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New Rule Information

The Revised Common Rule (Federal Policy for the Protection of Human Subjects; “New Rule”) will become effective on January 21, 2019 and we are obligated under federal law to implement these changes. This transition will likely cause delays to our normal review processing timelines, in part due to the concurrent and necessary updates that are required to our electronic forms, determination letters, and reviewer checklists in IRBManager. We thank you in advance for your patience during this time and your partnership as we work together to assure that Tulane’s research and oversight are in compliance with the New Rule. With that said, the HRPO has implemented a plan to help make the transition from Old to New Common Rule as smooth as possible.

 

Note that the Department of Health and Human Services has issued limited guidance for institutions on how to implement or interpret the New Common Rule. Policies and procedures will likely change as a result of evolving interpretations and guidance so be sure to periodically check the website for updates. If there are significant changes, an announcement will be shared with our research community via email, as well as our website.

 

Exempt and Expedited Studies

New Initial Exempt and Expedited submissions will not be accepted from 5pm on December 21, 2018-January 20, 2019. During that time period, the HRPO will be observing the University’s Holiday Schedule and processing existing Initial Exempt and Expedited submissions received by the office, under the Old Rule. Effective January 21, 2019, new Initial Exempt and Expedited submissions will be accepted on the new forms in IRBManager and will be processed under the New Rule.

 

Initial Exempt and Expedited Submissions ‘In Process’: If you currently have an Exempt or Expedited study in IRBManager that has not yet been approved, please be sure to reply to any outstanding requests as soon as possible so that an approval can be granted under the Old Rule, i.e., on or before January 20, 2019. If approval is not obtained by that date, re-submission utilizing the New Rule forms (including new consent template) in IRBManager, and re-review, will be required for compliance with the New Rule.

 

New Initial Full Board Studies

New Initial Full Board submissions will not be accepted after 5pm CST on December 21, 2018-January 20, 2019. During that time period, the HRPO will be observing the University’s Holiday Schedule and processing existing Initial Full Board submissions received by the office, under the Old Rule. Effective January 21, 2019, new Initial Full Board submissions will be accepted on the new forms in IRBManager and will be processed under the New Rule.

 

  • New Initial Biomedical Full Board submissions that were deemed complete by the HRPO by November 23, 2018, will be assigned to the January 8, 2019 Biomedical meeting date for review under the Old Rule. If an approval determination is granted at the January 8, 2019 meeting, the study will be subject to the requirements under the Old Rule.
  • If the study is granted a Conditions Required for Approval determination at the January 8th meeting, the stated conditions must be satisfied on or before January 20, 2019 in order to continue to be covered under the Old Rule.
  • If the study is granted a Deferred for Modifications determination at the January 8th meeting, or was granted a Conditions Required for Approval determination and those conditions are not satisfied by January 20, 2019, re-submission utilizing the revised Biomedical Consent Template (available on the HRPO shortly) will be required for subsequent review under the New Rule. Follow-up notifications to the research community will be made as soon as the new template is available.
  • New Initial Biomedical Full Board submissions received and deemed complete by the HRPO by December 21, 2018, will be assigned to the January 22, 2019 Biomedical meeting date for review under the New Rule. These submissions must utilize the revised Biomedical Consent Template that will be made available on the HRPO Website shortly. Follow-up notifications to the research community will be made as soon as the new template is available.
  • New Initial Social-Behavioral Full Board submissions received and deemed complete by the HRPO by January 11, 2019, will be assigned to the January 25, 2019 Social-Behavioral meeting date for review under the New Rule. These submissions must utilize the revised Social-Behavioral Consent Template that will be made available on the HRPO Website shortly. Follow-up notifications to the research community will be made as soon as the new template is available.

Education

We strongly encourage Investigators and IRB Members to enroll in the CITI Revised Common Rule Course. More education sessions will be held in the future. Please check the website and IRBManager periodically for upcoming training updates and our revised SOPs.

 

Presentations

NEW COMMON RULE PRESENTED BY HRP

Presented by Judy Matuk, M.S. and Cherly Savini, CIP of HRP Consulting Group on November 28, 2018

 

NEW COMMON RULE CHANGES

Tulane Human Research Protection Office Announcement - October 12, 2018

 

REVISIONS TO THE COMMON RULE - FINAL RULE

Presented by Jeffery Cohen, HRP Consulting Group on September 24, 2018

 

External Resources

OHRP Revised Common Rule Resources

 

OHRP Revised Common Rule Videos

 

Help

Contact us through irbmain@tulane.edu with questions and write New Common Rule in the subject line.

 

 

 

Tulane University HRPO
1440 Canal Street, Suite 1705, TW-8436
New Orleans, LA 70112
Tel: 504-988-2665
fax: 504-988-4766
e-mail: irbmain@tulane.edu