Guidance
Sep 9, 2020

De-identified Data Sets

NOTE : This page provides HIPAA -related guidance on “ de-identified data sets,”applicable only to data based on Protected Health Information (usually medical records). Other federal regulations enforced by the IRB have different standards and...
Guidance
Aug 16, 2012

Forms

The forms below are designed for use with various IRBMED submissions.
Guidance
Apr 10, 2018

Clinical Research Billing Guidance (CRB)

The Clinical Research Billing (CRB) process insures that services provided as part of a clinical study are billed properly to the sponsor or third-party payor. Many organizations (on campus and off) are involved, and compliance is required at...
Guidance
Jun 17, 2011

AHRQ: Mandatory Use of Data Safety and Monitoring Plans

The Agency for Healthcare Research and Quality ( AHRQ ) has issued notice requiring Data Safety and Monitoring Plans (DSMPs) for certain AHRQ-conducted or -supported projects. As of May 6, 2011, the inclusion of DSMPs will be considered pa of...
Policies
Apr 21, 2017

Indirect Cost Waiver

This policy addresses requests for reduced overhead recovery through the Indirect Cost Waiver mechanism.
Policies
Jul 1, 2019

Grants Processing Deadline

The Medical School Grant Services & Analysis (GS&A) Office requests that all proposals be submitted to the office ten (10) business days prior to the sponsor's proposal deadline. This includes the cumulative time needed for both the Medical...
Guidance
Dec 15, 2021

Waivers and Alterations under OHRP, FDA and HIPAA

Common Rule regulations and FDA guidance , and HIPAA regulations each allow for an IRB to approve research that departs from the usual requirements regarding the participant’s free and informed decision to participate in the study, or regarding the...
Guidance
Aug 10, 2020

Protected Health Information (PHI)

Protected Health Information (PHI) is individually identifiable health information held or maintained by covered entities , or by business associates acting for the covered entity. PHI is subject to HIPAA Privacy Rule protections. HIPAA Privacy Rule...

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