Frequently Asked Questions (FAQs) for ACCORD PAR-10-238

Important Changes since release of the FOA

The first submission date for applications to this PAR has been postponed to December 7, 2010. The subsequent submission dates remain the same.

Applicants proposing studies that utilize stored biospecimens and data collected during the ACCORD study do not need to obtain a letter of feasibility from the ACCORD Coordinating Center. Applicants should complete the budget form located on the ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) and send it to ACCORD_Ancillary@wfubmc.edu by July 15, 2011 for the 2010 submission date to obtain a budget estimate for their services. Investigators should contact Santica Marcovina smm@u.washington.edu at the ACCORD Central Lab by August 15, 2011 to obtain a budget estimate for Central Lab services.

Applicants proposing collection of new data from the ACCORD Follow-on participants must demonstrate collaboration with an ACCORD Steering Committee investigator. Please contact a member of the ACCORD Steering Committee to discuss your proposal (list of names can be found on the ACCORD website (http://www.accordtrial.org/web/public/pi.cfm). Additionally, applicants proposing the collection of new data must obtain approval from the ACCORD Steering Committee. This can be obtained by completing the ACCORD ancillary study application located on the ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) and submit the completed application to Denise Bonds (bondsde@nhlbi.nih.gov) by July 1, 2011 for the September 28, 2011 submission date. A letter indicating approval will be sent to the Ancillary study applicant to be included in the application packet.

General questions about the PAR

Q1. What is meant by the term "applicant", and can applicants submit more than one application?

A: The "applicant" is the grantee institution submitting the application. If there are sufficient resources at a single institution to justify multiple applications, an institution may submit multiple applications.

Q2. What are the page limits of the Research Plan?

A: There is a 12 page limit for the Research Plan of the application.

Q3. Can an application have multiple PIs, and can these PIs be from more than one university or institution?

A: Yes, multiple PI applications are allowed and the PIs may be located at different sites. If an application proposes multiple PIs, the leadership plan must address how leadership duties will be shared, and the application should follow the PHS 398 instructions at http://grants.nih.gov/grants/funding/phs398/phs398.html regarding Consortium/Contractual arrangements, such as including separate detailed budget pages for the sub-awards.

Q4. Are there any special requirements for this announcement?

A: Yes, there are a number of special requirements for the ACCORD Ancillary Study PAR. Please read Section IV. 6 "Other Submission Requirements" of the FOA carefully. Letters from the ACCORD Coordinating Center that state that the proposal is technically feasible are no longer required for applications utilizing only the stored biospecimens.

Applications proposing collection of new data from the ACCORD Follow-on participants must demonstrate collaboration with an ACCORD Steering Committee member (a list can be found at http://www.accordtrial.org/web/public/pi.cfm under Clinical Center Network Principal Investigators) and must obtain approval from the ACCORD steering committee. Please submit an Ancillary Study Application to ACCORD_Ancillary@wfubmc.edu prior to July 1, 2011 for the September 28, 2011 submission deadline. Applications that do not contain all of the remaining required documentation will be considered non-responsive.

Q5. Does the proposed ancillary study have to explain an ACCORD outcome?

A: Studies that explain the ACCORD findings are encouraged and reviewers will consider this during their evaluation of the project. Further information on this is provided in Section V, 2. "Review and Selection Process" of the FOA. Reviewers may consider two additional aspects during their review; first, does the proposed study address important outcomes in the overarching ACCORD Clinical Trial/ACCORD follow-up study and second, will the results of the proposed study test potential mechanisms of action for outcomes or clinical measures seen in the overarching ACCORD clinical trial/ACCORD follow-up study?

Q6. Does the PAR require me to have an ACCORD investigator as part of my proposal?

A: If your study involves only the stored biospecimens and previously collected data, you do not need to have an ACCORD investigator as a collaborator. However, ACCORD was a complex clinical trial and the inclusion of investigator who is familiar with the trial may strengthen your application.

If you are proposing the collection of new data from the ACCORD Follow-on study, you must demonstrate collaboration with an ACCORD Steering Committee investigator. Please contact one or more of the ACCORD Steering Committee members (http://www.accordtrial.org/web/public/pi.cfm listed under Clinical Center Network Principal Investigators) to discuss your proposal. Additionally, you must obtain the approval of the ACCORD Steering Committee. This can be done by completing the ACCORD ancillary study application located on the ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) and submit it to ACCORD_Ancillary@wfubmc.edu prior to July 1, 2011 for the September 28, 2011 submission date.

Q7. How can I find out if a particular type of data was collected during the ACCORD trial?

A: The ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) contains a copy of all of the data forms used in ACCORD (see "Clinical Data Entry Forms"). Variable names for each of the items can be found under "Data Dictionary Forms".

Q8. What was the frequency of collection of data during the ACCORD study?

A: The time schedule for collection of the various data forms can be found in the "Visit Procedure Grids".

Q9. How was the participant consent for genetic studies obtained in ACCORD? Can the genetic material be used for any type of study?

A: The genetic consent used in ACCORD is a layered consent. Participants could agree to provide genetic material, have their genetic material used for any analysis or only those related to ACCORD Outcomes, and to the use of their genetic material by any qualified investigator or only ACCORD investigator. For a breakdown of the participants who consented for each of the above, please see the PAR section of the ACCORD website: Level of Consent for use of genetic material key data.pdf. A copy of the genetic consent can be found on the PAR section of the ACCORD Study protocol.

Q10. What is meant by an ACCORD investigator in the genetic consent?

A: An ACCORD investigator is any investigator that was a member of the ACCORD main clinical trial, ACCORD substudy, or ACCORD Ancillary study during the data collection period of the clinical trial portion of ACCORD.

Q11. If I have an ACCORD investigator as a collaborator on my grant, can I gain access to the genetic material of participants who consented to genetic studies by ACCORD investigators only?

A: No, the ancillary PI must be an ACCORD investigator. Having an ACCORD investigator as a collaborator is not sufficient.

Q12. Where can I find the number of participants who consented to the various layers of the genetic consents?

A: This information is posted on the ACCORD PAR website: https://www.accordtrial.org/web/public/parInfo.cfm under Level of Consent for use of genetic material key data.pdf.

Questions about data sets, data analysis, and data management

Q13. I want to do my own statistical analysis of the data. How can I get a data set?

A: The ACCORD Coordinating Center will provide investigators with a data set upon release of the public access data set in 2013.

Q14. I wish to conduct my statistical analysis prior to 2013. Is this possible?

A: If you wish to analyze your study data prior to the release of the public access data set, you will need to contact the ACCORD Coordinating Center. All analysis prior to 2013 must be conducted at the ACCORD Coordinating Center.

Q15. Will the ACCORD Coordinating Center submit the results of Genome Wide Association Studies (GWAS) to dbGAP?

A: No, the Coordinating Center will not submit the result of any GWAS studies to dbGAP. The ancillary study investigator is responsible for this. Submission of these results may be delayed until the release of the public access data set in 2013 (see Section IV. 6 "Other Submission Requirements" of the PAR for details).

Questions about biospecimens

Q16. How can I find out what types of biospecimens were obtained during the ACCORD trial?

A: The ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) contains a list of the biospeciments (see ACCORD_Stored_Samples) by study (glycemia, lipid, blood pressure).

Q17. How can find out how often a particular biospecimen was collected?

A: The ACCORD PAR website (http://www.accordtrial.org/web/public/parInfo.cfm) contains a list (see ACCORD_Stored_Samples) of the number of specimens by collection date.

Q18. I want to perform the biospecimen tests in my own lab. Can I do that?

A: All biospecimen tests must be performed in the ACCORD Central Lab unless there is strong scientific rationale to do it elsewhere (for example, the Central Lab does not perform the test). This is to minimize the loss of biospecimen and freeze/thaw cycles.

Q19. I need to know how the biospecimens were processed at the time of collection. Who can tell me that?

A: Please contact Dr. Santica Marcovina at the ACCORD Central Lab. Her email is: smm@u.washington.edu.

Q20. How many participants had DNA collected? I don't see that in the grid.

A: The DNA for ACCORD has not been isolated. The figure for white blood cells in the ACCORD_Stored_Samples tables should be used to determine how many individuals have stored DNA.

Q21. Will the DNA be isolated prior to the start of the ancillary studies?

A: No, there are no plans at this time to isolate the DNA. Investigators should include the cost of DNA isolation in their budget.

Q22. The ACCORD PAR states that my application may be shared with the ACCORD Central lab to coordinate assays. What does this mean?

A: After the peer review of the applications has occurred, the project office will review the grants that have potentially fundable scores and generate a list of assays and participants. This list will be shared with the ACCORD Central lab to determine which assays can be combined into panels and analyzed at the same time. This is done to minimize the number of freeze/thaw cycles that the biospecimens will need to undergo.

Questions about budgeting

Q23. What if there are multiple investigators that want to use the DNA? How will the cost of DNA isolation for each investigator be determined?

A: Since we do not know which grants will be funded at the time of submission, you should assume that you will need to pay for everything in your budget. Once the review has occurred and we have a list of potentially fundable projects, we will determine if there is overlap in the request for DNA. If there is overlap, we will readjust the budget in the grants to account for the overlap.

Q24: Who will pay for the cost of placing the results of Genome Wide Association Studies (GWAS) to dbGAP?

A: The ancillary study investigator should budget for the any costs related to submission of the results of Genome Wide Association Studies (GWAS) to dbGAP. Please see http://www.ncbi.nlm.nih.gov/bookshelf/br.fcgi?book=helpdbgap&part=Submit.Beginning_the_Submis for additional information on the submission process.

Q25: If the Central Lab will be conducting all of the biospecimen analysis, do I need to include that cost in my application?

A: Yes, you will need to include the cost of all biospecimen analysis in your proposal budget. Please contact Dr. Santica Marcovina at the ACCORD Central Lab. Her email is: smm@u.washington.edu.

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Last Updated June 2011