Appendix C Jackson Heart Study Policies and Procedures for the

advertisement
Appendix C
Jackson Heart Study
Policies and Procedures for the Research Disposition of
Participant Archived Blood and DNA Specimens
Policy
The Jackson Heart Study (JHS) has an irreplaceable and non-renewable archive of participant blood and
DNA specimens. As guardians and custodians of this valuable resource, we have established the
following procedures, which are propagated and developed to assure their appropriate use for research
purposes.
The goals and purpose of the Jackson Heart Study are attached.
The archive of specimens provides a unique opportunity to comply with the JHS goals and purposes
today and in years to come for the scientific elucidation of more and more risk factors for cardiovascular
and cerebrovascular disease. This document specifically defines the process for requesting specimens,
criteria for the evaluation of the request, and assurances that the specimens will meet the expected goals
of the research proposal.
Procedure
The applicant for the JHS archived specimens submits in duplicate the completed application:
“Application to Jackson Heart Study Archived Specimens” available on the JHS website
http://jhs.jsums.edu/jhsinfo along with the Ancillary Studies Application. The Ancillary Studies
Subcommittee will submit the “Specimen Application” to the JHS Lab Subcommittee for review. After an
administrative review to determine the completeness of the application, nature of the request, and review
of records to assure that the request is not a duplication of other JHS research, the application is reviewed
by the committee to determine the following:
1. Documentation of the scientific authenticity for the request for participant blood or DNA
specimen
a.
b.
c.
d.
e.
2.
Are the goals and objectives compatible with those of the JHS?
Are the scientific methods described sufficiently to evaluate the potential for success?
Are the methods correct for the goals of the research?
Is there sufficient information to ascertain the potential for success?
Is the literature review appropriate?
Availability of the requested specimen in accordance with the updated Specimen Tracking Table
3. Impact of the request on the archive:
a. Does sample to be used exhaust that specific volume of archived sample, or after freeze
thaw, can the residual specimen be used for other research?
b. What kind of sample is left for future research?
c. Do the goals and outcome of the research justify the use of this limited specimen?
1
4. Impact of request on future requests for these kinds of samples as they relate to the permanent
threshold for a sample to be archived in perpetuity.
5.
Does this request exhaust our archive except for that archived in perpetuity?
6.
Does the researcher have resources to properly store the specimen:
Example: When stored at freezing temperatures until analyzed, -700 C, does the laboratory have
emergency power to the freezer 24/7 to prevent loss of the specimen with the loss of electricity?
7.
What will happen to any residual specimen?
Criteria Required to Establish Priority Order
For studies involving serum and plasma, smaller volume requests are viewed favorably. V250 uL or less.
1. The sample type (serum, EDTA, citrate) in greatest abundance will be approved first; justification
is needed to approve samples with lesser abundance.
2. The priority order for approval of samples is first Exam 2 and 3 samples and last Exam 1
(baseline) samples. Justification is needed to approve baseline samples.
3. Release of a scarce sample may be delayed until there is more than one user of the specimen at
the same time.
4. Release of a scarce sample may be delayed because of the need for sample analysis (e.g.,
genotyping) to be conducted within a study or lab of an already existing study, with the
agreement that the investigator proposing the new analyte or SNP analysis will be provided the
data(e.g., SNP or analyte) through the JHS data release policy.
5. Small sample required with small impact on archive
6. DNA methods not using plasma or serum
7. New method providing better analysis of a controversial parameter
8. Directly related to known and accepted risk factors for the JHS population
9. Results will have immediate impact on patient interventions
10. New parameter (risk factor) identification in the JHS population
11. Risk factor or parameter for comparison to another study
12. New parameter that would validate or explain findings in another study
General Requirements for Approval
1. The application has been properly submitted on a “JHS Archived Specimen Application Form”,
with an acknowledgement from prospective investigators that the policies and conditions
specified by the JHS will be followed.
2. There is documentation that after analyses are completed, any residual specimens will be returned
without delay to the Central Laboratory for re-inventory and storage.
3. Documentation is provided indicating that JHS is the best resource available
4. The project is consistent with the JHS mission and goals and will add substantially to the JHS
2
Scenarios for Disapproval
1. The study exhausts a very limited specimen supply, preventing future research
2. The details on how the samples are to be stored and maintained at the research site is not evident
in the proposal
3. Use of the last unthawed aliquot of DNA will not be approved
4. Proposals for pilot studies using JHS specimens will not be considered
5. Based on expert analysis the proposed research cannot be done as described
Committee Action
Upon completion of the written response to the assessment questions and their documentation, the
committee will review the documents and determine whether the specimens should be made available.
Approved: The archiving center is notified in writing or electronically that these specimens are
to be sent to the applicant. All important telephone numbers and any known specimen handling
issues etc are on file. The Archiving Center will make written and verbal contact with the
applicant to assure proper receipt of the specimens.
Approved but delayed: The committee will notify the applicant that the request is approved, but
must be delayed because of the limited specimen volume, and the need to have more than one
user of the specimen at the same time.
Not Approved: The committee will notify the applicant in writing that the request is not
approved and why. Reapplications will be encouraged.
Audit Process
1. Quarterly Rectification of Specimen Releases and Notification of Available Specimens
2. Quarterly Audit of the Requests of the Last Quarter, and Yearly, and Request Dispositions
3
JACKSON HEART STUDY
Application for Jackson Heart Study Archived Specimens
Date:
Title of Proposed Project:
Purpose of Project (one paragraph, use appendix for additional information):
Name, Degrees and institutional affiliation of Project Director/Principal Investigator:
Address:
Email Address:
Telephone/Fax Numbers:
Names of other participating investigators (list name, role in project, and contact information):
4
Name of Co-investigator
Co-investigator’s Role on Study
Contact Information
Position and Institution Affiliation
(Address/Phone/E-mail/Fax)
Name of Intramural Jackson Heart Study investigator who will provide a primary liaison:
Specific Measurement(s) Requested for known analytes:
1. List of tests to be measured and specific kinds of specimen required for each analyte
(serum, plasma, urine, DNA), volume of specimen, and numbers of participants.
a. Test
b. Kind of specimen
c. Amount of specimen
d. Number of participants
2. Exam cycle requested:
3. Location of Laboratory Performing analysis:
a. Address:
b. Investigator Contact numbers:
c. Means of specimen delivery to the laboratory
d. Storage resources: Emergency power for freezers etc.
e. Bar code reader available: YES___ NO_____
5
4. Method of analyses for each measurement requested (list)
a. Test(s)
b. Method of analysis: ELISA, RIA, HPLC…
5. Reproducibility (Percent intra-assay variability) of each measurement.
6. Upper and lower limit of analytical range of each measurement.
7. Number and kind of JHS archived applicable specimens currently in the research
laboratory.
8. Disposition of any residual specimen
9. Acknowledgement that policies and conditions specified by the JHS will be followed.
Specific Measurements for a New analyte/marker:
Name of test:
What is the test for and what does it provide for the JHS?
References for the method?
Kind of specimen required?
6
Download
Related flashcards

Cardiology

71 cards

Heart diseases

42 cards

Create Flashcards