IRB (Institutional Review Board)
New eIRB Upgrades:
We hope these upgrades will help make all of our jobs easier!
At the request of many study team members -
- The Study Team Inbox no longer has the 'Data Modified' or 'Coordinator' (which is for the IRB Coordinator use) Columns.
- The Study Team Inbox has a column titled 'Short Title'. This is useful when modifications are submitted to display the actual modification title instead (for example, "Revised Protocol" or "Study Team Member changes", etc.)
Note: Please remember to put the actual title of a modification in 'modification title' section at the top of the MOD/MODCR Smart Form and not the 'study title.'
- The Study Team Inbox has a new tab called 'Pending CRQs' so study teams may keep track of Continuing Reviews that are in process.
Note: Studies that still require Continuing Reviews to be created will not be under this tab.
Some additional system updates -
- The study workspace has a new 'Manage Notification Group Membership' activity located in the lower left hand margin. This is where you are able to add study team members and those added to the Guest List (in addition to the PI and Primary Contact) to be motified when -
- IRB Item Requires Study Team Action
- IRB Item Approved
- IRB Study has been Closed and Archived
- Study has Lapsed
- There are now more notifications after studies lapse: at time of study expiration (current), 10 days after study expiration (new) and 30 days after study expiration (new).
- There is now a 'Send Comment' activity where you are able to direct comments to specific ancillary groups and to specific recipients from a drop down list.
Note: CRBO and SRC will be added to the list of ancillaries in a future upgrade.
- The Study Details page of the IRQ has two new items -
- A check box for, "Decisionally Impaired: Study will involve subjects who are decisionally impaired." Please be sure to upload the Decisionally Impaired (DI) supplemental in Supporting Documents.
- A question that asks, "Does this study have or will it have a Certificate of Confidentiality?"
Note: Please indicate "Yes" if you intend to apply for one.
- We have expanded the list of items to potentially upload in the SUpporting Documents section of the IRQ. Here is the complete list of examples:
- All questionnaires, surveys, focus group or interview questions
- Subject ID cards, retention materials, diaries, dosing instructions
- Translation certificates
- CRISP roster
- IRB approval letters from other sites (if applicable)
- Data and Safety Monitoring documents (if applicable - DSMP, DSMC charter, etc.)
- Memos to IRB (submission and/or response memos)
- Individual Investigator Agreements (IIAs) & IRB Authorization Agreements (IAAs)
- Supplemental forms can be found on the OHSU IRB Policies and Forms or VA IRB Forms and Policies websites, as applicable for your study
- Other study-related documents not attached on previous forms
- For VA Repositories:
- Repository Standard Operating Procedures (SoP) template
- Scope of Work forms for all study staff listed on the Study Team Members page
- Conflict of Interest in Research form(s) for each principle investigator, study chair, and site co- and sub- investigators
- Refer to Repository FAQs
- As part of the upgrade, the IRB office has some additional functionality that should improve processes. For example, our 'Manage Documents' capability has been expanded and our IRB Coordinator Inboxes have been modified.
Important Reminders -
- As part of our ongoing mission to migrate all active studies to the new eIRB -
- Studies that have outstanding or open items still need to be migrated to the new system. We have a goal for early this year to be using only the new system, so please complete and submit any outstanding/open items right away. Otherwise, the IRB plans to start closing out some studies, such as those that have been in Researcher Preparation or have had no activity on them for more than 1 year.
- For additional instructions and helpful tips for what you need to do to help us migrate your outstanding studies to the new system, please click here.
- Accessing Documents in the new eIRB -
- There are still some study team members taking documents for modification from the wrong column. Below is a reminder of correct location:
- Draft - access in the left column to modify documents.
- Final - access in the right column to use finalized documents.
Note: please do not convert from PDF to Word on documents from the final column. Please use the clean Word version in the draft column.
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 at 503-346-3528.
You can also email firstname.lastname@example.org.
Thank you all for working together with us!
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)]