IRB Member Newsletter--Volume 10 (Fall 2017)
Meeting Preparation Tips
The Health Sciences (HS IRBs) utilize a primary reviewer system. Two primary reviewers are assigned to conduct an in-depth review of each item on the agenda. In order to determine if you have been assigned as a primary reviewer, you will need to review the meeting agenda to see if your name is listed next to an item.
Click to expand each topic.
Accessing the Agenda
You can access the agenda from the link in the email notifying you that the agenda is available. You can also access the agenda by:
- logging into ARROW
- selecting your IRB member role
- clicking on the meetings tab, and
- clicking the hyperlink for the upcoming meeting.
To view the printer friendly version of the agenda, click on “Print Closed Agenda” in the upper left. Of note, the printer friendly version of the agenda reminds IRB members of the meeting time, location, and conflict of interest policy.
Preparation for Members Assigned as Primary Reviewers for Initial Reviews
If you are assigned to be a primary reviewer for an initial review, please come to the meeting prepared to:
- Summarize the study, including overall goals, subject population, and study procedures
- Provide an analysis as to whether the study meets each of the criteria for IRB approval
- Outline your primary concerns or questions
- Make a motion
In order to do this, primary reviewers should thoroughly review the following items associated with the submission:
Please see the Primary Reviewer Guidance for Initial Reviews
for additional information on how to complete your review.
Submitting Your Reviews
Primary reviewers must submit the completed Primary Reviewer Form
at the IRB meeting or shortly after the meeting (i.e., before the next business day). There are two ways in which reviewers can submit their checklists:
- Print the form, write your responses, sign, and place the completed form in one of the baskets at the meeting.
- Save a copy of the form on your computer and complete it electronically. Of note, an electronic signature is not required. You can type your name and date and then email the checklist to firstname.lastname@example.org.
Preparation for Members Assigned as Primary Reviewers for Other Reviews
In addition to initial reviews, you may be assigned to be a primary reviewer for:
- Deferral responses: Submissions that were previously reviewed by the IRB and determined that they could not yet be approved. The deferral response is the study team’s response to the IRB’s concerns.
- Modifications responses: Submissions that were previously reviewed and approved by the IRB pending modifications. The modifications response is the study team’s response to the IRB’s modifications.
- Changes of protocol: Request to alter study.
- Continuing reviews: Request to renew study.
- Reportable events: Noncompliance, unanticipated problems and new information are the three reportable event types.
If you are assigned to review a deferral response or modifications response, please be prepared to summarize it at the meeting and conduct an in-depth review, as described above. If the deferral response or modifications response is for an initial review, please complete the Primary Reviewer Form
and submit to the IRB as described in the Submitting Your Reviews section above.
Changes of Protocol and Continuing Reviews
In general, all changes of protocol and continuing reviews will be reviewed approximately one week prior to the meeting during the preliminary review session (PRS)
. Each IRB handles the discussion of the submissions reviewed during PRS differently. For the Minimal Risk (MR) IRB, please be prepared to summarize all changes of protocol and continuing reviews listed on the agenda. For the HS IRB, please be prepared to summarize all changes of protocol designated as a **Full Discussion Item**. There is no paperwork that needs to be completed at the meeting for changes of protocol and continuing reviews by the primary reviewers.
If you are assigned to review a reportable event, please review the reportable event submission form in ARROW along with the staff reviewer’s checklist and any other relevant materials to assess the event (e.g., the protocol). Please come to the meeting prepared to summarize the reportable event and make a motion
. Like changes of protocol and continuing reviews, there is no paperwork that needs to be completed by the primary reviewers for reportable events.
Preparation for Members Not Assigned as Primary Reviewers
Even if you are not assigned to be a primary reviewer at the meeting, you are still expected to prepare in sufficient depth to participate in the discussion and final vote on each item on the agenda. Therefore, please read the staff reviewer’s checklist at a minimum for each item on the agenda that did not go through the PRS.
Updated Informed Consent Templates
The HS IRBs Office recently overhauled the informed consent guidance and templates that are available on its website
. The improved templates will help researchers create consent forms that are easier to read that comply with regulatory and institutional requirements. The consent forms will look significantly different to IRB members; however, the staff reviewers should be noting the use of the new templates in their staff review to assist IRB members. If you have any questions about the consent forms for an item you’ve been assigned, contact the staff reviewer.
Change to Consent Form Stamping Policy
As of February 2017, the IRB approval stamp for consent forms, information sheets, and assent forms no longer includes an expiration date or the UW’s federalwide assurance (FWA) number. Therefore, these documents no longer expire. Following a transition period, study teams will no longer need to request reapproval of these documents at continuing review. During the transition period, the staff reviewer, will determine if consent documents need to be reapproved at continuing review. This will be documented in the staff reviewer’s checklist. Additional guidance regarding this change in policy is available here
Upcoming Change to Continuing Review Policy
Coming fall 2017, continuing reviews may no longer be required for a subset of minimal risk studies. Please see II.D. of campus policy
for further details. This is one of the many initiatives that the IRBs have implemented to reduce regulatory burden on researchers while ensuring the protection of human subjects. This is unlikely to affect the number of continuing reviews that are reviewed by the convened IRB. Stay tuned for further details.
Revised Common Rule – Coming January 2018
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. Most of the changes will go into effect on January 19, 2018 but the majority of them will not affect convened board review. Of note, these changes do not yet apply to research that falls under FDA regulations, so the IRB will be applying two relatively different sets of regulations to research studies.
Key changes to the Common Rule include:
- Informed consent: additional elements of consent will be required as well as some restructuring of consent documents. In addition, the IRB will have the option to consider approving the use of broad consent for the secondary use of identifiable data and/or identifiable biospecimens for unspecified future research.
- Exempt human subjects research: new categories of research will qualify for exemption from IRB review.
- Continuing review: most non-exempt minimal risk research will be excused from continuing review (although the IRB will still need to review and approve changes of protocol prior to their implementation and assess reportable events)
- Single IRB review: by January 18, 2020, federally funded, multi-site research will be required, with few exceptions, to be overseen by one IRB (i.e., more research will be ceded to other IRBs). The National Institutes of Health already issued a policy that goes into effect January 25, 2018 that requires single IRB review for multi-site studies they fund that involve the conduct of the same protocol across sites.
Unless the current presidential administration takes action to overturn these regulations, the revised Common Rule will go into effect. Consequently, the HS IRBs Office will be finalizing an implementation approach over the next months and begin training the research community, IRB staff, and IRB members regarding the new requirements.