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Do I have to do a PPQ and send the project in for RCG review when it
is going to be funded in-house (internally)?
What is an Award Org Number and OGA Award Org Name? (for the PPQ)
What is cost-sharing and how come you are telling me that I have to make arrangements for it?
What approvals/signatures are needed for cost share?
The foundation that I want to apply to is disease-specific, (e.g., Juvenile Diabetes Research Foundation).
So do I have to get OHSU Foundation clearance?
What approvals are needed if Investigators are from multiple departments or units where each of the
participating Investigators has a significant portion of the proposed project?
At what point in time do I send supporting documents (VA MOU, VA PPQ, IRB, rDNA, IACUC forms) and do
they go directly to the specific RDA departments or do they just go to RGC?
Why is a PPQ needed each year when the grant proposal provides for a 5 year budget and the Chair has
signed off on the commitment of funds and effort?
For PPQ response purposes, what are the definitions of BasicandAppliedResearch?
Where do I find a list of official OHSU project-owning orgs?
What is the definition of a 'Clinical Research Organization' (CRO)?
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Do I have to do a PPQ and send the project in for RCG review when it is going to be funded in-house (internally)?
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A PPQ is required for all competitive applications, non-competing applications, supplements, and all other proposal
activities where new funding is requested. A PPQ is not required for a letter of intent to submit or white paper where
no budget information is included.
A PPQ is not required for most internally funded programs at the time of proposal submission. Usually, if a PPQ is
needed, it will be for those projects chosen for funding. The internal announcement will state whether a PPQ should be
submitted initially.
Internally funded projects that include human subjects will require a PPQ at the time the protocol is submitted to the IRB.
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What is an Award Org Number and OGA Award Org Name? (for the PPQ)
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The Award Org Number and its corresponding OGA Award Org Name identify the department that is responsible for the
project and will receive credit for it. For this reason, these are important entries on the PPQ and will be used
to assign the award if the project is funded.
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What is cost-sharing and how come you are telling me that I have to make arrangements for it?
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Cost sharing is a quantified commitment of time and/or resources made to a project that are covered by OHSU or a
third party. In certain types of programs, cost sharing is required and will be discussed in the Program Announcement.
In other circumstances, it is included at the discretion of the PI. In either case, once a commitment is promised to
a sponsor, OHSU is obligated by federal regulations to track and report it. These tracking requirements are a part of
OHSU's A-133 audit and can result in a disallowance of costs or reduction in awarded funding if cost sharing promises
are not kept. Thus, when cost sharing promises are made a part of an application, those having the authority to approve
the cost sharing need to authorize it. Specific questions concerning cost sharing should be directed to your GCA.
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What approvals/signatures are needed for cost share?
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When a commitment of OHSU resources is made, the appropriate fiscal authority will sign off on the commitment on
the line provided under Question 12 of the PPQ. If the cost sharing is coming from a different department or Org
than the one indicated as the OGA Award Org Name on the PPQ, Question 12 should be signed by the fiscal authority
for that Org.
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The foundation that I want to apply to is disease-specific, (e.g., Juvenile Diabetes Research Foundation).
So do I have to get OHSU Foundation clearance?
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An OHSU Foundation Clearance Request Form is not required when applying to a disease specific foundation.
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What approvals are needed if Investigators are from multiple departments or units where each of the
participating Investigators has a significant portion of the proposed project?
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If there is the intent to set up more then one OGA project for correct F&A distribution, each department should sign
approving the proposal and the agreement to split the award if made. This approval is always required when proposals
contain a component with the Primate Center, because the Primate Center has a different F&A rate and approved animal
charges that need to be verified.
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At what point in time do I send supporting documents (VA MOU, VA PPQ, IRB, rDNA, IACUC forms) and do
they go directly to the specific RDA departments or do they just go to RGC?
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If IRB, rDNA or IACUC forms are ready at the time of proposal submission, they should accompany the PPQ. RGC will separate
the compliance paperwork from the proposal packet and forward to ORIO.
VA MOU's need not be submitted until time of an award.* A new or updated MOU is required for each new award received.
The MOU should list all the projects for which the investigator has effort commitments, including the new award.
New MOUs are required annually, regardless of whether a change has been made in the investigator's effort commitments.
VA PPQ's are required when VA space, patients or other resources are being used. (Question 2 answered "Yes" on OHSU PPQ).
* Note that PPQs require the endorsement of VA administration if the project includes OHSU investigators who have VA appointments.
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Why is a PPQ needed each year when the grant proposal provides for a 5 year budget and the Chair has signed
off on the commitment of funds and effort?
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The PPQ provides a means for tracking the renewal or non-competing application, is used to assist in monitoring compliance
requirements, and provides specific information about the department's commitment of resources to the project for each
budget year.
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For PPQ response purposes, what are the definitions of Basicand Applied Research?
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Applied Research: Aimed at gaining knowledge or understanding to determine the means by which
a specific, recognized need may be met. In industry, applied research includes investigations oriented to discovering
new scientific knowledge that has specific commercial objectives with respect to products, processes, or services.
[National Science Foundation, Directorate for Social, Behavioral & Economic Sciences, US definitions for resource surveys 1996]
Basic Research: The objective of basic research is to gain more comprehensive knowledge or understanding of the subject
under study, without specific applications in mind. In industry, basic research is defined as research that advances
scientific knowledge but does not have specific immediate commercial objectives, although it may be in fields of present or
potential commercial interest. [National Science Foundation, Directorate for Social, Behavioral & Economic Sciences,
US definitions for resource surveys 1996]
* Note for PPQ: If a project includes both basic and applied components,
please identify the type that represents the majority of the research.
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Where do I find a list of official OHSU project-owning orgs?
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You can use the OHSU Project-Owning Org Tool to identify the official name
and number for active, project-owning orgs. To learn how to use the tool, view the instructions
that are provided at the right side of the screen.
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What is the definition of a 'Clinical Research Organization' (CRO)?
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A Clinical Research Organization (CRO) is an organization contracted by an industry sponsor delegated to
carry out some or all of the responsibilities of the industry sponsor in the development of a product or the
conduct of a clinical trial.
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If my mentor has an IACUC protocol 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 -
and say that my research has been approved?
Who needs to complete COI/RCR training?
On a NIH application if someone is not defined as key -- do they have to complete COI
or RCR training?
Does an OHSU volunteer need to complete COI and/or RCR?
If an application is pending review with the IRB, how do I indicate this on the face
page of an NIH application?
If an application doesn't involve animal and/or human subjects do you have to list the FWA
(4b. on the face page) number or Animal Welfare Assurance number (5b. on the face page)?
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?
If you have already filled out an initial Recombinant DNA (rDNA) Research Questionnaire, do you have
to fill out a new questionnaire each time you submit a new or continuing grant/contract application
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If my mentor has an IACUC protocol 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 - and say that my
research has been approved?
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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.
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Who needs to complete COI/RCR training?
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See the requirements below from OHSU's RDA Education website.
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On a NIH application if someone is not defined as key -- do they have to complete COI or RCR training?
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If they meet one of the criteria for RCR/COIR as noted below, it is required.
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Does an OHSU volunteer need to complete COI and/or RCR?
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See COIR requirements below. If the volunteer is participating in research and their duties meet the definition of
an Investigator below, RCR, and COIR are required.
RCR is required for (from the RDA Education website):
In compliance with federal regulation and OHSU institutional policy, all investigators, research staff, and o
ther relevant personnel (those reasonably involved in the design and/or conduct of human, animal, applied 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 subjects 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.
COIR is required for:
The principal investigator, co-investigator and other OHSU employees or volunteers, or any OHSU research
collaborator, including visiting scientists, responsible for the design, conduct or reporting of research or
educational activities or responsible for preparing a proposal for research funding. "Investigator" includes the
Investigator's spouse and dependent children.
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If an application is pending review with the IRB, how do I indicate this on the face page of an NIH application?
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When the 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.
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If an application doesn't involve animal and/or human subjects do you have to list the FWA (4b. on the face page)
number or Animal Welfare Assurance number (5b. on the face page)?
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No.
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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?
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As noted above, we do not enter human subjects approval pending on the application. But it should be noted
that a protocol covering the same work will not cover a new project until a Project Revision/Amendment Form
(PRAF) has been submitted officially incorporating it.
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If you have already filled out an initial Recombinant DNA (rDNA) Research Questionnaire, do you have to
fill out a new questionnaire each time you submit a new or continuing grant/contract application?
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For a full description of policies and approval requirements, please access the link below.
http://www.ohsu.edu/research/rda/spa/spin.shtml
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Where can I find the latest face page for the NIH 398 form? I want to use the one that is partially
completed, so I only have to fill in the personal grant information.
For an NIH modular application, what do I need to include in my budget justification?
For an NIH application, what defines key personnel versus other significant contributors?
I don't understand the new definitions for Key Personnel (NIH). Why can't I put my Research
Assistant in as Key?
On NIH applications, can I show Co-Investigators or Key personnel with "0%" effort?
Do you need to submit a biosketch if you are putting someone under the Other Significant Contributors?
Can I include Co-Investigators or key personnel with effort but no salary?
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Where can I find the latest face page for the NIH 398 form? I want to use the one that is partially
completed, so I only have to fill in the personal grant information.
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http://www.ohsu.edu/research/rda/forms.shtml#ap
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For an NIH modular application, what do I need to include in my budget justification?
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See PHS 398 Instructions. This section should describe the roles of all personnel on the project, including
those not requesting salary support. This includes Other Significant Contributors, collaborators and consultants.
Personnel committed effort should be indicated, if applicable. Also required is an explanation for any variation
in the number modules requested each year. Proposed consortium/contractual arrangements must be described indicating
whether the subcontractor will be foreign or domestic and showing subcontract costs rounded to the nearest $1,000.
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For an NIH application, what defines key personnel versus other significant contributors?
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The PI and other individuals who contribute to the scientific development or execution of a project in a substantive,
measurable way, whether or not they receive salaries or compensation under the grant. Typically these individuals
have doctoral or other professional degrees, although individuals at the masters or baccalaureate level may be considered
key personnel if their involvement meets this definition. Consultants also may be considered key personnel if they meet
this definition. "Zero percent" effort or "as needed" is not an acceptable level of involvement for key personnel.
Other Significant Contributors is a new classification that allows the PI to identify individuals who have committed
to contribute to the scientific development or execution of the project but are not committing any specified measurable
effort. (Biographical sketches will be required for these individuals; Other Support information will not be required.)
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I don't understand the new definitions for Key Personnel (NIH). Why can't I put my Research Assistant in as Key?
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The Research Assistant generally, does not have specific scientific expertise to contribute to the research in measurable,
substantive ways. Anyone who could be replaced without affecting the direction of the project should not be listed as key
personnel. It is important to keep in mind that there are requirements for reporting on key personnel for the life of each
project. Personnel listed as key, but not actually performing key functions, require unnecessary tracking on the part of
the department, RGC, and NIH.
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On NIH applications, can I show Co-Investigators or Key personnel with "0%" effort?
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No. See the definition of key personnel above.
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Do you need to submit a biosketch if you are putting someone under the Other Significant Contributors?
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Per the instructions for the PHS 398, a Biosketch is required.
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Can I include Co-Investigators or key personnel with effort but no salary?
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Yes, provided Question 12 on the PPQ has been answered "Yes" and the appropriate fiscal authority has authorized the
commitment of OHSU resources.
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On a new application, can a PI or other project personnel commit to a level of effort that
exceeds the level of their current appointment at OHSU? If so, what institutional base salary should we show
for them on the budget?
May I use actual fringe rates rather than the posted OPE rates for staff with different
salary levels? May I use a higher fringe rate?
Do I or don't I add fringe benefits to my Research Assistant's salary?
Under what circumstances can I budget greater than a 3% increase in salaries?
What approvals are necessary in that situation?
What if I know that we are going to give someone a promotion when this grant is funded?
What if I named someone in a grant application that is not a current OHSU employee but we want to
hire that person if funded -- what salary should I use?
Is it okay if I don't budget any money for my mentor's efforts on my grant? If I don't, should I
still show her/his percent effort and list her/him as Key?
My consultant (off-campus) wants to donate his/her time to my grant. How do I show this on the application
form and what "permission" is needed for this?
What if he/she is using another university's lab resources to assist in my grant?
What is the definition of patient care costs?
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On a new application, can a PI or other project personnel commit to a level of effort that exceeds the level
of their current appointment at OHSU? If so, what institutional base salary should we show for them on the budget?
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With their department chair's approval, signified by an email or signed memo to the designated RGC Grants and Contracts
Administrator, project personnel, including Principal Investigators, may commit effort at a level that exceeds their current
OHSU FTE level. The institutional base salary should be indicated as the full-time equivalent of their current partial-appointment
salary. For example: An investigator holds a .05 FTE appointment at OHSU, for which he receives a salary of $5,000. He wants
to commit 25% effort to a grant on which he will be the Principal Investigator. His full-time equivalent rate of pay would
be $100,000/year. With his chair's approval and full disclosure in the budget and budget justification, he can indicate
his institutional base salary as $100,000, show his proposed effort on the project as 25%, and request a salary of $25,000.
Full disclosure is provided with an asterisk next to the institutional base salary number on the budget, linked to an explanatory
note in the budget justification. To use this example, the note might read as follows: " Dr. Smith will commit 25% effort to
this project. Note that Dr. Smith currently holds a 5% appointment at OHSU, which will be increased to 25% if this application
is awarded. The indicated institutional base salary is quoted at the full-time equivalent rate." On modular budgets a note in
the budget justification will suffice. Again using this example, this might read: "Dr. Smith will commit 25% effort to this
project. Note that Dr. Smith currently holds a 5% appointment at OHSU, which will be increased to 25% if this application is awarded."
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May I use actual fringe rates rather than the posted OPE rates for staff with different
salary levels? May I use a higher fringe rate?
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Understanding that personnel may change their benefits before the application is funded, posted OPE rates should be used.
Higher rates should never be used. Please see the current rates posted on the RGC website;
click here. For TBD personnel,
you should use the published rates that correspond to annual salary requested. Effective 7/1/05, fringe benefits should not
be requested for GRA's.
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Do I or don't I add fringe benefits to my Research Assistant's salary?
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Graduate Research Assistants now receive stipends that are not paid through payroll. No fringe should be requested.
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Under what circumstances can I budget greater than a 3% increase in salaries?
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The standard inflation adjustment is 3 to 5% for the first year, depending on the time interval between
application and potential award. NIH and many other major sponsors restrict inflation adjustments between
non-competing years to 3%. An increase greater than the standard inflation adjustment can be given when an
individual's salary will increase by a definite amount due to a raise or change in appointment such as a promotion.
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What approvals are necessary in that situation?
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Projected increases that exceed standard inflation rates will require an explanatory email from the department fiscal
authority. Major increases may require written confirmation from the department chair.
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What if I know that we are going to give someone a promotion when this grant is funded?
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Follow the instructions for level of increase as stated above.
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What if I named someone in a grant application that is not a current OHSU employee but we want to hire
that person if funded -- what salary should I use?
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If an offer has been made, use the salary quoted in the offer and send a copy to RGC. If not, use the salary low to
mid-range for a comparable position of current OHSU employees.
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Is it okay if I don't budget any money for my mentor's efforts on my grant? If I don't, should I still show
her/his percent effort and list her/him as Key?
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In general, mentors should be listed as Other Significant Contributors with no effort committed unless the PA for the
specific application has overriding requirements.
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My consultant (off-campus) wants to donate his/her time to my grant. How do I show this on the application
form and what "permission" is needed for this?
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If a Consultant is donating his/her time, then they should so state in a letter of support which should be
included in the application. The level of effort they are contributing should be shown in budget justification.
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What if he/she is using another university's lab resources to assist in my grant?
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If resources from another university are committed, that university needs to have co-signed the letter describing
the services and resources.
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What is the definition of patient care costs?
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These are the costs of routine and ancillary services provided by hospitals to individuals participating in
research programs. If you believe your program includes patient care costs, please contact your Grants & Contracts
Administrator (GCA) to discuss. Patient care costs are relatively rare, but are an essential part of some programs.
Quantifying these costs, i.e., identifying the correct rates, usually requires RGC assistance, so a discussion with
your GCA should take place as early as possible in your grant development process.
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Is effort tracked by OHSU for all personnel or just key personnel?
When a grant is to be submitted electronically, does it need to be completely ready to be submitted
or can a rough draft be reviewed and then electronically submitted at a later time?
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Is effort tracked by OHSU for all personnel or just key personnel?
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Effort is tracked for all OHSU individuals paid on federal projects regardless of their role on the grant.
This is done through the Effort Certification Statement that is certified on a semi-annual basis. Whenever
effort is part of a commitment made to the sponsor without salary support requested, it is cost sharing and
needs to be tracked through a cost-sharing account set up on OGA.
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When a grant is to be submitted electronically, does it need to be completely ready to be submitted
or can a rough draft be reviewed and then electronically submitted at a later time?
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A rough draft of the science is enough, but all administrative components of the submission should be final.
Department contacts or PI's should call their GCA to discuss specific administrative components prior to the
arrival of the application for RGC review.
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What documentation is required from consortium collaborators at time of application? at time of a
non competing renewal?
When we are the recipient of a subaward from another organization, what documentation is required
for award set-up?
Why should an IRB be approved before a sub is established? If info is being reviewed in the IRB why is the
sub held?
If a sub is not listed in the proposal, is it necessary to obtain Sponsor approval?
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What documentation is required from consortium collaborators at time of application? at time of a
non competing renewal?
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For a summary of requirements for consortium arrangements, please refer to SPIN Newsletter, September 2003 that
can be accessed at
http://www.ohsu.edu/research/rda/spa/spin.shtml
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When we are the recipient of a subaward from another organization, what documentation is required
for award set-up?
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For the set up of subawards into OHSU, the same process for checking compliance and award analysis is followed as is for
other prime awards.
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Why should an IRB be approved before a sub is established? If info is being reviewed in the IRB why is the
sub held?
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Subcontract negotiations are not held up pending IRB approval. In fact, both processes can proceed simultaneously.
However, since no funds may be expended until IRB approval has been obtained, account set-up will be held until full
approval is in place.
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If a sub is not listed in the proposal, is it necessary to obtain Sponsor approval?
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Advance approval from sponsors for subcontracts is almost always required, particularly when subcontracting to foreign entities.
You should contact your GCA whenever you are considering adding a subcontract to a previously approved or awarded project.
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