SPECIAL INSTRUCTIONS FOR PROPOSALS INVOLVING HUMAN SUBJECTS RESEARCH

 

CRDF's policy on funding proposals involving human subjects research requires each Principal Investigator and his/her respective institutions certify that:

 

It has obtained Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approval of the research (or a determination that written approval is not required, e.g., exempt research) from an IRB/IEC registered with the U.S. Department of Health and Human Services'  Office of Human Research Protections (OHRP);

It has obtained the required approval(s) (or a determination that written approval is not required) from the applicable governmental office(s) for the research, including but not limited to the filing of the required applications related to investigational new drugs or investigational devices;

It has a Federalwide Assurance (FWA) on file with OHRP, and it will comply with the FWA throughout the term of the Project Agreement.  The FWA represents a public commitment to comply with the human subjects protections standards of the Belmont Report and the Common Rule;

It will conduct the research in accordance with the National Science Foundation (NSF) regulation entitled, “Protection of Human Subjects” [45 CFR § 690 et seq.];

If your proposal involves human research subjects, you must provide the following additional documentation:

 

• Completed CRDF Protocol Summary Form
• Copies of Institutional Review Board (IRB) or Institutional Ethics Committee (IEC) approval of the project or a formal written determination that said approval is not required, e.g. exempt research.  The IRB/IEC must be registered with the U.S.  Department of Health and Human Services' Office of Human Research Protections.
• Copies of required approval(s) (or determination that said approval is not required) from the applicable governmental bodies for the research, including but not limited to the filing of required applications related to investigational new drugs or investigational devices.
• Confirmation that the each institution has a Federalwide Assurance (FWA) on file with the U.S. Office for Human Research Protections and certification that it will comply with the FWA throughout the term of any resulting CRDF award.  If an FWA has not been obtained, please so note in the proposal.  Please be advised that, in the event the proposal is selected for an award, an FWA must be applied for and received by the Principal Investigators' institutions prior to the issuance of any project agreement by CRDF.

Failure to submit the information requested may result in your proposal being declared ineligible or in substantial processing delays.

Prior to the issuance of any award agreement by CRDF, the Principal Investigators and their institutions must provide certification that all project participants involved in the project have undertaken appropriate training in human subjects protections consistent with the requirements of the regulations cited above.

Privacy Policy |  Where We Work

an iapps site