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Human Subjects Division (HSD)

Announcements

eNews re: IRB Review - February 4, 2014

Feb 3, 2014 at 1:35pm

ANNOUNCEMENT: Education Sessions

The changes announced in this newsletter have a broad and significant impact. HSD is conducting several one-hour sessions on campus to describe the changes and answer questions about them.

Currently scheduled sessions include:

  • UW Tower Auditorium: Wednesday, 2/12, 1:30 - 2:30 pm
  • Health Sciences Room K-069: Friday, 2/14, 2:00 - 3:00 pm
  • Harborview R&T Auditorium: Thursday, 2/20, 12:30 - 1:30 pm

In addition, a four-minute video about the changes is available on the HSD Training Videos webpage.


CHANGE: How new applications are assigned to an IRB

Implementation: January 15, 2014

Expected impact: See the list of advantages below

Most new applications requiring full IRB review are now being assigned to a specific IRB based on the researcher's academic unit. For example, new biomedical research from the Department of Orthopaedics or from the School of Dentistry will now always be reviewed by IRB Committee D. Exceptions may occasionally be made due to IRB workload issues. In addition, research involving certain issues (emergency exception to consent; pregnant women) is now always being assigned to the same IRB. Academic units with lower volumes of human subjects applications will be assigned on a rotating basis to IRBs whose membership has the expertise to review the research. The significant advantages of this new policy:

  • Improved consistency of IRB reviews.
  • Improved quality of review (because departments are assigned to IRBs based on member expertise).
  • Increased opportunity to establish helpful and positive working relationships between researchers, HSD staff, and the IRB.
  • Departments will reap a direct benefit by having faculty members serve on the IRB that reviews the department's research.

See the HSD website for a list of the academic units reviewed by each IRB. Existing approved studies will stay with their already assigned IRBs.


NEW TOOL: Finding the right HSD staff person

Implementation: January 1, 2014

Expected impact: Quicker and more accurate process for obtaining answers to questions

Specific IRB staff teams and Minimal Risk teams have now been assigned to each of the academic units that submit most of the IRB applications. Look up your HSD staff contacts by using these tools:

Want to discuss a planned application or an application that is under review? Call or email the HSD staff contact identified for your academic unit. These are the same staff that will be involved in the review process. If your department/academic unit isn't listed, feel free to contact any staff listed for "general biomedical research" or "general social/behavioral research". Also, feel free to continue to use the frequently-monitored HSD help email: hsdinfo@uw.edu or to call our front desk at 206-543-0098


CHANGE: Who is identified by name on IRB applications

Implementation: January 31, 2014

Expected impact: Significant reduction in "nuisance" modifications to change team members

IRB applications no longer ask for the name of every member of your research team. Instead, applications ask for the names and contact information for only those individuals fulfilling the following specific roles for your research:

  • Lead Researcher: also called the principal investigator.
  • Faculty Advisor: required only when the lead researcher is a student.
  • IRB Contact Person: the person with whom the IRB should communicate.
  • Study Coordinator: the person who manages the day-to-day operations of the study.
  • Subject Contact Person: the person(s) to whom the participant questions, complaints, and adverse events should be directed

For all other team members, application forms now ask for only the qualifications required for individuals whose roles include conducting procedures that involve risk to subjects. Example: for a study involving a behavioral therapy intervention for drug abuse, the application should describe the background/experience/ licensing requirements (but not names) for individuals who will deliver the behavioral therapy. Modification forms about a change in the research team will be required only when there are changes to named individuals or the qualifications for a role.


CHANGE: Who is identified by name on consent forms

Implementation: January 31, 2014

Expected impact: Significant reduction in "nuisance" modifications to change team members

Consent forms are now required to list only the lead researcher, the subject contact person, and (for student research) the faculty advisor. Modifications to consent forms because of a change in the research team will be required only when there is a change to the lead researcher, subject contact person or faculty advisor. Researchers are not required to modify existing approved consent forms. However, if a consent form is being modified for some other reason, it is in the researcher's best interests to also change who is listed on the document.


CHANGE: Identification of involvement of other organizations and institutions

Implementation: January 31, 2014

Expected impact: Significant reduction of "back and forth", and significant reduction of non-compliance on this issue

All application forms now have a short new section for this specific purpose which also provides guidance to researchers. On the Modification form, this new section replaces a previous section that was long, complicated, and confusing.


CHANGE: Training verification

Implementation: January 31, 2014

Expected impact: Fewer attachments to IRB application; elimination of a major question on the IRB application; less "back and forth"

Researchers are no longer required to provide documentation that training requirements have been fulfilled by research team members, when the training has been completed solely to fulfill the requirements of an external funding agency. A careful analysis showed that the IRB's role in verifying fulfillment of training requirements was redundant with the process followed by the federal funding agencies. Therefore, the IRB's requirement has been eliminated. Note that the IRB has the authority to require training even when it is not required by funding agencies; in these cases, the researcher should provide documentation of training completion.


REVISION: Modification Form

Implementation: January 31, 2014

Expected impact: The form is easier to understand, navigate, and complete. Because it is a "smart" PDF form that displays only the information relevant to a specific study and modification, the printed copy will almost always be significantly shorter.

The new Modification Form is finally here! It is now a "smart" PDF form. This change to the most frequently used IRB form allows users to select and see only the sections pertinent to the changes being made. It also implements the policy changes described above meaning fewer modifications forms to complete and submit for IRB approval. The new form also has a shorter and simpler section about the involvement of other organizations and institutions. Previous versions of the Modification will not be accepted after February 28. Be sure to replace any downloaded versions of the previous Modification form.

HSD and the IRB expect researchers to begin using the revised forms immediately. We recognize that some applications may already be partially completed on the older forms. Researchers may complete the applications on those forms; HSD staff will contact you if they have any questions or need additional information because of these revisions.