Research Resources

Institutional Review Board (IRB)
Prior to starting your human subjects research, you must receive approval from the IRB by submitting your protocol on Harvard’s Electronic Submission Tracking and Reporting (ESTR) system. The IRB reviews human subjects research protocols and regularly monitors research milestones after approval. Any modifications, protocol deviations, and adverse events must be reported to the IRB in a timely manner. The IRB also requires annual reviews of protocols for research progress and updates.
Useful Links
IRB Module: Electronic Submission Tracking and Reporting system for IRB submissions and reviews
Investigator Manual: Guide for preparing an IRB submission and policies and procedures related to Human Subjects Research
IRB Decision Tool: Aid for determining whether project is considered Human Subjects Research

HCPDS affiliates who need more information about the IRB process should contact Elyse Jennings at ejennings@hsph.harvard.edu.

Data Safety Reviews

As per the Harvard Research Data Security Policy, research studies using sensitive data (see below for definitions) must receive approval from IT prior to the start of research activities. This can be done by submitting a Data Safety Review via Harvard’s Electronic Submission Tracking and Reporting (ESTR) system. Please note that this applies to research projects using either primary or secondary data and that only the IRB or IT can certify the data security level of your data.

Data Security Levels

Useful Links

Electronic Submission Tracking and Reporting system module for Data Safety Submissions reviewed by IT Data Safety Submission Guide – Guide for preparing a Data Safety Review Research Data Security Policy at Harvard HCPDS affiliates who need more information about data safety reviews should contact Elyse Jennings at ejennings@hsph.harvard.edu

Research Core staff at the HCPDS manage the public release of data through mechanisms such as Dataverse, as well as other platforms outside of Harvard. The Research Core also offers data storage options for the use of sensitive data through the following:

Harvard Dataverse: Dataverse is a free data repository available to all researchers, both inside and outside of Harvard, used for archiving, accessing, disseminating, and exploring research data. Each individual “dataverse” is made up of a collection of datasets that can be individually customized in terms of organization and access restrictions. HCPDS regularly publishes completed datasets to Harvard Dataverse, as the platform satisfies our goal of building a rich data archive for use within and outside of Harvard. The platform also allows us to control the levels of accessibility to users, from granting access to the data only upon approved request, to allowing full access to all users. All published datasets are open and searchable online, even when restricted.

Faculty of Arts & Sciences Secure Environment (FASSE): FASSE, maintained by FAS Research Computing (FASRC) at Harvard, is a powerful computer cluster that offers a wide range of research tools for data analysis and storage. FASSE can be used for analyses that are too intensive and for data too large for a personal computer. Project space can be used privately or shared with varying levels of access among collaborators. In addition to offering access to a range of statistical software (SAS, SPSS, Stata, R, etc.), FASSE is useful because it can be accessed securely from any computer via virtual private network (VPN) and two-factor authentication. Files up to Data Security Level 3 (DSL 3), or medium risk information, are supported on FASSE, and files are backed up regularly and automatically.

HCPDS Data Enclave: One of the special services offered by HCPDS is the on-site Data Enclave, a computer lab located at 9 Bow Street in Cambridge. The Enclave is complete with security controls in compliance with the Harvard Research Data Security Policy for Data Security Level 4 (DSL4) restricted human subjects research data. The room is equipped with three computers and locked cabinet space for storing sensitive data (e.g., identifying information). Two of the computers are disconnected from the internet, while one is connected but only to be used for accessing a remote enclave for restricted HRS data. The other computers can be used offline for restricted data transferable by portable hard drive or CD.

HCPDS affiliates who need more information about data storage or would like to request an account for any of these facilities should contact Elyse Jennings at ejennings@hsph.harvard.edu.

Data Use Agreements (DUAs): If you plan to use secondary restricted-use data for your research, the data provider may require the establishment of a Data Use Agreement (DUA). DUAs vary widely, depending on the unique stipulations of the particular data provider. If a Harvard institutional signature is required, the DUA must be submitted for approval on Harvard’s Electronic Submission Tracking and Reporting (ESTR) system and are then reviewed by one of Harvard’s research administration offices. Please note that you may also be required to submit a Data Safety Review (see previous section). HCPDS affiliates who would like more information about DUAs should contact Elyse Jennings at ejennings@hsph.harvard.edu.

Research Data Available at HCPDS upon Approved Application

Useful Links:
DUA Module: Electronic Submission Tracking and Reporting module for Data Use Agreements reviewed by research administration
DUA Submission Guide: Guide for preparing a Data Use Agreement submission
Research Data Management at Harvard

HCPDS offers access to nearly a dozen restricted datasets upon approved application.

The staff at the HCPDS is excited to collaborate with our Harvard faculty members and postdoctoral fellows on research, career development, and training grants that align with the Center’s mission and areas of interest. Grants hosted by the HCPDS can take advantage of a variety service offerings from both the administrative and research cores.