IRBO Update - 2020 Q3
Since our last update, the following new staff have joined the office: Lisa Bingaman- IRB Coordinator, Kelly Pauly-IRB Coordinator, Mollie Fraser -Program Specialist, Kevin Rasmussen-iRIS Trainer. We are excited to have them as part of our team!
During this past quarter, the IRBO sent out a number of notifications to the research community through the NIH iRIS Notification System which included important information for investigators and research support staff. We have summarized this information here for your convenience.
July 7, 2020 - Avoiding Having Your Protocol Lapse
Continuing Review (CR) of research by the IRB provides assurance that research activities remain approvable and that appropriate human subjects protections are in place. Ensuring that continuing review (when required) occurs in a timely manner, is a shared responsibility of both the Principal Investigator and the IRB. When IRB approval for a study lapses, all research activity must cease, except for those activities necessary to ensure the safety of research participants (with permission from the IRB Chair). Lapses in IRB approval are disruptive to the research and place the investigator and institution at regulatory risk as well as risk our status as an AAHRPP-accredited Human Research Protections Program (HRPP).
To facilitate timely continuing review, we ask that study teams submit their CR application to the IRBO 6 weeks ahead of the study expiration date. iRIS will send system generated messages to the study contacts at 75, 60 and 30 days prior to the expiration date to prompt you to submit your CR Application to the IRBO.
If a study team fails to submit the CR application and the study lapses, the IRB will enforce the following policies:
- The IRBO will not review any new studies submitted by the Principal Investigator of the lapsed study until the CR has been submitted or the study has been properly closed.
- If 45 days after study expiration, no CR application or study closure has been submitted, the IRB will administratively close the protocol. Continued research will require submission of a new protocol to the IRB.
August 10, 2020 – Updated Consent and Protocol Templates
- Consent Library: The consent library, found on the OHRSP website, has been greatly expanded to include descriptions and risks of numerous common procedures. Please note that most of this is suggested language. However, the GINA language and language regarding the risks of radiation should not be altered. We have now expanded the radiation risks to include the language for therapeutic radiation and radiation reviewed by the RDRC. This is a living document, and we will continue to add to it, so make sure to periodically check it out.
- Interventional Drug and Device Clinical Trials Protocol Template: This template has been updated with minor updates to make it consistent with new policy and the Natural History Protocol Template.
- NCI CIRB Approved Local Context Consent Templates (English & Spanish): These templates are to be used for studies reviewed by the NCI CIRB which are conducted in the Clinical Center. Please note that you cannot alter the template language in any way.
The Consent Library and the templates referred to above can be found on the “IRB Templates” page of the OHSRP website.
August 31, 2020 & September 18, 2020 - “Tips & Tricks for Submitting to the NIH IRB”
Continuing Reviews (CRs)
- You cannot make any changes to the protocol or consent form(s) at the time of continuing review.
- If you have consented subjects since the last CR, you must submit a redacted consent form(s). Redacted means that you have removed all PII associated with the subject (e.g. his or her signature). The date the subject signed the consent should not be removed.
- If NIH is the coordinating site and other sites have local IRB approval, you must attach copies of the most recent local IRB approvals.
- You must include a high-level summary of any minor and major protocol deviations (PDs), non-compliance, AEs and SAEs that have occurred since the last review, and all unanticipated problems (UPs) that have been reported during the last CR period.
Amendments (AMs) and New Protocols
- Remove all NIH personnel aside from the PI from the title page and include these individuals as part of a separate Study Personnel Page.
- Delete the “Investigator Qualifications” section.
- Include the blood volume amounts that will be obtained at each blood draw and the total amount of blood volume obtained over a two-week time period.
- Screening and Natural History protocols: Ensure you have only listed research procedures and removed clinically indicated procedures or have clarified which procedures are being done for research vs. clinical purposes.
- Remove the “Classification of Risk” Section and all IRB determinations of risk, including statements such as, “This study has direct benefit, so only one parent signature is required.”
- If the study involves a non-significant risk (NSR) device, ensure this is described.
- Pregnant Women: If you wish to enroll pregnant women or allow women who become pregnant to remain as part of your protocol, you must revise the protocol to provide a justification that demonstrates that the study objectives cannot be met without including pregnant women. In accordance with 45 CFR 46.204(b), you must make the case that “The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means”.
- For studies approved before January 21, 2019: If you are conducting screening activities before consenting and obtaining a signature from subjects, include a request for a waiver of informed consent (or a request for a waiver of documentation of informed consent, e.g. if you are using a phone script to consent subjects).
- Remove the use of a witness during the long form and telephone consent processes.
- Remove a request for approval to use the short form consent process.
- Secondary Research protocols: Ensure there is a section requesting a waiver of informed consent along with a justification which addresses all of the criteria in the regulations. (See the “Secondary Research” protocol template on our website).
- If enrolling children, describe the planned assent process and indicate ages of verbal and written assent.
- Update to include safety and event reporting information that is consistent with Policy 801.
Consent Forms (CFs)
- If you are transferring old consents over to the new template, or creating a new consent, form, always use the most current consent template that is posted on the OHSRP website.
- In the most recent consent template version (Revised Common Rule), the language regarding the storage of specimens/data for future use and sharing is now in blue. If you are conducting your study in the United States, you must include this language and may not alter it (except to choose those sections which apply to your protocol). If your study is being conducted internationally, you may alter this language, as appropriate to the locale of the research.
- Remove inclusion/exclusion criteria.
- Update to include the current radiation safety language.
- Include blood volume amounts obtained at each blood draw and the total amount of blood volume obtained over a two week period. The volumes should be labeled in household terms (teaspoons and/or tablespoons); e.g. 5mL=1 teaspoon, 3 teaspoons =1 Tablespoon.
- Address the use of non-significant risk (NSR) devices
- Covered protocols: Include the proper COI language.
- For COVID studies, unless behavioral research where research procedures are limited to questionnaires, include the PREP ACT language.
- Prior to submitting the consent forms to the IRB, keep only the signature blocks that are applicable to your study and delete the blocks which are not applicable.
Responding to Stipulations during Pre-Review
- When responding to stipulations, please keep all changes in tracked form, during the various rounds of submissions to the IRB, i.e. the cumulative changes should be visible to the IRB.