HS-IRBs News - January 2010
Health Sciences and Minimal Risk IRBs, IRB News / Volume 2, Number 1, January 2010
The HS-IRBs Office is in the final stages of ARROW development. Alpha testing of the system is taking place this January. This involves having IRB staff members test several IRB review scenarios in the system and check for bugs. Beta testing with volunteers from the research community will begin in early February. After beta testing is complete and any additional fixes to the system have been made, training of study team members will begin.
ARROW Implementation Timeline
ARROW will be implemented in phases over several months during 2010. The first phase will likely go live in late March with just a few research groups, including those from Asthma/Allergy and the Cancer Center. This will give these study teams, IRB staff, and IRB members a chance to use the system in real time on a small scale so that we can make any needed adjustments. We currently expect the second phase of study teams to go live with ARROW in late spring or early summer, depending on the success of the first phase.
Questions about ARROW?
The HS-IRBs will begin offering ARROW training and educational materials in the near future. In the mean time, the HS-IRBs Office has established a new email address for questions about ARROW: firstname.lastname@example.org. This email account is being monitored by IRB staff who are involved in the development of ARROW and thus able to answer any questions study teams might have about the new system. This email will continue to be used after ARROW is live to handle study team questions and system feedback.
Revised Campus Policies
The Human Research Protection Program Advisory Committee (HRPP AC), which develops and approves all policies for the HRPP, approved changes to two campus policies recently that affect the submission of continuing reviews and changes of protocol for investigators conducting human subjects research.
Continuing Review by Full IRB Policy
The Continuing Review by Full IRB Policy describes the policies and procedures that UW-Madison IRBs and researchers are expected to follow related to the continuing review of research. This policy stated that if a research team does not provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, the protocol automatically expires and research activities must stop, unless there is an overriding safety concern involved such that it is in the best interests of individual participants to continue participating in the research interventions or interactions based on the investigator’s clinical judgment. Enrollment of new participants cannot occur after the expiration of IRB approval.
This policy now clarifies what occurs when research teams do not obtain reapproval of their ongoing studies involving human subjects in a timely manner. IRBs will automatically close protocols if either of the following circumstances occurs: a) no continuing review progress report is received by the IRB within 3 months of the protocol’s expiration; or b) the IRB has received a continuing review progress report from the research team, defers the protocol or requests modifications or clarifications from the research team (either as part of a formal review or pre-review), and the research team does not respond to these requests within 3 months after they have been sent to the research team. If the research team provides a continuing review progress report or responds to the IRB’s requests within 12 months after the automatic closure date, the IRB can request the research team submit an initial review application to re-open the study.
Change of Protocol Review by Full IRB Policy
The Change of Protocol Review by Full IRB Policy describes the policies and procedures that UW-Madison IRBs and researchers are expected to follow related to the submission and review of changes of protocol. Federal regulations require researchers to obtain IRB approval of changes prior to their implementation unless to eliminate apparent immediate hazards to subjects. In addition, the federal regulations require IRBs to have written procedures to ensure prompt reporting to the IRB of proposed changes in a research activity. Campus policy now provides guidance to research teams regarding what constitutes prompt reporting as follows:
When a change of protocol is planned it should be submitted to the IRB for review as soon as possible, especially if the changes include revisions that 1) affect the risk/benefit ratio of the study (e.g., result in a change to the protocol); (2) affect alternatives to study participation for subjects; (3) represent new information that should be provided to subjects; or (4) affect the local conduct of the study.
Changes in approved research initiated without prior IRB review and approval to eliminate apparent immediate hazards to a participant must be reported to the IRB within ten (10) days of implementation, at which time an amendment to the protocol and, if needed, to the informed consent document must be submitted to the IRB. The report will be reviewed by the IRB to determine that the action taken by the investigator was necessary to eliminate an apparent immediate hazard to the participant(s) and the change of protocol is consistent with ensuring the participants’ continued welfare.
If changes are the result of new information, such as identification of unanticipated risks or findings that may affect a subject’s willingness to take part in the study, the research team must report this new information to the IRB independent of the change of protocol as a possible unanticipated problem within 10 business days after its discovery (or by the next business day if the new information suggests a problem that is immediately life-threatening to other subjects). This information can be submitted to the IRB before the change of protocol is submitted. The research team can note in the report that a change of protocol application is forthcoming or has been submitted separately.
In the case of sponsored studies that involve amendments that are externally generated, changes of protocol should be submitted to the IRB within a maximum of 60 days of their receipt by the local study team. This timeframe should allow the research team sufficient time to prepare the change of protocol application materials and obtain approval by a scientific review committee, when required, prior to review by the IRB.
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