Frequently-Asked Questions

January 21, 2019.

Feel free to contact the IRB if you have questions.  

1. Studies that are subject to the rules and regulations of one of the Common Rule Agencies; AND
2. Studies approved by the IRB on or after January 21, 2019.

 The Revised Common Rule doesn’t apply to every study.  The IRB will help you to know if you need to follow the Revised Common Rule. 

• FDA-regulated research ( which is still subject to 21 CFR).
• Non-Federal research, including research NOT conducted or supported by a Federal department or agency.  Other regulations/policies may be applicable, instead.

You can learn about all of the changes being made relating to the revisions to the Common Rule by viewing the IRB's Revised Common Rule video.

Most of the changes relate to:

1. Informed consent & waivers of consent
2. The levels of IRB review
3. Continuing review requirements & expiration dates

As part of the revised Common Rule, some of the requirements for informed consent are changing, and there are some new elements of consent that investigators will be required to address.  You can find out more about each of these changes by viewing the IRB's Revised Common Rule video.

1. One new element included in the revised Rule is an option to obtain “broad consent” for the storage, maintenance, and secondary research use of identifiable private information and identifiable biospecimens. 
2. The revised Rule includes a new requirement for clinical trials conducted or supported by a Federal department or agency to post their IRB-approved consent documents on a publicly-available website.
3. There are also a few changes relating to waivers of consent, including a new category for approving waivers, and a clarification related to approving waivers for recruitment only.
4. Another new element is the addition of a “concise summary” of the key information included in the consent document. 
5. Besides the “concise summary”, there are several other new required elements of consent related to future use of samples and data, returning research results, and whole genome sequencing.

For FDA-regulated studies, we also recommend reviewing the FDA's guidance document, "Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations".

Not necessarily. 

• Go-Live Date: The revisions to the Common Rule go live on January 21, 2019.
• Active Studies: Studies that are IRB-approved prior to the go-live date.
• New Submissions: Studies not submitted in ERICA before the go-live date (i.e. in "Creation").
• In Review Process: Studies submitted before or after the go-live date but not yet approved.  

Active Studies will be "grandfathered" in under the old Common Rule.  All University of Utah studies that are currently approved or determined Exempt by the IRB and actively ongoing will not be required to comply with changes.  At next amendment or continuing review, the ERICA application will have new fields that are related to the revisions. These fields will need to be completed but will not alter the study in any way.  Active studies will submit a continuing review application as normal and the IRB will make the determination regarding any change to the level of review or requirement for future continuing reviews.

 The revised Common Rule will apply to all New Submissions.  All new studies that have yet to be submitted in ERICA before the go live date will be required to comply with the revisions. This includes studies that are in ERICA ‘study creation’ phase at the go live date.  The ERICA application will be updated to reflect all changes and study teams can expect to complete the application as normal. By completing the ERICA application study teams will be compliant with the revised common rule.  The new consent form requirements will be implemented. All consent forms attached to submissions after the go live date will be expected to comply with changes.

 The revised Common Rule will apply to all studies In Review Process.  All study applications that have been submitted to the IRB prior to the go live date but have not been approved will be required to comply with the revised common rule changes.  In this case, the IRB will send the ERICA application back to the study team with a list of revisions required to comply with the changes.  Even if the study has been sent to board review before the go live date, if not approved yet, it will be returned for changes. This will include the consent form requirement and all the new elements within the ERICA application that will need to be completed.

You can find out more about each of these requirements by viewing the IRB's Revised Common Rule video.

The revised Common Rule includes an option that would allow institutions to obtain broad consent for the storage, maintenance, and secondary research use of identifiable private information and biospecimens.  You can find out more about this aspect of the revised Common Rule by viewing the IRB's Revised Common Rule video.

The University of Utah IRB already initiated a similar method of obtaining consent for the use of specimens several years ago with our Tissue Banking policy.  The current University of Utah IRB policy already addresses nearly all of the new components of the revised Common Rule.  Any remaining updates that are required will be made to that policy for consistency with the new Common Rule.

However, the use of “broad consent” as it is fully defined in the new Rule will NOT be implemented at the U.  We hope this will allow us to maintain flexibility in allowing waivers of consent for future research.

The Common Rule now requires clinical trials conducted or supported by a Federal department or agency to post the IRB-approved informed consent form used to enroll subjects on a publicly available Federal website.  The details relating to this requirement are very minimal at this time.  More information will be forthcoming.

There have been a few changes relating to waivers.  The IRB application will be updated to comply with these changes.  For previously-approved studies, you may see a few new questions you will have to fill out, but the information shouldn't change anything relating to the conduct of your study.  

The revised Common Rule includes requirement that the “Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or LAR in understanding the reasons why one might or might not want to participate in the research.”

You can find out more about this aspect of the revised Common Rule by viewing the IRB's Revised Common Rule video and by visiting the Consent Process Checklist page.

Learn more about the Concise summary here

Yes, but there are multiple ways to accomplish this, and the solution may be as simple as moving some of the information already in your document to the beginning.  

You can find out more about this aspect of the revised Common Rule by reviewing the IRB's Consent Document Guidance.

The IRB has also provided examples of how to satisfy the concise summary requirement on the Consent Document Models page. 

Informed consent now requires the following elements be addressed:

• A statement of whether or not identifiable private information or biospecimens may be used or distributed for future research.
• A statement of whether or not clinically relevant research results will be disclosed to subjects, and if so, under what conditions.
• A statement that the subject's biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit.
• Whether the research will or might include whole genome sequencing.

Our updated consent guidance includes these new requirements and provides you with example consent language.

Active Studies will be "grandfathered" in under the old Common Rule.  All University of Utah studies that are currently approved or determined Exempt by the IRB and actively ongoing will not be required to comply with changes.  At next amendment or continuing review, the ERICA application will have new fields that are related to the revisions. These fields will need to be completed but will not alter the study in any way.  Active studies will submit a continuing review application as normal and the IRB will make the determination regarding any change to the level of review or requirement for future continuing reviews.

You will not routinely be required to re-consent your participants if the only updates to your documents are related to transitioning your study to the Final Common Rule.  However, as always, re-consent requirements are handled on a case-by-case basis as appropriate for each specific study and participant population.

Most of the changes relate to exempt and expedited review and will have a large effect on how the IRB runs internally.  However, most researchers will notice only minor changes.  More research may qualify for exemption than before, and some studies may qualify for expedited review that didn't before.  

The most dramatic change that will be noticed by study teams is that most studies that qualify for expedited review will no longer expire, which means continuing reviews will no longer be required for some research.  Pay close attention to your IRB approval letters for details.

The Final Rule allows studies initiated (approved, approved with changes) before January 21, 2019 to continue to be subject to the pre-2018 Common Rule.  There will now be three (3) regulatory categories applicable to Common Rule research:

1. Grandfathered: Pre-2018 Common Rule requirements are applicable.
2. Transitioned: Research approved under pre-2018 Common Rule requirements, but switched over to the Final Rule.
3. Final Rule: Subject to the 2018 Common Rule requirements.  

You can request that the IRB consider transitioning your study to the 2018 Common Rule via a Continuing Review + Amendment application.  The Continuing Review is required to reset your expiration date, and the Amendment is required to approve the change to your study.  

The IRB may also suggest that your study transition to the 2018 Common Rule if we believe transitioning may be of benefit.  

No.  If you would like to transition your study, you must transition completely. 

For example, this means that if your study qualifies for expedited review, and you would like to remove the expiration requirement associated with the pre-2018 Common Rule, you must also update your consent document and application to comply with the rest of the 2018 Final Common Rule requirements.

However, if your study is no longer using a consent document, or your research is conducting using a Waiver of Consent, transitioning completely may be of benefit, as complying with the Final Rule would require minimal revision.

If you are not sure whether your study would be a good candidate for transitioning to the 2018 Final Common Rule, contact the IRB.

Yes, if the Final Common Rule requirements are not inconsistent with the FDA's requirements.  

The FDA has provided a guidance document that discusses the impact of the Common Rule on FDA-regulated clinical investigations here.

No, it was “approved with changes” on or before January 21, 2019.

The UU IRB is moving away from consent document templates towards a more flexible paradigm where we offer guidance for conducting a consent process, and drafting a consent document.

You can find out more by viewing the IRB's Consent Guidance Introduction video.

February 1, 2019.

There are many reasons, but primarily:

1. The UU IRB is working with more institutions and groups outside of the University than ever before.  The need for more generalizable and adaptable guidance has never been greater.
2. The changes to the Common Rule include many provisions that are not applicable to everyone, and are not as easily categorized by Health Sciences vs. Main Campus.  In order to capture as many scenarios as possible while still offering useful examples, less rigid models for obtaining consent are needed.

You can find out more by viewing the IRB's  Consent Guidance Introduction video.

The IRB will focus on two key pillars of obtaining informed consent for research:

1. The consent process, and
2. The consent document.

For each of these pillars, we have divided the guidance into two sections:

1. An operational checklist that covers all of the basic requirements of the process or the document and offers examples and references to help you, and
2. Models and examples of different consent documents that the IRB considers acceptable and approvable. 

You can find out more by viewing the IRB's Consent Guidance Introduction video.

Yes and no.  All consent documents must be stamped by the IRB in order to be considered approved, and only documents that are not expired (as indicated in the IRB stamp) are valid for consenting research participants.

However, ERICA can stamp documents using two different methods:

1. MS Word Documents: These documents must include the "mail merge" style watermark footer that has been used by the IRB for many years.
2. Adobe PDF Documents: ERICA can stamp these documents with an approval stamp image.  However, you must leave enough space at the bottom of the document so the image can be placed correctly. Note: Tracked copies of revised documents are still required with your IRB submission, even if the final document submitted for approval is a PDF.

The IRB watermark footer page will still be available on the Forms & Templates menu.