December 5, 2017
For the Record – December 4, 2017
Using an External (non-UW) IRB
New required process beginning January 12, 2018
Some UW studies are reviewed by an external IRB instead of the UW IRB. The possible reasons include: IRB expertise (e.g., oncology trials are reviewed by the Fred Hutch IRB); the NIH Single IRB requirement for multi-site studies; and the desire to eliminate duplicate IRB review for collaborative studies across institutions.
HSD already receives many requests to use an external IRB. We expect a sharp increase beginning early in 2018. These requests currently come into HSD through many routes and are handled in diverse ways.
The External IRB request process is being standardized with the January 12, 2018 changes to our Zipline e-IRB system. Beginning January 12, 2018, all studies that wish to rely on any external IRB must submit a request through Zipline. This will improve efficiency for many requests. It will also address changing federal compliance expectations. The process is essentially the same as the current process for using WIRB or the Hutch IRB, but it is now being expanded for all external IRB requests. A four-person HSD Reliance Team has been formed, to improve consistency and clarity for this sometimes-confusing process.
Click here to see three common examples of how you might use this process.
Questions? Contact the HSD Reliance Team at email@example.com.
Revisions to Zipline and the IRB Protocol Form
January 12, 2018
We are implementing some relatively minor changes to Zipline and to the IRB Protocol form, on January 12, 2018. Zipline will be unavailable for a few hours that evening while the revisions are loaded into the system. The biggest changes are described below. Complete Change Notes will be available on January 10th at the bottom of HSD’s webpage about Zipline.
Process changes. The biggest change is the extension of the External IRB process to all uses of an external IRB (i.e., this process will no longer be used just for studies that are being reviewed by WIRB or the Fred Hutch IRB). See the lead item (above) for more information. Also, it will now be more obvious how to change the study PI.
Smartform changes. You will notice changes to questions on several of the Smartforms when you prepare a new application. In addition, you will be prompted to answer any new required questions when you submit a modification to a currently approved study. Listed in order of the size and significance of the changes:
- Additional Study Scope. Several questions have been deleted. A few new questions have been added. Two questions have been combined.
- Study Scope. We have revised some questions for clarity.
- Drugs. We added two new questions, to obtain information about how and why the drug(s) are being used.
- Devices. We have clarified what types of devices we want you to describe and added a new question about device use.
- Basic Information. When you are preparing a Modification, you will no longer be able to accidentally change the answer about whether the study is a conversion. Also, if the PI is being changed, the form will prompt you to reconsider some related questions (for example, about PI financial conflict of interest).
- RNI (Reportable New Information). Question 3 has been deleted. This means you will no longer be required to select the category/type of problem or event you are reporting.
- Consent Form. We are now asking you to provide the draft consent form (if available) when you will be using an external IRB. This includes studies that are requesting authorization to use WIRB or the Fred Hutch IRB.
IRB protocol form. The changes are minor. Additional explanatory information has been added to several questions. A few questions have been sub-divided, re-worded, re-organized, or re-numbered (see especially Section 3 “Research Setting” and the questions about cognitively impaired subjects).
Revised Common Rule
Significant uncertainty. Significant uncertainty remains about the implementation of the revised Common Rule. While implementation is still scheduled for this January (1/19/18), it is also still subject to an administrative “hold” that began almost a year ago. Moreover, in October the federal Department of Health and Human Services (HHS) proposed a one-year delay of the implementation date (to 1/19/19) – a proposal whose fate has not yet been determined.
If the federal government takes no action on the hold or proposed delay between now and 1/19/18, the revised Common Rule takes effect on the originally proposed implementation date of 1/19/18. However, a decision is possible anytime before that date to delay implementation, re-open the revision process, or scrap the revisions entirely. In other words, we could literally find out on 1/18/18 that the implementation is being delayed by a year.
HSD plan. In the face of this uncertainty, HSD has made preparations to implement the minimum necessary changes on 1/19/18. This ensures that we will be compliant if the revised Rule is implemented, while reserving some of our limited planning and project resources for other changes and for improvements in our services for you.
Affected studies. We will initially apply the revised Common Rule only to studies that receive IRB approval on or after 1/19/18 and that are not subject to FDA regulations. Note that the new regulations must be applied to any initial applications that are already in some state of review but that have not yet received IRB approval.
The changes. There are two changes that would immediately affect researchers:
- Consent forms. New elements are required for most consent forms. HSD will post and publicize a revised consent template containing the new elements in mid-December.
- Continuing review (Status Reports). Continuing review of newly-approved minimal risk studies is eliminated, unless the IRB provides written justification for requiring it for a specific study. This means that most new minimal risk studies will not have an IRB expiration date.
Changes later in 2018. Other changes would be implemented by the middle of 2018. Examples include: (a) expanded categories of exempt research; and (b) HSD’s process for determining whether the revised Common Rule should be applied to any existing, already-approved studies.
Communication plans. HSD will immediately publish a special edition of this eNewsletter, should any news become available about the status of the revised Common Rule. We will publish the revised consent template (with embedded instructions) in mid-December, so that researchers have time to use it for any IRB applications they plan to submit on or after January 19, 2018. Information will also be posted in the “headline” area of our webpage.
Any questions may be directed to firstname.lastname@example.org.
What is a Clinical Trial?
NIH explains its broad interpretation of the definition
A new item in NIH’s All About Grants podcast series is called “Understanding the Definition of a Clinical Trial and What That Means for You”. This podcast was developed in response to the questions and controversy that arose this summer when NIH revealed its broad interpretation of the definition through a series of case studies published on its Clinical Trials webpage. The podcast is available as an audio mp3 file (see the first entry under “Submitting Your Application” at this link https://grants.nih.gov/news/virtual-learning/podcasts.htm) or you can read the transcript.
Did You Know?
Have you ever submitted an application to HSD and immediately realized that you’ve forgotten something? Is your My Inbox page cluttered with old submissions that you don’t plan to submit? Take a look at our INSTRUCTIONS: Withdraw or Discard Submission to learn what to do!