.

A significant change with implementation of the F-RPPR is that in order to maximize public transparency, NIH will not maintain the current Type 2 policy which in accordance with NIHGPS Chapter 8.6.2 states that "whether funded or not" the progress report contained in the Type 2 application may serve in lieu of a separate final progress report.

NIH will request that organizations submit an "Interim-RPPR" while their renewal application (Type 2) is under consideration. In the event that the Type 2 is funded, NIH will treat the Interim-RPPR as the annual performance report for the final year of the previous competitive segment. If the Type 2 is not funded, the Interim-RPPR will be treated by NIH staff as the institution's Final-RPPR.

NIH is aligning its reporting requirement with other Federal research agencies and therefore will not be making any changes to the deadline for submitting the final report- i.e., the Final RPPR or Interim-RPPR must be submitted via eRA Commons no later than 120 calendar days from the period of performance end date. If a recipient fails to comply with this reporting requirement, NIH may take one or more enforcement actions, such as a decision not to make a non-competing continuation award, consistent with NIHGPS Chapter 8.5.2. NIH also plans to maintain the business rule in the RPPR module enabling institutional signing officials (SOs), at their discretion, to delegate submission of the Final RPPR or Interim-RPPR to the Program Director/Principal Investigator (PD/PI).

Note: Implementation of the Final RPPR for Small Business Innovation and Research (SBIR) and Small Business Technology Transfer (STTR) grants will occur approximately 2 months after implementation for all other NIH grants due to unique final reporting requirements under the Small Business Administration's SBIR/STTR Policy Directive.

FAQs and additional information pertaining to NIH's implementation of the F-RPPR will be available on the NIH RPPR website.