Policy for Access and Distribution of ATN Resources
ATN resources that AMLG Principal Investigators may request to access are discretionary
funds, databases, and repository materials. During the course of ATN studies, databases and
repository materials will be accumulated which investigators may find beneficial for other
studies.
Stipulated discretionary funding is available within the ATN. Given the amount of this funding,
the most likely studies to be funded are 1) small pilot studies demonstrating feasibility of an
intervention or approach, 2) small pilot studies providing preliminary data to support further
development of a protocol or 3) testing of repository samples collected along with other data in a
targeted study. Another potential use of discretionary funds is to support personnel to complete
informative studies using available databases or repositories. Since discretionary funds within
the ATN may be limited, protocols selected for the network should be consistent with the
Network’s set scientific agenda.
To apply for the use of ATN discretionary funds, databases, or repository materials, an AMLG
investigator will follow the procedural steps for Study Concept Plan Development: a Protocol
Concept Capsule with a proposed budget is developed and presented to the appropriate group
for review, the Behavioral Leadership Group or the Therapeutic Leadership Group (BLG/TLG). If
approved by the BLG/TLG, the full AMLG reviews and prioritizes the Protocol Concept Capsule
and a full Protocol Concept Plan will be developed for review and approval by the AMLG. If
approved by the AMLG, the Protocol Concept Plan will then be presented to the Executive
Committee for review and approval in the context of the approved research agenda.
Alternatively, a full Protocol Concept Plan could be presented to the BLG/TLG if the study is
within the prioritized research agenda of the AMLG; if approved by the BLG/TLG, the Protocol
Concept Plan would then be presented to the AMLG and subsequently to the Executive
Committee for approval. Requests from non-AMLG investigators to access ATN resources must
be made through an AMLG principal investigator. Given the cooperative agreement for funding
within the ATN, final approval of all ATN approved usage of discretionary funds is dependent on
NICHD review.
Policy for Access of REACH Repository Specimens
Specimens exist in a contract repository, McKesson Bioservices, funded by NICHD: cells,
plasma, vaginal/anal swabs and cervical-vaginal lavage. All specimens were collected from
REACH subjects with site-specific certificates of confidentiality in place.
The specimens from REACH sites that did not continue in the ATN (n=5) have been rendered
anonymous. Proposals for these limited specimens may be judged on their scientific merit
alone. For the remaining specimens in the repository links to personal identifiers exist and these
proposals require full IRB review. Practically, this distinction is unlikely to matter for most studies
which will require specimens from both types of REACH sites.
All specimens are linked by subject identifiers to the REACH database and thus can provide a
wealth of supporting data to proposed analyses. In addition, since the identifier link remains for
the majority of subjects in REACH, follow-up studies can be proposed with the capacity for
prospective data and specimen collection from the majority of REACH sites.
Requests to Access REACH Repository Specimens
All requests to access REACH repository specimens must be submitted with a written proposal
to the AMHARN Steering Committee. After 30 November 2001, requests to access REACH
repository specimens should be submitted to the REACH Repository Committee (Send to
cjp@uab.edu for distribution to the committee).
Duties of the REACH Repository Committee include:
(1) Provide the NICHD IRB with the information it needs to set the conditions under which
specimens can be shared;
(2) Review all proposals to access the SID-linked REACH database and the REACH
specimens maintained in the NICHD-funded repository for
(a) scientific validity
(b) feasibility, and
(c) congruency with the scope of the research for which subjects gave initial consent for
future testing
(3) Collate the necessary information for the NICHD IRB review of the proposal to use
repository specimens including
(a) proposal
(b) judgment on congruency with scope of consent and justification
(c) a signed use agreement from the potential recipient attesting:
"Recipient acknowledges that the conditions for use of this research material are
governed by the cell repository IRB in accordance with Department of Health and
Human Services regulations at 45 CFR 46. Recipient agrees to comply fully with all
such conditions and to report promptly to the cell repository any proposed changes in
the research project and any unanticipated problems involving risks to subjects or
others. Recipient remains subject to applicable State and local laws or regulations
and institutional policies which provide additional protections for the human subjects.
This research material may only be used in accordance with the conditions stipulated
by the cell repository IRB. Any additional use of this material requires prior review
and approval by the cell repository IRB and, where appropriate, by an IRB at the
recipient site, which must be convened under the applicable OHRP assurance."
(4) Monitor the progress of laboratory work on REACH specimens.
(5) Notify local IRBs of any central NICHD IRB action.
Approved
Approved by EC 11/02/01
by
the
AMLG
6/21/01