Frequently Asked Questions (FAQs)

Q. It is still unclear to me how the money for this whole genome proposal is being distributed. The 2 million dollars to Cox I understand-but what about the budget for the members of the consortium who may collaborate on the study?

A. There is no money available for the investigators. The $2 million will cover the experiments and most of the data analysis by Perlegen. It may be possible to request a supplement to do secondary data analyses, etc. once the primary results have been obtained and/or submitted for publication. These would be competitive with all other supplements as there is no current set aside for them.

Q. I stongly feel that we need to have the data on at least the 45,000 snps. If we do not have the full sample, how do we determine significance? The reality is that multiple testing did occur and we are blind to it. How do we publish this? How would we determine a significance level?

A. Answers to these questions (and other questions on methods, statistics, etc) are forthcoming and we will try to get them to you as soon as we can. We do know that Perlegen will be making all of their data public by July. This means that you will have access to their entire database.

Q. Can we extend the deadline from July 1 to a later date?

A. We discussed this with Dr. Volkow, the NIDA Director, and we agreed that the deadline can and will be extended to August 15.

Q. An emergency kept me from participating in today's telephone conference. Will minutes of the meeting or a synopsis be available?

A. No minutes are available, however, the purpose of this communication is to address the issues that came up during the meeting.

Q. Further, I hope that we will have more than one additional phone conference on the Access genome scan issue.

A. We agree. We are happy to set these up as needed.

Q. Can an investigator requesting access to the resource for a genome wide SNP use samples and clinical data not currently in the NIDA Center for Genetic Studies?

A. Yes with the following conditions:

It is expected that

• A comprehensive and verified databases that contain clinical, diagnostic, pedigree structure, and genotypic information collected or produced exists for the clinical data
• Unlimited amounts of High quality DNA are available, preferably through cell lines.
• A mechanism or protocol and appropriate informed consent by which all databases and biological materials (DNA samples, cell lines) can be widely searched or distributed to qualified investigators in the scientific community
• Clinical data and DNA will be available for distribution within 12 months after the genome wide association scan has been completed.
• The clinical Data and DNA used in a publication are readily available for access by qualified investigators around the world.
• The data collected must conform minimally to the data requirements for NIDA Genetic Consortium membership
• Distribution of DNA and clinical data will be done at the expense of the investigator who originally collected the clinical data and DNA but did not join the NIDA Genetics Consortium and thus did not place the DNA and Clinical Samples in the repository originally. As outlined in NOT-DA-04-006, sufficient amounts of DNA to be used for verification of results, or which qualified investigators may request must be available for distribution after the scan has been completed. It is the responsibility of the PI to describe how the DNA will be made available and how much will be available after the scan has been completed.
• The PIs must become members of the NIDA Genetics consortium by August 15, 2004 and agree to abide by stipulations for membership the NIDA Genetics Consortium.

Q. Will an NIH lawyer be present to discuss some consent issues that came up during the phone conference?

A. We have requested our lawyer call in on the next conference call (May 21, 11 AM EST). However, in case he cannot be there, his office has addressed some of the issues in the next several Q & As below.

Q. There may be some difficulties for us to participate in the study if it is true that NIH has assigned 100% of the intellectual property to Perlegen. More details on the specifics of the agreement are needed so that we can make a decision concerning our potential involvement.

A. According to the Bayh-Dole Act, both Perlegen and the institutions will have standard patent rights. However, it should be noted that the institutions will retain most of the rights. The DNA being sent to Perlegen to do the study will not have clinical data associated with it. It will just have case/control status, age, ethnicity, and any other variable that may be important for matching. Other than that, Perlegen will not be able to make associations with the phenotype-they will simply be able to know which SNPs vary significantly between the cases and controls. If institutions patent something, Perlegen does not have reach through rights to the patent. Furthermore, all inventions have to be disclosed to the NIH Office of External Inventions-thus any inventions Perlegen makes or the institutions make will be reported to NIH. NIH does not believe it is appropriate to file patent applications on SNPs without more information other than case/control status and encourages Perlegen and the institutions not to file on such applications.

Q. Investigators from different institutions will be collaborating on this study. How do property issues get handled when multiple institutions are involved in a study?

A. This is really up to the institutions. Each institution would have equal rights in its inventions. The non-profit institutions cannot assign rights to one institution without the permission of NIH. Of course they can jointly own joint inventions.

Q. Consent issues-if Perlegen (or anyone else) patents data or SNPs obtained from patient samples, is it generally true that by signing the consent forms that they give up any claims to ownership of any product of commercial value that may be developed by using a subjectÕs blood sample?

A. Under most state law, subjects do not have property rights to the findings or materials produced. If you feel that your consent form does not explain this sufficiently, you should ask your IRB to re-review the form and determine if additional steps are needed.

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