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Policies

Recruiting Students, Employees (including study team members), Friends, & Family Members

Recruitment

This policy describes the responsibilities of the DUHS IRB and Duke Investigators when recruiting and enrolling students, employees, friends and family members as participants in research conducted under the DUHS IRB’s jurisdiction.  Published OHRP guidance, while allowing the possibility of enrolling these groups, emphasizes the need for carefully considering whether their inclusion can be justified since the investigator’s relationship with students, employees, friends and family members is potentially coercive.

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Reliance by External Sites on the DUHS IRB

Date of Last Revision
July 8, 2016
Conduct of Research

This policy describes the circumstances in which the DUHS IRB may choose to serve as a central IRB on a multi-site study, or serve as the IRB-of-Record for an external (non-Duke) site.  Additionally the policy outlines the responsibilities of the relying site, and the responsibilities of the Duke study team involved in a multi-site study, when the DUHS IRB is acting as the central IRB for the multi-site study.

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Reporting to DUHS Officials and Federal Agencies

Compliance

The policy describes procedures for the IRB to follow when reporting to DUHS officials and appropriate federal regulatory agencies the results of its deliberations related to unanticipated problems involving risks to subjects or others, suspension or termination of IRB approval, and serious or continuing noncompliance.

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Research Databases, Specimen Repositories, and Contact Lists

Database, Repository, & Retrospective Research

The policy describes IRB requirements when investigators use databases and specimen repositories for research purposes.  Databases/specimen repositories require consent and HIPAA authorization by subjects for the storage and potential future research use of their data/specimens, or a waiver of consent and HIPAA authorization by the IRB.  Exemption from IRB review is not an option if the data/specimens retain an identifier or a link that would permit anyone to identify, directly or indirectly, the person whose data/specimens are stored.

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Research for Which Review by the DUHS HRPP Is Required

Review by the IRB

This policy describes research for which review by the DUHS Human Research Protection Program (HRPP) is required.  It provides key definitions such as "research", "human subject", "intervention", "interaction", "private information", "identifiable information" and "clinical investigation".  This policy is also where you can find information on the criteria for exemption from IRB review.

Additionally, the OHRP Decision Charts for determining whether an activity is research that must be reviewed by the IRB can be found by clicking here.

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Research Involving Devices

Date of Last Revision
July 5, 2016
Drugs, Devices, & Biologics

This policy describes how the IRB confirms and documents the presence of an IDE for research conducted to determine the safety or effectiveness of a medical device. IDE exemption categories are presented, as are criteria for an abbreviated IDE.

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Research Involving Drugs or Biologics

Drugs, Devices, & Biologics

The policy describes how the IRB confirms and documents the presence of an IND for research involving the use of drugs or biologics (other than the use of a FDA approved, marketed drug/biologic in the course of medical practice). IND exemption criteria are outlined.

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Research Using Coded Private Information or Biospecimens

Database, Repository, & Retrospective Research

Research that uses coded specimens or coded identifiable private information, including protected health information, can be determined to be research not involving a human subject, and therefore not subject to IRB review, if the requirements outlined in this policy are met. 

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Retention of Records

Review by the IRB

This policy explains the retention of IRB records and other documents.

Retention of Records Policy

Significant Risk vs Non-Significant Risk Device Studies

Drugs, Devices, & Biologics

This policy provides definitions for significant risk (SR) device and non-significant risk (NSR) device, and discusses major differences between SR and NSR device studies.  The policy explains IRB responsibilities and Investigator/Sponsor responsibilities in making a risk determination for a device study.

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