IRB (Institutional Review Board)
Updated Consent and Authorization Form Templates (February 6, 2015)
Revised Consent and Authorization Form templates are available now on the IRB Policies and Forms page!
The changes include:
- New section called "Access to your Test Results." This section replaces the former "Subject Access to Genetic Information" section. It addresses the sharing of research test results with subjects and the possibility of incidental findings more broadly, not just for genetic studies.
- Added language for studies that may share genomic sequence data in a public and/or online database.
- Added language for studies that will seek a Certificate of Confidentiality from the NIH or other agency.
- Added statement in the Confidentiality section for industry-sponsored clinical trials that addresses the use of subject information to meet industry sponsors' federal reporting requirements.
- Small clarifications to language and instructions throughout.
Initial studies submitted on or after March 1, 2015 will be required to use the updated templates, unless an exception is approved by IRB staff. Use of the new templates for studies submitted before March 1 is optional. Currently approved studies are not required to incorporate the new language.
The Knight Cancer Institute template has also been updated. The main document is available on the IRB Policies and Forms page. See the Knight Clinical Research Management Bridge Page for more details about the new format.
Please contact us if you have questions!
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 Tracking NOT Required
- Waiver of HIPAA Authorization
- Decedents Representation
- Business Associate Agreement
- 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?
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)]