Extramural NCI Data Access Committee: Charter
1. Charge to the Committee
The Extramural National Cancer Institute (NCI) Data Access Committee (DAC) will review and approve or disapprove all requests from the research community for access to controlled data of genome-wide association studies (GWAS) of cancer and other genotype-phenotype studies (including sequencing and molecular diagnostic assays) for which it is responsible. The Committee evaluates if the request conforms to NIH policies and procedures including consistency of the proposed research use with data use limitations stipulated by the submitting institution for each study. "Research community" includes NIH staff who request access to datasets for research purposes.
The NCI DAC will also maintain records of all NCI employees requiring access to those controlled datasets for programmatic oversight and research purposes.
2. Composition of the Committee
NCI's DAC will be composed of a minimum of ten NCI senior staff members with appropriate scientific, bioethics, and human subjects' research expertise. Members will be appointed for a term of two years, and may serve more than one term. In the initial phase of the NCI DAC the length of first term will be variable (2 or 3 years), as determined by NCI DAC members.
To ensure continuity, three alternate members with appropriate expertise will be appointed; they will meet the criteria for NCI DAC membership. One alternate will have experience in bioethics or human research participant protection issues, and one will have experience or expertise in genetic or genomic research. Alternate members will be asked to attend meetings when it is anticipated that a quorum of members will not be available for reviewing requests; for these meetings alternate members will be considered voting members of the DAC. Alternate members will be provided orientation, including written material on NCI DAC procedures and studies and will have attended at least one NCI DAC meeting prior to serving as an alternate.
Guests with specific expertise may be invited to meetings or to provide written consultation. Investigators submitting GWAS data under the NIH data sharing policies may also be invited to attend DAC meetings. Guests may be Federal or non-Federal employees, and are not voting members of the DAC. Changes to the NCI DAC membership must have a unanimous vote.
Staff support of the DAC will be provided by NCI.
3. Scope of Work
What the NCI DAC will do:
The NCI DAC will review and approve or disapprove all requests from the research community for access to datasets assigned to them, as long as the request conforms to NIH policies and procedures including compliance of the proposed research use with data use limitations stipulated by the submitting institution for each study. The NCI DAC will consider all requests for access to data through the review of incoming Data Access Requests (DAR), submitted using the SF 424 [R&R]). Prior to DAC review of an incoming access request, DAC staff will review the relevant Websites for any current ban on research with human subjects involving the Requesting Investigator or his/her institution. Submission of a DAR indicates that the Requesting Investigator (Requester) and his/her institution have agreed to the terms and conditions for data use specified in the Data Use Certification (DUC) for each dataset requested. For example, the NIH GWAS Data Sharing Policy (detailed in the DUC agreement) requires that Requesters, at a minimum, agree to:
- Abide by the agreed upon research uses of the requested dataset,
- Not seek to identify individuals within the dataset,
- Not distribute the data in any form to any entity or individual other than his/her research staff or trainees or independent collaborating investigators listed in the DAR under "Research & Related Senior/Key Person Profile,"
- Keep the data secure, and
- Acknowledge NIH GWAS as appropriate in publications and presentations.
What the NCI DAC will not do:
The NCI DAC is not charged with:
- Determining that the data should be available for research access,
- Ensuring that, before the dataset is submitted for distribution through the NCI, the submitting investigator is in compliance with any applicable Federal, State, and Local laws and has adequate participant consent,
- Evaluating the scientific merit of a DAR, or
- Ensuring that a Requester is in compliance with local human subjects protections.
4. Conflicts of Interest
Conflict of interest will be consistent with NIH definitions and policies for Program Officials as described in the NIH Policy Manual. Conflict includes, but is not limited to: scientific publication with a Requester or a Co-Investigator listed on a DAR within three years of the submission date of the Request (excluding consortium publications with large numbers of authors, e.g., publications by case-control consortia or cohort consortia); supervisory relationship with a Requestor or a Co-Investigator listed on a DAR or listed as a Requester or a Co-Investigator on a DAR.
DAC members, alternate members, and guests are expected to review DARs in advance to identify conflicts and communicate them to DAC staff.
DAC members, alternate members, and guests will recuse themselves from, and will not be present for, discussion and voting for DARs for which they are in conflict. Any conflicts of interest will be recorded in the minutes.
Using a standardized DAR review checklist (template is available upon request), NCI DAC staff will review DARs to determine whether applications are complete prior to sending the request for a full NCI DAC review. Prior to a full NCI DAC review, NCI DAC staff may ask for more information from the Requester and/or her/his institution if necessary. Following this preliminary review, NCI DAC staff will post the DAR and completed checklist on a private Website. DAC members will then have the opportunity to review each request prior to voting. From an initial request, the ideal timeline for an NCI DAC decision is 15 working days.
A quorum is defined as more than 50% of the NCI DAC members.
Decisions about Data Access Requests
DAR will be reviewed by NCI DAC members who will vote via e-mail to approve, disapprove, or discuss the request. Voting responses will be tracked by NCI DAC staff. If a quorum of NCI DAC members vote by the stated deadline and the vote to approve or disapprove a request is unanimous, the request can be approved/disapproved without discussion at a DAC meeting. The decision will be reported at the next NCI DAC meeting. If the vote is not unanimous, the request will be reviewed at a NCI DAC meeting for which a quorum is present in person or on the telephone. The NCI DAC will strive to reach consensus for decisions about DARs. If consensus cannot be reached, the decision will be made by a simple majority vote of the NCI DAC members (i.e., more than 50% of the number of current NCI DAC members must vote for approval for data access to be granted for a request).
If a NCI DAC member is not able to attend a meeting at which DAR will be discussed, the member can raise issues and vote via e-mail. If the NCI DAC member votes by e-mail prior to the meeting and important issues are raised at the meeting that may affect the member's vote, as judged by the members attending the meeting, the member who voted by e-mail will be informed of the discussion and given the opportunity to reconsider her/his vote.
If it is anticipated that a quorum will not be present for making decisions about DARs at a DAC meeting, an alternate(s) will be asked to attend. At least one NCI DAC member or alternate with experience in bioethics or human research participant issues, and at least one NCI DAC member or alternate with experience or expertise in genetics or genomics research will be present for making decisions about DARs at NCI DAC meetings.
The decision-making process will be reviewed by the NCI DAC members at least once a year to determine whether changes need to be made.
NCI DAC meetings are closed meetings. Guests must have a specific reason for attending the meetings, such as monitoring or learning about NCI DAC procedures or providing consultation.
Generally, guests are not expected to be participants in NCI DAC discussions. They may raise relevant points during meetings but are expected to yield the discussion to NCI DAC members.
Guests must have the permission of the NCI DAC Chair to attend. Permission will generally be granted when the criteria in the first paragraph are met.
Procedures for Checking Elements for Research Use
Authentication and Terms of Access
Applicants and their institutions are authenticated through the electronic application process, which requires eRA Commons login. To successfully submit a DAR, Requesters and their institutions must agree to the terms of access specified in the DUC. Thus, authenticating Requesters and confirming agreement to the DUC require no further steps by the NCI DAC.
Generally, Institutional Review Board (IRB) or ethics approval is not required for access to data. By agreeing to the terms of access in the DUC, Requesters and their institutions are certifying that any applicable Federal, State, and Local laws are being followed and that, if applicable, a Requester is in compliance with local human subjects’ protections. NCI DAC staff will not review the IRB or ethics board approval letter, but may request the approval.
Single institution application
- The Principal Investigator (applicant) must be a full-time faculty member or government/private sector equivalent employed by the requesting institution.
- The Principal Investigator of the DAR and all collaborators listed as part of the request must be from the same institution. If they are not, NCI DAC staff will contact the Requester to explain to her/him that collaborators from different institutions will have to submit separate requests.
Sanction check for PI, co-PIs, and Institution
NCI DAC staff will check for Federal sanctions, by querying the following databases:
- The Excluded Parties List System: This site is provided as a public service by the General Services Administration (GSA) for the purpose of efficiently and conveniently disseminating information on parties that are excluded from receiving Federal contracts, certain subcontracts, and certain Federal financial and nonfinancial assistance and benefits.
- PHS Administrative Actions Listing: The bulletin board currently includes the names of individuals that have had administrative actions imposed against them by the Office of Research Integrity (ORI). It lists individuals who have had research misconduct findings made against them by the Public Health Service (PHS). PHS jurisdiction is limited to actions that fall within the definition of "research misconduct"and involve research that is supported by PHS research funding. Financial allegations, IRB issues, etc., are outside ORI's jurisdiction.
- FDA - Disqualified/Restricted/ Restrictions Removed/Assurance Lists for Clinical Investigators: The following lists contain the names of all clinical investigators who previously agreed to certain restrictions with respect to their conduct of clinical investigations:
- Disqualified / Totally Restricted List for Clinical Investigators
- Restricted List for Clinical Investigators
- Restrictions Removed List for Clinical Investigators
FDA also makes available a separate list of firms or persons debarred pursuant to the debarment provisions of the Federal Food, Drug, and Cosmetic Act (Debarment list):
- FDA Debarment List
Compliance with any data use limitations identified by the institutions that submitted the dataset(s):
The DAC members will review the research use statement provided by the Requester and information provided by the submitting institution, to determine whether the proposed research use is consistent with any data use limitations identified by the institutions that submitted the dataset(s).
Decisions on requests for access to datasets registered with the National Center for Biotechnology Information’s (NCBI) Database of Genotype and Phenotype (dbGaP) are relayed in an automated fashion through dbGaP. Any decision by the NCI DAC not to grant access will be conveyed to the Requester with feedback on the reasoning behind the determination, for instance, a brief summary of the points considered about the proposed use and how these were not consistent with the data use parameters for the dataset in question.
Reconsideration of DAC decisions
If a Requester contests the NCI DAC’s decision regarding the appropriateness of his or her access to data, the Requester may contact the NCI DAC Chair to discuss the issues or resubmit her/his request.
DAC Annual Reports
Annual Reports summarizing DAC activities will be generated by the NCI DAC Administrator and NCI DAC Chair and will be due in September, at the end of the fiscal year.