IRB (Institutional Review Board)

Updated Protocol Templates and DSMP Form Now Available (June 16, 2015)

The IRB has posted the following documents on the IRB Policies and Forms page:

  • A revised Minimal Risk Protocol Template with minor clarifications to instructions and more detail on how to address vulnerable populations.
  • A new Protocol Template that may be used for studies that are greater than minimal risk.
  • A revised Data Safety Monitoring Plan (DSMP) Form.  You may start using the new version of the form immediately, but if you have already started filling out the old form, you do not need to switch to the new form.
  • A new Quick Guide called Vulnerable Populations – Overview.  This document supplements the protocol templates and provides example language for describing the inclusion or exclusion of vulnerable populations (children, prisoners, pregnant women, neonates, etc.) in your protocol.

Please contact us if you have questions about any of the new materials.


HIPAA: Do You Need to Account for Disclosures?

What is the Accounting of Disclosures requirement?

HIPAA gives all OHSU patients and research subjects the right to request an accounting of certain disclosures of their Protected Health Information (PHI).  In order to provide that information if requested, OHSU must track those disclosures. 

What kinds of disclosures require accounting?

Tracking Required        

Disclosures made to another institution under a...

  • Waiver of HIPAA Authorization
  • Decedents Representation
  • Business Associate Agreement

Tracking NOT Required

  • Disclosures of a Limited Data Set under a Data Use Agreement
  • Disclosures authorized by a subject per a signed Consent and Authorization form
  • Disclosures of health information that does not contain any of the 18 HIPAA identifiers
  • Use of PHI within OHSU under a Waiver, Prep to Research, or Decedents Representation


Check out the HIPAA Research Guidelines for more information.

 

How do I track my disclosures?

Use OHSU's electronic Accounting of Disclosures System (ADS).  Step-by-step instructions on how to access and use the ADS are available here .  You can also find this document on the IRB Policies and Forms page under "IRB Help Sheets and Quick Guides."

For studies that plan to enroll 50+ subjects, make a single entry in the ADS at the beginning of the study.  For studies with <50 subjects, enter each individual subject into the ADS as they are enrolled.

Effective January 1, 2015, the IRB is adding a new question to its Waiver of Authorization and Decedents Representation forms.  If you submit one of these forms and indicate that you are disclosing PHI outside of OHSU, you will need to answer the following to help us ensure compliance with this requirement:

Indicate your plan for compliance with Accounting of Disclosures requirements:

[...]  This study will enroll 50 or more subjects.  The study was entered into the Accounting of Disclosures System on (date):

[...]  This study will enroll fewer than 50 subjects.  The person responsible for entering each subject into the Accounting of Disclosures System is:   

You are not required to enter past or ongoing studies/subjects into the ADS, but you must use the ADS for Waivers of Authorization or Decedents Representations submitted to the IRB on or after January 1, 2015.

 

What is Human Subject Research?

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The Code of Federal regulations defines Research as:

"A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." [45 CFR 46.102(d)]

and defines Human Subjects as:

"...living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual , or (2) identifiable private information." [45 CFR 46.102(f)(1-2)]