By Anna Mertes and Martha Hedberg
Expanding the scope of IRB oversight to include central and external IRB models is something HSO staff have been preparing for since the National Institutes of Health (NIH) published a draft policy in December 2014. This commitment was strengthened when the Department of Health and Human Services (HHS) issued a Notice of Proposed Rule Making in September 2015 that encourages the use of a single IRB for multi-site studies receiving federal funding. A Central/External IRB model occurs when there is one IRB of Record for multiple sites. The most common form is for each of the IRBs involved in the research protocol to rely on one IRB of Record to conduct the research review.
This includes the initial review, modifications, continuing reviews, reportable events, and noncompliance for the duration of the study. When utilizing the Central/External IRB model there are a few important items to keep in mind.
- Case by Case Review - Another important item to note is the Central/External IRB reliance requests are considered on a case by case basis by the University of Iowa Human Research Protections Program (HRPP) Review Committee. The HRPP review process could involve one or more components the UI HRPP, such as Other Committee reviews and training requirements. An IRB Chair, the Director of the Human Subjects Office, the Institutional Official, Research Counsel, &/or other HRPP components may be required to review studies that are greater than minimal risk. This may include, but is not limited to:
- Reviewing the size of the study (number of sites/subjects)
- Evaluating level of risk involved for subjects
- Reviewing qualifications of the lead and relying study team members
- Evaluation by other institutional human research protection program committees
- Reviewing contract language (when applicable)
- Considering local or state regulations in all the study locations
- Determining the accreditation status of the institution(s)
- Evaluating the expertise required for the IRB review
- Reliance Agreement - A key step in establishing a Central/External IRB model is to have a reliance agreement negotiated and signed between the relying IRB and the IRB of record. In some cases, a Master Agreement will already be in effect and in other cases a reliance agreement will need to be negotiated from the beginning. If a reliance agreement is not already established with the institution(s) you are collaborating with, it will take time to have the reliance agreement reviewed and negotiated. For this reason, we recommend contacting us early, even if you’ve just started discussing the possibility of a Central/External IRB model with your research team.
- Principal Investigator Responsibilities - When relying on an external or centralized IRB of record, it is the Principal Investigator’s responsibility to adhere to policies and procedures of the IRB of Record. These policies prevail for all sites relying on that IRB. The Principal Investigator will also be required to follow all University of Iowa institutional policies as well as state and local laws governing human subjects research. As the PI it is important for you to have answers to the following questions:
- What will the IRB of Record (or reviewing IRB) require?
- How do I submit to the IRB of Record?
- What are the IRB of Record policies?
- How will information about study progress, personnel changes, and determinations be communicated?
- Who supplies the IRB-approved documents?
- Who gets notified in the event of a problem?
- IRB of Record
- Your Institution
- In addition, the lead PI must know the following information for every study site:
- Applicable state laws or local institutional policies
- Any variability in study implementation
- Names of local PIs and research coordinators
- The point of contact at each site
- Finally, the lead PI must have thorough, detailed plans in place for:
- Training study personnel at each site
- Communicating with each site and for them to communicate back to you
- Monitoring compliance with the study protocol
For more information about this process, please check out our External and Central IRB webpage, especially the Final SOP for General External IRB located at the bottom of the page.
Please feel free to reach out to Anna Mertes at 319-335-9915, firstname.lastname@example.org for Central/External IRB questions. We look forward to working with you!
Changes to the Continuing Review reminder
By Sarah Heady
To help Principal Investigators stay ahead of regulatory requirements, HawkIRB sends annual notifications and reminder emails with the deadline for submitting Continuing Reviews (CR) forms. These emails go to the PI, their HawkIRB delegates, and any research team members listed as contact persons in Section II of the HawkIRB application. To further assist PIs with submitting all of the required information to the IRB, the Human Subjects Office (HSO) recently added a little more information to those CR notices.
During IRB Compliance Monitoring visits, when reviewing signed Informed Consent Documents, we occasionally find inconsistencies in the reporting of subject enrollment on past Continuing Review forms. There may have been a mis-count, or an invalid consent/s, or someone signed a consent more than once, etc. This finding is documented in the Monitoring report along with a required action for the Principal Investigator (PI) to correct the error at the next CR, which may be many months in the future.
In the past we haven’t had a good reminder system for this type of ‘delayed’ required action. The PI had to remember to complete it at a later date, and the IRB Compliance Team had to watch for the CR submission to verify that the action was completed. Needless to say, this type of required action was often forgotten by the time of the next CR form.
Until now! In a recent HawkIRB update we revised the email reminder notice to include a reminder to complete any ‘delayed’ required actions from the Monitoring report. If the IRB Monitor flags it in the HawkIRB system at the time of the Monitoring visit, the CR notice will include a reminder to the PI about the required action. And there is a reminder to the HSO staff reviewing the CR or Mod/CR form to make sure that change was made. The IRB Monitor will still track to make sure the action was completed in the CR form, but there are now some additional reminders to make sure these required actions are completed at the time of the continuing review.
The IRB Advisor Newsletter, June 2016
Featured Article: Transparency About Participation Incentives Could Benefit IRBs, Researchers, and Patients
Where do you fall on the issue of subject compensation? Many people have strong opinions either way, with some researchers saying that it is a boon for marginalized populations and others saying that such a practice could lead to possible undue influence, coercion, or bias in study results. Surprisingly, there is very little hard data on the effect of participant compensation and incentives, for better or worse. But what can be widely agreed on is that more transparency in the subject compensation process is needed. This is a conclusion borne out by studies, as researchers have found that a surprisingly large number of research articles do not disclose whether subjects have been compensated in their study. Some researchers are calling for a database that collects compensation data for various types of research studies. They hope that this data set can help researchers find the best level of compensation to maximize subject recruitment and retention while still minimizing possible bias or coercion.
IRB Advisor is a monthly newsletter that contains articles about regulatory issues, informed consent, current events in human subjects protections as well as articles about IRB administrative and management issues. The UI IRB subscribes to this publication as a resource for UI faculty, staff and student researchers as well as for IRB members and Human Subjects Office staff. Each month the IRB Connection Newsletter features an article from the current issue of IRB Advisor.
The June issue also includes articles about:
- The University of Minnesota’s opposition to a proposal for state government oversight of psychiatric drug research
- The psychiatric drug trial at the University of Minnesota that led to a participant suicide
- New NIH and FDA regulations for human gene transfer research
- Evidence-based practices in IRB education for researchers
Current and Past Issues
There is a link to current and past issues of IRB Advisor on the Education and Training page of the Human Subjects Office web site. This link provides automatic access to the newsletter from all computers with a University of Iowa IP address.
The University of Iowa username and password cannot be posted on the Human Subjects Office web site. UI researchers may contact the Human Subjects Office to request the username and password to access IRB Advisor from a personal computer. Contact us by e-mail (email@example.com) or call us at 319-335-6564.
Continuing Education Credits
Individual newsletter subscribers can receive 1.5 AMA PRA Category 1 Credits™ or 1.5 nursing contact hours for reading an issue and completing an online test. However, since this is an institution-level subscription, UI researchers must purchase access to an individual issue for $40, or purchase a full subscription, to receive CME/CE credits. Visit the AHC Media web site for information about subscription options.