Database and Specimens Repository (DSR) Research Summary Template
The Research Summary should include sufficient information for evaluation of the proposed
database/repository submission. The PI is expected to provide any additional information
requested for review by the IRB or the Departmental IRB Reviewer.
Use of the template research summary below will insure that certain minimum essential
information related to the implementation of the protocol at Duke has been provided to the IRB.
The information submitted to the IRB should describe what occurs at Duke in sufficient detail for
the IRB to determine that regulatory and institutional requirements have been met. Create a
Microsoft Word document into which you can describe the information below.
Using the bolded headings below will aid reviewers’ understanding of the study team’s
activities and/or oversight responsibilities for the DSR.
Include research summary version date and page numbers on each page of the summary (e.g.,
in the document’s footer). Text in italics is an instruction; text in a plain font can be copied and
used verbatim.
The DSR submission should also include any consent/HIPAA Authorization forms to be used to
enroll subjects in the DSR, the IRB application numbers for all studies that will submit data
and/or samples to the DSR, and the funding source(s) for the DSR.
Protocol title [insert Protocol title]
This summary outlines the specifications for a data and/specimens repository being collected
and stored for future research.
a. Purpose of the data/specimen repository (DSR). Describe the research to be done with
the data/specimens in the future including the purpose and any known objectives. To avoid
confusion, the DSR should be described as a repository, and/or database, rather than a
research study, since it is a source of data/specimens for future research studies, not a
research study. The DSR submission to the IRB will not constitute an approval for any human
subjects research.
b. Separate protocols for research studies. A statement should be made in the DSR
research summary that “A separate IRB approval will be requested for each specific research
study that proposes to use data/specimens from the DSR.” Each study is considered to be a
research activity that is separate from the activity of the DSR itself. The research study is
required to provide the IRB application number for the DSR from which samples/date will be
obtained.
c. Data/specimens to be included. Describe the data/specimens to be included, their sources,
whether they were/will be obtained from clinical or research procedures, and the process of
acquisition (including sampling method – e.g. blood draw, biopsy, etc.). If subject’s
data/samples will be added to the DSR over a period of time, describe that process and from
where the prospective data/samples will be obtained, by whom, and when.
d. Security and confidentiality. Describe how and where data/specimens will be stored and
how the confidentiality of subject’s data/specimens will be protected. Describe how the
samples/data are labeled (with what subject information) and for samples, what clinical
information is stored/available for research use with the samples in the DSR. Use definitive
statements, such as, “The sample and clinical information will be labeled with…” instead of “A
code number will be used” without a description of all subject information to be included.
Describe whether there is a key linking de-identified or coded samples/data to the subjects and
if so, who maintains and has access to the key.
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Database and Specimens Repository (DSR) Research Summary Template
e. Access to the data/specimens. Describe who will have access to the data/specimens, what
the requirements for access are, and who will control access. Describe how the data/samples
will be tracked when provided to researchers and how they will be labeled (with what subject
information). Describe what clinical or research data will be provided with the samples.
f. Consent and HIPAA Authorization (C/A). Describe how C/A will be obtained from subjects,
or (if applicable) how the criteria for waiver or alteration of C/A are being met.
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