September 25, 2018
The Common Rule News, September 26, 2018
Issue 2: Timing is Everything
Visit the revised Common Rule webpage
Timing is Everything
What timing determines whether a new IRB application is reviewed under the original Common Rule versus the revised Common Rule?
What effect does the January 21, 2019 implementation date of the revised Common Rule have on studies that were approved before that date?
Can researchers decide which set of rules they want to apply to their studies? Do they have any options?
Approved on or after January 21, 2019
All new studies for which the IRB application is approved on or after January 21, 2019 must comply with the revised Common Rule. (There are limited exceptions, as described in the University’s Flexibility Policy.) These applications must use the revised consent form template (available October 3) and revised IRB Protocol form (available November 30).
Approved prior to January 21, 2019
Studies that were approved under the current Common Rule (that is, they were approved prior to January 21, 2019) will not be switched over to the revised Common Rule, unless the researcher chooses to switch (after January 21, 2019 and at the time of the study’s continuing review). This switching over may be advantageous for many studies. This option will be described in detail in a December issue of this newsletter.
“In between” applications: Submitted prior to January 21, 2019 but not yet approved as of that date
By law, the transition to the revised Common Rule is based on the status of initial applications on January 21, 2019. The Zipline system shows the application status in a purple box in the upper left corner of the study workspace.
The “In Between” Applications
|Application Status||Version of the Common Rule|
|Clarifications Requested (Pre-Review)||Revised|
|Human Research, Not Engaged||Original|
|Not Human Research||Original|
*Sometimes also called conditional approval
Where to Find the Submission Status
Open up the study in Zipline. The application status is in the purple box on the left side of the screen, to the left of the study number and short title.
The Challenge of In Between Applications
In between applications are submitted under the original version of the regulations but their IRB approval and the research must comply with the revised version. What does this mean? The answer: Extra work and time for researchers and the IRB. Specifically:
- New consent elements and consent “key information”. The consent process and form cannot be approved unless they include the new consent elements and the Key Information section required by the revised Common Rule. If the application included a consent form in the “old” version of the template, it will have to be replaced with a consent form using the revised template with the new required elements.
- New criteria for waivers. The IRB cannot grant a waiver of consent or a waiver of documentation of consent unless it considers the criteria described in the revised Common Rule.
- Consent form registration. If the study is a clinical trial, a copy of the consent form must be uploaded to a national registry sometime during the life of the study.
The new consent requirements and criteria will be described in detail in later issues of this newsletter.
Four Strategies to Reduce the Challenges of In-Between Applications
- Reduce the number of in-between applications by publicizing application dates that will help researchers avoid this situation.
- Release the revised Consent Form template in advance.
- Release guidance about the new consent requirements in advance.
- Triage applications during the two months prior to January 21, 2019.
Submit your new IRB application by these dates. This will maximize the chances that the original Common Rule (not the revised Common Rule) will apply to your IRB application and study. HSD cannot guarantee this outcome but we will do our best to complete the reviews of applications submitted by these dates before January 21, 2019. These dates are based on the turnaround times for applications during the same time period last year. This is the most challenging time of year for turnaround, because numerous holidays, the frequency of staff and IRB member vacations, and the quarter break significantly reduce the number of IRB meetings and availability of IRB members.
On October 3, HSD will post the revised Consent Form template. This template will incorporate the new consent elements required by the revised Common Rule. HSD recommends that researchers immediately being using the revised template, to avoid the extra work that would otherwise be required if the application cannot be approved before January 21, 2019. The revised template is valid with either version of the Common Rule.
On October 3, HSD will begin posting guidance about the new consent requirements. These requirements include: new elements, the key information section of consent forms, additional criteria for waivers of consent, and the requirement to register the consent form of a clinical trial. The guidance will continue to evolve as federal regulatory agencies provide more information about these new requirements. This will allow researchers to plan ahead for studies that will be conducted under the revised Common Rule.
HSD will triage applications received in the two months before January 21, 2019. The goal is to minimize the impact on “in between” applications, and researchers.
For example, HSD will prioritize completion of the initial applications reviews for studies that have a consent form, to help these researchers avoid the extra work associated with the new consent requirements of the revised Common Rule.
Word of the Week
HSD is using the term In Between Applications for initial IRB applications that are submitted prior to January 21, 2019, and that are not approved by that date. These applications may have been prepared by researchers per the requirements of the original Common Rule – but the application review and the study itself will be governed by the revised Common Rule. The IRB review process will involve additional work for these researchers if the study has a consent form and if the researchers do not use the revised consent form template (available on October 3) with their applications.
Question from Campus
Q. I’ve heard that the original Common Rule will apply to my IRB application and my study as long as I get my application to HSD by January 21, 2019 (the implementation date of the revised Common Rule). Is that correct?
A. No. What matters is the status of your application on that January 21, 2019 date. The revised Common Rule and its new requirements will apply to all studies that have not received IRB approval prior to that date. Find your application status by looking at the purple box in the upper left corner of your study workspace in Zipline.
Send your questions about the revised Common Rule to email@example.com. Each issue of this newsletter will answer one or more questions.
Summary of Changes
HSD’s Common Rule webpage has a summary of the changes. Each issue of this special newsletter will focus on one of these changes – providing in-depth details about how it will affect researchers, the IRB review process, consent forms, application forms, and the Zipline e-IRB system. It will also link to any resources that are available to help with the change. The schedule of topics and newsletter dates is posted on the HSD Common Rule webpage.
Issue 3, October 3, 2018
Focus: Foundational Concepts