I. Statement of General Principles Regarding Clinical and Image Data Sharing
Overall Policy Goal: This policy provides information and guidelines for individuals and corporations wishing to request access to clinical or image data archived during ACRIN trials. ACRIN is committed to providing commercial and academic investigators an opportunity to access data collected as part of ACRIN studies for purposes that are consistent with the missions of ACRIN and the NCI. This may include ancillary research studies, technology development, and educational initiatives. The following policy is drafted to provide reasonable access to data while allowing ACRIN to meet its obligation of ensuring the data will be used responsibly, and that providing access will not burden ACRIN’s resources such as to impede its ability to pursue its primary research. Investigators interested in asking research questions of data collected as part of ACRIN trials are encouraged to do so as a collaborative effort within the ACRIN structure. This approach will engage ACRIN’s “know how” related to the data and the trial which will provide the best opportunity for a successful analysis. Requests to collaborate with ACRIN related to specific subject-matter research questions should be addressed to the applicable scientific committee (go to “Scientific Committes”on ACRIN’s Web site). The scientific committees are responsible for prioritizing projects within their research domain which, in turn, are forwarded for review by the ACRIN Steering Committee along with all requests for ACRIN resources. Requests to collaborate with ACRIN related to specific methodologic research questions should be addressed to the Biostatistics Center (go to“Biostatistics and Data Management Center ”on Brown University's Web site).
It is appreciated that ACRIN will not be able to support all requests for collaborative analysis and, therefore, the following policy for transfer of data to investigators for independent analysis is outlined below.
A. ACRIN archives the clinical and image data obtained as part of its clinical trial process. This archive is a resource that can be used for secondary research studies, to guide further technology development, and for educational purposes.
B. ACRIN encourages such use of its clinical and image data, however, has a resonsibility to ensure that their use remains ethical, purposeful and consistent with the missions of ACRIN and the NCI.
C. Any individual or entity may submit a request for clinical data (as collected and archived in the ACRIN database), image data, or images linked to clinical data archived as a result of an ACRIN trial.
D. In making the data available to individuals and entities, ACRIN is only bound by its responsibility to guard the confidentiality of study participants, sites, and participating readers (see H. below). No other responsibility is assumed by ACRIN about the data, except as specified in other sections of this policy document.
E. ACRIN data and images ordinarily will not be released to individuals or companies prior to the publication of the trial's primary aim manuscript. A companion or ancillary study based on ACRIN data and/or images typically is not to be reported before a trial's primary results are published.
F. In order to provide an academic incentive to institutions to participate in ACRIN trials and to accrue patients, researchers who have been involved in a specific trial have one year after the primary aim manuscript's publication to identify and begin work on a secondary aim paper in coordination with the trial PI and lead statistician. Extensions of the one-year period may be requested of the research dissemination committee.
G. Any data access preference for corporations facilitating the conduct of a specific ACRIN trial by contributing funds, agents, and/or equipment must be clearly defined and documented prior to accepting the contribution to include the specific data items requested and the timeline for receipt. Such arrangements must receive prior approval by the research dissemination committee.
H. The identity (and identifiable information) of trial participants, sites and ACRIN investigators will not be provided.
I. To the extent its resources allow, ACRIN aids individuals and/or entities in gaining access to its data archive, and generally requests payment for the cost of providing the requested data. It must be appreciated that the resources available to fulfill data requests are limited which may result in a prolonged timeline to satisfy requests. Limiting the requests to essential data desired may expedite data availability.
J. Under normal circumstances, ACRIN will reserve some portion of data from each study for use as a “test environment”. The quantum of information that can be made available will be communicated to the requestor.
K. At the completion of a study in which individual reader performance has been analyzed and summarized, a participating reader may request his or her own performance summaries. (See the Policy on Release for Reader Performance Data for more information.)
L. Individuals and corporations accessing and using ACRIN clinical or image data assume full responsibility for any and all uses of such data. Once the data has been successfully transferred, ACRIN is relieved of any further responsibilities.
III. Process for Submitting Requests
A. The application for requesting archived clinical and image data is available on the ACRIN Web site. Requests for access to the ACRIN archive should be sent to firstname.lastname@example.org.
B. In the case of independent researchers or corporations, requests should be of a research or educational nature or for purposes of technology development. Examples of projects include:
1. Image analysis studies
2. Reader performance studies
4. Radiologic/pathologic correlation
5. Cost Efficacy modeling
6. Development of educational material
7. Statistical methodology
C. Individuals or corporations may also request clinical or image data sets for such purposes as guiding further technology development or gaining regulatory or reimbursement approval.
D. Before indicating in a grant proposal that clinical and/or image data archived by ACRIN will be used to conduct the proposed research, an investigator should submit a request and obtain written approval from ACRIN prior to submitting the grant proposal. ACRIN treats such requests as it does any other, as detailed below.
A. The Research Dissemination Committee, which reviews and decides upon requests for archived clinical and/or image data sets on a regular basis, is composed of the following members:
1. The chair of the Research Dissemination Committee, who leads the discussions
regarding the requests
2. The ACRIN senior director or designee
3. The director of the ACRIN Biostatistics Center
4. Appropriate ACRIN support staff as needed
5. Invited representatives from the National Cancer Institute’s Cancer Imaging
6. Trial PI or his/her designee, whose input is invited in the case of trial-specific
B. The roles and responsibilities of the Data Access related to data distributed under the Data Sharing Policy include the following:
1. Reviewing all requests to access archived ACRIN clinical/image data by third party academic and commercial investigators to ensure that such requests are reasonably expected to result in a responsible use of data that will be consistent with the mission of ACRIN and the NCI.
2. Ensuring that manuscript representations related to ACRIN are accurate and that submission does not precede the primary trial publication
C. The review committee's recommendations are based on ACRIN-established criteria that consider such issues as:
1. The scientific quality of the proposal
2. Potential impact of the proposed project
3. Whether the scope of the data request is consonant with the scope of the scientific project in which data will be used
4. Whether the requesting party has sufficient resources to carry out the project
5. The performance of the investigators in employing ACRIN clinical/image data sets in the past
6. Whether the primary aim manuscript has been published
7. Whether the request conflicts with a secondary aim, either stated in the protocol or identified at a later date, and it is within a year of the publication of the primary aim results
8. The resource requirements needed to provide the requested data
The criteria, which may change from time to time, are widely promoted via the ACRIN Web site.
D. For studies that are still open to accrual or follow-up, permission of the Data and Safety
Monitoring Committee is required prior to any data release under this policy.
V. Requestor’s Responsibilities Regarding Data Use
A. Access to ACRIN archived clinical and image data is provided within the parameters described below:
1. The specific purpose for the data use must be agreed to by the individual requesting the material and ACRIN at the time that the request is approved.
2. The data set may be used only for that purpose and only by the requesting party.
3. The data may not be passed on to or shared with a third party unless first agreed to by ACRIN.
4. The data may be used only for the time period specified in the ACRIN request approval.
5. In the case of corporations, ACRIN must be informed of situations in which clinical/image data sets are passed on to collaborating corporations and the intent in sharing the material.
6. Those granted access to the ACRIN archive are required to sign a statement indicating their agreement with all policies prior to being allowed access to ACRIN clinical or image data.
7. Manuscripts must be submitted to the ACRIN DAC one month prior to journal submission for review to ensure representations related to ACRIN are accurate. Feedback to investigators is non-binding; however, investigators publishing manuscripts that appear to misinterpret ACRIN data risk the submission of commentary or letter to the editor by ACRIN.
8. Any publication based on ACRIN data/images must cite ACRIN as the source of data.
9. Reprints or photocopies of published manuscripts must be submitted to ACRIN headquarters at the time of publication.
10. The BDMC's participation must be acknowledged in a manner appropriate to the
nature and extent of its contributions, including authorship when warranted.
The National Cancer Institute has reviewed the ACRIN Data Sharing Policy and is in agreement with its intent and data sharing process.