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Investigators are encouraged to speak with the HRCC Manager early in the application process to determine which services can be provided by the High-Risk Cancer Clinics and which services are ordinarily paid with investigator funds. Services which are normally covered by investigator grant funding are ongoing genetic counseling services, study coordinator services, testing fees, and biospecimen shipping.

The High-Risk Cancer Clinics resource is funded by the Huntsman Cancer Foundation and the National Institutes of Health. Level of support for a particular project (provision of specific data, specimens and/or staff support) will be determined by the High-Risk Cancer Clinics Management.

In most cases, investigators will not be given data which include patient names. However, if an investigator is approved to access individually identifying information, he/she must not release any information that could identify a person or a family to anyone outside of the approved research group. Such information would include name, Social Security number, and address but also might include pedigree information and any combinations of medical and other information that might identify a unique individual. The investigator must agree to keep such information secure. Non-identifying yet descriptive information (such as pedigrees) must be made as anonymous as possible and kept confidential, although falsification of data or pedigrees is unacceptable. Please contact Jahn Barlow, RGE Director, (581-6351) for specific technical advice on how best to accomplish this.

The principal investigator is responsible for assuring that resource data are kept confidential. All collaborators and study staff with access to individually identifying information are required to sign a Confidentiality Pledge, and copies of those will be kept on file in the High-Risk Cancer Clinics Administrative Office.

1. manuscript review:



1. Manuscripts describing research supported by the High-Risk Cancer Clinics must be submitted to the HRCC Administration for review prior to publication. Please submit your manuscript to the HRCC Manager for distribution to the appropriate reviewer.



2. Manuscripts describing use of the Utah Population Database (UPDB) must also be submitted to the Resource for Genetic and Epidemiologic Research (RGE) prior to publication to ensure that the resource is accurately referenced and for review of confidentiality issues. Please contact the Director of RGE for details. (See staff list for contact information.)


2. acknowledgment of funding sources:

Any publications resulting from use of High-Risk Cancer Clinic resources must acknowledge the support of Huntsman Cancer Institute, and the Huntsman General Clinical Research Center. Please include the following footnote in all publications:

"Research resources were provided by Huntsman Cancer Foundation and the Huntsman General Clinical Research Center (NIH MO1 RR00064)."

In a similar way, include acknowledgement of any other public and private sources of funding (such as National Institutes of Health, American Cancer Society, etc.).

3. joint authorship:

We ask that you include the Medical Director of the appropriate High-Risk Clinic in the development, design and analyses of your project. We would expect that, in the majority of cases, this will result in joint authorship with that Director. This individual retains the right to review and approve the final version of the manuscript before submission for publication.

4. reporting of publications to HCI:

In order to justify continued funding of the High-Risk Cancer Clinics program, we maintain a listing of HCI-supported research publications. We will contact you annually for a list of publications that have resulted from your work using these resources, and also request that you forward copies of these publications to us as they become available.

All communications with the press concerning subjects and/or pedigrees must be approved by Huntsman Cancer Institute. Please contact the HRCC Manager.

The Huntsman Cancer Foundation has an agreement with the University of Utah that allows a first right of refusal to any intellectual property resulting from research conducted here. Therefore, you must declare any corporate associations or corporate sponsorships, or any forward licensing agreements that you may have (include this information on the "Terms of Agreement" form included with your application). If this provision creates a conflict for you (e.g. because of corporate support in your laboratory) please contact the Senior Director of the High Risk Cancer Clinics. (see staff list)

To ensure reasonable management of the data collected and distributed, we request that power calculations be performed to justify the requested sample size. We encourage you to contact the Director of the HCI Biostatistical Resource if you have questions about this calculation. (See staff list for contact information.) You may choose to apply for help through the Biostatistical Resource website at http://www.huntsmancancer.org/2030.html.

We request that you inform us of all individuals with whom you collaborate or plan to share the data/resources released to you for this project. Any collaborator or staff affiliations with a for-profit corporation must be declared in the application to use the resource. Please note that such a relationship does not mean that the application will be denied, only that it must be reviewed and approved by the Senior Director of the High Risk Cancer Clinics.

In order to keep the information in our databases current, we ask that you return change-of-status information to the research coordinator assigned to your project. This information may include change in contact information, address, referring physician, disease status, etc. The HCI research coordinator assigned to your project will work with you prior to the beginning of your project to determine what information will be returned to HCI and how.

Post-study communications with participants (e.g. newsletters, other correspondence) must be reviewed and approved by the HRCC Manager.

All resources provided by the HRCC to your project are released only for project-specific use. No data or specimens shall be transferred or reissued to other scientists at the end of the study, nor shall the data or specimens be reused for a subsequent project unless that project has been independently submitted and approved. We ask that you state in your application whether you will destroy or return data at the end of the project.

Any investigator who leaves the University may not take identifying information on research participants to a new location. If the HRCC data that is requested to move with the investigator includes scare resources, or if the investigator is moving to a for-profit company, specific approval and agreement must be obtained through the Senior Director of Research for the High Risk Cancer Clinics.

There are several steps a departing investigator needs to complete; please consult with the HRCC manager and/or the Director of the RGE for advice on the following items:

1. name and receive approval for a current HCI investigator who will act as a replacement PI and accept responsibility for the project;



2. specify which data is requested to take to the new setting and outline measures to keep this data secure;



3. complete a Material Transfer Agreement with the University's Technical Transfer Office;



4. negotiate a time line for completion of the project with the appropriate medical director;



5. keep the current IRB active or secure IRB approval from the new location;



6. contact the University's Office of Sponsored Projects to follow their procedures for departing investigators.