IRB (Institutional Review Board)
Data Migration is done!
Data Migration is a success - Both systems are up and running!
All studies that had no outstanding or open items successfully migrated to the new system - about 3/4 of all IRB studies!
For instructions and helpful tips for the new system, please click here.
Your part in the migration process:
- Joint VA studies and IRQ Information: If your migrated study involves the VA, at your next continuing review, you will need to move information from the currently uploaded VASQ forms to VA-specific pages in the electronic IRQ.
- Review your studies: For the correct IRQ information, documents, and study personnel.
- Correct any IRQ information or document (including anything missing):
- Submit a modification,
- Include a memo describing what is being corrected,
- Special note on age ranges: Most migrated studies will be missing the 'interval' information on the age range of study subjects. Please note if the age range is minutes, hours, days, weeks, months or years.
- Archive documents: For all submissions still in the old system waiting for migration, continue to archive any documents no longer in use.
- Withdraw old items: withdraw any studies or modifications/continuing reviews/UPs or PDs in the old system that you do not plan on completing/submitting in the immediate future. You will still be able to access information/documents in the old system if you need it to submit in the new system.
If you have any questions, concerns or difficulties or need any assistance, do not hesitate to contact us!
Call your IRB Coordinator (formerly your IRB Analyst) at 503-494-7887 option 1 or David Holmgren, IRB Manager at 503-346-3528, email: firstname.lastname@example.org.
Thank you all for working together with us to ensure a smooth and effective transition to the new eIRB!
HIPAA: Do You Need to Account for Disclosures?
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.
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:
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.
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:
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)]