From the Director
As noted in the October 8, 2018 regulatory newsletter, the Human Subjects Office has been working over the last year to implement much of the feedback we have received from the Human Research Protection Program (HRPP) survey and focus groups. We are excited to announce the next stage of changes to the HRPP/IRB review processes to better serve the needs of our research community and the Human Research Protection Program. Three changes rolling out this week, effective November 2, 2018, include:
- Post -approval survey
- Update to content of the IRB approval memo
- Elimination of continuing review for *qualifying studies
Effective November 2, 2018: Any new submission reviewed and approved by an IRB fully convened board (IRB-01 or IRB-02) will have a feedback survey sent to the Principal Investigator (PI) and, when applicable, a delegate. The PI will have an opportunity to provide feedback to the Human Research Protection Program with their perspective on the review of the new project. The survey will be sent, upon release of the project in HawkIRB, to all IRB-01 new projects that received a full board review. The survey will be sent to the PI and whomever is “submitting” the project on the PIs behalf (PI’s delegate). The HawkIRB system will send out an automated notice to inform the PI and their delegate a feedback form is available for them to complete to provide their experiences, concerns, or suggestions with the review of the project. The survey will be available in the respective PI and Delegates’ HawkIRB inbox(es) for completion for 30 days. After 30 days, the survey will automatically disappear if it is left incomplete. Responses from submitted surveys will be reviewed on a quarterly basis by the Research Compliance Director, Institutional Official, and applicable IRB or HRPP committee contacts for quality improvement purposes with the intent to adjust our review processes, when appropriate. Annual data will also be compiled as part of continuous quality improvement initiatives.
IRB approval memo upgrade
The Human Subjects Office has completed an extensive evaluation of the current contents of the IRB approval memos issued upon approval of any new projects, modifications, and continuing reviews. Based on feedback from our research community and discussions with our research peers, the following new fields have been added to the IRB approval memo:
- Name of all new approved attachment(s)
- Enhancements to the PI responsibilities section
Elimination of continuing review for *qualifying studies
For non-federally funded, non-FDA, and non-VA regulated human subjects research, Iowa will be piloting one of the 2018 Common Rule enhancements to test the new business processes and eResearch (HawkIRB) system functionality as an Iowa flexibility initiative prior to the proposed federal implementation.
Starting November 2, 2018, Annual Continuing Review will no longer be required for:
- Most studies that qualify for the expedited review process (45 CFR46.110).
- Studies that have completed subject intervention/interaction and have indicated “closed to accrual.”
- Studies that are limited to either final analysis of identifiable data/biospecimens or involve accessing follow-up clinical data from procedures that subjects undergo as part of clinical care.
*Eliminating continuing review for qualifying minimal-risk research reduces administrative burden for both the study team and IRB staff without impact to human subjects. To be eligible for this, the study cannot:
- Be subject to FDA oversight (involve an investigational drug or device)
- Have an active federal funding source issued by a Common Rule agency
- Be subject to VHA regulations (IRB-03 submissions)
- Involve prisoners as a subject population
- Have any non-UI team members or external sites relying on the UI as the IRB of record
NOTE: The IRB chair or their designee will issue an official "no annual continuing review required" determination for studies that qualify under this new policy. For open studies, this will occur when the PI submits the next continuing review or modification submitted on or after November 2, 2018. The modification must be for research related changes and may not be submitted only to change the continuing review determination. Continuing Reviews must be within 90 days of the next approval due by to be eligible for consideration for this pilot.
For eligible studies that do not require an annual continuing review, a Biennial check in will be required until the project is closed in HawkIRB by the Principal Investigator. The required Biennial check in will include a very brief, seven question check every two years. This review will be an administrative Human Subjects Office (HSO) review unless relevant information may be provided that would be subject to review by the IRB. The informed consent document and any IRB approved materials containing an IRB stamp will automatically update to the Biennial check in approval date.
Please contact the HSO if you have questions (319) 335-6564 or firstname.lastname@example.org .
For existing and new Federally funded, FDA regulated, or VAHCS research, continuing review is required per current regulations. It is the principal investigator's responsibility to submit a continuing review application before the expiration of the IRB approval of an active project and in adequate time for IRB review.
The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year per federal guidelines outlined at 45 CFR 46.109(e) (DHHS) and Continuing Review Guidance (2010) for federally funded research. FDA regulated research establishes continuing review guidance at 21 CFR 56.109(f) (FDA). The IRB is required to consider the following in the continuing review for non-exempt research:
- Risk assessment and monitoring;
- Adequacy of the process for obtaining informed consent;
- Investigator and institutional issues; and
- Research progress
If a project initially received expedited review and risks to subjects remain minimal, the continuing review may be expedited (reviewed by the chair alone). If a project initially received full board review, the project generally requires full board continuing review. The calculation of the approval period for research is based on the date and length of time at which the IRB approved the protocol by either a convened Full Board meeting or through the expedite review process.
Due date for submitting a continuing review
The date by which the continuing review must be approved is available on the project’s Summary page in the eResarch (HawkIRB) system. As a service to investigators, HawkIRB sends the reminders to the Principal Investigator (PI), and all contact persons listed for a given application. The reminder schedule is based on the Last Possible Submission Date (LPSD) of the project. The LPSD is the date that the investigator will need to have the project submitted to the Human Subjects Office to ensure that the project can obtain review and approval PRIOR to the project expiration date. The Principal Investigator, his or her delegates, and any team members listed as contact persons will receive automated reminders via email every:
- 60 days, 30 days, 14 days, 7 days and 1 day before the LPSD of the project.
- On the day prior to the expiration date, the Principal Investigator, his or her delegates, and contact persons will receive notice that the project will lapse and that no human subjects research activity may take place after 12:01 a.m. on the expiration date.
The PI will have 10 working days from the date of this notice to obtain review and approval of the continuing review for the project or it will be administratively closed by the IRB through the Human Subjects Office (HSO). On the day of the LPSD (if a continuing review application has not yet been received by the HSO) the investigator and his/her HawkIRB contacts will receive notice by email that there will not be adequate time prior to the expiration of the project for review and approval. This notice will state that IRB approval will lapse as of 12:01 a.m. on the expiration date and no further research activity may occur on or after that date. The PI will be asked to submit a continuing review application or a project closure form in HawkIRB to close the project.
Lapse of IRB approval
No human subjects activity (which includes the enrollment and follow-up of subjects and the collection and/or use of research data) may take place on or after the expiration date unless there is an over-riding safety concern (as determined by an IRB Chair) and until the continuing review application is approved by the IRB. In the event a Continuing Review lapses for studies greater than minimal risk, the PI must immediately submit to the IRB chair a list of research participants who could be harmed by stopping study procedures. The IRB chair, with appropriate consultation with the chief of staff for any studies enrolling VA subjects, determines whether participants on the list may continue participating in the research interventions or interactions. In these situations, IRB approval of a continuing review must be obtained immediately.
If the HSO closes the study due to no response, the HSO sends the PI, and in some cases the investigator’s departmental executive officer (DEO), a notification via email of study closure. In cases of on-going externally funded projects, the Division of Sponsored Programs (DSP) also receives a copy of the closure notice to make an independent determination regarding the need to notify the sponsor. Once a project is closed, the only way for the project to resume is for the investigator to submit a New Project Application (via HawkIRB) for IRB review and approval.
Instructions for completing a Continuing Review form
The investigator or his/her delegate should log into HawkIRB and choose the open project from the inbox. From the project summary page, the investigator/delegate can choose to initiate either of the following forms:
- Continuing review form [Use this form if the investigator is not submitting a modification/update in conjunction with the continuing review] OR
- Modification/Update + Continuing Review Form.
Complete all sections of the Continuing Review form and associated expected attachments. Upon completion, submit the form to the HSO for processing.
Review and approval process for Continuing Reviews
Procedures for expedited or full board review, criteria for approval, and revision prior to approval, are identical to how new projects are reviewed. When a Continuing Review is submitted, the IRB review includes, but is not limited to,
- Project summary
- Number of subjects enrolled
- Adverse/Reportable event summary
- Summary of any withdrawal of subjects
- Summary of complaints
- New or relevant study information
- Most recent consent documents, study protocol, IRB application content
- Any other significant information such as DSMB monitoring, progress report(s), or other federal regulatory reporting
HawkIRB notifies the PI and designated members of the research team of the approval and allows access to currently approved documents. Although the IRB does not require submission of Continuing Review forms for studies determined to be Exempt, if the study involves the VA, The VA Research and Development committee will require submission of continuing review information to that committee. This review is not conducted in HawkIRB.