IRB Member Newsletter--Volume 11 (Spring 2018)

Change in IRB Member Liaison Support

As you may be aware, the Health Sciences IRBs identify personnel to support IRB members with questions about meeting schedules, review processes (including help navigating ARROW), and any other member-related issues. Our current IRB Member Liaisons are:

Jackie and Lara are taking over for Emily Jenner, who has taken a position with the UW Carbone Cancer Center. Please do not hesitate to contact an IRB member liaison with any questions you have.

2018 IRB Member Scheduling, Part II

In 2017, the HS-IRBs Office tested out a new approach to scheduling convened IRB meetings and Preliminary Review Session (PRS) schedules. Instead of expecting responses to dates more than a year away, we limited the initial scheduling to January through June 2018. The second round of scheduling was sent on 4/2 to plan for July through December 2018. We appreciate your timely responses.

NOTE: the semi-annual scheduling process only applies to the members of the Health Sciences IRB, not the Minimal Risk IRB.

If you have any questions about the scheduling process, please contact IRBReview@medicine.wisc.edu or our main phone number 263-2362.

IRB Member Survey

We will be conducting a survey of all IRB Members in Qualtrics to provide the HS IRBs Office and Chairs with feedback. The questions are meant to elicit your thoughts about the IRB Chairs (and their management of meetings), the HS IRBs Office Staff (and their communication with you, as well as the materials they prepare for meetings), educational materials and experiences, and IRB Member experience. Please keep an eye out for an email asking you to take the survey, which will be sent April 30, 2018.

Delayed Implementation of Revised Common Rule

The Department of Health and Human Services (HHS) issued its final proposal for changes to the Federal Policy for the Protection of Human Subjects (what we know as the "Common Rule") on January 18, 2017. Although the effective date of the revised Common Rule was originally January 19, 2018, HHS postponed implementation until at least July 19, 2018 with the possibility of a further 6-month delay. In the meantime, many of the provisions of the revised Common Rule have been incorporated into campus policy as outlined below. Campus leadership adopted these policies because they allow more studies to qualify for quicker review processes.

Changes to Campus Policies

As of February 19, 2018, several changes to campus policy were made to reduce burdens on study teams while ensuring adequate protection of human subjects. Most of these updates only can apply to research that is NOT federally supported, FDA-regulated, or fall under VA purview. These include:

  • Exempt human subjects research: New categories of research will qualify for exemption from IRB review. The HS IRBs Office developed a tool to help research teams identify which studies qualify for these new exemption categories and can be found here. This change means that some projects that used to be reviewed by the full Minimal Risk IRB will now reviewed in-house instead, usually by Monica Esquibel.
  • Continuing review: In October 2017, campus policy was changed to excuse many non-exempt minimal risk research studies from continuing review. In February 2018, campus policy was revised again so that additional types of minimal risk research no longer require continuing review. You will notice that staff reviews for new initial applications now include a space for staff reviewers to recommend foregoing the Continuing Review requirement if applicable for that study.

Anticipating the Common Rule Revisions Relating to Informed Consent

The revised Common Rule will require re-organization of consent documents to begin with a concise and focused presentation of the key information that is most likely to assist in understanding the reasons why one might or might not want to participate in the research.

This approach was incorporated into recently revised campus policies. Additionally, these goals align with the ones we had in mind when overhauling our consent form templates last year.

For over a decade, the Health Sciences IRBs have required study teams to create and use an information sheet for most consent documents longer than 5 pages. We will continue this requirement, but with a small change due to the HS IRBs improved informed consent templates. Going forward, consent forms will be considered to meet the new requirements for presentation of key information if they are:

  • 5 pages or fewer
  • OR

  • 10 pages or fewer AND based on current UW-Madison Health Sciences IRBs templates or similar template

Consent documents longer than 5 pages and not based on current UW-Madison Health Sciences IRBs templates, or those that are longer than 10 pages even if based on current UW-Madison Health Sciences IRBs templates, will be required to include an information summary sheet.

We allow twice the amount of pages for consent forms based on our current templates because when we overhauled them, we arranged them with a concise and focused presentation of key information most likely to assist subjects in understanding based on community feedback, and also emphasized the use of white space on the page. Using “white space” facilitates understanding but also increases the total page count.



Keywords:member, IRBM, newsletter, scheduling consent, continuing review, CR, Common Rule, exemptions   Doc ID:81233
Owner:Faye L.Group:Health Sciences IRBs
Created:2018-03-29 16:59 CDTUpdated:2018-07-02 08:57 CDT
Sites:Health Sciences IRBs
Feedback:  0   0