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PRIM&R At Your Doorstep Certificate Program

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Women & Infants Hospital

101 Dudley Street

South Pavilion Auditoriums 3&4

Providence, RI 02905

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Description

Advance-CTR presents PRIM&R At Your Doorstep, a half-day certificate program led by experts from Public Responsibility in Medicine and Research (PRIM&R).

The workshop covers three modules that will teach participants how to overcome the most challenging issues in human subject protections. All Rhode Island-based investigators and research staff who are involved in human subject research are encouraged to attend this educational offering.

The workshop covers three modules:

  1. Criteria for the Approval of Research (a standard in all IRB 250 programs): This module reviews regulation 45 CFR 46/21 CFR 56.111(a) and how it relates to the Belmont principles. This module covers risk/benefit, subject selection and recruitment, informed consent, data safety monitoring, privacy and confidentiality, and vulnerable populations.

  2. Applying the Exemption Categories: The curriculum for this module will review what types of research are exempt, the OHRP guidance on research that evaluates public benefit service programs, vulnerable populations, and FDA exemptions. In addition, the module will discuss OHRP Guidance on exemptions, as well as using exempt review.

  3. HIPAA as it Pertains to IRBs and Research: The curriculum for this module will begin with an overview of the HIPAA privacy regulations, and will continue with a discussion on HIPAA and research and research authorizations. In addition, the module will present information on the use of PHI without authorization, including purposes of preparatory research, decedents’ information, waiver of authorization, limited data sets, de-identified data, and transition provision. Finally, the module will cover databases and tissue banks, recruitment of research subjects, and institutional considerations.

Who Should Attend

Anyone who is interested or currently involved in human subject research, including new and early-stage investigators, researchers and research coordinators, IRB administrators, institutional officials and others at Brown, URI and the affiliated hospital systems are invited to attend this workshop.

Workshop Details

The workshop is free but registration is required as space is limited. Walk-ins cannot be guaranteed admittance.

A certificate of completion will be provided to attendees upon completion of a post-workshop survey.

Breakfast and a bag lunch will be provided.

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Date and Time

Location

Women & Infants Hospital

101 Dudley Street

South Pavilion Auditoriums 3&4

Providence, RI 02905

View Map

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