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HS-IRBs News - February 2009
Health Sciences and Minimal Risk IRBs, IRB News / Volume 1, Number 3, February 2009
UW-Madison HRPP Achieves Full AAHRPP Accreditation!
AAHRPP (Association for the Accreditation of Human Research Protection Programs) awarded UW-Madison’s HRPP (Human Research Protection Program) full accreditation in December 2008. Many people across campus – including researchers and study coordinators – participated in a major effort to achieve accreditation, which included an extensive site visit and the revision of many policies regarding human subjects research. Only three other Big Ten institutions are fully AAHRPP accredited and we thank everyone who helped us reach this milestone.
New Health Sciences IRBs Staff Members
The HS IRBs Office is pleased to announce the arrival of 3 new staff members who will help us provide better service to the research community. Please join us in welcoming our new members:
- Gemma Gliori is a new staff reviewer who will support both the HS and MR IRBs by conducting pre-reviews of new applications and assisting study teams with their questions. Gemma was previously a study coordinator with Asthma/Allergy.
- Molly Lumley has been hired as the submission specialist for the office. Molly will be triaging all incoming applications received by the HS IRBs and will work closely with IRB staff and study teams to ensure the review process goes smoothly. Molly comes to the office from the Phase I G/U Oncology group.
- Jessica Scott has joined the office as the new continuing review analyst. Jessica will assume responsibility for coordinating continuing reviews that require full IRB review as well as reviewing reportable events like noncompliance. Jessica previous position was as a problem investigator with the Red Cross.
Development of the Health Sciences IRBs new electronic submission and review system – called ARROW – continues to make good progress. IRB staff have completed a draft of the new initial review application, which will use branching logic to create an application that will be tailored to study procedures and IRB review type. During the month of February, IRB staff will be meeting with members of the research community to review the draft form and receive feedback. Please stay tuned to the newsletter and listserv for further ARROW updates.
Pre-Review Process Changes
About 6 months ago, the HS IRBs implemented a pre-review process for most types of submissions, including new initial review applications. The goal of pre-review is to better facilitate the review process for study teams by identifying and hopefully resolving issues prior to applications undergoing full IRB review. As expected, this process has significantly reduced the number of deferrals and has increased the number of straight approvals issued by the IRB. The open-ended nature of this process has, however, posed challenges for IRB staff and study teams alike.
To help address these challenges and improve the pre-review process, the HS IRBs have modified the pre-review by limiting the number of times IRB staff will review an application before scheduling it for IRB review. IRB staff will now provide study teams with one set of comments and then conduct a second review of application materials when the study team responds to the first set of comments. In most cases, IRB staff will then schedule the submission for review by the full IRB. It is hoped these changes will both clarify and shorten the pre-review process. Pre-review should still resolve the most significant outstanding issues prior to full IRB review, although study teams should anticipate the possibility of receiving additional modification requests from the IRB. The HS IRBs will continue to monitor how well pre-review is working and will modify this important process as needed.
Separation of Continuing Reviews and Changes
In preparation for the new electronic submission system and to help ensure that progress reports are reviewed before studies expire, the HS IRBs are no longer concurrently review continuing reviews with changes of protocol. This includes both full changes of protocol and expedited changes. If you wish to submit a change of protocol but your study is within one month of expiring, please submit the continuing review progress report first, separately from the change form. After you have received approval for the continuing review, you can then submit the change of protocol.
In December 2007 and January 2008, the HS IRBs invited people listed as key personnel on HS and MR IRB protocols to complete a user satisfaction survey. A total of 330 people from 52 different departments/groups responded to provide feedback. In the next couple of newsletters, we’ll share the results from this survey.
According to the survey, people were generally satisfied with the IRBs. On a scale of 1 to 5, with 1 being very dissatisfied and 5 being very satisfied, 180 respondents were satisfied or very satisfied, and 93 were dissatisfied or very dissatisfied. Of the respondents, 263 primarily used the HS-IRB, and 58 primarily used the MR-IRB. IRB satisfaction did differ slightly depending on which IRB respondents primarily used: those primarily using the HS-IRB gave an average satisfaction score of 3.42, while those primarily using the MR-IRB gave an average satisfaction score of 3.29.
The survey also asked several questions about satisfaction with the review process. Regarding timeliness of IRB review, 155 were satisfied or very satisfied, with 93 being dissatisfied or very dissatisfied. The survey asked if the respondents agreed with the statement “The IRB’s determinations about my studies are consistent from protocol to protocol.” A total of 108 people agreed or strongly agreed with this statement, and 110 disagreed or strongly disagreed.
We’d like to thank to those of you who responded to our survey. The HS IRBs have taken the results into consideration, especially while developing the new electronic submission system. We ultimately hope that the new submission system, plus pre-review of initial review applications, will speed up review time and increase consistency.
To help us provide everyone with the most current updates and announcements more easily, we are happy to announce the development of a new Health Sciences IRBs listserv. We will use the HS IRBs listserv to provide you with useful information about upcoming changes and tips for how best to utilize the new processes. Anyone can subscribe to the listserv and this will allow us to reach out to people who are not listed in our current database, including administrators. To receive listserv announcements, you MUST subscribe to the listserv. To subscribe, please review [Link for document 17720 is unavailable at this time.] .
- Urgent issues (e.g., subject safety concerns), please call our main line (608-263-2362) and ask to speak with the staff reviewer on call for the day. Please do NOT use email for these kinds of questions.
- General IRB questions, please call our main line (608-263-2362) to speak with the staff reviewer on call or email firstname.lastname@example.org. These are the quickest ways to get help with general questions.
- Specific questions regarding the status of your review and/or reviewer notes, please contact the staff reviewer assigned to your application.
- Help with single IRB review and reliance questions, email email@example.com.
- Assistance with ARROW or technical questions, email firstname.lastname@example.org.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing email@example.com.
- Consultations: For investigators seeking assistance on a specific program or application, HS-IRBs staff are available for individual consultations. To request a consultation, complete the HS-IRBs Presentation and Consultation Request Form.
- Presentations: The HS-IRBs office is available to provide the research community with presentations and trainings on a variety of topics. To request a presentation, complete the HS-IRBs Presentation and Consultation Request Form.