Duke Alert Bar

Duke Privacy for Research

Campus Institutional Review Board

The campus Institutional Review Board (IRB) staff are available to help navigate the process for submitting research protocols to the campus IRB. In addition to guiding you through the research process, IRB staff provide one-on-one consultations to faculty and students, and are available to provide training, seminars and workshops.

De-identification

Section 164.514(a) of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule provides the standard for de-identification of protected health information (PHI). Under this standard, health information is not individually identifiable if it does not identify an individual and if the covered entity has no reasonable basis to believe it can be used to identify an individual.

Duke Office of Clinical Research (DOCR)

DOCR provides support for principal investigators (PIs), study coordinators and members of the Clinical Research Units (CRUs) at Duke.

DUHS Institutional Review Board (IRB)

The mission of the Duke Health IRB is to ensure the protection of human research subjects by conducting scientific and ethical review of research studies while providing leadership and education for the research community. Its scope includes the Common Rule, Federal Drug Administration (FDA)-regulated studies and HIPAA as it applies to research in Duke Health.

Duke University Research

This central resource for Duke University researchers includes links to funding opportunities, research leadership contacts and the latest news on research at Duke.

IRB @ ORS West

This office provides face-to-face service for all aspects of the IRB approval and submission process.

myRESEARCHhome

myRESEARCHhome provides a single location for research-related tasks and information, putting relevant applications, resources and information specific to researchers and their projects in easy reach. It can be personalized even further to save time and effort.

Office of Research Contracts (ORC)

ORC includes four main functional groups: 1) Duke Site-Based Research for agreements under which Duke will enroll subjects as a site in a clinical research study; 2) Basic Science and Pre-clinical Research for all SOM/SON pre-clinical and basic science research agreements and university-wide material transfer agreements (MTAs); 3) Research Program Collaborations for clinical research agreements (other than Duke as-a-site agreements), educational program agreements and clinical data transfer agreements; and 4) Government and Foundation Collaborations for federal and state contracts, foundation grants, and research agreements with other non-profit entities.

Office of Research Informatics (ORI)

ORI is a comprehensive research hub that combines information technology (vended system selection, custom software development, technical and user support, system integration), academic informatics, research faculty and curriculum development, and data stewardship.

The ORI mission is to create and support the world’s leading research infrastructure, including a cohesive portfolio of useful and user-driven applications that realize the integrated research home as well as support the Duke Health "Learning Health" and "Personalized Health" visions.

Duke University Office of Research Support (ORS)

The campus Human Subjects Protections Program works with investigators to protect the rights and welfare of research participants. Program staff will pre-review submissions to the IRB for non-medical research, providing feedback, consultation and interpretation of applicable regulations. Program staff also offer seminars about research ethics and the IRB review process for undergraduate and graduate students.

Social Science Research Institute (SSRI) Protected Research Data Network (PRDN)

The SSRI PRDN is designed to accommodate the growing sensitive data needs of the Duke social science research community. This collaboration taps expertise in the Office of Information Technology (OIT), IT Security Office (ITSO) and SSRI to create a space that researchers will find useful for projects requiring a high level of security.

The foundational layer for the SSRI PRDN is the Duke Data Classification Standard. 'Sensitive' data is anything Duke has to protect in specific ways due to legislation, regulation or contracts; so all research or corporate data which comes with a data use agreement (DUA) or digital signal processing (DSP) is 'sensitive' by the Duke standard.

Undergraduate Research with Human Subjects

Are you interested in conducting an undergraduate research project? Before you begin research with human subjects, you must obtain written approval from the non-medical IRB, which can also assist you with the process.

Undergraduate Research Support Office

Students conducting undergraduate research make original intellectual or creative contributions to a discipline – from art history to economics to biology. Your contribution may be large, such as a new discovery or game-changing way of thinking in that discipline. Or it may be more modest, an extension of existing ideas that broadens our knowledge or deepens the practice of the field. But, as long as you are asking questions using the methodologies of the discipline, it is ‘research.’

Reporting Research Concerns

Any concerns related to human research, animal research, conflict of interest, research misconduct, research financial accounting, research safety or other research compliance matters can be reported through the Integrity Line: 1-800-826-8109.

The Integrity Line is a telephone hotline open 24 hours a day, 365 days a year. You can call the hotline to report a concern without giving your name. Your call will not be traced. If you want to leave your name to help answer questions about the situation, your confidentiality will be protected to the extent the law allows.

Additional Resources

Note: Most links below open in the same window; please use the back arrow to return to current page. Links with * require NetID login.

Authorizations for Use and Disclosure of Protected Health Information*

Campus Resources:  Student Affairs

Certificates of Confidentiality

Confidential Shredding (On-Site Document Destruction)

Covered Entity

Data Security FAQ

Data Security Policy

Data Storage, “Big Data”

Deidentification of Health Information Subject to the Privacy Rule (HIPAA), aka HIPAA Exemption policy

Disclosing Protected Health Information without Patient Authorization or Consent*

Duke Box

Duke’s Data Classification Standard

Duke Breach of Protected Health Information/Patient Privacy Policy

eGRC*

Electronic Communication Policy*

EU General Data Protection Regulation (GDPR)

Experimental Subject Payment Form

Export Controls

The Genetic Information Nondiscrimination Act of 2008 (GINA)

US Department of Health & Human Services, HIPAA Information

Health Insurance Portability and Accountability Act of 1996 (HIPAA) at Duke

Human Subjects Research

IRB@ORS West

Uses and Disclosures Involving Limited Datasets*

Minimum Necessary Standard for Using, Disclosing, and Requesting Protected Health Information*

Patient Photography, Video, and Audio Recording Policy*

Duke Policies and Procedures*

The Privacy Rule (“HIPAA”) in Research, aka HIPAA as it Relates to Research policy

Office of Research Administration

Office of Research Contracts

Research Integrity Office

Retention, Preservation and Destruction of Records (Records Retention Policy)*

Social Security Number Usage Policy (Duke University)

State Data Security Breach Notification Laws (from Mintz Levin)

Uses and Disclosures of Protected Health Information for Marketing*