OHSU

Compliance Questions

If my mentor has an IACUC proposal that has been approved, and my animal research is very similar to his/her research, can't I just use his/her IACUC number in my grant application?

No. If you are to use your mentor's IACUC approval, your mentor will need to submit paperwork to add your name, aims, and grant title to the protocol before the approval can apply to your project.

Who needs to complete COIR/RCR training?

To be compliant with federal regulation and OHSU institutional policy:

Responsible Conduct of Research (RCR) training is required for: All investigators, research staff, and other relevant personnel (those reasonably involved in the design and/or conduct of human, animal, and/or basic science research) must complete OHSU's Responsible Conduct of Research (RCR) education. No activity resulting in data collection can be initiated or any human enrolled until all key personnel have completed the required RCR modules. For non-OHSU collaborators, documentation of completion of RCR education at their own institution must be provided.

Conflict of Interest in Research (COIR) training is required for: The PI, co-investigator, other OHSU employees and volunteers, and any OHSU research collaborator (including visiting scientists) who are responsible for the design, conduct or reporting of research or educational activities, or who are responsible for preparing a proposal for research funding. "Investigator" includes the investigator's spouse and dependent children.

Please note: The NIH recently updated their RCR training policy. For more information, visit the Research Funding & Development website.

On an NIH application, if someone is not defined as "key," do they still have to complete the COIR or RCR training?

If they meet one of the criteria above, it is required.

Does an OHSU volunteer need to complete COIR and RCR?

If the volunteer is participating in research, and they meet one of the above criteria, it is required.

If an application is pending review with the IRB, how do I indicate this on the face page of an NIH application?

When the Institutional Review Board (IRB) approval is pending at the time of application, indicate "Yes" under Item 4 on the Face Page. Do not enter "Pending." NIH will ask for protocol approval details when it makes its request for Just-In-Time information.

If an application doesn't involve animal and/or human subjects, do you need to list the FWA (4b. on the face page) number or Animal Welfare Assurance number (5b. on the face page)?

No.

Do I have to indicate an application as "pending review" when this work is identical to research involving humans that I am already involved with?

As noted above, do not enter "approval pending" on the application; rather, indicate "Yes" under Item 4 on the Face Page. Please note, however, that a protocol covering the same work will not cover a new project until a Project Revision/Amendment  Form (PRAF) has been submitted to officially incorporate it.

If I've already filled out an Initial Classification Form for Research Involving Recombinant DNA or Synthetic Nucleic Acids, do I need to fill out a new questionnaire each time I submit a new or continuing grant or contract application?

For a full description of policies and approval requirements, please visit Sponsored Projects Administration and Research Integrity.