icddr,b Data Access Policy

icddr,b Data Access Policy subjects’ informed consent and all applicable IRB
requirements. Under no circumstances may a
icddr,b recognizes the public health, social and Recipient attempt to identify or contact study
intellectual value of providing access to its knowledge subjects.
data to increase the amount of their innovative analyses,
and will share such data according to this policy. 8. The rights and interests of the respective icddr,b PI
and Interested Third Parties shall take priority over
1. Data from the icddr,b Data Repository (icddr,b the requests of Recipients and no grant of access to
Datasets) will be provided to interested researchers icddr,b Datasets shall be construed or allowed to
(Recipients) for purposes of secondary data analyses infringe such priority rights and interests.
upon approval of a Data Licensing Application &
Agreement (Application) ([to be] attached hereto as 9. Considerations of the DRC will include but not be
Annex A) by the icddr,b Data Repository Committee limited to:
(DRC).
a. Whether the request is appropriate and
2. icddr,b Datasets are subject to any and all interests
consistent with the mission of icddr,b;
and limitations imposed by statutory requirement,
icddr,b institutional policy, or written agreement with b. Whether the proposed research is consistent
any third-party institution or individual (Interested with the subjects’ informed consent;
Third Party). Requests for icddr,b Datasets that would c. Whether icddr,b researchers have been or will
negate or infringe any such interest will not be be involved in the development and execution of
approved. the proposed secondary analysis;
d. Whether the requested access would result in
3. Biological, chemical and other material samples are
duplicative research and, if so, whether granting
not considered data for purposes of this policy and
such access would be inappropriate under the
will not be made available under this policy.
circumstances; and
4. Only those data that icddr,b’s Internal Data Policy, e. The capacity of the requesting party to correctly
donor and publisher requirements, and ethical understand and/or interpret the requested data.
considerations permit will be made publicly available
in the icddr,b Data Repository. 10. The DRC will set access fees on a periodic basis, which
must be paid by the Recipient in a timely manner.
5. Requests from interested researchers to conduct Such fees will be waived for icddr,b Post-Doctoral
secondary data analysis of icddr,b Datasets will be Fellows and may be reduced or waived for students
considered by the DRC upon receipt of a completed on a case-by-case basis.
Application and in discussion with the PI or her/his
designated co-investigator, which must include a 11. In any abstract, manuscript, publication,
thorough description of the research project for dissemination, presentation or other public disclosure
which the data are requested. Recipients must also based on icddr,b Datasets, icddr,b, its PI, and the
include a copy of their own institution’s Institutional original donor must be properly acknowledged.
Review Board (IRB) approval of their study. In the Recipients publishing secondary analyses based on
event the Recipient is not affiliated with an institution icddr,b Datasets must give each icddr,b Researcher
that has an IRB satisfactory to the DRC, a full protocol
who made an intellectually significant contribution to
must be approved by the icddr,b internal IRB process
the dataset an option to be listed as an author,
before the Application will be Approved.
provided it would meet international standards for
6. icddr,b Datasets will only be provided with all authorship in peer-reviewed journals and the policies
personally identifiable information removed, and of the publishers.
every reasonable effort will be made to keep the
12. If the Recipient identifies an apparent error or
identification of study subjects in the strictest
confidence. However, due to the wealth of individual inconsistency in any icddr,b Dataset received,
level data available on study participants, the Recipient must convey it to the DRC as soon as is
possibility of direct identification of a study subject reasonably possible.
cannot be completely eliminated. Therefore, only IRB 13. Any proposed abstract, manuscript, publication or
approvals from an expedited or full review can be other formal public dissemination based on an icddr,b
accepted. Waiver for exemption of IRB approval will
Dataset must be submitted to icddr,b for its review
only be accepted from icddr,b IRB.
and comments at least 30 days prior to submission or
7. As more fully set forth in the Application, use of presentation.
icddr,b Datasets shall be strictly limited to use in and
Recommended by the Senior Leadership Team (SLT) and Adopted by
for the purpose of the described research project;
the Executive Director
may not be shared, sold, transferred, or otherwise
released to another party without the written 30 April 2018
consent of the DRC; and must strictly comply with

Third Revision Version: 1.4 3 0 April 2018

icddr,b Data Access Policy

Annex A: icddr,b Data Licensing Application and Agreement

(DLAA)
Annex B: icddr,b Repository Standards & Procedures (attached)

Third Revision Version: 1.4 3 0 April 2018

icddr,b Data Repository Standards and Procedures

icddr,b Data Repository media.

Standards and Procedures 2. The following steps will be followed to ensure 100% and
timely compliance with the data archival policy by PIs as
General well as Heads of Units responsible for Routine (clinical,
lab, DSS) data collection, and quality control:
This document entails the responsibilities of icddr,b,
its employees and those scientists visiting in an official a. For Research Protocols, PIs will be required to
capacity (such as a secondment or other long-term submit all data generated from the protocol along
official relationship), collectively designated as icddr,b with adequate documentation (questionnaires, tools,
Researcher(s), regarding submission of data collected in data dictionary/code books, manuals, enumeration
icddr,b’s research protocols, surveillance systems, surveys, data and data monitoring or progress sheets if
clinical or laboratory records or statistics, training available/applicable, but not including
activities and any other data that (i) have intellectual value, constructed/calculated variables) at the time of
and (ii) are generated through icddr,b activities, which submitting Protocol Completion reports. For
together constitute icddr,b Dataset.
qualitative data, this would inlclude interview and
discussion guides, observational notes (e.g., field
icddr,b recognizes the public health, social and notes, notes on interview/discussion situation), along
intellectual value of providing access to its knowledge with softcopies of transcribed data. The Protocol
data to increase the amount of their innovative analyses, Completion report will be incomplete otherwise.
and will share such data according to this policy. Submitted materials must be certified by the Division
Directors to be complete and correct. Protocol
1. Data from the icddr,b Data Repository (icddr,b Completion reports are required to be submitted
Datasets) will be provided to interested researchers within 3 months of IRB approved Protocol
(Recipients) for purposes of secondary data analyses completion. Failure to do so should trigger weekly
upon approval of a Data Licensing Application & reminders – for up to 12 weeks. After the 13th
Agreement (Application) ([to be] attached hereto as week of having missed the submission deadline for
Annex A) by the icddr,b Data Repository Committee Protocol Completion reports and data, appropriate
(DRC). action will be taken based on policies determined by
the SLT. Failure to submit Protocol
2. icddr,b Datasets are subject to any and all interests Completion/data should also be reported at the SLT
and limitations imposed by statutory requirement, meetings. RA will analyse response rates of data
icddr,b institutional policy, or written agreement with received by time/division etc, and submit reports
any third-party institution or individual (Interested quarterly to the SLT. The report would also
Third Party). Requests for icddr,b Datasets that would summarize pattern of use of the archived data
negate or infringe any such interest will not be (requests made, data provided,
approved. publication/thesis/reports completed).

3. Biological, chemical and other material samples are For routine data, Heads of responsible units will be
not considered data for purpose of icddr,b Data required to submit all routinely generated data along
Policies. with adequate documentation/meta data
4. Only those data that icddr,b’s Internal Data Policy, (questionnaires, tools, data dictionary/code books).
donor and publisher requirements, and ethical For such routine data collection platforms existing
considerations permit will be made publicly available currently, “Activity” forms must be completed and
in the icddr,b Data Repository. approved, and data and documentation should be
submitted within 6 months of revised icddr,b data
Data Submission and Storage policies coming into effect. For new platforms, pre-
approval as an “Activity” is required and data and
documentation should be submitted within 6 months
1. Research Administration has undertaken an initiative to of the platform being initiated. Updated data must be
implement an online system to manage protocols and submitted every 6 months. Submitted materials must
activities. The current planned project includes the be certified by the Division Directors/Department
following work flows: protocol, activity, proposal Heads to be complete and correct. Failure to submit
approvals; protocol addendum, continuation and
data and documentation should be reported at the
extension approvals; protocol completion and
abstract & manuscript approval. The development of SLT meetings for appropriate corrective action as per
this work is nearing completion. Once an effective policies determined by the SLT.
online system is established, workflows for Protocol /
Activity from submission to final archival will be All submitted data must be stripped of personal
completed through that electronic system, and the identifiers before submission.
relevant PI or her/his designated staff shall directly upload
data in the electronic system. Until such time, data should
b. RA will verify 10% of all data files randomly selected
be submitted to the Repository Administrator located at
for completeness and quality. A data set (and
Research Administration (RA) on an appropriate transfer

Version: 1.1 30 April 2018

icddr,b Data Repository Standards and Procedures

documentation), once selected will be stripped of all

Division/Department identifiers and independently
sent to one PI and one data professional (from a
previously established pool of such experts) will be
asked to verify the data unbeknownst to each other.
RA will reach a final determination on the quality and
completeness of the submitted data and meta data,
based on the feedback of the two experts. In order
to ensure that this random checking has the desired
impact on overall quality and completeness of
submissions, icddr,b management will, from time to
time, establish appropriate actions for PIs and
Divisions / Departments submitting incomplete
and/or poor quality data

c. With the final authorization by RA, data shall be

stored in the repository. Research / Routine Data
and all allied Metadata will be stored in a searchable
database and made available for secondary use
following icddr,b Data Access Policy. Only RA will
have full access of the data stored in the database.

Recommended by the Senior Leadership Team (SLT) and Adopted by

the Executive Director

30 April 2018

Annex A: icddr,b Data Licensing Application and Agreement

(DLAA)
Annex B: icddr,b Data Access Policy
Annex C: icddr,b Internal Data and Data Archival Policy

Version: 1.1 30 April 2018