IRB

New information about using IRB templates

Anonymous — Tue, 11 Dec 2018 16:05:07 +0000

New information about using IRB templates Anonymous (not verified) Tue, 12/11/2018 - 09:05

Beginning December 21, 2018, the IRB will no longer accept Initial Applications for non-exempt research that do not include the most current versions of the protocol and consent form templates. This is to ensure that all new studies will be in compliance with the newly revised Code of Federal Regulations when they are implemented in January. The templates can be downloaded from the Templates page on the IRB’s website.

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NIH Updates Policy for Certificates of Confidentiality

Anonymous — Wed, 29 Nov 2017 18:16:57 +0000

NIH Updates Policy for Certificates of Confidentiality Anonymous (not verified) Wed, 11/29/2017 - 11:16

NIH has updated its policy regarding Certificates of Confidentiality in order to implement Section 2012 of the 21st Century Cures Act, enacted December 13, 2016. Effective October 1, 2017, NIH funded (partially or wholly) research studies that are collecting identifiable, sensitive information will automatically be issued a Certificate of Confidentiality as part of the terms and conditions of the award. More information is available on the IRB's Guidance Documents page and NIH's Website .

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Updated Guidance Documents

Anonymous — Fri, 17 Mar 2017 20:53:16 +0000

Updated Guidance Documents Anonymous (not verified) Fri, 03/17/2017 - 14:53

The IRB has posted updated guidance documents regarding Research in Public Schools, IRB Authorization Agreements, and the use of Deception and Incomplete Disclosure in Research. Check out the Guidance Documents page to see these new guides.

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Guidance for Investigational Device Studies

Anonymous — Tue, 30 Aug 2016 21:41:43 +0000

Guidance for Investigational Device Studies Anonymous (not verified) Tue, 08/30/2016 - 15:41

The IRB has posted Guidance for Investigational Device Studies on the Guidance Documents page. This guidance provides information for investigators to follow in determining whether a study falls under FDA Device Regulations for IRB review and oversight.

Go to the Guidance page to review this new document.

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Updates to Study Personnel Roles

Anonymous — Wed, 27 Jul 2016 13:22:13 +0000

Updates to Study Personnel Roles Anonymous (not verified) Wed, 07/27/2016 - 07:22

The IRB is changing the way study personnel Roles function in eRA. Starting Wednesday, July 25, 2016, the following changes will take effect:

- Individuals listed on studies in eRA with Co-Investigator with Edit and Research Coordinator roles will have the ability to view study documents and to create and submit study submissions such as Amendments and Continuing Reviews on behalf of a PI.

- A new role, Research Assistant, will be included in eRA. Personnel who may not have a direct role in the science of a research study but need to access and download documents from eRA for study activities can be assigned this role (Undergraduate and Graduate Research Assistants, etc.).

FAQs

Why are you making this change?

Updating these roles helps the you more clearly define the activities that are being undertaken by the personnel on your Protocol. Giving the Co-Investigator with Edit and Research Coordinator roles the ability to submit on your behalf allows you to delegate some of these more administrative tasks to others. This also allows the IRB greater oversight of these roles for investigators who currently utilize Delegates in the eRA system.

How do I update my Co-Investigator's roles for my study?

Submit an Amendment to any study where you would like to update the roles of your Co-Investigators to allow them to submit Amendments or Continuing Reviews on your behalf. These changes will only take effect once the IRB has reviewed and Approved this change, and updated their role in the system. Note that these roles are protocol-specific, so if you need to make this change on several studies, separate submissions will be needed. Note that if you already have personnel with these roles assigned, these changes will take place automatically and no action need be taken unless you wish to revoke these permissions.

Can my Research Coordinator or Co-Investigator with Edit submit my Initial Application?

No. The Principal Investigator of a study will be required to complete the Initial Application process. Part of the submission process is a certification that the investigator will abide by the rules and requirements of CU Human Subjects Research Policy outlined in the Investigator Manual. This certification must be completed by the PI for the Initial Application, and would not be recorded if submitted by another study staff member.

Do I need to make these changes if I have Delegates?

Delegate permissions, which allow an individual to fully act on behalf of a PI in the eRA system for any study, whether listed on that study or not, are being phased out. The IRB is no longer assigning new Delegates. Existing Delegates will continue to be active until this transition is complete. Look for an email in the coming months requesting you update the IRB with your delegate's information in order to ensure they have the appropriate Research Coordinator or Co-Investigator with Edit role in the necessary Protocols.

More information about study personnel roles can be found on the IRB's website, here: http://www.colorado.edu/vcr/irb/getting-started/roles-responsibilities.

The IRB is changing the way study personnel Roles function in eRA. Starting Wednesday, July 25, 2016, the following changes will take effect:
- Individuals listed on studies in eRA with Co-Investigator with Edit and Research Coordinator roles will have the ability to view study documents and to create and submit study submissions such as Amendments and Continuing Reviews on behalf of a PI.
- A new role, Research Assistant, will be included in eRA. Personnel who may not have a direct role in the science of a research study but need to access and download documents from eRA for study activities can be assigned this role (Undergraduate and Graduate Research Assistants, etc.).

Click the title above for more...

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New IRB Staff Member Announcement

Anonymous — Mon, 20 Jun 2016 20:57:08 +0000

New IRB Staff Member Announcement Anonymous (not verified) Mon, 06/20/2016 - 14:57

This past April, the IRB welcomed a new Panel Coordinator, Misty White. Misty, a Certified IRB Professional, comes to us from, most recently, LSU Health Sciences Center in New Orleans, and her previous IRB experience includes several years at the University of Alabama at Birmingham. Here, she will coordinate all biomedical protocols and the convened IRB meetings. Please join us in welcoming Misty to the ��񱦵� family!

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Changes to Pre-review Process for Full Board Studies

Anonymous — Mon, 20 Jun 2016 20:55:40 +0000

Changes to Pre-review Process for Full Board Studies Anonymous (not verified) Mon, 06/20/2016 - 14:55

Full Board Review Deadline and Pre-review of Full Board Studies

In an effort to better serve our research community and streamline the review process, the IRB will change its procedures for all protocol submissions that require full board review: Initial Applications, Continuing Reviews, and Amendments. Starting June 23, 2016, all submissions requiring full board review will undergo an administrative pre-review. An IRB staff member will review all documents submitted for review to ensure they adhere to all applicable federal and ��񱦵� regulations. Any required revisions will be communicated through eRA. After all required revisions are complete, the protocol will be scheduled for review at the next available convened IRB meeting. If no revisions are required, the submission will be scheduled for the next available board meeting.

FAQs

Why are you making this change?

Addressing administrative issues prior to the meeting will allow board members to focus on substantive issues during the board meeting, rather than things such as missing information, typographical errors, and contradictions in the submission.

What about deadlines?

There will no longer be deadlines for board meetings; however, there will be an internal agenda close date, after which no additional items may be added to the agenda. The agenda close date will be 6 business days before the meeting date. The meeting schedule can be found here.

How do I plan my timeline for the new pre-review process?

All submissions will be reviewed within 10 business days. The majority of Initial Applications will require some kind of revisions before they are board-ready, so you should plan on that. If all issues noted in the pre-review are not adequately addressed, a second response will be required; however, if you address each issue noted in the pre-review it will be scheduled for the next available Board meeting. The agenda closes 6 business days before the meeting date so you should factor that in with timing your response.

What if I don’t want to make a revision requested in the pre-review?

Protocols will not be scheduled for board review until all required changes have been addressed. If there is a justifiable reason to not make a change noted in the pre-review, the investigator should reply with the justification and the protocol will be scheduled for board review.

See Also: /vcr/irb/getting-started/submission-timeline

/vcr/node/2719/attachment/newest

In an effort to better serve our research community and streamline the review process, the IRB will change its procedures for all protocol submissions that require full board review. Starting June 23, 2016, all submissions requiring full board review will undergo an administrative pre-review before they will be scheduled for review at a convened meeting. The pre-review will ensure that only submissions that are complete and free of errors will go before the board. The change will affect how investigators determine timelines for submitting items to the IRB for review. Click the title above for more information.

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Changes are coming to the eRA Log-in Process

Anonymous — Fri, 05 Feb 2016 16:28:36 +0000

Changes are coming to the eRA Log-in Process Anonymous (not verified) Fri, 02/05/2016 - 09:28

Logging into the eRA application is about to get easier! Click through for more. Beginning Saturday, February 6, the process for logging into the InfoEd eRA portal will change.

When first accessing the eRA Portal, the system will present you with the campus dropdown field without requiring an additional login.

If you are logged into an enterprise application that allows for single sign-on (like the employee portal), clicking on the eRA URL will take you straight into the application. If you have not logged into an application that allows for single sign-on, you will be directed to log in with your campus credentials once you’ve selected your campus from the drop down.

For more information, click HERE

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IRB Institutes Data Security Questionnaire for New Submissions

Anonymous — Fri, 28 Aug 2015 15:07:45 +0000

IRB Institutes Data Security Questionnaire for New Submissions Anonymous (not verified) Fri, 08/28/2015 - 09:07

The IRB has recently updated the HRP-211 Initial Application Form and Protocol Template to include questions specifically geared to assessing the data security requirements for all human research studies. This follows coordination with the ��񱦵� Office of Information Security (OIS), which manages all data security activities on the Boulder Campus. A guidance document outlining OIS' requirements for IRB users is found on our Guidance Documents Page, titled "Data Security". More specific data security related questions should generally be directed to OIS.

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IRB

New information about using IRB templates

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NIH Updates Policy for Certificates of Confidentiality

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More Guidance Documents Updated

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Updated Guidance Documents

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Guidance for Investigational Device Studies

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Updates to Study Personnel Roles

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New IRB Staff Member Announcement

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Changes to Pre-review Process for Full Board Studies

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Changes are coming to the eRA Log-in Process

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IRB Institutes Data Security Questionnaire for New Submissions

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