IRB (Institutional Review Board)
Upcoming Common Rule Changes – New Implementation Date!
HHS has announced an Interim Final Rule (IFR) that will delay the effective date and general compliance date of the New Common Rule. The provisions of the New Common Rule that were previously scheduled to go into effect on January 19th, 2018, will now be implemented on July 19th, 2018, with the potential for a further delay. (Note: we are awaiting confirmation from the FDA that these changes will also apply to FDA-regulated research).
What Researchers need to know:
- The IRB is required to continue complying with the pre-2018 Common Rule in the review of submissions until the 7/19/2018 implementation date.
- All new studies approved on or after 7/19/2018 will be subject to New Common Rule requirements.
- Research approved prior to 7/19/2018 may be converted to the New Common Rule, which will be determined on a case-by-case basis, based on whether it can easily meet all the new requirements and will offer review process streamlining. Existing studies will NOT be automatically transitioned.
- Going forward, the current, revised Consent Form Templates posted in December 2017 should be used for:
- Any new study submissions
- An entirely new consent form being added to an existing study
- Existing studies do NOT need to change their existing consent forms to the current revised Consent Form Templates. However, an existing study cannot be transitioned to the New Common Rule (after 7/29/2018) unless it meets all the New Common Rule requirements including the new consent elements.
Here are highlights of the changes (when officially implemented):
Consent Form (see the revised templates)
- Consent forms will need to start with a 'clear and concise summary' of 'key information' for the subject.
- Additional new required statements (note: most of these are already in our template, but are now specifically required):
- Whether information or biospecimens will or will not be used for future research
- Whether research results will be returned to subjects or not
- Whether research will include whole genome sequencing
- Whether biospecimens will be used for commercial profit
- Consent forms will be required to be posted on a (yet-to-be-determined) federal website within 60 days after the last study visit.
IRB Review Process
- New exempt categories for 'benign behavioral interventions' in adults with consent
- Revision to educational exempt category
- Expedited Studies and all studies once they reach 'clinical care follow-up' or 'data analysis only' stages will no longer require continuing review!
- These studies will still have an annual 'check-in' to determine if the study is still ongoing and have an annual compliance review (all staff are trained, have CoI disclosures, etc)
Keep an eye out for additional updates regarding the implementation of the New Common Rule here as well as on the OHSU IRB Policies and Forms page. Please contact Research Integrity at email@example.com with any questions regarding changes due to the New Common Rule.
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)]