IRB Submission Review Time

2019 IRB Meeting and Deadline Dates

Reportable Events Policy

"One Protocol" Policy

Changes to Continuing Review

Consent requirements

IRB Submission Review Time

HRPP is currently reviewing:

  • amendment submissions received on November 15th, 2018*

  • exempt submissions received on November 16th, 2018*

  • expedited submissions received on October 31st, 2018*

*The current submission date is updated weekly on Wednesdays*

Protocol reviews are prioritized as follows:

  • All progress reports are prioritized based on expiration date to ensure approval does not lapse. 
     
  • Protocols that must be reviewed due to impending funding (e.g., at Just-in-Time) will always be prioritized over other submissions in the review queue. Please note in your email submission "Priority Protocol: Funding" when submitting such a protocol to the IRB email inbox.
2019 IRB Meeting and Deadline Dates

SUBMISSION DEADLINE                         MEETING DATE

January 2, 2019

January 17, 2019

January 31, 2019

February 21, 2019

February 28, 2019

March 21, 2019

April 1, 2019

April 18, 2019

April 30, 2019

May 16, 2019

May 31, 2019

June 20, 2019

July 1, 2019

July 18, 2019

July 31, 2019

August 15, 2019

September 3, 2019

September 19, 2019

September 30, 2019

October 17, 2019

October 31, 2019

November 21, 2019

December 2, 2019

December 12, 2019

REPORTABLE EVENTS POLICY

The HRPP recently published a new Reportable Events Policy. We encourage you to read it carefully, as many of the protocol deviations that researchers have been reporting to the HRPP/IRB will no longer require formal reporting at the time the incident occurs. We believe the research community will appreciate the clear guidance regarding what must be reported and when, and anticipate that this will reduce burden for investigators and free up time for the HRPP to tackle your protocol submissions. When submitting a qualifying Reportable Event, please use our *new* Reportable Events form, found here.

"ONE PROTOCOL" POLICY

The HRPP is pleased to announce that we will begin transitioning to a "one IRB-approved protocol" approach. Gone will be the days of trying to piece together which version of your protocol is the most recently IRB-approved version!

Starting with the November Full Board IRB protocols, the HRPP is instituting the one-protocol policy. In accordance with Title 45 CFR 46.115 (Health and Human Services, IRB Records) and Title 21 CFR 56.115 (Food and Drug Administration, IRB Records), the IRB-approved protocol should reflect current study procedures with all modifications included. Every Brown University research study will maintain a single, active protocol that incorporates all IRB-approved amendments. Any changes to an approved protocol will now be made via "track changes" (in Word) or highlighted (in Adobe Acrobat), and integrated directly into the protocol document upon IRB approval. Stay tuned for further details as we continue to roll out this process for all new protocols and protocols with a limited number of amendments!

CHANGES TO CONT. REVIEW

Currently, all non-exempt research requires continuing review and approval by the IRB at least once a year. Effective on January 21, 2019, Continuing Review will no longer be required for:

  • Most studies eligible for expedited review (minimal risk research);

  • Studies that underwent Full Board review for which ongoing activity is limited to data analysis, including analysis of identifiable data/biospecimens OR involve accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care.

Are there exceptions?

  • For studies that meet the above criteria the IRB can, on a case-by-case basis with documented justification, impose continuing review requirements. 

  • Continuing review will still be required for FDA regulated research studies.

Starting in November 2018, the HRPP is proactively identifying investigators with expedited protocols that will no longer require continuing review. You will be contacted if no continuing review is required for your study. If your study is released from continuing review requirements, there will be ongoing quality assurance monitoring efforts conducted to confirm if the study is still ongoing, remind investigators to continue to submit amendments and Reportable Events related to the research, and to prompt investigators to close the study if human subject research activities are complete.


Consent requirements

As first announced by HRPP to our research community in April 2018, the changes to the Common Rule require that consent forms “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject … in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.”

While the HRPP has eased investigators into this requirement since the spring, we are unable to make individual exceptions starting in October 2018.

NEW PROTOCOLS:

To comply with this requirement we have created two consent format templates/options that must be used for new studies being submitted to the IRB for review:

  1. The Standard Consent format is required for more complex and/or greater than minimal risk research studies that are 3 or more pages in length.
     
  2. The Bulleted Consent Template which may be used when a study is minimal risk and is only 1-2 pages in length.

EXISTING PROTOCOLS:   

Below, please review the criteria for updating your existing consent documents:

  1. If the existing consent form is consistent with a Standard Consent, the Key Information may be pasted to the beginning of the existing consent document
     
  2. If the existing consent meets the criteria for the Bulleted Consent, the existing consent document should be reformatted to match the bulleted template.
     
  3. If the transition to the required formatting is the only change being made, the revised consent(s) must be submitted to HRPP with the new “Amendment Request form *Key Information*.” If any other changes to the protocol or the consent form are also being requested, the standard amendment submission form must be used.

The HRPP has templates and tools available on the Forms page of our website to assist investigators with developing consent documents that conform to this requirement.