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Ancillary Study Policies & Procedures

Updated:  4/10/18

 

Ancillary Study proposals must obtain CHS and NHLBI approval before submission to a funding agency. 

To submit your proposal for review:  Download the Ancillary Study Proposal form from the Forms & Agreements menu

Instructions:

  • New Data Collection studies:  complete the full Ancillary Study Proposal form
  • Analysis-only studies:  complete Part 1 only + first planned paper proposal (online submission form via internal site (password protected))

Submission Deadlines:  

New proposals must be submitted to CHS a minimum of 6 weeks prior to a grant deadline, preferably earlier if the project involves a subcontract.

Upcoming Deadlines:

CHS 6-week Deadline NIH Deadline
4/24/18 6/5/18
8/24/18 10/5/18
12/21/18* 2/5/19

*adjusted due to holiday

Agreement with the Coordinating Center and, if applicable, the CHS Central Laboratory about the costs needed to perform an ancillary study is required for Steering Committee approval.

 

Policies Overview

An ancillary study is an investigation which is not part of the central, NHLBI-funded CHS protocol but uses CHS participants, samples, or data collected by CHS.  In most cases, an ancillary study will involve acquisition of additional data which are not compiled as part of the standard CHS data set.  Support for ancillary studies is derived from sources other than CHS contract funds. Examples include studies funded by investigator-initiated NIH research awards (R01s), grants from academic institutions, private sources (e.g. drug companies), or those performed at no cost (generally because of the special interest of a researcher).

Investigators are encouraged to propose and conduct ancillary studies.  Such studies enhance the value of CHS and ensure the continued interest of the diverse group of investigators who are critical to the successes of the study as a whole.  They provide an exceptional opportunity for investigators, either within or outside of CHS, to conduct additional projects at minimal cost.  Ancillary studies will require outside (non CHS) funding.
 

The Review Process

To protect the integrity of CHS, all ancillary studies must be reviewed and approved before access to CHS data or participants is permitted. The review process is as follows:

  1. New ancillary study proposals should be sent to the Ancillary Study Coordinator at the CHS Coordinating Center.  The Coordinating Center will ascertain that the form is completed satisfactorily and that Coordinating Center costs have been incorporated.  If all required parts of the proposal are included, the proposal will be logged into the Ancillary Study Tracking System and a file will be established.  If the form is incomplete, the initiator of the proposal will be contacted and requested to modify or add the required information.  Ancillary Study forms can be obtained by downloading them from the CHS website.
  2. The Lab Subcommittee will review the proposal to determine if issues pertaining to blood laboratory use need to be addressed.  Analysis-only studies will be reviewed by the Publications Committee. Both evaluations must be completed within 2-3 weeks.
  3. Following review by the Subcommittees, the proposal will be sent to the Steering Committee.  The recommendations made by the previous reviews will be attached to the proposal before it is submitted to the Steering Committee.
  4. Initial approval/disapproval will be made by the Steering Committee. The Steering Committee will be allowed two weeks to make their decision.   If concerns are major, Steering Committee comments will be sent back to the initial investigator for response and modification of the proposal if desired.
  5. Once approved by the Steering Committee, the proposal will be sent to the Project Officer for NHBLI (new data collection studies only). Three weeks are required for NHLBI approval.
  6. Once all approvals have been granted, letters documenting the approval will be sent separately from the Coordinating Center on behalf of the Steering Committee and from Project Officer on behalf of NHLBI.

 

Other Requirements of an Ancillary Study

Funding

No funds from the main CHS contract may be used to support an ancillary study in any way. Thus, it is crucial that a subcontract to the Coordinating Center or estimate for invoicing via fee-for-service account be included which will cover all data handling costs as well as data analyses if needed. Blood laboratory costs will be billed separately via a fee-for-service account.

All ancillary study proposals have 3 years to obtain funding, after which they will be withdrawn and must be resubmitted for reapproval (unless started without funding).

Industry Involvement & Patents

Ancillary study proposals must indicate whether a for-profit corporation is involved and whether intellectual property protection (i.e., patent or copyright, or to license any process, aspect or outcome of the study, including copyrightable software) will be sought. Local analyses performed by a for-profit corporation or an entity intending to seek intellectual property protection are required to be verified by the CHS Coordinating Center. The Coordinating Center may require that analyses also be performed centrally, depending on the extent of CHS data requested. Said corporation or entity must bear the cost of the analysis and/or verification via an agreement between the requesting organization and the University of Washington.

Proposals for 3rd party industry-sponsored studies require a formal agreement between the sponsor and the PI's institution. Agreements should be drafted according to NHLBI Guidelines and sent to the NHLBI Project Officer for review and concurrence as a condition for NHLBI approval of the proposal prior to completion of any DMDA.

For-profit involvement will necessitate that the dataset exclude participants who did not consent to use of their data by private companies.

IRB Review

The use of CHS data or biological materials is not exempt from review by an Institutional Review Board (IRB). If the Ancillary Study will be conducted at a non-CHS institution, evidence of IRB review must be provided to the Ancillary Studies Committee before the study begins.
Studies that will collect new data from participants must obtain a separate informed consent from all ancillary study participants.  This consent should clearly identify the ancillary study as one being performed in addition to the main study and inform subjects that their participation in the ancillary study is not necessary for them to continue in CHS.  IRB approval and the informed consent must be provided to the Ancillary Study Subcommittee before implementation of the proposed study begins.

Genetic Consent

If an approved proposal involves genetic studies, sample selection will  be based on the CHS informed consent status.  Ethical, legal and social implications, as well as reporting of results, must be proactively addressed in the proposal.

CHS Sponsorship

A CHS investigator or other approved collaborating investigator is expected to be a co-investigator or principal investigator on an ancillary study in the role of CHS sponsor. The sponsor is responsible for presenting the study to the Ancillary Studies Committee, monitoring the study to assure continuing compatibility with CHS and serving as a liaison to the CHS Steering Committee. In addition, manuscripts and abstracts are generally expected to include a CHS sponsor, except under circumstances that should be stated and justified as part of the original proposal.

CHS Site Involvement

All CHS sites designated for inclusion in the study must have agreement from the respective Principal Investigator.

Data Access and Integration

The data collected by the ancillary study and any accompanying documentation are first to be provided to the CHS Coordinating Center for integration into the main database. This must occur before the integrated file containing data from the main study will be sent to the ancillary study investigators. The ancillary study PI will be given the first and exclusive opportunity to analyze, present and publish data collected under the auspices of the ancillary study.  After a reasonable time (in general, 12 months after data collection and cleaning are complete), the ancillary study data will be made available for additional uses by other investigators. Collaboration with the ancillary study investigators who collected the data is encouraged. It is the responsibility of the ancillary study PI to state in writing to the Steering Committee any special circumstances that would militate against these guidelines for data sharing.  In the spirit of encouraging collaboration, reasonable and justified requests for limiting Steering Committee access to the data will be honored or some compromise will be worked out.

A manuscript proposal must be reviewed and approved by CHS before data from the main study will be provided to ancillary study investigators. For information on manuscript proposals, see “Publications and Presentations Resulting from Ancillary Studies” below. Studies that have a special arrangement with CHS may be exempted from this policy.

Time Limit for Approval

All ancillary studies have 3 years to become active (with or without funding), after which they will be withdrawn and must be resubmitted for reapproval.

 

Data Distribution Requirements

The Coordinating Center will send CHS individual level main study data to investigators of an approved ancillary study following:

(1) CC receipt of new data collected by the ancillary study & accompanying documentation (when applicable)

(2) Approved manuscript proposal

(3) Data and Materials Distribution Agreement (DMDA – applies to all non-CHS Investigators)
 

Publications Resulting from Ancillary Studies

All the publications from an ancillary study must be reviewed and approved by the CHS Publications Subcommittee (P&P), Steering Committee, and reviewed by NHLBI prior to submission, in accordance with CHS publications policy. (See Publications & Presentations Protocol for guidelines.

Modifications to Ancillary Studies

Substantial changes to the science or scope of an approved ancillary study require review by the CHS Steering Committee and, if relevant, Lab or Publications Subcommittee. The PI must submit to the CHS Ancillary Studies coordinator:

1. a revised study proposal with changes tracked, highlighted or bolded;
2. a brief modification request memo summarizing the changes and stating the rationale for the changes. The memo may be addressed to the CHS Steering Committee.

Substantial changes would include requests for additional biospecimens, significant additional data, or requests to add new outcomes or change the main analytical exposure. Formal modification requests are NOT needed for notification of a reduction in needed biospecimens or to add covariates or co-investigators, or to slightly modify the analytic approach. However, all such minor changes must still be communicated to the Ancillary Studies Coordinator.

 

Back to the Ancillary Studies home page

 

See also:

 

 

Contact information:

General questions:                    Erika Enright, CHS Research Coordinator: eenright@uw.edu, 206-897-1922

Data cost & availability:             Anthony Wilsdon, CHS Data Manager:  tonyw@uw.edu, 206-897-1917

Biological specimens:                Elaine Cornell, CHS Central Blood Laboratory:    Elaine.Cornell@uvm.edu, 802-656-8963

UW Subcontracts:                     Mary Lou Biggs, CHS Project Director:  mlbiggs@uw.edu, 206-897-1945                                             

Agreement with the Coordinating Center and, if applicable, the CHS Central Laboratory about the costs needed to perform an ancillary study is required for Steering Committee approval.