Biospecimen Policy

Rules and Guidelines for Approval of Proposals Which Utilize Stored Biosamples

As of May, 2015:

Anyone considering a CHS Ancillary Study that would use stored samples must contact the Central Laboratory as early as possible in their planning process. While there are still many CHS samples in the Repository, some sample types are limited, and any given study may not be feasible. Also, please especially note #10, below.

1. We do not set aside samples while projects are being reviewed for funding or in other ways delayed or not ready to start; we will try to work with investigators to assure availability by the time of funding.
2. We only consider projects of high scientific merit, as assessed by the Lab Committee.
3. We only consider projects that are consistent with CHS Mission and Goals; the project must add substantially to CHS.
4. We only consider projects for which CHS samples are the best resource available; in other words, why CHS samples rather than ARIC, CARDIA, MESA, etc?
5. We will approve year 9 samples first; justification is needed to obtain year 5 samples; further justification is needed to obtain year 2 samples.
6. We will approve thawed samples first; justification is needed to obtain unthawed samples.
7. We will approve the sample type (serum, EDTA, citrate) in greatest abundance first; justification is needed to obtain samples with lesser abundance.
8. We will only approve a sample volume of 250 uL or less; a Steering Committee vote is required to approve more than that.
9. We will leave one unthawed aliquot; a Steering Committee vote is required to use the last unthawed aliquot.
10. We will only consider proposals with an attached Repository Report (an estimate of the impact of the proposal on the Repository) obtained by the applicant from the Central Lab in Vermont (two weeks are needed for preparing such a report before submitting a proposal for approval).
11. We will only consider proposals in which the proposed assays have been validated as sensitive enough and reproducible enough for the study; if done at an outside laboratory, that laboratory must provide evidence that they understand population-based assay work, including a brief review of quality assurance/quality control.
12. We will consider the following issues as important in prioritizing proposals:
    
    1. Does the proposal integrate activities with other studies to limit freeze-thaw cycles?
    2. Is the proposal important to a new investigator(s)?
    3. Does the proposal help fill out the overall CHS portfolio?
13. Approved ancillary studies have 3 years to become active (with or without funding), after which they will be withdrawn and must be resubmitted for reapproval.

To request a Repository Report: Elaine Cornell, Central CHS Blood Laboratory, Vermont