HS-IRBs News October 2011
Health Sciences and Minimal Risk IRBs, IRB News / Volume 3, Number 10, October 2011
Coming Soon: Next Round of 5 Year Renewal RemindersAs a courtesy to study teams, the HS-IRBs office will soon be sending out 5 year renewal reminders for studies from 2006 and earlier. Campus policy requires that all studies that have been open for 5 years or longer submit a new IRB application. unless they meet the criteria for exception. Continuing review approval letters also are including information about the 5 year renewal requirement for studies that have been open 5 years or longer. Study teams are advised to be familiar the requirements of the 5 year renewal policy so they can plan accordingly. For more information about this policy, please see 18868.
What Reportable Events Need to Be Submitted to the IRB?Although many research teams are aware of the federal and
institutional requirement to report adverse events to the IRB that represent potential
unanticipated problems, we would like to highlight other types of events and
information that may constitute unanticipated problems and thus require
reporting to the IRB. These include:
- A subject becoming incarcerated during a research study – there are special regulations that apply to prisoners participating in a research study
- Implementation of a change of protocol prior to IRB approval in order to eliminate an apparent immediate hazard to subjects
- Data safety monitoring board report or other interim findings that suggests that the risks to participants have been altered, including in their severity or frequency
- Discovery of publication that indicates an unexpected change to risks, including severity or frequency, to participants
- A complaint from a study participant that indicates unexpected risks or that cannot be resolved by the study team
- Inadvertent breach of a participant’s confidentiality or privacy that involves risks to the participant or others
- Premature completion of the study
- Change in FDA labeling or withdrawal from the market of any drug, biologic, or device under study
- Dosing errors
Understanding Quality Improvement vs. ResearchThe HS-IRBs are required to review and oversee health sciences human subjects research studies occurring at UW-Madison. If a project does not involve research as defined by the federal regulations, however, it may not require IRB review and/or ongoing IRB oversight. One of the most common question asked by researchers is, "Does my project constitute human subjects research or can it be classified as quality improvement or program evaluation?" In order to provide additional guidance on this topic, the HS-IRBs drafted the document Elements of Quality Improvement vs. Research, which compares typical characteristics of research, quality improvement, and program evaluation projects. In addition, UW-Madison's Defining Human Subjects Research policy can be helpful in making a determination about whether a project should be considered research. For assistance in determining whether your project constitutes research, please contact the HS-IRBs Office.
What Happens If IRB Approval of My Research Study Expires?
Federal regulations require at least annual review of research
studies by an IRB. The IRB may require review of studies more frequently than a
year, especially if they pose significant risk to subjects or may finish within
a short period of time. If an IRB does not review and approve a study before it
expires, the federal regulations do not allow for grace periods. Thus, all
research activities must cease EXCEPT for those that must continue in order to
assure subject safety. In the case of research that falls under VA purview, the
study team must provide a list to the IRB Chair (via the IRB Office) of
research subjects who could be harmed by stopping study procedures. The IRB
Chair will then determine, with appropriate consultation with the VA Chief of
Staff, if any of the subjects on the list may continue participating in the
research interventions or interactions. If multiple expirations of approval
occur on the same research protocol or across research protocols for the same
investigator, this may be viewed as continuing noncompliance and the study team will be asked to provide a plan for preventing expirations in the future.
Reminder: Campus Policy Regarding Student Research
Per UW-Madison campus policy, all UW-Madison undergraduates and graduate students engaged in any kind of research project involving human participants (including independent study, research credits, senior thesis projects, etc.) must obtain approval from a campus IRB before beginning the research. For additional information regarding the difference between student research and course assignement work, please review the Student Research policy. In addition, a student who submits an application for new protocol review by an IRB must list a faculty member or instructor as the principal investigator (PI), as students cannot serve as the PI on a research study. For additional details regarding who can serve as a PI, please the Principal Investigator Status policy.
ARROW Tips: Entering the Long Study Title in the IRB Application
Whatever study title is entered into the IRB application by the study team is the title that will be used by ARROW for all IRB correspondence as well as all internal IRB documentation (e.g., minutes, meeting agendas). Please keep the following tips in mind when entering a study title into the IRB application:
- DO make sure the title is correctly spelled and check for typos. After a study is approved by the IRB, errors in the study title can be fixed only via submission of an expedited change. To avoid this, study teams are advised to proofread their study title before submitting their application to the IRB.
- Do NOT hit return at the end of a line or at the end of the title. The text box for the long study title in ARROW includes an automatic return function, so no manual returns should be needed. Entering manual returns results in line breaks that cause problems in formatting correspondence as well as IRB meeting agendas.
- Do NOT type the entire study title in all caps. Titles in all caps are difficult to read and can cause formatting problems for IRB agendas and minutes. Acronyms should be entered using all caps, but the remainder of the study title should be entered using title case or sentence case (i.e., first word of the title capitalized, the remainder in lower case).
Reviewing Medical Records to Identify Potential Subjects and Waivers of Informed ConsentCurrent federal guidance requires that a waiver of informed consent be obtained when medical records will be reviewed to identify potential subjects. As a result, study teams planning on reviewing medical records for this purpose should check the Waiver of Informed Consent option in the Informed Consent section of the IRB application to request a waiver of informed consent.
Reminder: Summary of Investigator ResponsibilitiesBefore the transition to ARROW, the Health Sciences IRBs Office sent out with every formal letter a copy of a document that provided an overview of investigator responsibilities called Summary of Investigator Responsibilities . This document is no longer sent out to study teams in paper form and is instead referenced in ARROW approval notices as well as posted on the Health Sciences IRBs website on the Policy and Guidance page. This document outlines important information that research teams, especially principal investigators, need to be aware of regarding the conduct of human subjects research. Responsibilities of investigators include:
- Ensuring compliance with the principles of the Belmont Report and Common Rule regulations as well FDA regulations, when applicable.
- Completing required training, including human subjects protection and HIPAA Privacy Rule training, as well as ensuring study team members are adequately trained to perform protocol-related activities.
- Providing complete and accurate information about a research study to the IRB for review.
- Obtaining legally effective informed consent and HIPAA authorization, when applicable.
- Submitting a continuing review protocol progress report to the IRB in a timely manner.
- Obtaining IRB approval of changes of protocol prior to their implementation unless the changes are implemented to avoid an apparent immediate hazard to subjects.
- Reporting potential unanticipated problems and noncompliance to the IRB.
- Complying with the campus Conflict of Interest Policy.
- Submitting a closure report to the
IRB when the research protocol is completed.
- 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 email@example.com. 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 firstname.lastname@example.org.
- Assistance with ARROW or technical questions, email email@example.com.
- Newsletter and other IRB updates, please sign up for the general HS-IRBs listserv by emailing firstname.lastname@example.org.
- 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.